Benazepril HCl/Hydrochloorthiazide 10/12,5, filmomhulde tabletten 10 mg/12,5 mg

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BENAZEPRILHYDROCHLORIDE 10 mg/stuk SAMENSTELLING overeenkomend met ; BENAZEPRIL 9,21 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk

Beschikbaar vanaf:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-code:

C09BA07

INN (Algemene Internationale Benaming):

BENAZEPRILHYDROCHLORIDE 10 mg/stuk SAMENSTELLING overeenkomend met ; BENAZEPRIL 9,21 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CASTOROLIE, GEHYDREERD ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Benazepril And Diuretics

Product samenvatting:

Hulpstoffen: CASTOROLIE, GEHYDREERD; CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 4000; MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2003-12-22

Bijsluiter

Sandoz B.V.
Page 1/10
Benazepril HCl/Hydrochloorthiazide 10/12,5 en 20/25,
filmomhulde tabletten RVG 28629-30
V13
1.3.1.3 Package leaflet
Februari 2022
Note: Yellow highlighted ongoing IA variation NL/H/0529/IA/030 and
NL/H/0530/IA/029
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BENAZEPRIL HCL/HYDROCHLOORTHIAZIDE 10/12,5, FILMOMHULDE TABLETTEN 10
MG/12,5 MG
BENAZEPRIL HCL/HYDROCHLOORTHIAZIDE 20/25, FILMOMHULDE TABLETTEN 20
MG/25 MG
benazepril hydrochloride and 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 used to treat:
•
HIGH BLOOD PRESSURE
, which cannot be adequately lowered using other medicines containing
benazepril
alone.
Benazepril contains two active substances. Benazepril belongs to the
medicine group called ACE inhibitors.
It relieves the heart by reducing blood pressure and widening blood
vessels.
Hydrochlorothiazide is known as a “water tablet” and increases
urine output.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]:
•
if you are ALLERGIC
to benazepril hydrochloride and hydrochlorothiazide or any of the
other ingredients

Productkenmerken

Sandoz B.V.
Page 1/19
Benazepril HCl/Hydrochloorthiazide 10/12,5 en 20/25,
filmomhulde tabletten RVG 28629-30
V14
1.3.1.1 Summary of Product Characteristics
Februari 2022
Note: Yellow highlighted ongoing IA variation NL/H/0529/IA/030 and
NL/H/0530/IA/029
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Benazepril HCl/Hydrochloorthiazide 10/12,5, filmomhulde tabletten 10
mg/12,5 mg
Benazepril HCl/Hydrochloorthiazide 20/25, filmomhulde tabletten 20
mg/25 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains benazepril hydrochloride 10 mg and
hydrochlorothiazide 12.5 mg.
Excipient with known effect
Each film-coated tablet contains 106.9 mg lactose (as monohydrate).
Each film-coated tablet contains benazepril hydrochloride 20 mg and
hydrochlorothiazide 25 mg.
Excipient with known effect
Each film-coated tablet contains 213.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
10/12.5 mg: round, pink, film-coated tablet, convex with a breaking
notch on one side.
20/25 mg: white to off white, round film-coated tablet, convex with a
cross breaking notch on one side.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of patients with essential hypertension who have
insufficiently responded to treatment with
benazepril as monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The administration of the fixed combination of benazepril and
hydrochlorothiazide is usually
recommended after dose titration with the individual components. When
clinically appropriate a direct
change from monotherapy to the fixed combination may be considered.
In patients who do not respond to monotherapy with benazepril (10 or
20 mg) once daily, therapy
should be converted to half a tablet of Benazepril
HCl/Hydrochlorothiazide 10/12.5. If the blood
pressure cannot sufficiently be controlled after 3 to 4 weeks, a dose
increase up to 10 mg benazepril HCl
and 12.5 mg hydroch