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This is indicated in oral contraception.

Oral Contraceptive preparations

This is a combined oral contraceptive tablet containing the synthetic progestogen, drospirenone and the synthetic estrogen, ethinylestradiol. The contraceptive effect of this tablet is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in cervical secretion. When this tablet is taken according to instructions, the egg cells are prevented from maturing to the point at which they can be fertilized, the cervical mucus remains thick so as to constitute a barrier to sperm and the endometrium is rendered unreceptive to implantation. As well as protection against pregnancy, estrogen/progestogen combinations have several positive properties which, next to the negative properties, can be useful in deciding on the method of birth control. The cycle is more regular and the menstruation is often less painful and bleeding is lighter.

Drospirenone has antimineralocorticoid activity, counteracting estrogen related sodium retention. In combination with ethinylestradiol, drospirenone displays a favourable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinylestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens. Drospirenone is devoid of any androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. This in combination with the antimineralocorticoid and antiandrogenic properties, gives drospirenone a biochemical and pharmacological profile closely resembling the natural hormone progesterone.

When and how to take the tablets: The this tablet pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days don't take any tablet. A period should begin during these 7 days (the withdrawal bleed), unusually it will start on day 2-3 after the last this tablettablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week and also that you have your withdrawal bleed on about the same days each month.

Starting your first pack of this tablet: When no hormonal contraceptive has been used in the past month. Start taking this tablet on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Sunday, take a tablet marked Sunday. Then follow thedaysin order. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.

When changing form another combined Pill: You can start taking this tablet the day after you have the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains inactive tablets you can start this tablet on the day after taking the first active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet free break of your present Pill (or the day after the last inactive tablet of your present Pill).

When changing from progestogen-only Pill (Mini Pill): You can stop taking the mini pill any day and start taking this tablet the next day, at the same time. But make sure you also use an additional-contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.

When changing from an Injectable or Implant: Start using this tablet when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.

After having a baby: If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking this tablet. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take this tablet you should discuss this first with your doctor.

After a miscarriage or an abortion: Your doctor will advise you.

If too many this tablet tablets are taken (overdose): There have been no reports of serious harmful effects from taking too many this tablet tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken this tablet ask your doctor for advice.

When you want to stop taking this tablet: You can stop taking this tablet at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control. If you stop taking this tablet because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive.

If you forget to take tablets

• If you are less than 12 hours late in taking a tablet, the reliability of the Pill is maintained. Take the tablet as soon as you remember and take the next tablets at the usual times.
• If you are more than 12 hours late in taking any tablet, the reliability of the Pill may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or at the end of the pack. Therefore, you should follow the rules given below.

More than one tablet forgotten in a pack: Ask your doctor for advice.

• 1 tablet missed in week 1: Take the missed tablet as soon as your remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days. If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. So tell your doctor immediately.
• 1 tablet missed in week 2: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. The reliability of the Pill is maintained. You need not use extra contraceptive precautions.
• 1 tablet missed in week 3: You may choose either of the following options, without the need for extra contraceptive precautions.

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Start the next pack as soon as the current pack is finished so that no gap is left between packs. You may not have a withdrawal bleed until the end of the second pack but you may have spotting or breakthrough bleeding on tablet-taking days. Or

Stop taking tablets from your current pack, have a tablet-free break of 7 days or less (also count the day you missed your tablet) and continue with the next pack. When, following this method, you can always start your next pack on the same day of the week as you usually do.

If you have forgotten tablets in a pack and you do not have the expected period in the first normal tablet-free break, you may be pregnant. Consult your doctor before you start with the next pack.

you vomit: If you vomit within 3 to 4 hours after taking your this tablet tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.

you want to delay your period: you can delay your period if you start with your next pack of this tablet immediately after finishing your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet taking. While using the second pack you may have some breakthrough bleeding or spotting on tablet-taking days. Start with your next pack after the usual 7 days tablet free break.

you want to change the starting day of your period: If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the next tablet- free break. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your tablet-free break very short (e.g. 3 days or less) you may not have bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.

you have unexpected bleeding: With all Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the Pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.

you have missed a period: If you have taken all of your tablets at the right time and you have not vomited or used other medicines then you are very unlikely to be pregnant. Continue to take this tablet as usual.

If you miss your period twice in row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.

Like other contraceptives some undesirable effects may have seen with this tablet, these include venous and arterial thromboembolic disorders. The following undesirable effects have been reported in users of COCs and whether this association is causal has not been confirmed: Nausea, abdominal pain, Vomiting, diarrhoea, Weight increased, Fluid retention, Headache, Migraine, Depressed mood, mood altered, Breast pain, breast tenderness, Libido decreased, Breast hypertrophy, Rash, urticaria. In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.

Preparations containing estrogen/progestogen combinations should not be used in the presence of any of the conditions listed below. If any of the conditions appear for the first time during their use, the product should be stopped immediately.

• Thrombosis (venous or arterial) present or in history (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident)
• Presence or history of prodromi of a thrombosis (e.g.transient ischaemic attack, angina pectoris)
• Presence or history of migraine with focal neurological symptoms
• Diabetes mellitus with vascular involvement
• Disturbed lipometabolism
• The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
• Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal
• Severe renal insufficiency or acute renal failure
• Presence or history of liver tumours (benign or malignant)
• Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced
• Undiagnosed vaginal bleeding
• Known or suspected pregnancy
• Hypersensitivity to any of the components of this tablet.

The clinical and epidemiological evidence for estrogen/progestogen combinations like this tablet is predominantly based on experience with COCs in general. Therefore, the following warnings related to the use of COCs apply also to the use of this tablet. Also, increased risk of arterial, venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents. These events occur rarely.

• Cervical cancer
• Hypertriglyceridemia
• Blood pressure
• Jaundice
• Erythematosus
• Haemolytic uraemic syndrome
• Sydenham's chorea
• Herpes gestationis
• Otosclerosis-related hearing loss.
• Hereditary angioedema
• Acute or chronic disturbances of liver or kidney
• Crohn's disease and ulcerative colitis
• Chloasma

The Pill and other Medicines: Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenyton, barbiturates) and tuberculosis (e.g. rifampicin); and antibiotics (e.g. ampilicllin, tetracyclines, griseofulvin); for some other infectious diseases. Always tell the doctor, who prescribes the Pill, which medicines you are already using. Also tell other doctor/dentist who prescribes another medicine (or the dispensing pharmacist) that you use this tablet. They can tell you if you need to take additional contraceptive precautions and if so, for how long.

The Pill and Ability to Drive: There are no observed effects.

The Pill and Breastfeeding: This tablet is generally not recommended for use during breast feeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.

The Pill and Pregnancy: This tablet must not be used by women who are pregnant or who think they may be pregnant.

Store below 30°C. Store all drugs properly and keep them out of reach of children.

This tablet is indicated for:

• As an oral contraceptive
• Treatment of moderate acne vulgaris
• Treatment of premenstrual dysphoric disorder (PMDD)

Oral Contraceptive preparations

This contains two active ingredients- Ethinylestradiol and Drospirenone. Ethinylestradiol is a synthetic version of estrogen and Drospirenone is a synthetic form of progesterone. The hormonal components of this preparation inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of this tablet as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).

Drospirenone has antimineralocorticoid activity, counteracting estrogen-related sodium retention. In combination with Ethinyloestradiol, Drospirenone displays a favorable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinyloestradiol-related sex hormone-binding globulin increase which is useful for binding and inactivating the endogenous androgens.

To achieve maximum contraceptive effectiveness tablets must be taken in the order directed on the package every day at about the same time. Tablet-taking should be started with the first pink tablet of the upper row & have to continue daily for 24 consecutive days. After completion of pink tablet, white tablet should be taken from 25th day to 28th day. Withdrawal bleeding usually starts on days 2-3 after starting the white tablets & don't stop taking white tablets though your menstruation is already started. Each subsequent new pack is started on the day after the last white tablet of the previous pack.

No preceding hormonal contraceptive use in the past month: Tablet taking has to start on day 1 of the woman’s menstrual cycle. The woman should be instructed to take the first light pink active tablet from the upper row of this tablet according to the direction and in this case no additional methods of contraception are required. Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking.

Changing from another combined hormonal pill or vaginal ring or transdermal patch: In case of combined hormonal pill, woman should start with the first light pink tablet of upper row on the day after the last active tablet of her previous COC. In case of a vaginal ring or transdermal patch has been used, the woman should start using this tablet preferably on the day of removal.

Changing from a progestogen-only-method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): The woman may switch any day from the minipill (or from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method (like-condom) for the first 7 days of tablet-taking.

Following first-trimester abortion: The woman may start immediately and in this case no need to take additional contraceptive method.

Following delivery or second-trimester abortion: Women are advised to start at day 21 to 28 after delivery or second-trimester abortion. When starting later, the woman are advised to additionally use a barrier method (like-condom) for the first 7 days of tablet-taking.

Management of Missed Tablets: Missed white pills from the last row of the blister are placebo tablets and thus can be disregarded. But if you forgot to take a light pink tablet one day, take the missed tablet as soon as you remember. This may mean taking two tablets the very next day. Additionally you should use some other method of contraception (like a condom) until next 7 days. If you forget to take the tablets for two continuous days, then it is likely that you will no longer be protected against pregnancy. You should therefore discontinue taking the tablet and adopt some other temporary methods (condom/foam tablet) till your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the light pink tablet of the top row of a fresh pack from the first day of next menstruation.

If you have missed a period after taking tablet: If you have taken all of your pills at the right time and you have not vomited or used other medicines then you are very unlikely to be pregnant. Continue to take tablet as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.

How to Delay a Period: To delay period women should continue with another new pack of this tablet just after finishing the light pink active tablet of the present pack (that is no need to take white placebo tablet of present pack). The extension can be carried on for as long as wished until the end of light pink color tablet of the second pack. When women wish their period to begin, just stop tablet taking. While using the second pack woman may have some breakthrough bleeding or spotting. Start with your next pack after the usual 4 day white inactive tablet interval.

Advice in case of Vomiting: If vomiting occurs within 3-4 hours after light pink tablet taking, absorption may not be complete. In such an event, the advice concerning management of missed tablets is applicable. The woman must take the extra active tablet (light pink color) needed from a back up pack after vomiting.

Different types of tablet suit to different types of woman. At the initial stage some women may experience side-effects like dizziness, headache, breast pain, nausea or unscheduled uterine bleeding. These symptoms may occur in >3% of users. After starting one brand of oral contraceptive tablets, if you feel any inconvenience such as migraine, changes in eyesight or speech, unusual pain or swelling in your legs, sharp chest pains or shortness of breath, rash, yellow skin or a rise in blood pressure take immediate advice from your doctor.

This tablet should not be used:

• Known or suspected pregnancy
• If you have heart disease, clotting of blood in the vein
• If you suffer from liver disease or jaundice
• If you suffer from high blood pressure, migraine, feel something hard in your breast, diabetes with vascular involvement, experience excessive bleeding for which no reason has yet been ascertained
• The presence or a history of venous or arterial thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction or of a cerebrovascular accident)
• History of migraine with focal neurological symptoms
• Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia
• Severe renal insufficiency or acute renal failure
• Presence or history of liver tumours (benign or malignant)
• Undiagnosed vagina! bleeding
• Hypersensitivity to any of the components of this preparation.

If any circulatory disorder (like- myocardial infarction, deep venous thrombosis, pulmonary embolism, cerebrovascular injury etc) or other risk factors(like smoking, obesity, hypertension, dyslipidemia, migraine, atrial fibrillation etc) are present, the benefits of COC use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors after taking pill, the woman should contact with her physician. The physician should then decide on whether its use should be discontinued.

Interactions between ethinylestradiol and other drugs may lead to decreased or increased ethinylestradiol concentrations, respectively. Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinylestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates. Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives. During concomitant use of this tablet & other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non hormonal back-up method of contraception to be used in addition to the regular intake of this tablet.

Use during pregnancy: This is contraindicated during pregnancy. Pregnancy must be excluded before starting this tablet. If pregnancy occurs during use of this tablet, the preparation must be withdrawn immediately. Women who discontinue oral contraceptives with the intent of becoming pregnant, a non-hormonal method of contraception is recommended for three months before attempting to conceive.

Use during lactation: Lactation may be influenced by combined pill as they may reduce the quantity and change the composition of breast milk, therefore the use of estrogen containing combined pill should generally not be recommended until the nursing mother has completely weaned her child. Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk.

Pediatric Use: This is only indicated after menarche. There is no data suggesting the need for a dosage adjustment.

Use in the Elderly: This is not indicated after menopause.

Symptoms of oral contraceptive overdose may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

Do not store above 30°C. Keep away from light and out of the reach of children.

Oral Contraceptive preparations

How to Take this contraceptive pill: Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive and PMDD effectiveness, this contraceptive pill must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.

How to Start this contraceptive pill: Instruct the patient to begin taking this contraceptive pill either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start: During the first cycle of this contraceptive pill use, instruct the patient to take one pink contraceptive pill daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink contraceptive pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. this contraceptive pill should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. this contraceptive pill can be taken without regard to meals. If this contraceptive pill is first taken later than the first day of the menstrual cycle, this contraceptive pill should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as backup during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start: During the first cycle of this contraceptive pill use, instruct the patient to take one pink contraceptive pill daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink contraceptive pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. this contraceptive pill should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. this contraceptive pill can be taken without regard to meals. this contraceptive pill should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as backup during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of this contraceptive pill on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last light orange folate tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of this contraceptive pill is started later than the day following administration of the last light orange tablet, the patient should use another method of contraception until she has taken a pink contraceptive pill daily for seven consecutive days.

When switching from a different birth control pill: When switching from another birth control pill, this contraceptive pill should be started on the same day that a new pack of the previous oral contraceptive would have been started.

The most frequent adverse reactions (≥ 2%) in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%). The most frequent adverse reactions (≥ 2%) in PMDD clinical trials are menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%)

Vascular risks: Stop this contraceptive pill if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating this contraceptive pill in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.

Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.

Liver disease: Discontinue this contraceptive pill if jaundice occurs.

High blood pressure: Do not prescribe this contraceptive pill for women with uncontrolled hypertension or hypertension with vascular disease.

Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking this contraceptive pill. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.

Headache: Evaluate significant change in headaches and discontinue this contraceptive pill if indicated.

Uterine bleeding: Evaluate irregular bleeding or amenorrhea.

Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.

Nursing mothers: Not recommended; can decrease milk production.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Oral Contraceptive preparations

How to Take this contraceptive pill: Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive and PMDD effectiveness, this contraceptive pill must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.

How to Start this contraceptive pill: Instruct the patient to begin taking this contraceptive pill either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start: During the first cycle of this contraceptive pill use, instruct the patient to take one pink contraceptive pill daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink contraceptive pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. this contraceptive pill should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. this contraceptive pill can be taken without regard to meals. If this contraceptive pill is first taken later than the first day of the menstrual cycle, this contraceptive pill should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as backup during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start: During the first cycle of this contraceptive pill use, instruct the patient to take one pink contraceptive pill daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink contraceptive pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. this contraceptive pill should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. this contraceptive pill can be taken without regard to meals. this contraceptive pill should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as backup during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of this contraceptive pill on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last light orange folate tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of this contraceptive pill is started later than the day following administration of the last light orange tablet, the patient should use another method of contraception until she has taken a pink contraceptive pill daily for seven consecutive days.

When switching from a different birth control pill: When switching from another birth control pill, this contraceptive pill should be started on the same day that a new pack of the previous oral contraceptive would have been started.

The most frequent adverse reactions (≥ 2%) in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%). The most frequent adverse reactions (≥ 2%) in PMDD clinical trials are menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%)

Vascular risks: Stop this contraceptive pill if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating this contraceptive pill in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.

Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.

Liver disease: Discontinue this contraceptive pill if jaundice occurs.

High blood pressure: Do not prescribe this contraceptive pill for women with uncontrolled hypertension or hypertension with vascular disease.

Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking this contraceptive pill. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.

Headache: Evaluate significant change in headaches and discontinue this contraceptive pill if indicated.

Uterine bleeding: Evaluate irregular bleeding or amenorrhea.

Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.

Nursing mothers: Not recommended; can decrease milk production.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

This is indicated in-

• Rheumatoid arthritis
• Osteoarthritis
• Sexual debility
• Nervous debility
• Numbness
• Sciatica
• Paralysis & Facial Paralysis

Herbal and Nutraceuticals

This is a unique unani medicine, prepared with of Nux-vomica (Strychnos nux-vomica), Black Pepper (Piper nigrum), Long Pepper (Piper longum) and other effective natural ingredients. It is very effective in nervous debility, rheumatism, numbness, paralysis, facial paralysis and sexual debility. This is also helps to relieve tremor and sciatica.

1-2 tablet(s) 1-2 time(s) daily after meal or as prescribed by the physician.

No significant side effect has been observed in the therapeutic dosage.

There is no known contraindication.

Keep out of reach of the children.

Store at cool and dry place, protect from light.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Mebeverine is indicated for the:

• Symptomatic treatment of irritable bowel syndrome (IBS)
• Chronic irritable colon
• Spastic constipation
• Mucous colitis
• Colicky abdominal pain
• Persistent non-specific diarrhoea

Anticholinergics

For adults, elderly and children over 10 years:

• Mebeverine Hydrochloride 135 mg tablet: 1 tablet 03 times daily.
• Mebeverine Hydrochloride 200 mg capsule: 1 capsule 02 times daily.

This is most effective when taken 20 minutes before meals. After several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

Missed dose: If a dose of this medicine is missed, that should be taken as soon as possible. However, if it is almost time for the next dose, then skip the missed dose and the regular dosing schedule should be maintained. Dose should not be doubled at the same time to compensate the missed dose.

Use in children: Mebeverine is not recommended for children under 10 years.

Generally Mebeverine is well tolerated. However, few side-effects like skin rash, urticaria and angioedema may appear

Hypersensitivity to the drug or any other ingredients.

Caution should be exercised in porphyria or allergic reaction to this or any other medicine of this group.

No teratogenicity has been shown in animal experiments. However, the usual precautions concerning the administration of any drug during pregnancy should be exercised. Mebeverine does not excrete in the breast milk after administering at therapeutic dose.

On theoretical grounds it may be predicted that CNS excitability will occur in case of overdosage. No specific antidote is known: gastric lavage and symptomatic treatment is recommended

Do not store above 30°C. Keep away from light and out of the reach of children.

Ispaghula Husk and Mebeverine Hydrochloride is indicated for the treatment of all kinds of IBS such as IBS-C, IBS-D & IBS-A.

Bulk-forming laxatives, Herbal and Nutraceuticals

This is a combination of Ispaghula Husk and Mebeverine Hydrochloride which is specially designed for IBS. Painful spasms of the gut and irregular bowel habits are the main symptoms of IBS. This product successfully relives these symptoms. Ispaghula Husk contains up to 70% of soluble and 30% of insoluble fibers. This unique feature makes it capable of absorbing up to 40 times of water of its own weight. Ispaghula Husk increases fiber in the diet, helps digestive system work more efficiently and gently relieve bowel problem in a natural way helping to restore and maintain regularity. Mebeverine is an antispasmodic drug that relieves spasms and cramps which occur in the gut causing pain without affecting normal gut motility.

Ispaghula Husk and Mebeverine Hydrochloride is intended for oral use as a suspension in a drink of water. The granules of the sachet should be stirred into a glass of water and taken as soon as the effervescence subsides.

Adults and children over 12 years: One sachet in the morning and one in the evening with 1 glass of water. This medicine should be taken before half an hour of meal. A midday dose may be taken if necessary.

Ispaghula Husk and Mebeverine Hydrochloride are generally safe. But, some people may experience mild abdominal distension or flatulence for the first few days after starting this medicine. These effects should lessen as you continue the treatment.

The drug is contraindicated if patients are allergic to it, in cases of intestinal obstruction, fecal impaction and if the patient has phenylketonuria.

Do not take this medicine without water. It is important that each dose of granules is stirred into a glass of water before taking.

Ispaghula Husk may delay gastric emptying time and reduce the absorption of Calcium, Iron and Zinc. Therefore, other agents should be taken one hour before or a few hours after taking Ispaghula Husk and Mebeverine.

Ispaghula Husk is not absorbed into the bloodstream and does not pass into breast milk but Mebeverine Hydrochloride is absorbed into the bloodstream and passes through the breast milk. Therefore, this medicine should not be used during pregnancy unless considered essential by the physician.

Symptoms of Ispaghula Husk and Mebeverine overdose may include abdominal discomfort and flatulence. In case of overdose, patient should drink plenty of water.

This should be stored at room temperature. Protect from moisture and light. Keep it away from children.

Mebeverine is indicated for the:

• Symptomatic treatment of irritable bowel syndrome (IBS)
• Chronic irritable colon
• Spastic constipation
• Mucous colitis
• Colicky abdominal pain
• Persistent non-specific diarrhoea

Anticholinergics

For adults, elderly and children over 10 years:

• Mebeverine Hydrochloride 135 mg tablet: 1 tablet 03 times daily.
• Mebeverine Hydrochloride 200 mg capsule: 1 capsule 02 times daily.

This is most effective when taken 20 minutes before meals. After several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

Missed dose: If a dose of this medicine is missed, that should be taken as soon as possible. However, if it is almost time for the next dose, then skip the missed dose and the regular dosing schedule should be maintained. Dose should not be doubled at the same time to compensate the missed dose.

Use in children: Mebeverine is not recommended for children under 10 years.

Generally Mebeverine is well tolerated. However, few side-effects like skin rash, urticaria and angioedema may appear

Hypersensitivity to the drug or any other ingredients.

Caution should be exercised in porphyria or allergic reaction to this or any other medicine of this group.

No teratogenicity has been shown in animal experiments. However, the usual precautions concerning the administration of any drug during pregnancy should be exercised. Mebeverine does not excrete in the breast milk after administering at therapeutic dose.

On theoretical grounds it may be predicted that CNS excitability will occur in case of overdosage. No specific antidote is known: gastric lavage and symptomatic treatment is recommended

Do not store above 30°C. Keep away from light and out of the reach of children.