Χώρα: Ολλανδία
Γλώσσα: Ολλανδικά
Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
HYDROCHLOORTHIAZIDE ; TELMISARTAN
Apotex Europe BV
C09DA07
HYDROCHLOROTHIAZIDE ; TELMISARTAN
Tablet
CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE ROOD (E 172) ; ISOMALT (E 953) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MEGLUMINE ; POVIDON K 30 (E 1201),
Oraal gebruik
Telmisartan And Diuretics
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE ROOD (E 172); ISOMALT (E 953); KALIUMHYDROXIDE (E 525); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); MEGLUMINE; POVIDON K 30 (E 1201);
2016-01-21
TELHYD 40/12,5, 80/12,5, 80/25 MG, TABLETTEN – RVG 116678-79-80 MODULE 1.3 Product Information Version: 2019-02-22 MODULE 1.3.1 Package Leaflet Replaces: 2018-01-26b 1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ TELHYD 40 MG/12,5 MG TABLETTEN TELHYD 80 MG/12,5 MG TABLETTEN TELHYD 80 MG/25 MG TABLETTEN Telmisartan/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 Telhyd is and what it is used for 2 What you need to know before you take Telhyd 3 How to take Telhyd 4 Possible side effects 5 How to store Telhyd 6 Contents of the pack and other information 1. WHAT TELHYD IS AND WHAT IT IS USED FOR Telhyd is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both of these substances help to control high blood pressure. - Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin-II is a substance produced in your body which causes your blood vessels to narrow thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. - Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase, leading to a lowering of your blood pressure. High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure be Διαβάστε το πλήρες έγγραφο
TELHYD 40 MG/12,5 MG / 80 MG/12,5 MG / 80 MG/25 MG, TABLETS - RVG 116678-79-80 MODULE 1.3 Product Information Version: 2018-11-19 MODULE 1.3.1 Summary of Product Characteristics Replaces: 2018-01-26d 1 1. NAME OF THE MEDICINAL PRODUCT Telhyd 40 mg/12,5 mg tabletten Telhyd 80 mg/12,5 mg tabletten Telhyd 80 mg/25 mg tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide. Excipients with known effect: 40 mg/12.5 mg: 135.25 mg Isomalt (E953) Excipients with known effect: 80 mg/12.5 mg: 270.50 mg Isomalt (E953) Excipients with known effect: 80 mg/25 mg: 270.50 mg Isomalt (E953) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 40 mg/12.5 mg: White and red coloured, two layered, modified capsule shaped, biconvex uncoated tablets, 14.1 x 6.9 mm with “APO” engraved on one side and “40/12.5” on the other side. White layer may contain red specks and red layer may contain white specks 80 mg/12.5 mg: White and red coloured, two layered, modified capsule shaped, biconvex uncoated tablets, 16.3 x 8.0 mm with “APO” engraved on one side and “80/12.5” on the other side. White layer may contain red specks and red layer may contain white specks. 80 mg/25 mg: White and yellow coloured, two layered, modified capsule-shaped, biconvex uncoated tablets, 16.3 x 8.0 mm with “APO” engraved on one side and “80/25” on the other side. White layer may contain yellow specks and yellow layer may contain white specks. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. TELHYD 40 MG/12,5 MG / 80 MG/12,5 MG / 80 MG/25 MG, TABLETS - RVG 116678-79-80 MODULE 1.3 Product Information Version: 2018-11-19 MODULE 1.3.1 Summary of Product Characteristics Replaces: 2018-01-26d 2 Telhyd 40 mg/12.5 mg and Telhyd 80 mg/12.5 mg Telhyd fixed dose combination (40 mg Διαβάστε το πλήρες έγγραφο