Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
VALSARTAN, AMLODIPINE BESILATE
Teva B.V.
VALSARTAN, AMLODIPINE BESILATE
5/80 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
2017-03-10
PRODUCT: 1 7-4-17 WA INDESIGN CS6 Body: Univers 55 Roman/ 65 Bold/ 55 Oblique 9pts Subhead: Univers 65 Bld 11pts Header: Univers 65 Bld 13pts 48793 AMLODIPINE/VALSARTAN (BEVACOMB) 5MG/80MG, 5MG/160MG, 10MG/160MG FC TABS ALL (DUPNITSA) TEI 7-4-17 190 x 380mm WA Leafl et CUTTER GUIDE PMS PROCESS BLACK PMS GREEN - Y Y - SUPPLIER INSTRUCTIONS Artwork, text and content must NOT be altered. The only exceptions to this are: bleeds, chokes, spreads or other adjustments required for print reproduction purposes only. If you have any diffi culties please contact the Teva Artwork Team. We must receive a copy of the 3rd Party Vendors Proof before fi nal approval can be made. BEVACOMB 5 MG/80 MG FILM-COATED TABLETS BEVACOMB 5 MG/160 MG FILM-COATED TABLETS BEVACOMB 10 MG/160 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. 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 leafl et. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT BEVACOMB IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BEVACOMB 3. HOW TO TAKE BEVACOMB 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BEVACOMB 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT BEVACOMB IS AND WHAT IT IS USED FOR Bevacomb 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 Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bevacomb 5 mg/80mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Yellow, 8mm round, biconvex, film-coated tablet, imprinted with “I” on one side and “LD” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Bevacomb 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 Bevacomb is one tablet per day. Bevacomb 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone. Bevacomb 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 Bevacomb 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_ Bevacomb is contraindicated in patients with severe hepatic impairment (see section 4.3). Caution should be exercised when administering Bevacomb to patients with hepatic impairment or biliary obstructive disorders (see section 4.4). In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan. Amlodipine dosage recommendati Citiți documentul complet