CoAprovel

Posology CoAprovel can be taken once daily, with or without food. e. irbesartan and hydrochlorothiazide) may be recommended. 5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone.

5 mg. 5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. 1). 3 Special Populations 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. 4). Hepatic impairment CoAprovel is not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic function.

3). Older people No dosage adjustment of CoAprovel is necessary in older people. Paediatric population CoAprovel is not recommended for use in children and adolescents because the safety and efficacy have not been established. No data are available.

Method of Administration For oral use.

5% of the patients experienced adverse reactions. 4%). 1%) were also commonly observed in the trials. Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials. The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4) Musculoskeletal and connective tissue disorders: Uncommon: swelling extremity Not known: arthralgia, myalgia Metabolism and nutrition disorders: Not known: hyperkalaemia Vascular disorders: Uncommon: flushing General disorders and administration site conditions: Common: fatigue Immune system disorders: Not known: cases of hypersensitivity reactions such as angioedema, rash, urticaria Hepatobiliary disorders: Uncommon: Not known: jaundice hepatitis, abnormal liver function Reproductive system and breast disorders: Uncommon: sexual dysfunction, libido changes Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with CoAprovel.

Tables 2 and 3 below detail the adverse reactions reported with the individual components of CoAprovel. 1). The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.

12 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Hypotension - Volume-depleted patients:

CoAprovel has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension. Symptomatic hypotension may be expected to occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.

Such conditions should be corrected before initiating therapy with CoAprovel. Renal artery stenosis - Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists.

While this is not documented with CoAprovel, a similar effect should be anticipated. Renal impairment and kidney transplantation: when CoAprovel is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.

There is no experience regarding the administration of CoAprovel in patients with a recent kidney 4 transplantation. 3). Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function. No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥ 30 ml/min.

However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but < 60 ml/min) this fixed dose combination should be administered with caution. Dual blockade of the renin-angiotensin-aldosterone system (RAAS): there is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).

1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

1).