COVERSYL ARGININE Film-coated tablet Ref.[7037] Active ingredients: Perindopril

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 daily in 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 Coversyl Arginine (see section 4.4).

In hypertensive patients in whom the diuretic cannot be discontinued, therapy with Coversyl Arginine should be initiated with a 2.5 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Coversyl Arginine should be adjusted according to blood pressure response. If required, diuretic therapy may be resumed.

In elderly patients treatment should be initiated at a dose of 2.5 mg which may be progressively increased to 5 mg after one month then to 10 mg if necessary depending on renal function (see table below).

Symptomatic heart failure

It is recommended that Coversyl Arginine, generally associated with a non-potassium-sparing diuretic and/or digoxin and/or a beta-blocker, be introduced under close medical supervision with a recommended starting dose of 2.5 mg taken in the morning. This dose may be increased after 2 weeks to 5 mg once daily if tolerated. The dose adjustment should be based on the clinical response of the individual patient.

In severe heart failure and in other patients considered to be at high risk (patients with impaired renal function and a tendency to have electrolyte disturbances, patients receiving simultaneous treatment with diuretics and/or treatment with vasodilating agents), treatment should be initiated under careful supervision (see section 4.4).

Patients at high risk of symptomatic hypotension e.g. patients with salt depletion with or without hyponatraemia, patients with hypovolaemia or patients who have been receiving vigorous diuretic therapy should have these conditions corrected, if possible, prior to therapy with Coversyl Arginine. Blood pressure, renal function and serum potassium should be monitored closely, both before and during treatment with Coversyl Arginine (see section 4.4).

Stable coronary artery disease

Coversyl Arginine should be introduced at a dose of 5 mg once daily for two weeks, then increased to 10 mg once daily, depending on renal function and provided that the 5 mg dose is well tolerated.

Elderly patients should receive 2.5 mg once daily for one week, then 5 mg once daily the next week, before increasing the dose up to 10 mg once daily depending on renal function (see Table 1 “Dosage adjustment in renal impairment”). The dose should be increased only if the previous lower dose is well tolerated.

Special population

Patients with renal impairment

Dosage in patients with renal impairment should be based on creatinine clearance as outlined in table 1 below:

Table 1. Dosage adjustment in renal impairment:

* Dialysis clearance of perindoprilat is 70 ml/min.

For patients on haemodialysis, the dose should be taken after dialysis.

Patients with hepatic impairment

No dosage adjustment is necessary in patients with hepatic impairment (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of perindopril in children and adolescents aged below 18 years have not been established.

Currently available data are described in section 5.1 but no recommendation on a posology can be made.

Therefore, use in children and adolescents is not recommended.

Method of administration

For oral use.

Coversyl Arginine is recommended to be taken once daily in the morning before a meal.

Limited data are available for overdosage in humans. Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.

The recommended treatment of overdosage is intravenous infusion of sodium chloride 9 mg/ml (0.9%) solution. If hypotension occurs, the patient should be placed in the shock position. If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered. Perindopril may be removed from the general circulation by haemodialysis (see section 4.4). Pacemaker therapy is indicated for therapy-resistant bradycardia. Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.

3 years.

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

White polypropylene tablet container equipped with a polyethylene flow reducer and a white opaque stopper containing a desiccant gel.

Box of 5, 10, 14, 20, 28, 30, 50, 60 (60 or 2 containers of 30), 84 (84 or 3 containers of 28), 90 (90 or 3 containers of 30), 100 (100 or 2 containers of 50), 120 (120 or 4 containers of 30) or 500 tablets (500 or 10 containers of 50).

Not all pack sizes may be marketed.

No special requirements.