Страна: Швеція
мова: шведська
Джерело: Läkemedelsverket (Medical Products Agency)
kabergolin
Hexal A/S
N04BC06
cabergoline
1 mg
Tablett
laktos (vattenfri) Hjälpämne; kabergolin 1 mg Aktiv substans
Apotek
Receptbelagt
Kabergolin
Avregistrerad
2010-11-04
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CABARSUSS 1 MG TABLETS CABARSUSS 2 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 dopamine agonists. It acts in a similar way to a chemical present in the nervous system called dopamine. Patients with Parkinson’s disease do not have enough of this important chemical in their body. CABARSUSS is used to treat Parkinson’s disease. It can be used either taken alone or in combination with levodopa, as second choice following non-ergot derived therapies. Treatment by a specialist is required with regular checks. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABARSUSS DO NOT TAKE CABARSUSS IF YOU: are allergic to cabergoline or other ergot alkaloid medicines (e.g. bromocriptine) or any of the other ingredients of this medicine ( _see Section 6 and end of Section 2_ ) will be treated with CABARSUSS for a long period and _have_ or had fibrotic reactions (scar tissue) affecting your heart have ever been diagnosed in the past with a problem known as fibrosis affecting the lungs, lower back and kidneys or heart. Before you are given CABARSUSS your doctor will arrange for you to have tests to assess the condition of your heart. Прочитайте повний документ
Produktinformationen för Cabarsuss, 1 mg och 2 mg Tablett, MTnr 42522 och 42523, 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, 1 mg, tablets Cabarsuss, 2 mg, tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cabarsuss, 1 mg, tablets: Each tablet contains 1 mg cabergoline. Cabarsuss, 2 mg, tablets: Each tablet contains 2 mg cabergoline. Excipient(s): Cabarsuss, 1 mg, tablets: Each tablet contains 75, 4 mg anhydrous lactose. Cabarsuss, 2 mg, tablets: Each tablet contains 150, 8 mg anhydrous lactose For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Cabarsuss, 1 mg, tablets: White, oval, uncoated, biconvex tablet, scored and debossed with “C 1“ on one side. Cabarsuss, 2 mg, tablets: White, oval, uncoated, biconvex tablet, scored and debossed with “C 2“ on one side. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Parkinson's disease. If treatment with a dopamine agonist is being considered, cabergoline is indicated as second line therapy in patients who are intolerant or fail treatment with a non-ergot compound, as monotherapy, or as adjunctive treatment to levodopa plus dopa-decarboxylase inhibitor, in the management of the signs and symptoms of Parkinson's disease. Treatment should be initiated under specialist supervision. The benefit of continued treatment should be regularly reassessed taking into account the risk of fibrotic reactions and valvulopathy (see sections 4.3, 4.4 and 4.8). 4.2 POSOLOGY AND Прочитайте повний документ