COAPROVEL Tablet Ref.[50773] Active ingredients: Hydrochlorothiazide Irbesartan Irbesartan and Hydrochlorothiazide

Posology

CoAprovel can be taken once daily, with or without food.

Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended.

When clinically appropriate direct change from monotherapy to the fixed combinations may be considered:

• CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
• CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.
• CoAprovel 300 mg/25 mg may be administered in patients insufficiently controlled by CoAprovel 300 mg/12.5 mg.

Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).

Special Populations

Renal impairment

Due to the hydrochlorothiazide component, CoAprovel is not recommended for patients with severe renal dysfunction (creatinine clearance <30 ml/min). Loop diuretics are preferred to thiazides in this population. No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥30 ml/min (see sections 4.3 and 4.4).

Hepatic impairment

CoAprovel is not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic function. No dosage adjustment of CoAprovel is necessary in patients with mild to moderate hepatic impairment (see section 4.3).

Older people

No dosage adjustment of CoAprovel is necessary in older people.

Paediatric population

CoAprovel is not recommended for use in children and adolescents because the safety and efficacy have not been established. No data are available.

Method of Administration

For oral use.

No specific information is available on the treatment of overdose with CoAprovel. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Management depends on the time since ingestion and the severity of the symptoms. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdose. Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.

The most likely manifestations of irbesartan overdose are expected to be hypotension and tachycardia; bradycardia might also occur.

Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloremia, hyponatraemia) and dehydration resulting from excessive diuresis. The most common signs and symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.

Irbesartan is not removed by haemodialysis. The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.

3 years.

Do not store above 30°C.

Store in the original package in order to protect from moisture.

Cartons of 14 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 56 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 56 × 1 tablets in PVC/PVDC/Aluminium perforated unit dose blisters.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.