Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Amlodipine; Valsartan
Clonmel Healthcare Ltd
C09DB; C09DB01
Amlodipine; Valsartan
5/160 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and calcium channel blockers; valsartan and amlodipine
Marketed
2016-09-09
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER AMLODIPINE/VALSARTAN CLONMEL 5MG/80MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN CLONMEL 5MG/160MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN CLONMEL 10MG/160MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN 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 Amlodipine/Valsartan Clonmel is and what it is used for 2. What you need to know before you take Amlodipine/Valsartan Clonmel 3. How to take Amlodipine/Valsartan Clonmel 4. Possible side effects 5. How to store Amlodipine/Valsartan Clonmel 6. Contents of the pack and other information 1. WHAT AMLODIPINE/VALSARTAN CLONMEL IS AND WHAT IT IS USED FOR Amlodipine/Valsartan Clonmel tablets contain two substances called AMLODIPINE and VALSARTAN . Both of these substances help to control high blood pressure. • Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening. • Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II. This means that both of these substances help to stop the blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered. Amlodipine/Valsartan Clonmel is used to treat high blood pressure in adults whose blood pressure Přečtěte si celý dokument
Health Products Regulatory Authority 08 August 2022 CRN00CZSC Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amlodipine/Valsartan Clonmel 5 mg/160 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg amlodipine (as amlodipine besilate) and 160 mg valsartan For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Dark yellow, oval, biconvex film-coated tablets with length of 14.6±0.2mm and width 6.8±0.2mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Amlodipine/valsartan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The recommended dose of Amlodipine/Valsartan Clonmel is one tablet per day. Amlodipine/valsartan 5 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone. Amlodipine/Valsartan Clonmel can be used with or without food. Individual dose titration with the components (i.e. amlodipine and valsartan) is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered. For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Amlodipine/Valsartan Clonmel containing the same component doses. RENAL IMPAIRMENT There are no available clinical data in severely renally impaired patients. No dosage adjustment is required for patients with mild to moderate renal impairment. Monitoring of potassium levels and creatinine is advised in moderate renal impairment. HEPATIC IMPAIRMENT Amlodipine/valsartan is contraindicated in patients with severe hepatic impairment (see section 4.3). Caution should be exercised when administering amlodipine/valsartan to patients with hepatic impairment or biliary obstructive dis Přečtěte si celý dokument