Captopril Denk 25

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

captopril

Available from:

Denk Pharma GmbH & Co. KG

INN (International Name):

captopril

Dosage:

25mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Patient Information leaflet

_Captopril Denk 25_
Captopril 25 mg tablets
Oral use
Antihypertensive, ACE inhibitor
INSTRUCTIONS FOR USE
Please read this leaflet carefully.
ACTIVE INGREDIENTS
1 tablet contains 25 mg captopril.
OTHER INGREDIENTS
Lactose
anhydrous,
microcrystalline
cellulose,
maize
starch,
stearic acid, colloidal anhydrous silica, talc
WHAT IS _ CAPTOPRIL DENK 25_ AND WHAT IS IT
USED FOR?
_Captopril Denk 25_ belongs to a class of drugs known as angio -
tensin conversion enzyme inhibitors (ACE inhibitors). These inhi bit
ACE, the enzyme involved in the conversion of angio tensin 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).
WHAT MUST YOU OBSERVE BEFORE TAKING
_CAPTOPRIL DENK 25_?
_CAPTOPRIL DENK 25_ is not allowed
– if you have ever had an allergic reaction to captopril or any
other ACE inhibitor or any of the other ingredients,
– if you have ever suffered from tissue swelling (angioedema) as
a result of treatment with an ACE inhibitor,
– if you tend to suffer from tissue swelling (angioedema),
– in the second or third trimester of pregnancy,
– if you are breastfeeding.
Particular caution should be exercised when
taking _CAPTOPRIL DENK 25_ in the following cases
Certain illnesses, which you may suffer or have suffered from,
require special treatment prior to or during treatment with _Capto-_
_pril Denk 25_. Before taking this medication you should therefore
inform your physician if you suffer from any of the following com-
plaints:
– severe vomiting or diarrhoea
– haemodialysis at regular intervals
– impaired liver function
– impaired kidney func

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Captopril Denk 25
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: captopril
Each tablet contains 25 mg captopril.
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_
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 hypertension,
-
in the treatment of cardiac insufficiency- supplementary to diuretics
and, in the event of severe heart
insufficiency, to digitalis and beta-blocking agents (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
a