Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TELMISARTAN
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
C09CA07
TELMISARTAN
Tablet
CROSPOVIDON (E 1202) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MEGLUMINE ; NATRIUMHYDROXIDE (E 524) ; POVIDON K 25 (E 1201) ; POVIDON K 30 (E 1201),
Oraal gebruik
Telmisartan
Hulpstoffen: CROSPOVIDON (E 1202); LACTOSE 0-WATER; LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MEGLUMINE; NATRIUMHYDROXIDE (E 524); POVIDON K 25 (E 1201); POVIDON K 30 (E 1201);
2011-02-22
Sandoz B.V. Page 1/9 Telmisartan Sandoz 20/40/80 mg RVG 105913/4/5 V9 1.3.1.3 Bijsluiter Mei 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TELMISARTAN SANDOZ ® 20 MG, TABLETTEN TELMISARTAN SANDOZ ® 40 MG, TABLETTEN TELMISARTAN SANDOZ ® 80 MG, TABLETTEN telmisartan 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] belongs to a class of medicines known as 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. [Nationally completed name] blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. [Nationally completed name] IS USED TO treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition. 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 before damage occurs. Thus it is important to regularly measur Lees het volledige document
Sandoz B.V. Page 1/19 Telmisartan Sandoz 20/40/80 mg RVG 105913-4 V9 1.3.1.1 Samenvatting van de Productkenmerken Mei 2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Telmisartan Sandoz 20 mg, tabletten Telmisartan Sandoz 40 mg, tabletten Telmisartan Sandoz 80 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg telmisartan. Excipient(s) with known effect Each tablet contains 76.690 mg lactose (as lactose anhydrous and lactose monohydrate) and 0.97 mg (0.042 mmol) sodium (as sodium hydroxide). Each tablet contains 40 mg telmisartan. Excipient(s) with known effect Each tablet contains 153.381 mg lactose (as lactose anhydrous and lactose monohydrate) and 1.94 mg (0.084 mmol) sodium (as sodium hydroxide). Each tablet contains 80 mg telmisartan. Excipient(s) with known effect Each tablet contains 306.761 mg lactose (as lactose anhydrous and lactose monohydrate) and 3.88 mg (0.169 mmol) sodium (as sodium hydroxide). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. [Nationally completed name] White, round, plane tablet, debossed with ‘20’ on one side. The tablets dimension is 6.9-7.2 mm. [Nationally completed name] White, oblong, plane tablet, scored on one side and debossed with ‘40’ on the other side. The tablets are 11.5-11.8 mm long and 6.4-6.8 mm wide. Sandoz B.V. Page 2/19 Telmisartan Sandoz 20/40/80 mg RVG 105913-4 V9 1.3.1.1 Samenvatting van de Productkenmerken Mei 2020 [Nationally completed name] White, oblong, plane tablet, scored on one side and debossed with ‘80’ on the other side. The tablets are 14.7-15.0 mm long and 8.2-8.6 mm wide. The tablet with a score line can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in adults with: • manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial diseas Lees het volledige document