Coversyl Arginine 10 mg film coated tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Perindopril arginine

MAH:

Les Laboratoires Servier

ATC_code:

C09AA; C09AA04

INN:

Perindopril arginine

dosage:

10 milligram(s)

pharmaceutical_form:

Film-coated tablet

prescription_type:

Product subject to prescription which may be renewed (B)

therapeutic_area:

ACE inhibitors, plain; perindopril

authorization_status:

Marketed

authorization_date:

2005-10-28

SPC

Health Products Regulatory Authority
29 June 2022
CRN00CZVZ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine 10 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine
One film-coated tablet contains 6.790 mg perindopril corresponding to
10 mg Perindopril arginine
Excipient with known effect: 145.16 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Green, round, biconvex, film-coated tablet engraved with
on one face and
on the other face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension.
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 volume and/or
salt depleted.
If possible, the diuretic should be discontinued 2 to 3 days before
beginning