Ena-Denk 20

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

enalapril (enalapril maleate)

Available from:

Denk Pharma GmbH & Co. KG

INN (International Name):

enalapril (enalapril maleate)

Dosage:

20mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Patient Information leaflet

_Ena-Denk 20_
Tablet – oral use
ACE inhibitor
Active substance: Enalapril
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 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 ENA-DENK 20 IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ENA-DENK 20
3. HOW TO TAKE ENA-DENK 20
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ENA-DENK 20
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ENA-DENK 20 IS AND WHAT IT
IS USED FOR
Ena-Denk 20 is an ACE inhibitor, i.e. an antihyper-
tensive drug that relieves the heart.
ENA-DENK 20_ _IS USED
• in
the
treatment
of
high
blood
pressure
(hypertension)
• in the treatment of cardiac insufficiency – sup-
plementary to diuretics and, in the event of
severe heart insufficiency, to digitalis.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ENA-DENK 20
DO NOT TAKE ENA-DENK 20_ _
• if you are allergic to enalapril or any of the other
ingredients of this medicine (listed in section 6)
• if you have ever had an allergic reaction to a type
of medicine similar to this medicine called an ACE
inhibitor
• if you have ever had swelling of your face, lips,
mouth, tongue or throat which caused difficulty
in swallowing or breathing (angioedema) when
the reason why was not known or it was inherited
• if you have diabetes or impaired kidney function
and you are treated with a blood pressure low-
ering medicine containing aliskiren
• if you are more than 3 months pregnant. (It is also
better to avoid Ena-Denk 20 in early pregnancy –
see pregnancy sect

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ena-Denk 20
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Enalapril
Each tablet contains 20 mg enalapril maleate.
Excipient with known effect:
Each tablet contains 117.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Round, flat, bevelled-edged, one-sided scored tablet, pale orange with
dark orange spots.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Hypertension
-
Cardiac insufficiency - supplementary to diuretics and, in the event
of severe heart
insufficiency, to digitalis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The absorption of enalapril is not affected by food.
The dosage should be individualised according to patient profile (see
section 4.4) and blood
pressure response.
_Hypertension _
The initial dose is 5 mg to maximally 20 mg of enalapril maleate,
depending on the degree of
hypertension and the condition of the patient. Ena-Denk 20
_ _
is administered once daily. In mild
hypertension, the recommended starting dose is 5-10 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 volume
depletion and a risk of hypotension
when initiating treatment with enalapril. A starting dose of 5 mg or
lower is recommended in such
patients. If possible, diuretic therapy should be discontinued for 2-3
days prior to initiation of
therapy with Ena-Denk 20. Renal function and serum potassium should be
monitored.
The usual maintenance dose is 20 mg of enalapril maleate daily. The
maximum maintenance dose
is 40 mg of enalapril maleate daily.
2
_Heart failure / asym