Χώρα: Σουηδία
Γλώσσα: Σουηδικά
Πηγή: Läkemedelsverket (Medical Products Agency)
amlodipinbesilat; valsartan
Genericon Pharma Ges.m.b.H.
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, 60 tabletter; Blister, 56 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Blister, 280 tabletter
Avregistrerad
2017-01-27
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMLODIPINE/VALSARTAN GENERICON 5 MG/80 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN GENERICON 5 MG/160 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN GENERICON 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 Amlodipine/Valsartan Genericon is and what it is used for 2. What you need to know before you take Amlodipine/Valsartan Genericon 3. How to take Amlodipine/Valsartan Genericon 4. Possible side effects 5. How to store Amlodipine/Valsartan Genericon 6. Contents of the pack and other information 1. WHAT AMLODIPINE/VALSARTAN GENERICON IS AND WHAT IT IS USED FOR Amlodipine/Valsartan Genericon 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 Genericon is used to treat high blood Διαβάστε το πλήρες έγγραφο
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Amlodipine/Valsartan Genericon 5 mg/80 mg film-coated tablets Amlodipine/Valsartan Genericon 5 mg/160 mg film-coated tablets Amlodipine/Valsartan Genericon 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. Amlodipine/Valsartan Genericon 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 Genericon is one tablet per day. Amlodipine/Valsartan Genericon 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. Amlodipine/Valsartan Genericon 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. 3 Amlodipine/Valsartan Genericon 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 Amlodipine/Valsartan Genericon 5 mg/160 mg. Amlodipine/Valsartan G Διαβάστε το πλήρες έγγραφο