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  • Belara
    / Tec-O-Pharm


    Active Ingredient *

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    21

    not in the basket chart 61868 2411

    Film Coated Tablets

    3 X 21

    not in the basket chart 61869 2418

    Related information


    Dosage

    Before initiating treatment with hormonal contraceptives, a thorough general and gynaecological examination should be carried out, in which special emphasis should be placed on excluding pregnancy.
    If pregnancy occurs during the use of BELARA, the medication is to be discontinued. Previous intake of BELARA, however, does not justify termination of pregnancy.
    Check-ups should be performed at intervals of about six months during the use of BELARA.
    For users starting on or changing to BELARA, regular intake begins with the first tablet on the first day of the cycle, which corresponds to the first day of menstrual bleeding.
    If BELARA is taken at the first onset of bleeding after childbirth, there may be no reliable contraceptive protection during the first two weeks since it may no longer be possible to suppress this ovulation.
    If Belara is taken immediately after a miscarriage or abortion in the first three months of pregnancy, there is no need to use any additional contraceptive
    methods.
    See prescribing information for full details.


    Indications

    Oral hormonal contraceptive.


    Contra-Indications

    Pregnancy. Lactation: Milk production may be reduced. Very small amounts of the active ingredients are excreted in breast milk. Liver, vascular and metabolic diseases. Certain malignant tumors (e.g. of the breast, uterine cervix or uterine mucosa), including after treatment of suspected cases. Endometrial hyperplasia. History of gestational herpes. Otosclerosis with deterioration during previous pregnancies. Severe obesity. Migraine associated with sensory, perceptual and/or motorial disorders (migraine accompagnee). Undiagnosed abnormal genital bleeding. Hypersensitivity to any of the ingredients.
    See prescribing information for full details.


    Special Precautions

    Pregnancy and lactation: Pregnancy should be ruled out before starting treatment. If pregnancy occurs during use, discontinue immediately. Contraception is only indicated during prolonged lactation periods. If possible, non-hormonal methods of contraception should be used until the infant has been completely weaned. Six months should elapse after resolution of viral hepatitis. Past or existing liver neoplasms. Previous or existing thrombo-embolic disorders. Disorders of the coagulation system with a tendency to thrombus formation, congenital AT III, protein C and protein S deficiency, certain cardiac diseases. Arterial hypertension requiring treatment. Severe diabetes, sickle-cell anemia, severe disorders of lipid metabolism. Reasons for immediate discontinuation: Initial signs of thrombophlebitis or thromboembolic manifestations. Planned surgery (6 weeks beforehand) and for the duration of immobilization. First occurrence of migraine-like or unusually severe headache. Acute sensory deficits. Motorial disorders. Rise in blood pressures to levels constantly above 140/90 mmHg. Jaundice, hepatitis, generalized pruritis, cholestasis and abnormal liver function tests. Increase in epileptic seizures. First onset or recurrence of porphyria. Acute decompensation of diabetes mellitus. Renal diseases, migraine, epilepsy, past and present asthma, history of phlebitis. Marked tendency to varicosity. Multiple sclerosis, Sydenham’s chorea, tetany, diabetes mellitus and tendency to this disorder, past history of liver diseases, considerable overweight. Endometriosis, mastopathy, otosclerosis, uterus myomatosus. Spotting and breakthrough bleeding may occur but is rare and occurs almost only during the first few medication cycles. Continue treatment in these cases. If bleeding does not cease spontaneously within a few days, it can usually be stopped by an additional 20-40 mcg ethinyl oestradiol for 4-5 days (but not beyond the last tablet of a pack). If bleeding still persists or is repeated during several cycles, a thorough examination is recommended to exclude organic pathology. If in very rare cases withdrawal bleeding does not occur during the medication-free days,


    Side Effects

    Breast tension, changes in weight, depression, changes in libido, gastric complaints. Nausea, emesis, headache (also migraine-like), reduced tolerance to contact lenses. After long-term use, particularly susceptible women may occasionally develop patchy facial skin discoloration (chloasma) which is exacerbated by excessive exposure to sunlight. Vaginal infections, such as candidiasis. Skin rash and erythema. See prescribing information for full details. Slight increase incidence of biliary tract disease during long-term use. Breast cancer is one of the hormone-dependent malignancies. Breast secretion and enlargement has been observed. Ovarian cysts. Thrombo-embolic risk.


    Drug interactions

    Drugs that increase the biodegradation of steroid hormones, e.g. barbiturates, rifampicin, griseofulvin, phenylbutazone and antiepileptic agents. Antibiotics such as ampicillin or tetracyclines, activated charcoal. Insulin or oral antidiabetics. The effect of theophylline or caffeine may be increased and prolonged.


    Manufacturer
    Gedeon Richter
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