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. This fixed dose combination is also indicated as initial treatment when hypertension is severe and rapid control of blood pressure (within days to weeks) is of primary clinical importance (see section “Pharmacodynamic Properties” on SmPC for details).

POSOLOGY AND METHOD OF ADMINISTRATION

Once daily, with or without food. CoAprovel® 150/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with HCTZ, or irbesartan 150 mg alone. CoAprovel® 300/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or CoAprovel® 150/12.5 mg. CoAprovel® 300/25 mg may be administered in patients insufficiently controlled by CoAprovel 300/12.5 mg. Doses higher than CoIrvebal® 300 mg irbesartan/25 mg HCTZ once daily are not recommended. Renal impairment: due to the HCTZ component, CoAprovel® is not recommended for patients with severe renal dysfunction (creatinine clearance<30 ml/min). Hepatic impairment: no dosage adjustment. Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to administration of CoAprovel®. Older people: no dosage adjustment. Paediatric population: CoAprovel® is not recommended for use in children and adolescents because the safety and efficacy have not been established. Method of administration of CoAprovel® is by oral use.

CONTRA-INDICATIONS

Hypersensitivity to any component of the products or other sulfonamide-derived substances. 2 nd and 3 rd trimester of pregnancy. Lactation. Severe renal impairment. Refractory hypokalemia, hypercalcaemia. Severe hepatic impairment, biliary cirrhosis and cholestasis. The concomitant use with aliskiren-containing product contraindicated in patients with diabetes mellitus or renal impairment (GFR<60 ml/min/1.73 m2 )

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Hypotension Volume-depleted patients, renal artery stenosis renovascular hypertension, renal impairment and kidney transplantation, dual blockade of the renin-angiotensin-aldosterone system (RAAS), psoriasis, hepatic impairment, aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy, primary aldosteronism, metabolic and endocrine effects, electrolyte imbalance, lithium, anti-doping test, CoAprovel® should not be used during pregnancy, patient with lactose intolerance, non-melanoma skin cancer, choroidal effusion, acute myopia and secondary accute angle-closure glaucoma. See full SmPC for details.

INTERACTIONS

Other antihypertensive medications: antihypertensive effect may be increased. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension. Aliskiren-containing products or ACE-inhibitors: dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors. Lithium: increased risk of lithium toxicity. Drugs affecting potassium: adequate monitoring recommended. Drugs affected by serum potassium disturbances (digitalis glycosides, antiarrhythmics): periodic monitoring of serum potassium is recommended. NSAID. Repaglinide: irbesartan has the potential to increase the maximum concentration and AUC of repaglinide, dose adjustment may be required See full SmPC, for other interactions.

FERTILITY, PREGNANCY AND LACTATION

Pregnancy : not recommended during 1 st trimester, and contraindicated during 2 nd and 3 rd trimester. Breastfeeding : Hydrochlorothiazide is excreted in human milk in small amounts. The use of CoAprovel during breast feeding is not recommended. If CoAprovel is used during breast feeding, doses should be kept as low as possible. Fertility : Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Unlikely to affect the ability to drive and use machines. Occasionally dizziness or weariness may occur during treatment.

UNDESIRABLE EFFECTS

Common: investigations (increases in blood urea nitrogen (BUN), creatinine and creatine kinase), nervous system disorders (dizziness), gastrointestinal disorders (nausea/vomiting), renal and urinary disorders (abnormal urination), musculoskeletal and connective tissue disorders (swelling extremity), general disorders and administration site conditions (fatigue). For uncommon and not known side effects, see full SmPC.

OVERDOSAGE

The patient should be closely monitored, and the treatment should be symptomatic and supportive. Irbesartan is not removed by haemodialysis. Serum electrolytes and creatinine should be monitored frequently. Irbesartan is not removed by haemodialysis. The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.

PHARMACOLOGICAL PROPERTIES :

ATC code: C09DA04.

Manufactured by :

Sanofi Winthrop Industrie, 1 rue de la Vierge – Ambarès et Lagrave, 33565 Carbon Blanc Cedex – France. Imported by: PT Aventis Pharma, Jakarta – Indonesia.

PRESENTATION :

CoAprovel® 150/12.5 mg Reg. No. DKI1077402817A1, CoAprovel® 300/12.5 mg Reg. No. DKI1077402817B1, CoAprovel® 300/25 mg Reg. No. DKI1077402817C1.

HARUS DENGAN RESEP DOKTER.

Updated based on approval PI CoAprovel by BPOM on 22 December 2021

This information is intended for Health Care Professional only. See local product information for full details information