Country: Malta
Language: English
Source: Medicines Authority
ATORVASTATIN
Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic
C10AA05
ATORVASTATIN 10 mg
FILM-COATED TABLET
ATORVASTATIN 10 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2015-04-01
PAGE 1 OF 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATORVASTATINA ZENTIVA ITALIA 10 MG FILM-COATED TABLETS ATORVASTATINA ZENTIVA ITALIA 20 MG FILM-COATED TABLETS ATORVASTATINA ZENTIVA ITALIA 40 MG FILM-COATED TABLETS ATORVASTATINA ZENTIVA ITALIA 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 Atorvastatina Zentiva Italia is and what it is used for 2. What you need to know before you take Atorvastatina Zentiva Italia 3. How to take Atorvastatina Zentiva Italia 4. Possible side effects 5. How to store Atorvastatina Zentiva Italia 6. Contents of the pack and other information 1. WHAT ATORVASTATINA ZENTIVA ITALIA IS AND WHAT IT IS USED FOR Atorvastatina Zentiva Italia belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatina Zentiva Italia is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and lifestyle changes on their own have failed. If you are at an increased risk of heart disease, Atorvastatina Zentiva Italia 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 ATORVASTATINA ZENTIVA ITALIA DO NOT TAKE ATORVASTATINA ZENTIVA ITALIA − if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6). − if you have or have ever had a disease which affects the liver. Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Atorvastatina Zentiva Italia 10 mg film-coated tablets Atorvastatina Zentiva Italia 20 mg film-coated tablets Atorvastatina Zentiva Italia 40 mg film-coated tablets Atorvastatina Zentiva Italia 80 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient with known effect: Each film-coated tablet contains 11.990 mg lactose monohydrate. For the full list of excipients, see section 6.1. Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient with known effect: Each film-coated tablet contains 23.980 mg lactose monohydrate. For the full list of excipients, see section 6.1. Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient with known effect: Each film-coated tablet contains 47.960 mg lactose monohydrate. For the full list of excipients, see section 6.1. Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient with known effect: Each film-coated tablet contains 95.920 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Atorvastatina Zentiva Italia 10 mg film-coated tablets: White to off white, film-coated, round, biconvex tablet. Diameter of the tablet is approx. 6 mm. Atorvastatina Zentiva Italia 20 mg film-coated tablets: Yellowish, film-coated, round, biconvex tablet. Diameter of the tablet is approx. 8 mm. Atorvastatina Zentiva Italia 40 mg film-coated tablets: Orange-yellow to yellow-orange, film- coated, round, biconvex tablet. Diameter of the tablet is approx. 10 mm. Atorvastatina Zentiva Italia 80 mg film-coated tablets: Yellow-orange film-coated round, biconvex tablet. Diameter of the tablet is approx. 12 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholeste Read the complete document