देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
AMLODIPINE, ATORVASTATIN
Pfizer Hellas S.A.
C10BX03
AMLODIPINE, ATORVASTATIN
FILM-COATED TABLET
AMLODIPINE 10 milligram(s) ; ATORVASTATIN 10 milligram(s)
POM
LIPID MODIFYING AGENTS
Authorised
2006-05-26
Page 1 of 9 PACKAGE LEAFLET Page 2 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER CADUET 5 MG/10 MG AND 10 MG/10 MG FILM-COATED TABLETS Amlodipine besilate/Atorvastatin calcium trihydrate 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 or nurse. - 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 Caduet is and what it is used for 2. What you need to know before you take Caduet 3. How to take Caduet 4. Possible side effects 5. How to store Caduet 6. Contents of the pack and other information 1. WHAT CADUET IS AND WHAT IT IS USED FOR Caduet is used to prevent cardiovascular events (e.g. angina, heart attacks) in patients with high blood pressure, who have additional cardiovascular risk factors such as smoking, being overweight, increased blood cholesterol, a family history of heart disease, or diabetes. The existence of such risk factors associated with high blood pressure puts patients at an increased risk of having cardiovascular events. Caduet is a product that contains two active ingredients amlodipine (calcium antagonist) and atorvastatin (statin) and is to be used when your doctor considers it appropriate to use both medications. Amlodipine is used to treat high blood pressure (hypertension) and atorvastatin lowers cholesterol. High blood pressure (hypertension) is a medical condition when blood pressure is persistently found to be abnormally high and is one of the risk factors for cardiovascular events (angina, heart attack, stroke). Cholesterol is a naturally occurring substance in the body necessary for normal growth. However, if ther पूरा दस्तावेज़ पढ़ें
Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 24 1. NAME OF THE MEDICINAL PRODUCT CADUET 10 mg/10 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate) and 10 mg atorvastatin (as atorvastatin calcium trihydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Blue film-coated tablets, oval shape, debossed with ‘Pfizer’ on one side and CDT 101 on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CADUET 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) CADUET should be used when response to diet and other non pharmacological measures is inadequate 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology CADUET is for oral use. The usual starting dose is 5 mg/10 mg once daily. If a patient is identified as needing greater blood pressure control, 10 mg/10 mg once daily can be administered. Doses may be taken at any time of day with or without food. CADUET 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. _Renal impairment _ No dose adjustment is required in patients with impaired renal function (see section 4.4 and section 5.2). Page 3 of 24 _Hepatic impairment _ CADUET is contra-indicated in patients with active liver disease (see section 4.3). _Paediatric population_ Safety and efficacy of CADUET have not been established in children and adolescents. Therefore, the use of CADUET is not recommended in these populations. _Elderly patients _ It is unnecessary to adjust the dose in elderly patients (see section 5. पूरा दस्तावेज़ पढ़ें