Land: Niederlande
Sprache: Niederländisch
Quelle: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
HYDROCHLOORTHIAZIDE ; TELMISARTAN
Sandoz B.V.
C09DA07
HYDROCHLOROTHIAZIDE ; TELMISARTAN
Omhulde tablet
CITROENZUUR 1-WATER (E 330) ; CROSPOVIDON (E 1202) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MEGLUMINE ; NATRIUMHYDROXIDE (E 524) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E1203) ; POVIDON K 25 (E 1201) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551),
Oraal gebruik
Telmisartan And Diuretics
Hulpstoffen: CITROENZUUR 1-WATER (E 330); CROSPOVIDON (E 1202); LACTOSE 0-WATER; LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MEGLUMINE; NATRIUMHYDROXIDE (E 524); POLYETHYLEENGLYCOL (E 1521); POLYVINYLALCOHOL (E1203); POVIDON K 25 (E 1201); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551);
2013-11-05
Sandoz B.V. Page 1/12 Telmisartan/Hydrochloorthiazide Sandoz 40/12,5 mg, 80/12,5 mg, 80/25 mg, omhulde tabletten RVG 111925, 111926, 111927 1311-V7 1.3.1.3 Bijsluiter Januari 2019 PACKAGE LEAFLET: INFORMATION FOR THE USER TELMISARTAN/HYDROCHLOORTHIAZIDE SANDOZ 40 MG/12,5 MG, OMHULDE TABLETTEN TELMISARTAN/HYDROCHLOORTHIAZIDE SANDOZ 80 MG/12,5 MG, OMHULDE TABLETTEN TELMISARTAN/HYDROCHLOORTHIAZIDE SANDOZ 80 MG/25 MG, OMHULDE 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 [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [nationally completed name] 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 lo Lesen Sie das vollständige Dokument
Sandoz B.V. Page 1/26 Telmisartan/Hydrochloorthiazide Sandoz 40/12,5 mg, 80/12,5 mg, 80/25 mg, omhulde tabletten RVG 111925, 111926, 111927 1311-V7 1.3.1.1 Samenvatting van de Productkenmerken Januari 2019 1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Telmisartan/Hydrochloorthiazide Sandoz 40 mg/12,5 mg, omhulde tabletten Telmisartan/Hydrochloorthiazide Sandoz 80 mg/12,5 mg, omhulde tabletten Telmisartan/Hydrochloorthiazide Sandoz 80 mg/25 mg, omhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Invented name, 40/12.5 mg, coated tablets] Each coated tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. [Invented name, 80/12.5 mg, coated tablets] Each coated tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. [Invented name, 80/25 mg, coated tablets] Each coated tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide. Excipient(s) with known effect: [Invented name, 40/12.5 mg, coated tablets] Contains 153.4 mg lactose. [Invented name, 80/12.5 mg, coated tablets] Contains 306.8 mg lactose. [Invented name, 80/25 mg, coated tablets] Contains 306.8 mg lactose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Coated tablet. [Invented name, 40/12.5 mg, coated tablets] Red, oval, biconvex coated tablet debossed with 40 on one side and with 12.5 on the other side (12.4 mm x 6.2 mm). [Invented name, 80/12.5 mg, coated tablets] Sandoz B.V. Page 2/26 Telmisartan/Hydrochloorthiazide Sandoz 40/12,5 mg, 80/12,5 mg, 80/25 mg, omhulde tabletten RVG 111925, 111926, 111927 1311-V7 1.3.1.1 Samenvatting van de Productkenmerken Januari 2019 White to off-white, oval, biconvex coated tablet debossed with 80 on one side and with 12.5 on the other side (15.4 mm x 8.0 mm) [Invented name, 80/25 mg, coated tablets] Yellow, oval, biconvex coated tablet debossed with 80 on one side and with 25 on the other side (15.4 mm x 8.0 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. [nationally completed name] Lesen Sie das vollständige Dokument