País: Alemanya
Idioma: alemany
Font: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
Amlodipinbesilat; Valsartan; Hydrochlorothiazid
betapharm Arzneimittel GmbH (3364323)
C09DX01
Amlodipine Besylate, Valsartan, Hydrochlorothiazide
Filmtablette
Teil 1 - Filmtablette; Amlodipinbesilat (24866) 13,87 Milligramm; Valsartan (26826) 160 Milligramm; Hydrochlorothiazid (00512) 25 Milligramm
zum Einnehmen
zugelassen
2019-10-17
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER [INVENTED NAME] 5 MG/160 MG/12.5 MG FILM-COATED TABLETS [INVENTED NAME] 10 MG/160 MG/12.5 MG FILM-COATED TABLETS [INVENTED NAME] 5 MG/160 MG/25 MG FILM-COATED TABLETS [INVENTED NAME] 10 MG/160 MG/25 MG FILM-COATED TABLETS [INVENTED NAME] 10 MG/320 MG/25 MG FILM-COATED TABLETS amlodipine/valsartan/hydrochlorothiazide 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 [Invented Name] is and what it is used for 2. What you need to know before you take [Invented Name] 3. How to take [Invented Name] 4. Possible side effects 5. How to store [Invented Name] 6. Contents of the pack and other information 1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR [Invented Name] contains three substances called amlodipine, valsartan and hydrochlorothiazide. All 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. - Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”. Hydrochlorothiazide increases urine output, which also lowers blood pressure. As a result of all three mechanisms, t Llegiu el document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Invented Name] 5 mg/160 mg/12.5mg film-coated Tablets [Invented Name] 10 mg/160 mg/12.5mg film-coated Tablets [Invented Name] 5 mg/160 mg/25mg film-coated Tablets [Invented Name] 10 mg/160 mg/25mg film-coated Tablets [Invented Name] 10 mg/320 mg/25mg film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Invented Name] 5 mg/160 mg/12.5mg film-coated Tablets Each film-coated tablet contains 5 mg of Amlodipine (as Amlodipine besilate), 160 mg of Valsartan and 12.5 mg of Hydrochlorothiazide. [Invented Name] 10 mg/160 mg/12.5mg film-coated Tablets Each film-coated tablet contains 10 mg of Amlodipine (as Amlodipine besilate), 160 mg of Valsartan and 12.5 mg of Hydrochlorothiazide. [Invented Name] 5 mg/160 mg/25mg film-coated Tablets Each film-coated tablet contains 5 mg of Amlodipine (as Amlodipine besilate), 160 mg of Valsartan and 25 mg of Hydrochlorothiazide. [Invented Name] 10 mg/160 mg/25mg film-coated Tablets Each film-coated tablet contains 10 mg of Amlodipine (as Amlodipine besilate), 160 mg of Valsartan and 25 mg of Hydrochlorothiazide. [Invented Name] 10 mg/320 mg/25mg film-coated Tablets Each film-coated tablet contains 10 mg of Amlodipine (as Amlodipine besilate), 320 mg of Valsartan and 25 mg of Hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. [Invented Name] 5 mg/160 mg/12.5mg film-coated Tablets White, oval shaped, biconvex, film-coated tablets debossed with “T23” on one side and plain on other side. (Dimension - 15.1± 0.3 mm X 7.1± 0.3 mm) [Invented Name] 10 mg/160 mg/12.5mg film-coated Tablets Pale yellow, oval shaped, biconvex, film-coated tablets debossed with “C96” on one side and plain on other side. (Dimension - 15.6 ± 0.3 mm X 6.6 ± 0.3 mm) [Invented Name] 5 mg/160 mg/25mg film-coated Tablets Yellow, oval shaped, biconvex, film-coated tablets debossed with “T25” on one side and plain on other side. (Dimension- 15.1± 0.3 mm X 7.1± 0.3 Llegiu el document complet