Land: Sverige
Språk: svensk
Kilde: Läkemedelsverket (Medical Products Agency)
amlodipinbesilat; valsartan
Actavis Group PTC ehf.
C09DB01
amlodipine besylate; valsartan
5 mg/160 mg
Filmdragerad tablett
amlodipinbesilat 6,95 mg Aktiv substans; valsartan 160 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 AMLODIPIN/VALSARTAN ACTAVIS 5 MG/80 MG FILM-COATED TABLETS AMLODIPIN/VALSARTAN ACTAVIS 5 MG/160 MG FILM-COATED TABLETS AMLODIPIN/VALSARTAN ACTAVIS 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 Amlodipin/Valsartan Actavis is and what it is used for 2. What you need to know before you take Amlodipin/Valsartan Actavis 3. How to take Amlodipin/Valsartan Actavis 4. Possible side effects 5. How to store Amlodipin/Valsartan Actavis 6. Contents of the pack and other information 1. WHAT AMLODIPIN/VALSARTAN ACTAVIS IS AND WHAT IT IS USED FOR Amlodipin/Valsartan Actavis 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. Amlodipin/Valsartan Actavis is used to treat high blood pressure in adults whose blood pressure is not controlled Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amlodipin/Valsartan Actavis 5 mg/80 mg film-coated tablets Amlodipin/Valsartan Actavis 5 mg/160 mg film-coated tablets Amlodipin/Valsartan Actavis 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. Amlodipin/Valsartan Actavis 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 Amlodipin/Valsartan Actavis is one tablet per day. Amlodipin/Valsartan Actavis 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. Amlodipin/Valsartan Actavis 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. Amlodipin/Valsartan Actavis 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 Amlodipin/Valsartan Actavis 5 mg/160 mg. Amlodipin/Valsartan Actavis can be used with or without Les hele dokumentet