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CoAprovel

irbesrtan/hydrochlorothiazide

 

QUALITATIVE AND QUANTITATIVE FORMULA

CoAprovel 150 mg/12.5 mg tablets

Each tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.

CoAprovel 300 mg/12.5 mg tablets

Each tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.

 

PHARMACEUTICAL FORM

150 mg/12,5 mg Tablets

Peach biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.

300 mg/12.5 mg Tablets

Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.

 

CLINICAL PARTICULARS

 - Therapeutic indications - Treatment of essential hypertension.

 - This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.

 

Posology and method of administration

CoAprovel can be used once daily, with or without food in-patients whose blood pressure is not adequately controlled by irbesartan or hydrochlorothiazide alone.

 

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 insufficiently controlled by irbesartan 300 mg or by CoAprovel 150/12.5 mg.

CoAprovel 300/25mg may be administered in patients insufficiently controlled by CoAprovel 300/12.5mg

 

Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, CoAprovel may be administered with another antihypertensive drug (see interactions with other medicinal products and other forms of interaction).

 

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 Contra-indications and Special warnings and special precautions for use).

 

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 Contra-indications).

 

Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients.

 

Children: safety and efficacy of CoAprovel have not been established in children (< 18 years).

 

Contraindications

Second and third trimester pregnancy (see Pregnancy and lactation)

 

Lactation (see Pregnancy and lactation)

 

Hypersensitivity to the active substances, to any of the excipients, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance).

 

The following contraindications are associated with hydrochlorothiazide:

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

refractory hypokalemia, hypercalcaemia,

severe hepatic impairment, biliary cirrhosis and cholestasis.

 

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