Ena+HCT-Denk 20/12,5 tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

enalapril (enalapril maleate), hydrochlorothiazide

Available from:

Artesan Pharma GmbH & Co. KG

ATC code:

C09BA02

INN (International Name):

enalapril (enalapril maleate), hydrochlorothiazide

Dosage:

20mg+ 12,5mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-06-07

Patient Information leaflet

_Ena+HCT-Denk 20/12.5_
Tablet – oral use
Combination of an angiotensin-converting enzyme
inhibitor and a diuretic
Active substances: enalapril + hydrochlorothiazide
Package leaflet: Information for the
patient
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 symptoms 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 ENA+HCT-DENK IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ENA+HCT-DENK
3.
HOW TO TAKE ENA+HCT-DENK
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ENA+HCT-DENK
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Ena+HCT-Denk is and what it
is used for
ENALAPRIL belongs to a group of medicines called
angiotensin
converting
enzyme
inhibitors
(ACE
inhibitors) and lowers blood pressure by widening
the blood vessels.
HYDROCHLOROTHIAZIDE (HCT) belongs to a group of
drugs called diuretics (“water tablets”) and lowers
blood pressure by increasing urine output.
Ena+HCT-Denk contains a combination of enalapril
and hydrochlorothiazide and is 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
Ena+HCT-Denk
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.
2.
What you need to know before you
take Ena+HCT-Denk
DO NOT TAKE ENA+HCT-DENK:
• if you are allergic to enalapril, hydrochlorothiazide
or any of the other ingredients of this medicine
(listed in sectio

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ena+HCT-Denk 20/12.5
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: enalapril + hydrochlorothiazide
Each tablet contains 20 mg enalapril maleate and 12.5 mg
hydrochlorothiazide (HCT).
Excipients with known effect:
Each tablet contains 259.54 mg of lactose monohydrate and less than 1
mmol (23 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round tablets that are scored on one side, with lateral
notches.
The tablets can be divided 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 medications.
This fixed dose combination is not suitable for initial therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one tablet taken once a day.
This medicine can be administered in a single dose/day with or without
food.
Individual dose titration with both active substances is recommended.
When clinically appropriate, direct
change from ACE inhibitor monotherapy to the fixed combination may be
considered.
DOSAGE IN RENAL INSUFFICIENCY
2
Creatinine clearance > 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 combination. Loop diuretics
are preferred to thiazides in this
population. The dose of enalapril and hydrochlorothiazide should be
kept as low as possible (see section 4.4).
Potassium and creatinine should be monitored periodically in these
patients, e.g. every 2 months when the
treatment has been stabilised (see section 4.4).
Creatinine clearance ≤ 30 ml/min