Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ATORVASTATIN CALCIUM; AMLODIPINE BESYLATE
UPJOHN (MALAYSIA) SDN. BHD.
ATORVASTATIN CALCIUM; AMLODIPINE BESYLATE
30Tablet Tablets; 7Tablet Tablets
Pfizer Manufacturing Deutschland GmbH.
Pfizer Confidential _Consumer Medication Information Leaflet (RiMUP) _ CADUET _®_ FILM-COATED TABLET Amlodipine besylate, Atorvastatin calcium (5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg) 1 WHAT IS IN THIS LEAFLET 1 What CADUET is used for 2 How CADUET works 3 Before you use CADUET 4 How to use CADUET 5 While you are using it 6 Side effects 7 Storage and Disposal of CADUET 8 Product Description 9 Manufacturer and Product Registration Holder 10 Date of Revision 11. Serial Number WHAT CADUET IS USED FOR CADUET is a prescription drug that combines amlodipine besylate and atorvastatin calcium in one pill. CADUET is used in adults who need both amlodipine besylate and atorvastatin calcium. Amlodipine besylate is used to treat: • High blood pressure (hypertension) and • Chest pain (angina). Atorvastatin calcium is used to lower “bad” cholesterol and triglycerides in your blood. It can also raise the levels of “good” cholesterol. Atorvastatin calcium is also used to lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as: • Age, smoking, high blood pressure, low HDL-C, heart disease in the family. Atorvastatin calcium can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as: • Diabetic eye problems, kidney problems, smoking, or high blood pressure. HOW CADUET WORKS 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 to lower cholesterol levels. BEFORE YOU USE CADUET - _When you must not use it _ Do not take CADUET: • if you are allergic (hypersensitive) to amlodipine or atorvastatin or any other calcium channel blocker; • if you are allergic (hypersensitive) to any of the ingredients in this medicin Lire le document complet
Pfizer Confidential 1 1. TRADE NAME OF THE MEDICINAL PRODUCT CADUET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients: amlodipine besylate, atorvastatin calcium. The tablets for oral administration contain amlodipine besylate and atorvastatin calcium equivalent to 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg amlodipine/atorvastatin dosage strengths, respectively. 3. PHARMACEUTICAL FORM Film-coated tablet. Amlodipine/atorvastatin 5 mg/10 mg is white, oval, film-coated tablets debossed with “Pfizer” on one side and product code on the other: “CDT” and “051”. Amlodipine/atorvastatin 5 mg/20 mg is white, oval, film-coated tablets debossed with “Pfizer” on one side and product code on the other: “CDT” and “052”. Amlodipine/atorvastatin 5 mg/40 mg is white, oval, film-coated tablets debossed with “Pfizer” on one side and product code on the other: “CDT” and “054”. Amlodipine/atorvastatin 10 mg/10 mg is blue, oval, film-coated tablets debossed with “Pfizer” on one side and product code on the other: “CDT” and “101”. Amlodipine/atorvastatin 10 mg/20 mg is blue, oval, film-coated tablets debossed with “Pfizer” on one side and product code on the other: “CDT” and “102”. Amlodipine/atorvastatin 10 mg/40 mg is blue, oval, film-coated tablets debossed with “Pfizer” on one side and product code on the other: “CDT” and “104”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is considered appropriate. Hypertension The amlodipine component is indicated for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure (BP) in the majority of patients. Patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of amlodipine component of amlodipine/atorvastatin, in the same manner as they would b Lire le document complet