Telmisartan/Hydrochloorthiazide Sandoz 40 mg/12,5 mg, omhulde tabletten

Country: Belanda

Bahasa: Belanda

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

Bahan aktif:

HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; TELMISARTAN 40 mg/stuk

Boleh didapati daripada:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Kod ATC:

C09DA07

INN (Nama Antarabangsa):

HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; TELMISARTAN 40 mg/stuk

Borang farmaseutikal:

Omhulde tablet

Komposisi:

CITROENZUUR 1-WATER (E 330) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MEGLUMINE ; NATRIUMHYDROXIDE (E 524) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E 1203) ; POVIDON K 25 (E 1201) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551), CITROENZUUR 1-WATER (E 330) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; 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),

Laluan pentadbiran:

Oraal gebruik

Kawasan terapeutik:

Telmisartan And Diuretics

Ringkasan produk:

Hulpstoffen: CITROENZUUR 1-WATER (E 330); CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); 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);

Tarikh kebenaran:

2013-11-05

Risalah maklumat

Sandoz B.V.
Page 1/13
Telmisartan/hydrochloorthiazide Sandoz 40/12,5 mg,
80/12,5 mg, 80/25 mg, omhulde tabletten
RVG 111922, 111923, 111924
1311-v10
1.3.1.3 Bijsluiter
Oktober 2022
NOTICE:
LIGHT
BLUE
HIGHLIGHTED
TEXT
SHOULD
BE
CONSIDERED
ONLY
IN
THE
PLS
OF
[NATIONALLY
COMPLETED NAME] 40 MG/12.5 AND [NATIONALLY COMPLETED NAME] 80 MG/12.5.
LIGHT
GREEN
HIGHLIGHTED
TEXT
SHOULD
BE
CONSIDERED
ONLY
IN
THE
PL
OF
[NATIONALLY
COMPLETED NAME] 80 MG/25 MG.
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN/HYDROCHLOOTHIAZIDE SANDOZ 40 MG/12,5 MG, OMHULDE TABLETTEN
TELMISARTAN/HYDROCHLOOTHIAZIDE SANDOZ 80 MG/12,5 MG, OMHULDE TABLETTEN
TELMISARTAN/HYDROCHLOOTHIAZIDE 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

Ciri produk

Sandoz B.V.
Page 1/27
Telmisartan/hydrochloorthiazide Sandoz 40/12,5 mg,
80/12,5 mg, 80/25 mg, omhulde tabletten
RVG 111922, 111923, 111924
1311-V10
1.3.1.1 Samenvatting van de Productkenmerken
December 2021
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]
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)
Sandoz B.V.
Page 2/27
Telmisartan/hydrochloorthiazide Sandoz 40/12,5 mg,
80/12,5 mg, 80/25 mg, omhulde tabletten
RVG 111922, 111923, 111924
1311-V10
1.3.1.1 Samenvatting van de Productkenmerken
December 2021
[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
na