Страна: Швеция
Язык: шведский
Источник: Läkemedelsverket (Medical Products Agency)
kabergolin
Hexal A/S
G02CB03
cabergoline
0,5 mg
Tablett
laktos (vattenfri) Hjälpämne; kabergolin 0,5 mg Aktiv substans
Apotek
Receptbelagt
Kabergolin
Avregistrerad
2010-11-04
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CABARSUSS 0.5 MG TABLETS cabergoline READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Cabarsuss is and what it is used for 2. What you need to know before you take Cabarsuss 3. How to take Cabarsuss 4. Possible side effects 5. How to store Cabarsuss 6. Contents of the pack and other information 1. WHAT CABARSUSS IS AND WHAT IT IS USED FOR Cabarsuss belongs to a group of medicines known as prolactin inhibitors. Cabarsuss prevents lactation (production of milk) by decreasing levels of a hormone known as prolactin. Cabarsuss can also be used to reduce abnormal quantities of the hormone prolactin in the blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABARSUSS DO NOT TAKE CABARSUSS IF YOU: are allergic to cabergoline or any of the other ingredients of this medicine (listed in section 6) have psychosis, or a history of psychosis, or you are at risk of psychosis after childbirth will be treated with Cabarsuss for a long period and _have_ stiff and inflamed heart valves (cardiac valvulopathy) have ever been diagnosed in the past with a problem known as fibrosis affecting the lungs, lower back and kidneys or heart. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING CABARSUSS If you have any of the following health problems you must inform your doctor BEFORE taking Cabarsuss as this medicine may be unsuitable for you: cardiovascular disease stomach ulcer or bleeding in the gastrointestinal tract (this condition can Прочитать полный документ
Produktinformationen för Cabarsuss, 0,5 mg Tablett, MTnr 42521, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cabarsuss, 0,5 mg, tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0,5 mg cabergoline. Excipient(s): Each tablet contains 75, 9 mg anhydrous lactose For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, oval, uncoated, biconvex tablet, scored and debossed with “C 1/2“ on one 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 is taken with meals for all therapeutic indications. The maximum dose is 3 mg cabergoline per day. Treatment of hyperprolactinaemic disorders. The recommended initial dosage of cabergoline is 0.5 mg 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 0.5 mg per week at monthly intervals until an optimal therapeutic response is achieved. The therapeutic dosage is usually 1 mg caberg Прочитать полный документ