COVERSYL ARGININE PLUS Film-coated tablet Ref.[116777] Active ingredients:

Posology

One Coversyl Arginine Plus 5mg/1.25mg film-coated tablet per day as a single dose, preferably to be taken in the morning, and before a meal.

When possible individual dose titration with the components is recommended. Coversyl Arginine Plus 5mg/1.25mg film- coated tablet should be used when blood pressure is not adequately controlled on Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablet (where available). When clinically appropriate, direct change from monotherapy to Coversyl Arginine Plus 5mg/1.25mg film-coated tablet may be considered.

Special populations

Elderly (see section 4.4)

Treatment should be initiated after considering blood pressure response and renal function.

Renal impairment (see section 4.4)

In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contra-indicated.

In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), it is recommended to start treatment with the adequate dosage of the free combination.

In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium.

Hepatic impairment (see sections 4.3, 4.4 and 5.2)

In severe hepatic impairment, treatment is contra-indicated.

In patients with moderate hepatic impairment, no dose modification is required.

Paediatric population

The safety and efficacy of perindopril arginine/indapamide in the paediatric population have not yet been established. No data are available.

Coversyl Arginine Plus 5mg/1.25mg should not be used in children and adolescents.

Method of administration

Oral use.

Symptoms

The most likely adverse reaction in cases of overdose is hypotension, sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion, oliguria which may progress to anuria (due to hypovolaemia). Salt and water disturbances (low sodium levels, low potassium levels) may occur.

Management

The first measures to be taken consist of rapidly eliminating the product(s) ingested by gastric lavage and/or administration of activated charcoal, then restoring fluid and electrolyte balance in a specialised centre until they return to normal.

If marked hypotension occurs, this can be treated by placing the patient in a supine position with the head lowered. If necessary an intravenous infusion of isotonic saline may be given, or any other method of volaemic expansion may be used.

Perindoprilat, the active form of perindopril, can be dialysed (see section 5.2).

3 years.

Keep the container tightly closed in order to protect from moisture.

14, 20, 28, 30 or 50 tablets in polypropylene white container equipped with a low density polyethylene flow reducer and a low density polyethylene white opaque stopper containing a white desiccant gel.

Pack sizes:

1 x 14, 1 x 20, 1 x 28, 1 x 30 or 1 x 50 tablets
2 x 28, 2 x 30 or 2 x 50 tablets
3 x 30 tablets
10 x 50 tablets

Not all pack sizes may be marketed.

No special requirements.