Enalapril

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

enalapril (enalapril maleate)

Pieejams no:

Replek Farm Ltd.-Skopje

SNN (starptautisko nepatentēto nosaukumu):

enalapril (enalapril maleate)

Deva:

20mg

Zāļu forma:

tablets

Receptes veids:

Prescription

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENALAPRIL 5 MG TABLETS
ENALAPRIL 10 MG TABLETS
ENALAPRIL 20 MG TABLETS
enalapril maleate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or your
pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What ENALAPRIL is and what it is used for
2.
Before you take ENALAPRIL
3.
How to take ENALAPRIL
4.
Possible side effects
5.
How to store ENALAPRIL
6.
Further information
1. WHAT ENALAPRIL IS AND WHAT IT IS USED FOR
ENALAPRIL
tablets
contain
an
active
substance
called
enalapril
maleate.
This
belongs to the group of medicines called ACE inhibitors (angiotensin
converting
enzyme inhibitors).
ENALAPRIL is used:
•
to treat high blood pressure (hypertension).
•
to treat heart failure (weakening of heart function). It can lower the
need to go
to hospital and can help some patients live longer.
•
to prevent the signs of heart failure. The signs include: shortness of
breath,
tiredness after light physical activity such as walking, or swelling
of the ankles
and feet.
ENALAPRIL
works
by
widening
your
blood
vessels.
This
lowers
your
blood
pressure. The medicine usually starts to work within an hour, and the
effect lasts for at
least 24 hours. Some people will require several weeks of treatment
until the best
effect on your blood pressure is seen.
2. BEFORE YOU TAKE ENALAPRIL
DO NOT TAKEENALAPRIL IF:
•
you are allergic (hypersensitive) to enalapril maleate or any of the
other
ingredients of the medicine (listed in Section 6).
•
you have ever had an allergic reaction to a type of medicine similar
to
ENALAPRIL called an ACE inhibitor.
•
you have ever had swelling of your face, lips,

Produkta apraksts

- 1 -
- 1 -
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
ENALAPRIL 5 MG TABLETS
ENALAPRIL 10 MG TABLETS
ENALAPRIL 20 MG TABLETS
enalapril maleate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ENALAPRIL 5 mg tablet contains enalapril maleate 5 mg.
Each ENALAPRIL 10 mg tablet contains enalapril maleate 10 mg.
Each ENALAPRIL 20 mg tablet contains enalapril maleate 20 mg.
* For full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
ENALAPRIL 5 mg are uniform, round, white tablets, with flat surfaces,
with a facet and a
score line on one side.
ENALAPRIL 10 mg are uniform, round, pale pink tablets with different
intensity of color,
with flat surfaces, with a facet and a score line on one side.
ENALAPRIL 20 mg are uniform, round, white tablets, with flat surfaces,
with a facet and a
score line on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Treatment of Hypertension.

Treatment of Symptomatic Heart Failure.

Prevention of Symptomatic Heart Failure in patients with Asymptomatic
Left
Ventricular Dysfunction (ejection fraction ≤35%).
(See section 5.1.)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The absorption of ENALAPRIL tablets is not affected by food.
The dose should be individualised according to patient profile (see
section 4.4) and blood
pressure response.
- 2 -
- 2 -
Hypertension
The initial dose is 5 to maximally 20 mg, depending on the degree of
hypertension and the
condition of the patient (see below). Enalapril is given once daily.
In mild hypertension, the
recommended
initial
dose
is
5
to
10
mg.
Patients
with
a
strongly
activated
renin-
angiotensin-aldosterone
system
(e.g.,
renovascular
hypertension,
salt
and/or
volume
depletion, cardiac decompensation, or severe hypertension) may
experience an excessive
blood pressure fall following the initial dose. A starting dose of 5
mg or lower is
recommended in such patients and the initiation of treatment should
take place under
medical supervision.
Prior treatment with high dose diuretics may result in v