APROVASC Film-coated tablet Ref.[50621] Active ingredients: Amlodipine Irbesartan Irbesartan and Amlodipine

The usual initial and maintenance dose of Aprovasc is one tablet per day. Aprovasc can be administered with or without food.

Aprovasc should be administered in patients whose blood pressure is not adequately controlled on monotherapy with irbesartan or amlodipine or for continuation of therapy for patients receiving irbesartan and amlodipine as separate tablets. Dose should be determined on a case-by-case basis, based on patient response to therapy with the individual components and the desired antihypertensive response. The maximum recommended dose with Aprovasc is 300 mg/10 mg per day.

Treatment should be adjusted based on blood pressure response.

Pediatric patients: The safety and efficacy of Aprovasc has not been established in this population.

Elderly patients and patients with impaired renal function: In general, no dosage reduction is necessary in elderly patients or patients with impaired renal function (regardless of the degree of impairment).

Patients with impaired hepatic function: As the medicinal product contains amlodipine, Aprovasc should be administered with caution in these patients (see Warnings).

Medicinal product for oral administration.

Experience in adults exposed to Irbesartan doses up to 900 mg/day for 8 weeks revealed no toxicity. No specific information is available on the treatment of overdosage with irbesartan. The information available on the overdose of amlodipine suggests that it could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension and shock with fatal prognosis have been reported. Close monitoring of patient should be done and treatment should be symptomatic and supportive.

Suggested measures include gastric lavage. Administration of activated charcoal to healthy individuals immediately or up to two hours after the ingestion of 10mg amlodipine has shown a significant decrease in the absorption of amlodipine. As amlodipine is highly protein bound and irbesartan is not removed from the body by hemodialysis, hemodialysis does not seem to offer any benefit..

If massive overdose occurs, initiate active cardiorespiratory monitoring. Frequent measurement of blood pressure is essential. Clinically significant hypotension due to amlodipine overdose requires active cardiovascular support including limb elevation and monitoring of circulating fluid volume and urine output. A vasoconstrictor can help restore 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.

Please refer to outer box packaging for more information.

Store below 30°C.