COVERAM Tablet Ref.[51481] Active ingredients: Amlodipine Perindopril Perindopril and Amlodipine

Posology

Oral route.

One tablet per day as a single dose, preferably to be taken in the morning and before a meal.

The fixed dose combination is not suitable for initial therapy.

If a change of posology is required, the dose of Coveram could be modified or individual titration with free combination may be considered.

Special populations

Renal impairment and elderly (see sections 4.4 and 5.2)

Elimination of perindoprilat is decreased in the elderly and in patients with renal failure. Therefore, the usual medical follow-up will include frequent monitoring of creatinine and potassium. Coveram can be administered in patients with Clcr ≥60ml/min, and is not suitable for patients with Clcr <60ml/min. In these patients, an individual dose titration with the monocomponents is recommended. Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialysable.

Hepatic impairment: see sections 4.4 and 5.2

Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (see sections 4.4 and 5.2). To find the optimal starting dose and maintenance dose of patients with hepatic impairment, the patients should be individually titrated using the free combination of amlodipine and perindopril. The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment.

Paediatric population

Coveram should not be used in children and adolescents as the efficacy and tolerability of perindopril and amlodipine, in combination, have not been established in children and adolescents.

There is no information on overdosage with Coveram in humans.

For amlodipine, experience with intentional overdose in humans is limited.

Symptoms: available data suggest that gross overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.

Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.

Treatment: clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output.

A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade. Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine. Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.

For perindopril, limited data are available for overdosage in humans. Symptoms associated with the 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 normal saline 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. Periondopril can be removed from the systemic circulation by haemodialysis (see section 4.4). Pacemaker therapy is indicated for treatment-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. Store in the original package. This medicinal product does not require any special temperature storage conditions.

5, 7, 10, 14, 20, 28, 30 or 50 tablets in polypropylene container equipped with a low density polyethylene flow reducer and a low density polyethylene stopper containing a desiccant gel.

Box of 1 container of 5, 7, 10, 14, 20, 28, 30 or 50 tablets.

Box of 2 containers of 28, 30 or 50 tablets.

Box of 3 containers of 28 tablets

Box of 3 containers of 30 tablets.

Box of 4 containers of 30 tablets.

Box of 10 containers of 50 tablets.

Not all pack sizes may be marketed.

No special requirements.