País: Malta
Idioma: anglès
Font: Malta Medicines Authority
AMLODIPINE, ATORVASTATIN
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
C10BX03
AMLODIPINE 10 mg ATORVASTATIN 10 mg
FILM-COATED TABLET
AMLODIPINE 10 mg ATORVASTATIN 10 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2013-03-07
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER AMORIRO 5 MG/10 MG FILM-COATED TABLETS AMORIRO 10 MG/10 MG FILM-COATED TABLETS Amlodipine/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 Amoriro is and what it is used for 2. What you need to know before you take Amoriro 3. How to take Amoriro 4. Possible side effects 5. How to store Amoriro 6. Contents of the pack and other information 1. WHAT AMORIRO IS AND WHAT IT IS USED FOR Amoriro contains two active substances, amlodipine and atorvastatin. Amlodipine belongs to the group of medicines called ‘calcium channel blockers’ and is used to treat high blood pressure (hypertension). Atorvastatin belongs to a group of medicines called ‘statins’ and is used to reduce the amount of fats (cholesterol and triglycerides) in the blood. Amoriro is used for the prevention of cardiovascular (heart and blood vessels) events (for example angina pectoris, heart attack or stroke) in people with high blood pressure who have additional cardiovascular risk factors, such as tobacco smoking, being overweight, elevated blood cholesterol levels, a family history of heart disease or diabetes. If such factors are present in people with high blood pressure, there is an increased risk for developing cardiovascular events. How Amoriro works High blood pressure is a condition during which blood pressure stays abnormally high; it is one of the risk factors for cardiovascular events (for example angina pectoris, heart attack or stroke). Amlodipine work Llegiu el document complet
Page 1 of 22 1. NAME OF THE MEDICINAL PRODUCT Amoriro 5 mg/10 mg film-coated tablets Amoriro 10 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg amlodipine (as besilate) and 10 mg atorvastatin (as calcium). Each film-coated tablet contains 10 mg amlodipine (as besilate) and 10 mg atorvastatin (as calcium). For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White film-coated tablets, oval shaped, biconvex, 4.2 mm x 8.2 mm in size, with the marking AA debossed on one side. Blue film-coated tablets, oval shaped, biconvex, 4.2 mm x 8.2 mm in size, with the marking AA1 debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoriro is indicated for prevention of cardiovascular events in hypertensive patients, with three concomitant cardiovascular risk factors, normal to mildly elevated cholesterol levels, without clinically evident coronary heart disease where combined use of amlodipine and a low dose of atorvastatin is considered appropriate, in accordance with current treatment guidelines (see section 5.1). Amoriro should be used when response to diet and other non-pharmacological measures is inadequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual starting dose is amlodipine/atorvastatin 5 mg/10 mg once daily. If a patient is identified as needing greater blood pressure control, amlodipine/atorvastatin 10 mg/10 mg once daily can be administered. Amoriro can be used either alone or in combination with anti-hypertensive drugs, but should not be taken in combination with another calcium channel blocker, or another statin. The combination of Amoriro and fibrates should be avoided (see sections 4.4 and 4.5). Page 2 of 22 _Patients with renal impairment _ No dose adjustment is required in patients with impaired renal function (see section 5.2). _Patients with hepatic impairment _ Amoriro is contra-indicated in patients with active liver disease (see section 4.3). _Paediatric population Llegiu el document complet