Enalaprilmaleaat/Hydrochloorthiazide 20/12,5, tabletten 20/12,5 mg

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ENALAPRILMALEAAT 20 mg/stuk SAMENSTELLING overeenkomend met ; ENALAPRIL 15,3 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk

Beschikbaar vanaf:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-code:

C09BA02

INN (Algemene Internationale Benaming):

ENALAPRILMALEAAT 20 mg/stuk SAMENSTELLING overeenkomend met ; ENALAPRIL 15,3 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; TALK (E 553 B),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Enalapril And Diuretics

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMWATERSTOFCARBONAAT (E 500 (II)); TALK (E 553 B);

Autorisatie datum:

2006-10-30

Bijsluiter

Hexal AG
Page 1/10
Enalaprilmaleaat/Hydrochloorthiazide 20/12,5, tabletten 20/12,5 mg
RVG 34509
1313-V16
1.3.1.3 Package Leaflet
December 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENALAPRILMALEAAT/HYDROCHLOORTHIAZIDE 20/12,5, TABLETTEN 20/12,5 MG
enalapril maleate/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] tablets contain a combination of enalapril
and hydrochlorothiazide and
are used as a treatment for high blood pressure when treatment with
enalapril as a single agent on its
own has proven insufficient.
Your doctor may also prescribe [nationally completed name] tablets
instead of separate tablets of the
same doses of enalapril and hydrochlorothiazide.
This fixed dose combination is not suitable for initial therapy.
You must talk to a doctor if you do not feel better or if you feel
worse.
ENALAPRIL
belongs to a group of medicines called angiotensin converting enzyme
inhibitors (ACE
inhibitors) and lowers blood pressure by widening the blood vessels.
HYDROCHLOROTHIAZIDE
belongs to a group of medicines called diuretics (“water tablets”)
and lowers
blood pressure by increasing urine output.
2.
W

Productkenmerken

Hexal AG
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Enalaprilmaleaat/Hydrochloorthiazide 20/12,5, tabletten 20/12,5 mg
RVG 34509
1311-V12
1.3.1.1 Summary of Product Characteristics
December 2021
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Enalaprilmaleaat/Hydrochloorthiazide 20/12,5, tabletten 20/12,5 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg enalapril maleate and 12.5 mg
hydrochlorothiazide.
Excipient with known effect
Each tablet contains 85.1 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White, oval, biconvex snap tap tablet, one side scored, other side
marked “EH”
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
This fixed dose combination is indicated in patients whose blood
pressure is not adequately controlled
with enalapril alone.
This
fixed
dose
may
also
replace
the
combination
of
20 mg
enalapril
maleate
and
12.5 mg
hydrochlorothiazide in patients who have been stabilised on the
individual active substances given in
the same proportions as separate medicinal products.
This fixed dose combination is not suitable for initial therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one tablet daily.
[nationally completed name] can be administered in a single dose/day
with or without food.
Individual dose titration with both active substances can be
recommended.
When clinically appropriate, direct change from ACE inhibitor
monotherapy to the fixed combination
may be considered.
_ _
Prior diuretic therapy
Treatment with diuretics should be discontinued 2 to 3 day before the
start of the treatment with
[Nationally completed name].
Hexal AG
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Enalaprilmaleaat/Hydrochloorthiazide 20/12,5, tabletten 20/12,5 mg
RVG 34509
1311-V12
1.3.1.1 Summary of Product Characteristics
December 2021
2
_ _
Renal impairment
- Creatinine clearance greater than 30