Coversyl Arginine 10 mg orodispersible tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Perindopril arginine

Διαθέσιμο από:

Les Laboratoires Servier

Φαρμακολογική κατηγορία (ATC):

C09AA; C09AA04

INN (Διεθνής Όνομα):

Perindopril arginine

Δοσολογία:

10 milligram(s)

Φαρμακοτεχνική μορφή:

Orodispersible tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

ACE inhibitors, plain; perindopril

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2010-07-09

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL ARGININE 10 MG ORODISPERSIBLE TABLETS
perindopril arginine
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, pharmacist or
nurse.
-
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 or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Coversyl arginine is and what it is used for
2.
What you need to know before you take Coversyl arginine
3.
How to take Coversyl arginine
4.
Possible side effects
5.
How to store Coversyl arginine
6.
Content of the pack and other information
1.
WHAT COVERSYL ARGININE IS AND WHAT IT IS USED FOR
Coversyl arginine is an angiotensin converting enzyme (ACE) inhibitor.
These work by widening the blood
vessels, which makes it easier for your heart to pump blood through
them.
Coversyl arginine is used:
-
to treat _high blood pressure_ (hypertension),
-
to reduce the risk of cardiac events, such as heart attack, in
patients with _stable coronary artery disease _(a
condition where the blood supply to the heart is reduced or blocked)
and who have already had a heart
attack and/or an operation to improve the blood supply to the heart by
widening the vessels that supply it.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COVERSYL ARGININE
DO NOT TAKE COVERSYL ARGININE
-
if you are allergic to perindopril or any of the other ingredients of
this medicine (listed in Section 6), or to
any other ACE inhibitor.
-
if you have experienced symptoms such as wheezing, swelling of the
face, tongue or throat, intense itching
or severe skin rashes with previous ACE inhibitor treatment or if you
or a member of your family have
had these symptoms in any

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
09 November 2021
CRN00CMKL
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine 10 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One orodispersible tablet contains 6.790 mg perindopril corresponding
to 10 mg perindopril arginine.
Excipients with known effect: 125.46 mg lactose, 0.4 mg aspartame.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
White, round tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension.
Heart failure:
Treatment of symptomaticheart 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 volume and/or
salt depleted.
If possible, the diuretic should be discontinued 2 to 3 days before
beginning therapy with Cov