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  • Progyluton
    / Bayer


    Active Ingredient *

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    21

    full basket chart 1796 16252

    Tablets

    28

    full basket chart 2981 16400

    Related information


    Dosage

    Proguluton is a cyclic HRT product. One tablet is to be taken orally once a day for 21 days, followed by a 7 day tablet free interval. Therefore each new pack is started after a 28 day cycle. The white tablets should be taken from days 1 to 11 followed by the brown tablets from days 12 to 21. It is recommended that the tablets are taken at the same time every day.
    For initiation and continuation of treatment of peri- and post-menopausal symptoms the lowest effective dose for the shortest duration should be used.
    For women still having periods, the first tablet should be taken on the 5th day of their menstrual period. If menstruation has stopped, or is infrequent or sporadic, then the first tablet can be taken any time.
    If the patient is being transferred from a continuous HRT product, the patient may start Progyluton on any convenient day. For those transferring from a cyclic or sequential product, Progylton should be started following completion of the previous regimen If a tablet is missed, it should be taken as soon as possible, unless it is more than 12 hours late. In this case the missed tablet should be left in the pack and the next tablet taken at the right time. Missing a dose may result in breakthrough bleeding or spotting.
    Unless there is a previous diagnosis of endometriosis, it is not recommended that progestagen-containing HRT be given to hysterectomised women.
    Children and adolescents: Progyluton is not indicated for use in children and adolescents.
    Geriatric patients: There are no data suggesting a need for dosage adjustment in women aged 65 years or older.
    Patients with hepatic impairment: Progyluton has not been specifically studied in patients with hepatic impairment.
    Patients with renal impairment: Progyluton has not been specifically studied in renally impaired patients. Available data do not suggest a need for dosage adjustment in this patient population.


    recommended drugs

    Indications

    Two phase preparation for climacteric and cycle disturbances.


    Contra-Indications

    Pregnancy and lactation, undiagnosed vaginal bleeding, known or suspected cancer of the breast, severe hepatic disease, jaundice or persistent pruritis during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome. Previous or existing liver tumors (benign or malignant), existing or previous thromboembolic processes (e.g. stroke, myocardial infarction), active deep venous thrombosis, thromboembolic disorders, or a documented history of these conditions. Sickle-cell anemia, existing or suspected hormone-dependent tumors of the uterus or mammae, endometriosis, severe diabetes with vascular changes, disturbances of lipometabolism, severe hypertriglyceridemia, known hypersensitivity. A history of herpes of pregnancy, otosclerosis with deterioration during pregnancy.
    See prescribing information for full details.


    Special Precautions

    Cannot be used as a contraceptive. Venous thromboembolism, risk of VTE, endometrial cancer, breast cancer, liver tumor, gallbladder disease, treatment should be stopped at once if migrainous or frequent and unusually severe headaches occur for the first time, or if there are other symptoms that are possible premonitory signs of cerebrovascular occlusion. Elevated levels of triglycerides, uterine myomas may increase in size, chloasma may occasionally occur. Epilepsy, benign breast disease, asthma, migraine, porphyria. A complete medicdbal history should be taken and a physical examination should be conducted prior to the initiation or reinstitution of HRT.
    Pregnancy and lactation: Not indicated for use.
    See prescribing information for full details.


    Side Effects

    Changes in vaginal bleeding pattern, dysmenorrhea, changes of vaginal secretion, premenstrual-like syndrome, breast pain, tenderness or enlargement. Dyspepsia, bloating, nausea, vomiting, abdominal pain. Rashes, various skin disorders. Headache, migraine, dizziness, anxiety/depressive symptoms, fatigue. Palpilations, edema, muscle cramps, changes in body weight, increased appetite, changes in libido, visual disturbances, intolerance to contact lenses, hypersensitivity reactions.
    See prescribing information for full details.


    Drug interactions

    Barbiturates, carbamazepine, dichloralphenazone, griseofulvin, phenytoin, primidone, rifampicin. Coumarin anticoagulants, bile acids, antihypertensives, diuretics, topical corticosteroids.
    See prescribing information for full details.


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