País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
CABERGOLINE
Norton Waterford
0.5 Milligram
Tablets
2008-02-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dalzior 0.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg cabergoline. Excipient: lactose 75.8 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, oval- shaped, flat, bevelled tablets containing 0.5 mg cabergoline. Each tablet is scored on one side and has ‘CBG’ on one side and ‘0.5’ on the other side of the breakline. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inhibition of lactation for medical reasons. Hyperprolactimaemic disorders Prolactin secreting pituitary adenomas Idiopathic hyperprolactinaemia It is recommended that the medicinal product is initially prescribed by an appropriate specialist or after consulting a specialist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cabergoline is to be administered by the oral route. In order to reduce the risk of gastrointestinal undesirable effects it is recommended that cabergoline is taken with meals for all therapeutic indications. The maximum dose of 3 mg/day of cabergoline must not be exceeded. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/08/2011_ _CRN 2101061_ _page number: 1_ ADULTS: Treatment of hyperprolactinaemic disorders: The recommended initial dosage is 0.5 mg cabergoline per week given in one or two doses (e.g. on Monday and Thursday) per week. The weekly dose should be increased gradually, preferably by adding 0.5 mg cabergoline per week at monthly intervals until an optimal therapeutic response is achieved. The therapeutic dosage is usually 1 mg cabergoline per week and ranges from 0.25 mg to 2 mg cabergoline per week. Doses of up Leer el documento completo