Telmisartan Lek 20 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TELMISARTAN 20 mg/stuk

Beschikbaar vanaf:

Lek Pharmaceuticals d.d. Verovskova ulica 57 1526 LJUBLJANA (SLOVENIË)

ATC-code:

C09CA07

INN (Algemene Internationale Benaming):

TELMISARTAN 20 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Telmisartan

Product samenvatting:

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);

Autorisatie datum:

2011-02-22

Bijsluiter

Lek Pharmaceuticals d.d.
Page 1/10
Telmisartan Lek 20/40/80 mg
RVG 105928-30-31
V9
1.3.1.3 Bijsluiter
Mei 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TELMISARTAN LEK
® 20 MG, TABLETTEN
TELMISARTAN LEK
® 40 MG, TABLETTEN
TELMISARTAN LEK
® 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 me

Productkenmerken

Lek Pharmaceuticals d.d.
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Telmisartan Lek 20/40/80 mg
RVG 105928-30-31
V9
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Telmisartan Lek 20 mg, tabletten
Telmisartan Lek 40 mg, tabletten
Telmisartan Lek 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.
Lek Pharmaceuticals d.d.
Page 2/19
Telmisartan Lek 20/40/80 mg
RVG 105928-30-31
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
peripher