Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
CABERGOLINE
Arrow Generics Limited
CABERGOLINE
0.5 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-04-29
UK/H/955/01/DC 2 PACKAGE LEAFLET: INFORMATION FOR THE USER CABERGOLINE 0.5MG TABLETS _cabergoline _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Cabergoline 0.5mg Tablets are and what they are used for 2. Before you take Cabergoline 0.5mg Tablets 3. How to take Cabergoline 0.5mg Tablets 4. Possible side effects 5. How to store Cabergoline 0.5mg Tablets 6. Further information. 1. WHAT CABERGOLINE 0.5MG TABLETS ARE AND WHAT THEY ARE USED FOR Cabergoline belongs to a group of medicines known as prolactin inhibitors. Cabergoline prevents lactation (production of milk) by decreasing the level of a hormone known as prolactin. Cabergoline 0.5mg Tablets are also used to reduce abnormol quantities of the hormone prolactin in the blood. 2. BEFORE YOU TAKE CABERGOLINE 0.5MG TABLETS Do not take Cabergoline 0.5mg Tablets - if you are allergic (hypersensitive) to cabergoline or other ergot alkaloids medicines (e.g bromocriptine), or to any of the other ingredients of Cabergoline 0.5mg Tablets - if you have uncontrolled high blood pressure - if you have swelling of the hands, feet and high blood pressure during or after pregnancy (pre- eclampsia, eclampsia) - if you have ever suffered from or are being treated for psychosis (currently or in the past) or if you are at risk of psychosis during pregnancy or after childbirth - if you have ever been diagnosed in the past with problems described as fibroti Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cabergoline 0.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5mg cabergoline. Excipient: lactose monohydrate 75mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet A white to off-white, capsule-shaped tablet, embossed with ‘C | 5’ on one side and ‘partial score >’ on the other side. 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 be preferably taken with meals for all the therapeutic indications. _TREATMENT OF HYPERPROLACTINAEMIC DISORDERS_ The recommended initial dosage of cabergoline is 0.5mg per week given in one (single 0.5 mg) or two (separate 0.25 mg) doses (e.g. on Monday and Thursday) per week. The weekly dose should be increased gradually, preferably by adding 0.5mg per week at monthly intervals until an optimal therapeutic response is achieved. The therapeutic dosage is usually 1mg per week and ranges from 0.25mg to 2mg cabergoline per week. Doses of cabergoline up to 4.5mg per week have been used in hyperprolactinaemic patients. The maximum daily dose should not exceed 3mg/day. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/03/2013_ _CR Lesen Sie das vollständige Dokument