Telmisartan/Hydrochloorthiazide Sandoz 80 mg/12,5 mg, omhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

HYDROCHLOORTHIAZIDE ; TELMISARTAN

Beschikbaar vanaf:

Sandoz B.V.

ATC-code:

C09DA07

INN (Algemene Internationale Benaming):

HYDROCHLOROTHIAZIDE ; TELMISARTAN

farmaceutische vorm:

Omhulde tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Telmisartan And Diuretics

Product samenvatting:

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);

Autorisatie datum:

2013-11-05

Bijsluiter

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

Productkenmerken

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]