COAPROVEL FILM-COATED TABLET 300/12.5 mg

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**Posology and method of administration** CoAprovel can be taken once daily, with or without food. **_Initial therapy:_** The usual starting dose is CoAprovel 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks therapy to a maximum of one 300/25 mg tablet once daily as needed to control blood pressure (see _Pharmacodynamic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). CoAprovel is not recommended as initial therapy in patients with intravascular volume depletion (see _Special warnings and precautions for use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Replacement therapy: CoAprovel may be substituted for the titrated components. **_Add on therapy:_** Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) can be recommended. When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: - CoAprovel 150/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; - CoAprovel 300/12.5 mg may be administered in patients whose blood pressure is insufficiently controlled by irbesartan 300 mg or by CoAprovel 150/12.5 mg; - CoAprovel 300/25 mg (2 tablets of CoAprovel 150/12.5 mg) may be administered in patients whose blood pressure is insufficiently controlled by CoAprovel 300/12.5 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 _Contraindications, Special warnings and precautions for use, Interaction with other medicinal products and other forms of interaction,_ and _Pharmacodynamic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 _Contraindications_ and _Special warnings and precautions for use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to administration of CoAprovel. 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 _Contraindications_). Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients. Paediatric patients: CoAprovel is not recommended for use in children and adolescents because the safety and efficacy have not been established. No data are available.