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    Active Ingredient *

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    28

    not in the basket chart 83043 25017

    Film Coated Tablets

    3 X 28

    not in the basket chart 6993

    Related information


    Dosage

    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 must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
    Initiating: Instruct the patient to begin taking 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 use, instruct the patient to take one pink pill daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. The pills 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 drug can be taken without regard to meals. If this drug is first taken later than the first day of the menstrual cycle, this drug 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 back-up 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 use, instruct the patient to take one pink pill daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. This 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. Can be taken without regard to meals.  This drug  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 back-up 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 drug 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 the pills 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 pill daily for seven consecutive days.
    When switching from a different birth control pill: When switching from another birth control pill, This drug should be started on the same day that a new pack of the previous oral contraceptive would have been started.
    When switching from a method other than a birth control pill: When switching from a transdermal patch or vaginal ring, this contraceptive should be started when the next application would have been due. When switching from an injection, this drug should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, this drug should be started on the day of removal. Withdrawal bleeding usually occurs within 3 days following the last pink tablet. If spotting or breakthrough bleeding occurs while taking this drug instruct the patient to continue taking it by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.
    Although the occurrence of pregnancy is low if this drug is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue if pregnancy is confirmed. The risk of pregnancy increases with each active pink tablet missed. For additional patient instructions regarding missed pills.
    If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more light orange tablets, she should still be protected against pregnancy provided she begins taking a new cycle of pink tablets on the proper day. For postpartum women who do not breastfeed or after a second trimester abortion, start this drug  no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on this contraceptive  postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken this drug  for 7 consecutive days.
    Advice in Case of Gastrointestinal Disturbances: In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, this can be regarded as a missed tablet.
    Folate Supplementation: The U.S. Preventive Services Task Force recommends that women of childbearing age consume supplemental folic acid in a dose of at least 0.4 mg (400 mcg) daily.
    Pediatric Use: Safety and efficacy of this drug has been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.
    Geriatric Use: This drug has not been studied in postmenopausal women and is not indicated in this population.
    Patients with Renal Impairment: This drug is contraindicated in patients with renal impairment.
    Patients with Hepatic Impairment: This drug is contraindicated in patients with hepatic disease. The mean exposure to DRSP in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. The drug has not been studied in women with severe hepatic impairment.
    See prescribing information for full details.


    Indications

    Oral contraception. Treatment of symptoms of premenstrual dysphoric disorder (PMDD ) in women who choose to use an oral contraceptive as their method of birth control. Treatment  of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. In women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.


    Contra-Indications

    Renal impairment. Adrenal insufficiency. A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35. Have deep vein thrombosis or pulmonary embolism, now or in the past. Have cerebrovascular diseaseHave coronary artery diseaseHave thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)Have inherited or acquired hypercoagulopathiesHave uncontrolled hypertensionHave diabetes mellitus with vascular disease. Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35. Undiagnosed abnormal uterine bleeding. Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the pastLiver tumors, benign or malignant, or liver disease. Pregnancy, because there is no reason to use COCs during pregnancy.


    Special Precautions

    Stop this drug if an arterial or venous thrombotic (VTE) event occurs. Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins.
    Hyperkalemia: This drug contains 3 mg of the progestin DRSP, which has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25 mg dose of spironolactone. This drug  should not be used in patients with conditions that predispose to hyperkalemia (that is, renal impairment, hepatic impairment, and adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration should have their serum potassium concentration checked during the first treatment cycle. Medications that may increase serum potassium concentration include ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs.
    Carcinoma of the Breasts and Reproductive Organs: Women who currently have or have had breast cancer should not use this drug because breast cancer is a hormonallysensitive tumor. There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings. Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.
    Liver Disease: Discontinue this drug if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded.
    Effects of Folates on Other Drugs: Folates may modify the pharmacokinetics or pharmacodynamics of certain antifolate drugs, e.g., antiepileptics (such as phenytoin), methotrexate or pyrimethamine, and may result in a decreased pharmacological effect of the antifolate drug.
    Effects of Other Drugs on Folates: Several drugs have been reported to reduce folate concentrations by inhibition of the dihydrofolate reductase enzyme (e.g., methotrexate and sulfasalazine) or by reducing folate absorption (e.g., cholestyramine), or via unknown mechanisms (e.g., antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone and valproic acid).
    Interference with Laboratory Tests: The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. DRSP causes an increase in plasma renin activity and plasma aldosterone induced by its mild antimineralocorticoid activity. Folates may mask vitamin B12 deficiency.
    See prescribing information for full details.


    Side Effects

    Irregular uterine bleeding, nausea, breast tenderness, headache, serious cardiovascular events and stroke, vascular events, liver disease.
    See prescribing information for full details.


    Drug interactions

    Substances diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John’s wort. Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure.  Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
    Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin and certain COCs containing EE increase AUC values for EE by approximately 20%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone concentrations.
    Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma concentrations of estrogen and progestin. have been noted in some cases of co-administration with HIV/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.
    Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.
    Effect on DRSP: The main metabolites of DRSP in human plasma are generated without involvement of the CYP system. Inhibitors of this enzyme system are therefore unlikely to influence the metabolism of DRSP.
    Effects of Combined Oral Contraceptives on Other Drugs: COCs containing EE may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations.


    Pregnancy and Lactation

    Pregnancy: There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy.
    Lactation: When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen containing COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.             


    Overdose

    There have been no reports of serious ill effects from overdose, including ingestion by children. Overdose may cause withdrawal bleeding in females and nausea. DRSP is a spironolactone analogue which has antimineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose. Levomefolate calcium doses of 17 mg/day (37-fold higher than the levomefolate calcium dose of this drug) were well tolerated after long-term treatment up to 12 weeks.


    Manufacturer
    Bayer Weimar und co. KG GmbH, Weimar, Germany
    Licence holder
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