Captopril Denk 25 tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

captopril

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

C09AA01

INN (International Name):

captopril

Dosage:

25mg

Pharmaceutical form:

tablets

Units in package:

(20/2x10/) and (100/10x10) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-08-08

Patient Information leaflet

_Captopril Denk 25_
Tablet – oral use
Antihypertensive, ACE inhibitor
Active substance: Captopril
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 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 CAPTOPRIL DENK 25 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPTOPRIL DENK 25
3.
HOW TO TAKE CAPTOPRIL DENK 25
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CAPTOPRIL DENK 25
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Captopril Denk 25 is and what it is used for
Captopril Denk 25 belongs to a class of drugs known as angiotensin
conversion
enzyme inhibitors (ACE inhibitors). These inhibit ACE, the enzyme
involved in
the conversion of angiotensin I to angiotensin II. Angiotensin II, a
substance
produced naturally in the body, binds to the receptors of blood
vessels and
thus leads to blood vessel constriction. This results in a rise in
blood pressure.
Captopril prevents the formation of angiotensin II and thus causes
relaxation
of the blood vessels and a reduction in blood pressure.
Captopril Denk 25 is used
• in the treatment of high blood pressure (hypertension),
• in the treatment of chronic impairment of cardiac performance
(cardiac
insufficiency).
2.
What you need to know before you take Captopril Denk 25
Do not take Captopril Denk 25
• if you are allergic to captopril, any other ACE inhibitor or any
of the other
ingredients of this medicine (listed in section 6),
• if you have ever suffered from tissue swelling (angioedema) as a
result of
treatment with an

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Captopril Denk 25
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: captopril
Each tablet contains 25 mg captopril.
Excipient with known effect: Each tablet contains 52 mg of anhydrous
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat tablets with facet, with a break-line
on one side and the inscription “25”
on the other side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Captopril Denk 25 is used
•
in the treatment of hypertension,
•
in the treatment of chronic cardiac insufficiency with reduction of
systolic ventricular function, in
combination with diuretics and, when appropriate, digitalis and
betablockers (see sections 4.3, 4.4,
4.5 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage should be adjusted individually and according to blood
pressure response. The
recommended maximum daily dose is 150 mg.
Hypertension
The recommended initial dose is 25-50 mg daily, administered in two
doses. In order to achieve the
desired therapeutic effect, the dosage may be gradually increased to
100–150 mg daily, administered
in two doses, at 2-week intervals depending on necessity.
Captopril may be administered alone or in combination with other
antihypertensive agents,
particularly with thiazide diuretics (see sections 4.3, 4.4, 4.5 and
5.1). When antihypertensive
medication such as thiazide diuretics are administered concomitantly,
a once daily dosage scheme may
be indicated.
In patients with a very active renin angiotensin aldosterone system
(hypovolaemia, renovascular
hypertension, cardiac decompensation), a single dose of 6.25 mg or
12.5 mg is preferable as an initial
dose. The treatment should be commenced preferably under careful
medical supervision, and the
dosages then administered two times a day. The dosage can be gradually
increased to 50 mg daily and,
if necessary, to 100 mg daily, given in one or two doses.
_ _
2
Cardiac insu