البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
CABERGOLINE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
N04BC06
TABLETS
CABERGOLINE 0.5 MG
PER OS
Required
PFIZER ITALIA S.R.L, ITALY
CABERGOLINE
CABERGOLINE
Treatment of hyperprolactinemic disorders.Dostinex is indicated for the treatment of dysfunctions associated with hyperprolactinemia, including amenorrhea, oligomenorrhea, anovulation and galactorrhea. Dostinex is indicated in patients with prolactin-secreting pituitary adenomas (micro-and macroprolactinomas), idiopathic hyperprolactinemia, or empty sella syndrome with associated hyperprolactinemia. Inhibition and supression of lactation .
2023-08-31
Dostinex PIL CC 240621 2021-0070329 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only DOSTINEX ® TABLETS EACH TABLET CONTAINS: CABERGOLINE 0.5 MG Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? The medicine supresses production of prolactin and is indicated for the treatment of hyperprolactinemia and to prevent/stop breast milk production. THERAPEUTIC GROUP: Dopamine receptor agonist. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • you are sensitive (allergic) to cabergoline, other medicines called ergot alkaloids (e.g. pergolide, bromocriptine, lisuride, ergotamine or ergometrine) or to any of the other ingredients of this medicine (listed in section 6). • you have severe liver disease. • you have high blood pressure in pregnancy associated with swelling and protein in the urine (toxaemia of pregnancy). • you are being treated with anti-psychotics or have a history of mental illness associated with child-birth (puerperal psychosis). • you are pregnant or breastfeeding. • you will be treated with Dostinex ® for a long period and have stiff and inflamed heart valves (cardiac valvulopathy). • you have had fibrotic reactions (scar tissue) affecting your abdomen, heart or lungs. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH DOSTINEX ® , TELL YOUR DOCTOR IF YOU HAVE OR HAD ANY OF THE FOLLOWING CONDITIONS: • Disease that involves the heart and blood vessels (ca اقرأ الوثيقة كاملة
Dostinex LPD CC 311220 Page 1 of 11 2013-0003257, 2016-0018531, 2019-0056084 DOSTINEX ® 1. NAME OF THE MEDICINAL PRODUCT Dostinex ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One Dostinex ® tablet contains 0.5 mg cabergoline. Excipients with known effect: Each tablet contains 75.90 mg of lactose anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, flat, oblong, white engraving "PU" divided by a score on one side; engraving "700" and light score above and below the central "0" on other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of hyperprolactinemic disorders. Dostinex ® is indicated for the treatment of dysfunctions associated with hyperprolactinemia, including amenorrhea, oligomenorrhea, anovulation and galactorrhea. Dostinex ® is indicated in patients with prolactin-secreting pituitary adenomas (micro-and macroprolactinomas), idiopathic hyperprolactinemia, or empty sella syndrome with associated hyperprolactinemia. Inhibition and suppression of lactation. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Dostinex ® is to be administered by the oral route. Since the tolerability of this class of compounds is improved with food, it is recommended that Dostinex ® be preferably taken with meals for all the therapeutic indications. In patients known to be intolerant to dopaminergic drugs, the likelihood of adverse events may be lessened by starting therapy with Dostinex ® at reduced doses (e.g., 0.25 mg once a week) with subsequent gradual increase until the therapeutic dosage is reached. If persistent or severe adverse events occur, temporary reduction of dosage followed by a more gradual increase (e.g., increments of 0.25 mg per week every two weeks) may increase tolerability. Inhibition/suppression of physiological lactation For inhibition of lactation Dostinex ® should be administered during the first day post-partum. The recommended therapeutic dose is 1 mg (two 0.5 mg tablets) given as a single dose. For suppression of established lacta اقرأ الوثيقة كاملة