Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
Pharmacare Srl Via Marghera, 29 20149, Milan, Italy
C10AA05
ATORVASTATIN 80 mg
FILM-COATED TABLET
ATORVASTATIN 80 mg
POM
LIPID MODIFYING AGENTS
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2023-06-20
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ATORVASTATIN P-CARE 10/20/30/40/60/80 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 Atorvastatin P-Care is and what it is used for 2. What you need to know before you take Atorvastatin P-Care 3. How to take Atorvastatin P-Care 4. Possible side effects 5. How to store Atorvastatin P-Care 6. Contents of the pack and other information 1. WHAT ATORVASTATIN P-CARE IS AND WHAT IT IS USED FOR Atorvastatin P-Care belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin P-Care 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, Atorvastatin P-Care 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 P-CARE DO NOT TAKE ATORVASTATIN P-CARE: - if you use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C - if you are allergic to Atorvastatin or to any similar medicines used to lower blood lipids 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 - if you have had any unexplained abnormal blood tests for liver function - if you are a woman able to have children and not usin Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Atorvastatin P-Care 10 mg film-coated tablets Atorvastatin P-Care 20 mg film-coated tablets Atorvastatin P-Care 30 mg film-coated tablets Atorvastatin P-Care 40 mg film-coated tablets Atorvastatin P-Care 60 mg film-coated tablets Atorvastatin P-Care 80 mg film-coated tablets _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of atorvastatin (as 10.83 mg atorvastatin calcium trihydrate). Each film-coated tablet contains 20 mg of atorvastatin (as 21.66 mg atorvastatin calcium trihydrate). Each film-coated tablet contains 30 mg of atorvastatin (as 32.49 mg atorvastatin calcium trihydrate). Each film-coated tablet contains 40 mg of atorvastatin (as 43.32 mg atorvastatin calcium trihydrate). Each film-coated tablet contains 60 mg of atorvastatin (as 64.98 mg atorvastatin calcium trihydrate). Each film-coated tablet contains 80 mg of atorvastatin (as 86.64 mg atorvastatin calcium trihydrate). Excipients with known effect: Each Atorvastatin P-Care 10 mg film-coated tablet contains 28 mg of lactose monohydrate. Each Atorvastatin P-Care 20 mg film-coated tablet contains 56 mg of lactose monohydrate. Each Atorvastatin P-Care 30 mg film-coated tablet contains 84 mg of lactose monohydrate. Each Atorvastatin P-Care 40 mg film-coated tablet contains 112 mg of lactose monohydrate. Each Atorvastatin P-Care 60 mg film-coated tablet contains 168 mg of lactose monohydrate. Each Atorvastatin P-Care 80 mg film-coated tablet contains 225 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The tablets in strength 10 mg are round, biconvex, white film-coated tablets debossed with ‘T’on one side. Tablet dimensions are: 5.6 ± 0.5 m. The tablets in strength 20 mg are round, biconvex, white film-coated tablets debossed with ‘VT20’ on one side. Tablet dimensions are: 7.3 ± 0.5 mm. The tablets in strength 30 mg are oval, biconvex, white film-coated tablets with a Baca dokumen lengkapnya