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

국가: 네덜란드

언어: 네덜란드어

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

유효 성분:

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

제공처:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC 코드:

C09BA02

INN (국제 이름):

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

약제 형태:

Tablet

구성:

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

관리 경로:

Oraal gebruik

치료 영역:

Enalapril And Diuretics

제품 요약:

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

승인 날짜:

1900-01-01

환자 정보 전단

Sandoz B.V.
Page 1/11
Enalaprilmaleaat/Hydrochloorthiazide Sandoz 20/12,5
RVG 25418
1313-V24
1.3.1.3 Package Leaflet
December 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENALAPRILMALEAAT/HYDROCHLOORTHIAZIDE SANDOZ® 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 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.
WHAT YOU

제품 특성 요약

Sandoz B.V.
Page 1/28
Enalaprilmaleaat/Hydrochloorthiazide Sandoz
®
20/12.5
RVG 25418
V14
1.3.1 Summary of Product Characteristics
December 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Enalaprilmaleaat/Hydrochloorthiazide Sandoz 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(s) 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
Round, flat, bevelled edge, one-side scored, white tablets.
Diameter: 8 mm.
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 replaces 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
Sandoz B.V.
Page 2/28
Enalaprilmaleaat/Hydrochloorthiazide Sandoz
®
20/12.5
RVG 25418
V14
1.3.1 Summary of Product Characteristics
December 2021
Treatment with diuretics should be discontinued 2 to 3 day before the
start of the treatment with
[Nationally completed name].
_ _
Renal impairment
_ _
- Creatinine clearance greater than 30 ml/min
The dose of enalapril should be titrated in patients with renal
impairment whose creatinine clearance
is ≥ 30 ml/min before switching to the fixed combinatio