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  • Yasmin Plus
    / Bayer


    Active Ingredient *
    Ethinylestradiol (as betadex calthrate) 0.03 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    1 X 28

    not in the basket chart 85445 25018

    Film Coated Tablets

    3 X 28

    not in the basket chart 24752 25019

    Related information


    Dosage

    How to take this product: 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 effectiveness, this product 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 product: Instruct the patient to begin taking this product 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 product use, instruct the patient to take one orange this product daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one orange this product daily for 21 consecutive days, followed by one light orange tablet, containing levomefolate alone, daily on Days 22 through 28. This product 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 product can be taken without regard to meals. If this product is first taken later than the first day of the menstrual cycle, this product 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 this product use, instruct the patient to take one orange this product daily, beginning on the first Sunday after the onset of her menstrual period. She should take one orange this product daily for 21 consecutive days, followed by one light orange tablet, containing levomefolate alone, daily on Days 22 through 28. This product 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 product can be taken without regard to meals. This product 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 this product on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her orange 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 product 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 an orange this product daily for seven consecutive days.
    When switching from a different birth control pill: When switching from another birth control pill, this product 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 product should be started when the next application would have been due. When switching from an injection, this product should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, this product should be started on the day of removal. Withdrawal bleeding usually occurs within 3 days following the last orange tablet. If spotting or breakthrough bleeding occurs while taking this product, instruct the patient to continue taking this product 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 product 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 this product if pregnancy is confirmed. The risk of pregnancy increases with each active orange 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 orange tablets on the proper day. For postpartum women who do not breastfeed or after a second trimester abortion, start This  product no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts this product 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 product 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.1 Consider other folate supplementation that a woman may be taking before prescribing this product. Ensure that folate supplementation is maintained if a woman discontinues this product due to pregnancy.


    Indications

    Oral contraceptive. 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 disease. Have coronary artery disease. Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation). Have inherited or acquired hypercoagulopathies. Have uncontrolled hypertension. Have 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 past. Liver tumor (benign or malignant) or liver disease. Pregnancy, because there is no reason to use COCs during pregnancy.  


    Special Precautions

    Thromboembolic Disorders and Other Vascular Problems: Stop this product if an arterial or venous thrombotic (VTE) event occurs. Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (this formulation), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. Before initiating use of this product 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. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs. If feasible, stop this product at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start this product no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors. Stop this product if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.Evaluate for retinal vein thrombosis immediately.
    Hyperkalemia: This product 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 product 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 product 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. 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 product 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. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users. Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use.
    High Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop this product if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs. An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.
    Gallbladder Disease: Studies suggest a small increased relative risk of developing gallbladder disease among COC users.
    Carbohydrate and Lipid Metabolic Effects: Carefully monitor prediabetic and diabetic women who are taking this product. COCs may decrease glucose tolerance in a dose-related fashion. Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
    Headache: If a woman taking this product develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue this product if indicated. An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.
    Bleeding Irregularities: Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC.
    COC Use Before or During Early Pregnancy: Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect when COCs are taken inadvertently during early pregnancy, particularly in so far as cardiac anomalies and limb-reduction defects are concerned. Discontinue this product if pregnancy is confirmed and initiate a prenatal vitamin containing folate supplementation. The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy.
    Depression: Women with a history of depression should be carefully observed and this product discontinued if depression recurs to a serious degree.
    Interference with Laboratory Tests: The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increase with use of COCs. DRSP causes an increase in plasma renin activity and plasma aldosterone induced by its mild antimineralocorticoid activity. Folates may mask vitamin B12 deficiency.
    Monitoring: A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
    Other Conditions: In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs.
    See prescribing information for full details.          


    Side Effects

    Irregular uterine bleeding, Nausea, Breast tenderness, Headache.
    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.
    Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin with 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. 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. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of COCs.
    Potential to Increase Serum Potassium Concentration: There is a potential for an increase in serum potassium concentration in women taking this product with other drugs that may increase serum potassium concentration. 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. 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).


    Pregnancy and Lactation

    Pregnancy: There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion. Women who do not breastfeed may start COCs no earlier than four weeks postpartum.
    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.
    See prescribing information for full details.                          


    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 product) were well tolerated after long-term treatment up to 12 weeks.


    Important notes

    Storage: Do not store above 25°C.


    Manufacturer
    Bayer Pharma AG
    Licence holder
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