CONVERIDE FILM COATED TABLET 300MG/12.5MG

MEDOCHEMIE SINGAPORE PTE. LTD.

MEDOCHEMIE SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Posology and method of administration** Posology Converide can be taken once daily, with or without food. **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: - Converide 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; - Converide 300 mg/12.5 mg may be administered in patients whose blood pressure is insufficiently controlled by irbesartan 300 mg or by Converide 150 mg/12.5 mg. - Converide 300 mg/25 mg (2 tablets of Converide 150mg/12.5mg) may be administered in patients whose blood pressure is insufficiently controlled by Converide 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, Converide may be administered with another antihypertensive medicinal product (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Initial therapy:** The usual starting dose is Converide 150/12.5mg once daily. The dosage can be increased after 1 to 2 weeks therapy to a maximum of one 300/25mg tablet once daily as needed to control blood pressure (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Converide is not recommended as initial therapy in patients with intravascular volume depletion (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Replacement therapy:** Converide may be substituted for the titrated components. _Renal impairment_: due to the hydrochlorothiazide component, Converide 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 – _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 Converide. _Hepatic impairment:_ Converide 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 Converide is necessary in patients with mild to moderate hepatic impairment (see section 4.3). _Elderly patients:_ no dosage adjustment of Converide is necessary in elderly patients. _Paediatric population:_ Converide is not recommended for use in children and adolescents due to lack of data on safety and efficacy. Method of administration For oral use.