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  • Primolut-Nor
    / Bayer


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    20 X 5 mg

    full basket chart 17913 16826

    Related information


    Dosage

    Dosage is according to doctor’s instructions only.
    Do not exceed the recommended dosage.
    Do not chew! Swallow the medicine with a small amount of water.
    The tablet may be halved.


    Indications

    Dysfunctional bleeding, primary and secondary amenorrhea, premenstrual syndrome, mastophathy, uterine hypoplasia, timing of menstruation, endometriosis.


    Contra-Indications

    Pregnancy, severe disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumors, history of jaundice or severe pruritus during pregnancy, history of herpes of pregnancy, thromboembolic processes.
    See prescribing information for full details.


    Special Precautions

    Before starting treatment, a thorough general medicdbal and gynecological examination should be carried out and pregnancy must be excluded. Control examinations should be conducted at intervals of about 6 months during long-term treatment. Diabetes. Increased incidence of thromboembolic diseases. In rare cases, benign and in even rarer cases malignant liver tumors have been observed after the use of hormonal substances. Reasons for immediate discontinuation of the tablets are: Migrainous or unusually severe headaches, sudden perceptual disorders, first signs of thrombophlebitis or thromboembolic symptoms, pain or tightness in the chest, pending operations (six weeks beforehand) and immobilization, onset of jaundice, onset of anicteric hepatitis, generalized pruritus, significant rise in blood pressure, hypercalcemia. Pregnancy and lactation: Masculization of the female fetus has occurred. Effect on nursing infant has not been fully determined. Pretreatment physical examination should include special reference to breasts and pelvic organs as well as a Pap smear. Epilepsy, migraine, asthma, cardiac or renal dysfunction. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment. Impaired liver function. Undiagnosed vaginal bleeding. History of psychic depression. Slight bleeding during tablet-taking: Occasionally slight bleeding may occur after initial arrest of bleeding. In these cases tablet-taking must not be interrupted. Missing arrest of hemorrhage, heavy breakthrough bleeding: If the bleeding does not stop in spite of regular tablet-taking, an organic cause or an extra-genital factor (e.g. polyps, high-situated carcinoma of the cervix uteri or endometrium, myoma, residua of abortion, extra-uterine pregnancy, thrombopenia, thromboasthenia) must be assumed, so that other measures are called for. This applies also in cases where, after initial arrest of hemorrhage, fairly heavy bleeding recurs within a few days even during tablet-taking.
    See prescribing information for full details.


    Side Effects

    Rarely: Slight nausea, exacerbation of epilepsy and migraine. With extremely high dosage there may be cholestatic liver changes.
    See prescribing information for full details.


    Drug interactions

    Rifampicin, griseofulvin, barbiturates, phenytoin, primidone, carbamazepine. See prescribing information for full details.


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