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  • Meliane
    / Bayer


    Active Ingredient *
    Gestodene 0.075 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Coated Tablets

    21

    full basket chart 85170 13249

    Coated Tablets

    21 X 3

    full basket chart 85171 13250

    Related information


    Dosage

    First treatment cycle: 1 tablet for 21 days, starting on the first day of the menstrual cycle. Contraceptive protection begins immediately.
    Subsequent cycles: Tablet taking from the next pack of Meliane is continued after a 7-day interval, beginning on the same day of the week as the first pack.
    Changing from 21 day combined oral contraceptives: The first tablet of Meliane
    should be taken on the first day immediately after the end of the previous oral
    contraceptive course. Additional contraceptive precautions are not required.
    Changing from a combined Every Day pill (28 day tablets): Meliane should be started after taking the last active tablet from the Every Day Pill pack. The first Meliane tablet is taken the next day. Additional contraceptive precautions are not then required.
    Changing from a progestogen-only pill (POP): The first tablet of Meliane should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not then required. The remaining progestogen-only pills should be discarded.
    Post-partum and post-abortum use: After pregnancy, oral contraception can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contraceptive precautions will be required for the first 7 days of pill taking. Since the first post-partum ovulation may precede the first bleeding, another method of contraception should be used in the interval between childbirth and the first course of tablets. After a first-trimester abortion, oral contraception may be started immediately in which case no additional contraceptive precautions are required.
    Special circumstances requiring additional contraception
    Incorrect administration: A single delayed tablet should be taken as soon as possible, and if this can be done within 12 hours of the correct time, contraceptive protection is maintained. With longer delays, additional contraception is needed. Only the most recently delayed tablet should be taken, earlier missed tablets being omitted, and additional non-hormonal methods of contraception (except the rhythm and temperature methods) should be used for the next 7 days, while the next 7 tablets are being taken. Additionally, therefore, if tablet(s) have been missed during the last 7 days of a pack, there should be no break before the next pack is started. In this situation, a withdrawal bleed should not be expected until the end of the second pack.
    Some breakthrough bleeding may occur on pill taking days but this is not clinically significant. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before starting the next pack.
    Gastro-intestinal upset: Vomiting or diarrhoea may reduce the efficacy of oral
    contraceptives by preventing full absorption. If vomiting or diarrhoea occurs within 4 hours of taking Meliane tablet-taking from the current pack should be continued.
    Additional non-hormonal methods of contraception (except the rhythm or
    temperature methods) should be used during the gastro-intestinal upset and for 7 days following the upset. If these 7 days overrun the end of a pack, the next pack should be started without a break. In this situation, a withdrawal bleed should not be expected until the end of the second pack. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before starting the next pack. Other methods of contraception should be considered if the gastro-intestinal disorder is likely to be prolonged.
    Children: Not applicable.
    Elderly: Not applicable.


    Indications

    Oral contraceptive.


    Contra-Indications

    Hypersensitivity to any of the components. Pregnancy. Severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumours. Current or past confirmed venous thromboembolism (VTE), family history of idiopathic VTE and other known risk factors for VTE. Existing or previous arterial thrombotic or embolic processes; conditions which predispose to them, e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation. Sickle cell anaemia. Mammary or endometrial carcinoma, or a history of these conditions. Severe diabetes mellitus with vascular changes. Disorders of lipid metabolism. History of herpes gestationis. Deterioration of otosclerosis during pregnancy. Undiagnosed abnormal vaginal bleeding.
    See prescribing information for full details.


    Special Precautions

    Reasons for immediate discontinuation: Migrainous headaches or more frequent severe headaches, perceptual disorders, first signs of thrombophlebitis or thromboembolic symptoms. A feeling of pain and tightness in the chest, six weeks before an operation, immobilization. Hepatitis, itching, increase in epileptic seizures, rise in blood pressure, pregnancy, onset of severe depression. Diabetes mellitus or a tendency towards diabetes mellitus, hypertension, varicose veins, a history of phlebitis, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, Sydenham? chorea, renal dysfunction, family history of clotting disorders, obesity, family history of breast cancer and patient history of breast nodules, history of clinical depression, systemic lupus erythematosus, uterine myoma and migraine. An association between the use of hormonal contraceptives and an increased risk of venous and arterial thromboembolic diseases such as myocardial infarction, pulmonary embolism, thrombophlebitis, stroke or retinal thrombosis, cannot be ruled out. Should any of these occur or be suspected, treatment should be discontinued immediately. Women over 35 years of age who use oral contraceptives should be strongly advised not to smoke. Furthermore, hypertension, hyperlipidemias, obesity and diabetes mellitus may increase the risk in women taking oral contraceptives. Changes in serum triglycerides, cholesterol and lipoprotein levels have been reported in users of oral contraceptives. Decrease in glucose tolerance. Increase in blood pressure has been reported. Amenorrhea or oligomenorrhea after discontinuation of oral contraceptives. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal hemorrhage occur, the possibility of a liver tumor should be included in the differential diagnosis. Laboratory staff should be informed about oral contraceptive use. If pregnancy occurs during medicdbation, the preparation is to be withdrawn immediately. Use during lactation may lead to a reduction in the volume of milk produced and to a change in its composition.
    See prescribing information for full details.


    Side Effects

    Headaches, gastric upsets, nausea, a feeling of tension in the breasts, changes in body weight and libido, depressive moods. Long-term use can sometimes cause brownish patches on the face, which can worsen by long exposure to the sun.
    See prescribing information for full details.


    Drug interactions

    Enzyme inducers: Interactions can occur with drugs that induce microsomal enzymes (especially cytochrome P450 3A4) which can result in increased clearance of sex hormones and which may lead to breakthrough bleeding and/or contraceptive failure.
    Women on short term treatment with any of these drugs should temporarily use a barrier method in addition to the COC or choose another method of contraception. The barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. If the period during which the barrier method is used runs beyond the end of a pack, the next pack should be started without a break. In this situation,
    a withdrawal bleed should not be expected until the end of the second pack. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before resuming with the next pack.
    For women receiving long-term therapy with enzyme inducers, another method of contraception should be used.
    The following have been shown to have clinically important interactions with COCs:
    Anticonvulsants: barbiturates (including phenobarbitone), primidone, phenytoin, carbamazepine, oxcarbazepine, topiramate.
    Antibiotics/antifungals: griseofulvin , rifampicin.
    Herbal remedies: St. John’s wort (Hypericum perforatum)
    Antiretroviral agents: ritonavir, nelfinavir, nevirapine.
    Note: There are other antiretroviral agents that may increase plasma concentration of sex hormones.
    Substances decreasing the clearance of COCs (enzyme inhibitors):
    Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g. itraconazole, voriconazole, fluconazole) and macrolides (e.g. erythromycin) can increase plasma concentrations of the estrogen or the progestin or both.
    Etoricoxib doses of 60 to 120 mg/day have been shown to increase plasma concentrations of ethinylestradiol 1.4 to 1.6-fold, respectively when taken concomitantly with a combined hormonal contraceptive containing 0.035 mg ethinylestradiol.
    Effects on other drugs: Oral contraceptives may affect the metabolism of certain other drugs. Accordingly, plasma and tissue concentrations may either increase (e.g. cyclosporin, tizanidine, theophylline) or decrease (e.g. lamotrigine).
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Meliane is not indicated during pregnancy. If pregnancy occurs during treatment with Meliane, further intake must be stopped. However, extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during early pregnancy.
    The increased risk of VTE during the postpartum period should be considered when restarting Meliane.
    Lactation: The use of Meliane during lactation may lead to a reduction in the volume of milk produced and to a change in its composition. Minute amounts of the active substances are excreted with the milk. These amounts may affect the child particularly in the first 6 weeks postpartum.
    Mothers who are breast-feeding may be advised instead to use another method of contraception.


    Overdose

    Overdosage may cause nausea, vomiting and withdrawal bleeding in females.
    There are no specific antidotes and treatment should be symptomatic.


    Manufacturer
    Delpharm Huningue SAS, Huningue, France
    Licence holder
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