Benazepril HCl/Hydrochloorthiazide 20/25, filmomhulde tabletten 20 mg/25 mg

Country: Холандија

Језик: Холандски

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

Активни састојак:

BENAZEPRILHYDROCHLORIDE SAMENSTELLING overeenkomend met ; BENAZEPRIL ; HYDROCHLOORTHIAZIDE

Доступно од:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

АТЦ код:

C09BA07

INN (Међународно име):

BENAZEPRILHYDROCHLORIDE COMPOSITION corresponding to ; BENAZEPRIL ; HYDROCHLOROTHIAZIDE

Фармацеутски облик:

Filmomhulde tablet

Састав:

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

Пут администрације:

Oraal gebruik

Терапеутска област:

Benazepril And Diuretics

Резиме производа:

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

Датум одобрења:

2003-12-22

Информативни летак

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
of this medicine (listed in section 6)

if you are ALLERGIC to other ACE inhibitors e.g. ramipril or to
sulphonamide-derived medicines (mostly
antibiotics e.g. sulfamethoxazole)

if you are UNABLE TO PRODUCE URINE

if you have S

Карактеристике производа

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 hydrochlorothiazide can be conducted. If the blood
pressure is still not yet under control
after the same period has passed, the dose increase can go up to 20 mg
benazepril HCl and 25 mg
hydrochlorothiazide.
In patients for whom this dosage scheme is not suffici