Negara: Swedia
Bahasa: Swedia
Sumber: Läkemedelsverket (Medical Products Agency)
amlodipinbesilat; valsartan
Teva B.V.
C09DB01
amlodipine besylate; valsartan
10 mg/160 mg
Filmdragerad tablett
valsartan 160 mg Aktiv substans; amlodipinbesilat 13,9 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 7 tabletter; Blister, 14 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Blister, 280 tabletter
Godkänd
2016-11-25
PACKAGE LEAFLET: INFORMATION FOR THE USER 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 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 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 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. Bevacomb is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BEVACOMB DO NOT TAKE BEVACOMB − if you are allergic to amlodipine or to any other calcium c Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bevacomb 5 mg/80 mg film-coated tablets Bevacomb 5 mg/160 mg film-coated tablets Bevacomb 10 mg/160 mg 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. Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan. Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 5mg/80mg Yellow, 8mm round, biconvex, film-coated tablet, imprinted with “I” on one side and “LD” on the other side. 5mg/160mg Yellow, 13.5 x 7mm oval, biconvex, film-coated tablet, imprinted with “2” on one side and “LD” on the other side. 10mg/160mg White, 13.5 x 7mm oval, biconvex, film-coated tablet, imprinted with “3” 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 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. Bevacomb 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Bevacomb 5 mg/160 mg. 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 Baca dokumen lengkapnya