CONVERIDE FILM COATED TABLET 300MG/12.5MG [SIN15459P]

Product Info

CONVERIDE FILM COATED TABLET 300MG/12.5MG

[SIN15459P]

4.1 Therapeutic indications

Treatment of essential hypertension
This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
This fixed dose combination is also indicated as initial therapy in patients with moderate to severe essential hypertension for whom the benefit of a prompt blood pressure reduction exceeds the risk of initiating combination therapy in these patients (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

4.3 Contraindications

• Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance)

• Second and third trimesters of pregnancy (see sections 4.4 and 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),

• Lactation (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

The following contraindications are associated with hydrochlorothiazide:

• Severe renal impairment (creatinine clearance < 30 ml/min),

• Refractory hypokalaemia, hypercalcaemia,

• Severe hepatic impairment, biliary cirrhosis and cholestasis.

• Co-administration of Converide with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m²) (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Co-administration of Converide with angiotensin-converting enzyme inhibitors (ACEIs) in patients with diabetic nephropathy (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).