Candesartan cilexetil/Hydrochloorthiazide Torrent 16 mg/12,5 mg tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CANDESARTANCILEXETIL 16 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk

Beschikbaar vanaf:

Torrent Pharma GmbH Sudwestpark 50 90449 NURNBERG (DUITSLAND)

ATC-code:

C09DA06

INN (Algemene Internationale Benaming):

CANDESARTANCILEXETIL 16 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; DINATRIUMEDETAAT 2-WATER ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAÏSZETMEEL,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Candesartan And Diuretics

Product samenvatting:

Hulpstoffen: CALCIUMSTEARAAT (E 470A); CELLULOSE, MICROKRISTALLIJN (E 460); DINATRIUMEDETAAT 2-WATER; HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAÏSZETMEEL;

Autorisatie datum:

2011-08-23

Bijsluiter

Candesartan cilexetil/Hydrochloorthiazide Torrent 8 mg/12,5 mg, 16
mg/12,5 mg, 32 mg/12,5 mg, 32 mg/25 mg tabletten
Page 1
– NL/H/2070/001-002,005-006/DC
NL (common) pl
NL/p/004/16/11
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDESARTAN CILEXETIL/HYDROCHLOORTHIAZIDE
TORRENT 8 MG/12,5 MG TABLETTEN
CANDESARTAN CILEXETIL/HYDROCHLOORTHIAZIDE TORRENT 16 MG/12,5 MG
TABLETTEN
CANDESARTAN CILEXETIL/HYDROCHLOORTHIAZIDE TORRENT 32 MG/12,5 MG
TABLETTEN
CANDESARTAN CILEXETIL/HYDROCHLOORTHIAZIDE TORRENT 32 MG/25 MG
TABLETTEN
candesartan cilexetil, 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 Candesartan cilexetil/Hydrochloorthiazide Torrent is and what
it is used for
2. What you need to know before you take Candesartan
cilexetil/Hydrochloorthiazide Torrent
3. How to take Candesartan cilexetil/Hydrochloorthiazide Torrent
4. Possible side effects
5. How to store Candesartan cilexetil/Hydrochloorthiazide Torrent
6. Contents of the pack and other information
1. WHAT CANDESARTAN CILEXETIL/HYDROCHLOORTHIAZIDE TORRENT IS AND
WHAT IT IS USED FOR
The name of your medicine is Candesartan cilexetil/Hydrochloorthiazide
Torrent. It is used for treating
high blood pressure (hypertension) in adult patients. It contains two
active ingredients: candesartan
cilexetil and hydrochlorothiazide. These work together to lower your
blood pressure.
•
Candesartan cilexetil belongs to a group of medicines called
angiotensin II receptor antagonists. It
makes your blood vessels relax and widen. This helps to l

Productkenmerken

Candesartan cilexetil/Hydrochloorthiazide Torrent 8 mg/12,5 mg, 16
mg/12,5 mg, 32 mg/12,5 mg. 32 mg/25 mg tabletten – Page 1
NL/H/2070/001-002,005-006/DC
NL (common) SmPC
NL/s/001/16/7
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Candesartan cilexetil/Hydrochloorthiazide Torrent 8 mg/12,5 mg
tabletten
Candesartan cilexetil/Hydrochloorthiazide Torrent 16 mg/12,5 mg
tabletten
Candesartan cilexetil/Hydrochloorthiazide Torrent 32 mg/12,5 mg
tabletten
Candesartan cilexetil/Hydrochloorthiazide Torrent 32 mg/25 mg
tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Candesartan cilexetil/Hydrochloorthiazide Torrent 8 mg/12,5 mg:
One tablet contains 8 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
Each tablet contains 69.72 mg lactose monohydrate.
Candesartan cilexetil/Hydrochloorthiazide Torrent 16 mg/12,5 mg:
One tablet contains 16 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
Each tablet contains 61.2 mg lactose monohydrate.
Candesartan cilexetil/Hydrochloorthiazide Torrent 32 mg/12,5 mg:
One tablet contains 32 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
Each tablet contains 112.1 mg lactose monohydrate.
Candesartan cilexetil/Hydrochloorthiazide Torrent 32 mg/25 mg:
One tablet contains 32 mg candesartan cilexetil and 25 mg
hydrochlorothiazide.
Each tablet contains 98.82 mg lactose monohydrate.
This medicine contains less than 1 mmol sodium (23 mg) per tablet.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Candesartan cilexetil/Hydrochloorthiazide Torrent 8 mg/12,5 mg:
White to off white, oval, biconvex, 9.5 x 4.5 mm, bevel edged uncoated
tablets with breakline on
both sides.
Candesartan cilexetil/Hydrochloorthiazide Torrent 16 mg/12,5 mg:
Peach colored to light orange colored, oval, biconvex, 9.5 x 4.5 mm,
bevel edged uncoated tablets
with breakline on both sides.
Candesartan cilexetil/Hydrochloorthiazide Torrent 32 mg/12,5 mg:
Light yellow colored to yellow colored, oval, biconvex, 11.0 mm x 6.5
mm, bevel edged uncoated
t