Coversyl Arginine 5 mg film-coated tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Perindopril arginine

Fáanlegur frá:

Les Laboratoires Servier

ATC númer:

C09AA; C09AA04

INN (Alþjóðlegt nafn):

Perindopril arginine

Skammtar:

5 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

ACE inhibitors, plain; perindopril

Leyfisstaða:

Marketed

Leyfisdagur:

2005-10-28

Vara einkenni

Health Products Regulatory Authority
29 June 2022
CRN00CZVZ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine.
One film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril arginine.
Excipient with known effect: 72.58 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light-green, rod-shaped film-coated tablet engraved with
on one face and scored on both edges. The tablet can be
divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension.
Heart failure:
Treatment of symptomatic heart failure.
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of
myocardial infarction and/or revascularisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be individualised according to the patient profile
(see section 4.4) and blood pressure response.
- Hypertension:
Coversyl Arginine may be used in monotherapy or in combination with
other classes of antihypertensive therapy (see sections
4.3, 4.4, 4.5 and 5.1).
The recommended starting dose is 5 mg given once dailyin the morning.
Patients with a strongly activated renin-angiotensin-aldosterone
system (in particular, renovascular hypertension, salt and/or
volume depletion, cardiac decompensation or severe hypertension) may
experience an excessive drop in blood pressure
following the initial dose. A starting dose of 2.5 mg is recommended
in such patients and the initiation of treatment should
take place under medical supervision.
The dose may be increased to 10 mg once daily after one month of
treatment.
Symptomatic hypotension may occur following initiation of therapy with
Coversyl Arginine; this is more likely in patients who
are being treated concurrently with diuretics. Caution is therefore
recommended since these patients may be volu