Страна: Швеція
мова: шведська
Джерело: Läkemedelsverket (Medical Products Agency)
atorvastatinkalcium, amorft
Krka d.d., Novo mesto
C10AA05
atorvastatinkalcium, amorphous
80 mg
Filmdragerad tablett
atorvastatinkalcium, amorft 82,88 mg Aktiv substans; laktosmonohydrat Hjälpämne
Apotek
Receptbelagt
Atorvastatin
Avregistrerad
2011-09-16
PACKAGE LEAFLET: INFORMATION FOR THE USER ATOVANS 30 MG FILM-COATED TABLETS ATOVANS 60 MG FILM-COATED TABLETS ATOVANS 80 MG FILM-COATED TABLETS Atorvastatin 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 Atovans is and what it is used for 2. What you need to know before you take Atovans 3. How to take Atovans 4. Possible side effects 5. How to store Atovans 6. Contents of the pack and other information 1. WHAT ATOVANS IS AND WHAT IT IS USED FOR Atovans belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atovans is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Atovans can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment. 2. What you need to know BEFORE YOU TAKE ATOVANS DO NOT TAKE ATOVANS a. if you are allergic to atorvastatin or to any similar medicines used to lower blood lipids or to any of the other ingredients of this medicine (listed in section 6). b. if you have or have ever had a disease which affects the liver c. if you have had any unexplained abnormal blood tests for liver function d. if you are a woman able to have children and not using reliable contraception e. if you are pregnant or trying to become pregnant f. if you are breast-feeding. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacis Прочитайте повний документ
Produktinformationen för Atovans 30 mg, 60 mg, 80 mg, filmdragerad tablett, MTnr 44163, 44164, 44165, 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 Atovans 30 mg film-coated tablets Atovans 60 mg film-coated tablets Atovans 80 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Atovans 30 mg film-coated tablets Each film-coated tablet contains 30 mg of atorvastatin as atorvastatin calcium . Atovans 60 mg film-coated tablets Each film-coated tablet contains 60 mg of atorvastatin as atorvastatin calcium . Atovans 80 mg film-coated tablets Each film-coated tablet contains 80 mg of atorvastatin as atorvastatin calcium . Excipient: 30 mg tablets 60 mg tablets 80 mg tablets Lactose monohydrate (mg/tablet) 175 mg 350 mg 467 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 30 mg tablets: White to almost white, round, slightly convex, film-coated tablets, bevel-edged, tablet diameter 9 mm. 60 mg tablets: White to almost white, oval, biconvex, film-coated tablets, tablet dimensions 16 mm x 8.5 mm. 80 mg tablets: White to almost white, capsule shape, biconvex, film-coated tablets, tablet dimensions 18 mm x 9 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atovans is indicated as an adjunct to diet for reduction of elevated total cholesterol (totalC), LDL- cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hyperchol Прочитайте повний документ