Telmisartan/Hydrochloorthiazide Apotex 40 mg/12,5 mg tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

HYDROCHLOORTHIAZIDE ; TELMISARTAN

Beschikbaar vanaf:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC-code:

C09DA07

INN (Algemene Internationale Benaming):

HYDROCHLOROTHIAZIDE ; TELMISARTAN

farmaceutische vorm:

Tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE ROOD (E 172) ; ISOMALT (E 953) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MEGLUMINE ; POVIDON K 30 (E 1201),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Telmisartan And Diuretics

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE ROOD (E 172); ISOMALT (E 953); KALIUMHYDROXIDE (E 525); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); MEGLUMINE; POVIDON K 30 (E 1201);

Autorisatie datum:

2013-10-28

Bijsluiter

1
TELMISARTAN/HYDROCHLOORTHIAZIDE APOTEX 40/12.5, 80/12.5, 80/25 MG
TABLETS
RVG 112003-4-5
MODULE 1.3
Product Information
Version: 2019-08
MODULE 1.3.1
Package Leaflet
Replaces : 2018-03-
262018-03-26b
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN/HYDROCHLOORTHIAZIDE
APOTEX 40 MG/12,5 MG
TABLETTEN
TELMISARTAN/HYDROCHLOORTHIAZIDE
APOTEX 80 MG/12,5 MG
TABLETTEN
TELMISARTAN/HYDROCHLOORTHIAZIDE
APOTEX 80 MG/25 MG
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 Telmisartan/Hydrochloorthiazide Apotex is and what it is used for
2
What you need to know before you take Telmisartan/Hydrochloorthiazide
Apotex
3
How to take Telmisartan/Hydrochloorthiazide Apotex
4
Possible side effects
5
How to store Telmisartan/Hydrochloorthiazide Apotex
6
Contents of the pack and other information
1.
WHAT TELMISARTAN/HYDROCHLOORTHIAZIDE APOTEX IS AND WHAT IT IS USED FOR
Telmisartan/Hydrochloorthiazide Apotex 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,

Productkenmerken

1
TELMISARTAN/HYDROCHLOROTHIAZIDE APOTEX
40 MG/12.5 MG / 80 MG/12.5 MG / 80 MG/25 MG, TABLETS
RVG 112003-4-5
MODULE 1.3
Product Information
Version: 2019-08
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2018-03-26b
1. NAME OF THE MEDICINAL PRODUCT
Telmisartan/Hydrochloorthiazide
Apotex 40 mg/12,5 mg tabletten
Telmisartan/Hydrochloorthiazide
Apotex 80 mg/12,5 mg tabletten
Telmisartan/Hydrochloorthiazide
Apotex 80 mg/25 mg tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Each tablet contains 80 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Excipients with known effect: 40 mg/12.5 mg: 135.25 mg Isomalt (E953)
Excipients with known effect: 80 mg/12.5 mg: 270.50 mg Isomalt (E953)
Excipients with known effect: 80 mg/25 mg: 270.50 mg Isomalt (E953)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
40 mg/12.5 mg:
White and red coloured, two layered, modified capsule shaped, biconvex
uncoated tablets, 14.1 x 6.9 mm
with “APO” engraved on one side and “40/12.5” on the other
side. White layer may contain red specks and
red layer may contain white specks
80 mg/12.5 mg:
White and red coloured, two layered, modified capsule shaped, biconvex
uncoated tablets, 16.3 x 8.0 mm
with “APO” engraved on one side and “80/12.5” on the other
side. White layer may contain red specks and
red layer may contain white specks.
80 mg/25 mg:
White and yellow coloured, two layered, modified capsule-shaped,
biconvex uncoated tablets, 16.3 x 8.0 mm
with “APO” engraved on one side and “80/25” on the other side.
White layer may contain yellow specks and
yellow layer may contain white specks.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
2
TELMISARTAN/HYDROCHLOROTHIAZIDE APOTEX
40 MG/12.5 MG / 80 MG/12.5 MG / 80 MG/25 MG, TABLETS
RVG 112003-4-5
MODULE 1.3
Product Information
Version: 2019-08
MODULE 1.3.1
Summary of Product Characteri