Ena+HCT-Denk 20/12,5

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

enalapril (enalapril maleate), hydrochlorothiazide

Tilgængelig fra:

Artesan Pharma GmbH & Co. KG

INN (International Name):

enalapril (enalapril maleate), hydrochlorothiazide

Dosering:

20mg+12,5mg

Lægemiddelform:

tablets

Recept type:

Prescription

Indlægsseddel

_Ena+HCT-Denk 20/12.5_
Tablet – oral use
Combination of an angiotensin-converting enzyme
in hibitor and a diuretic
Active ingredients: Enalapril + hydrochlorothiazide
Package leaflet:
Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CON-
TAINS 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 doc-
tor or pharmacist. This includes any pos-
sible side effects not listed in this leaflet.
See section 4.
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 in-
hibitors) and lowers blood pressure by widening
the blood vessels.
HYDROCHLOROTHIAZIDE 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 enal-
april and hydrochlorothiazide and are used as a
treatment for high blood pressure when treat-
ment with enalapril as a single agent on its own
has proven insufficient.
Your doctor may also prescribe Ena+HCT-Denk in-
stead of separate tablets of the same doses of enal-
april and hydrochlorothiazide.
This fixed dose combination is not suitable for
initial therapy.
2.
Before you take Ena+HCT-Denk
Do not take Ena+HCT-Denk:
• if you are allergic to enalapril maleate, hydro-
chlorothiazide or any of the other ingredients of
this medicine (listed in section 6).
• if you are allergic (hypersensitive) to sulpho na-
mide-derived medicin

Produktets egenskaber

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 and hydrochlorothiazide
Each tablet contains 20 mg enalapril maleate and 12.5 mg
hydrochlorothiazide.
Excipient with known effect
: lactose monohydrate
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 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 medications.
This fixed dose combination is not suitable for initial therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ena+HCT-Denk 20/12.5 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.
_DOSAGE IN PATIENTS WITH NORMAL RENAL FUNCTION _
The usual dosage is one tablet, taken once daily.
_DOSAGE IN RENAL INSUFFICIENCY _
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 combination. Loop
diuretics are preferred to thiazides in this
population. The dose of enalapril maleate 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 stabilis