Land: Schweden
Sprache: Schwedisch
Quelle: Läkemedelsverket (Medical Products Agency)
atorvastatinkalciumtrihydrat
Krka d.d., Novo mesto
C10AA05
atorvastatin calcium trihydrate
10 mg
Filmdragerad tablett
laktosmonohydrat Hjälpämne; atorvastatinkalciumtrihydrat 10,845 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 4 tabletter; Blister, 7 tabletter; Blister, 10 tabletter; Blister, 14 tabletter; Blister, 20 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 84 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Blister, 100 tabletter
Godkänd
2019-05-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATORVASTATIN KRKA D.D. 10 MG FILM-COATED TABLETS ATORVASTATIN KRKA D.D. 20 MG FILM-COATED TABLETS ATORVASTATIN KRKA D.D. 40 MG FILM-COATED TABLETS ATORVASTATIN KRKA D.D. 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. Whatis and what it is used for 2. What you need to know before you take Lesen Sie das vollständige Dokument3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. 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, 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 DO NOT TAKE a. if you are allergic to atorvastatin 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 pregn
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Atorvastatin Krka d.d. 10 mg film-coated tablets Atorvastatin Krka d.d. 20 mg film-coated tablets Atorvastatin Krka d.d. 40 mg film-coated tablets Atorvastatin Krka d.d. 80 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION10 mg film-coated tablets Each film-coated tablet contains atorvastatin calcium trihydrate equivalent to _ _ 10 mg atorvastatin. Lesen Sie das vollständige Dokument20 mg film-coated tablets Each film-coated tablet contains atorvastatin calcium trihydrate equivalent to _ _ 20 mg atorvastatin. 40 mg film-coated tablets Each film-coated tablet contains atorvastatin calcium trihydrate equivalent to _ _ 40 mg atorvastatin. 80 mg film-coated tablets Each film-coated tablet contains atorvastatin calcium trihydrate equivalent to _ _ 80 mg atorvastatin. Excipient with known effect 10 mg tablets 20 mg tablets 40 mg tablets 80 mg tablets Lactose monohydrate (mg/tablet) 27 55 109 218 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 10 mg film-coated tablets The tablets are white to almost white, round, biconvex, film-coated tablets with beveled edges and engraved with a mark 10 on one side of the tablet. Tablet diameter: approximately 6 mm. 20 mg film-coated tablets The tablets are white to almost white, round, biconvex, film-coated tablets with beveled edges and engraved with a mark 20 on one side of the tablet. Tablet diameter: approximately 8 mm. 40 mg film-coated tablets The tablets are white to almost white, round, biconvex, film-coated tablets with beveled edges and engraved with a mark 40 on one side of the tablet. Tablet diameter: approximately 10 mm. 80 mg film-coated tablets The tablets are white to almost white, oval, biconvex, film-coated tablets engraved with a mark 80 on one side of the tablet. Tablet dimension: approximately 18 mm x 9 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEU