Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
ATORVASTATIN CALCIUM TRIHYDRATE
Accord Healthcare Limited
C10AA05
ATORVASTATIN CALCIUM TRIHYDRATE
FILM-COATED TABLET
ATORVASTATIN CALCIUM TRIHYDRATE 40 mg
POM
LIPID MODIFYING AGENTS
Authorised
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATORVASTATIN 10 MG FILM-COATED TABLETS ATORVASTATIN 20 MG FILM-COATED TABLETS ATORVASTATIN 40 MG FILM-COATED TABLETS ATORVASTATIN 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, pharmacist Perskaitykite visą dokumentą. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Atorvastatin tablets are and what they are used for 2. What you need to know before you take Atorvastatin tablets 3. How to take Atorvastatin tablets 4. Possible side effects 5. How to store Atorvastatin tablets 6. Contents of the pack and other information 1. WHAT ATORVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR Atorvastatin tablets belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin tablets are 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, Atorvastatin tablets 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 ATORVASTATIN TABLETS DO NOT TAKE ATORVASTATIN TABLETS IF YOU: are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6) have or have ever had a disease which affects the liver have had any unexplained abnormal blood tests for liver function are a woman able to have children and not using reliable cont
1. NAME OF THE MEDICINAL PRODUCT Atorvastatin 10 mg film-coated tablets Atorvastatin 20 mg film-coated tablets Atorvastatin 40 mg film-coated tablets Atorvastatin 80 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate). Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate). Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate). Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient(s) with known effect Each Atorvastatin 10 mg film-coated tablet contains 23.38 mg lactose monohydrate. Each Atorvastatin 20 mg film-coated tablet contains 46.76 mg lactose monohydrate. Each Atorvastatin 40 mg film-coated tablet contains 93.52 mg lactose monohydrate. Each Atorvastatin 80 mg film-coated tablet contains 187.04 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Atorvastatin 10 mg film-coated tablet: White to off-white, round shaped, biconvex, film coated tablets with approx. 5.6 mm diameter, debossed with “FUI” on one side and plain on other side. Atorvastatin 20 mg film-coated tablet: White to off-white, round shaped, biconvex, film coated tablets with approx. 7.1 mm diameter, debossed with “FU2” on one side and plain on other side. Atorvastatin 40 mg film-coated tablet: White to off-white, round shaped, biconvex, film coated tablets with approx. 9.6 mm diameter, debossed with “FU3” on one side and plain on other side. Atorvastatin 80 mg film-coated tablet: White to off-white, round shaped, biconvex, film coated tablets with approx. 12.1 mm diameter, debossed with “FU4” on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and tr Perskaitykite visą dokumentą