COAPROVEL FILM-COATED TABLET 300/12.5 MG [SIN11647P]

Product Info

COAPROVEL FILM-COATED TABLET 300/12.5 MG

[SIN11647P]

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 Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

Contraindications

• Hypersensitivity to the active substances or to any of the excipients listed in List of excipients – 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 Special warnings and precautions for use and Fertility, pregnancy and lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),

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

• Refractory hypokalaemia, hypercalcaemia,

• Severe hepatic impairment, biliary cirrhosis and cholestasis,

• The concomitant use of CoAprovel with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m²) (see 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).