Telmisartan Torrent 40 mg tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

TELMISARTAN

Beschikbaar vanaf:

Torrent Pharma GmbH Sudwestpark 50 90449 NURNBERG (DUITSLAND)

ATC-code:

C09CA07

INN (Algemene Internationale Benaming):

TELMISARTAN

farmaceutische vorm:

Tablet

Samenstelling:

MANNITOL (D-) (E 421) ; MEGLUMINE ; NATRIUMHYDROXIDE (E 524) ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Telmisartan

Product samenvatting:

Hulpstoffen: MANNITOL (D-) (E 421); MEGLUMINE; NATRIUMHYDROXIDE (E 524); NATRIUMSTEARYLFUMARAAT; POVIDON K 30 (E 1201);

Autorisatie datum:

2012-07-17

Bijsluiter

Telmisartan Torrent, 20/40/80 mg, tablets – NL/H/2404/001-003/DC
Page 1
NL pl
NL/p/004/13/8
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN TORRENT 20 MG TABLETTEN
TELMISARTAN TORRENT 40 MG TABLETTEN
TELMISARTAN TORRENT 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 [product name] is and what it is used for
2. What you need to know before you take [product name]
3. How to take [product name]
4. Possible side effects
5. How to store [product name]
6. Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[product 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. [product name] blocks the effect of
angiotensin II so that the blood
vessels relax, and your blood pressure is lowered.
[PRODUCT 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 measure blood pressure
to verify if it is within the normal range.
[PRODUCT NAME] IS ALSO USED TO reduce cardiovascular events (i.e.

Productkenmerken

Telmisartan Torrent, 20/40/80 mg, tablets – NL/H/2404/001-003/DC
Page 1
NL SmPC
NL/s/001/13/7
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Telmisartan Torrent 20 mg tabletten
Telmisartan Torrent 40 mg tabletten
Telmisartan Torrent 80 mg tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[product name] 20 mg tablets
Each tablet contains 20 mg telmisartan.
[product name] 40 mg tablets
Each tablet contains 40 mg telmisartan.
[product name] 80 mg tablets
Each tablet contains 80 mg telmisartan.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
[product name] 20 mg tablets
White or off white to yellowish, round, uncoated tablets with a
diameter of approx. 7.2 mm, plain on
both sides.
[product name] 40 mg tablets
White or off-white to yellowish, oblong, biconvex uncoated tablets,
approx. 12.0 x 5.9 mm, with
breakline on one side and plain on the other side. The tablet can be
divided into equal doses.
[product name] 80 mg tablets
White or off-white to yellowish, oval, biconvex uncoated tablets,
approx. 16.3 x 6.9 mm, with
breakline on one side and plain on other sides. The tablet 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:
i) manifest atherothrombotic cardiovascular disease (history of
coronary heart disease, stroke, or
peripheral arterial disease) or
ii) type 2 diabetes mellitus with documented target organ damage
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Telmisartan Torrent, 20/40/80 mg, tablets – NL/H/2404/001-003/DC
Page 2
NL SmPC
NL/s/001/13/7
Treatment of essential hypertension
The usually effective dose is 40 mg once daily. Some patients may
already benefit at a daily dose of
20 mg. In cases where the target blood pressure is not achieved, the
dose of telmisartan can be
increased to a maximum of 80 mg once daily. Alternatively, telmisartan
may be used in combination
wi