EPROSARTAN MYLAN

Posology The recommended dose is 600 mg eprosartan once daily. Achievement of maximal blood pressure reduction in most patients may take 2 to 3 weeks of treatment. 1). In particular, addition of a thiazide-type diuretic such as hydrochlorothiazide or a calcium channel blocker such as sustained release nifedipine has been shown to have an additive effect with eprosartan.

Duration of treatment is not limited. Geriatric patients No dose adjustment is required in the elderly. 3). Dosage in renally impaired patients In patients with moderate or severe renal impairment (creatinine clearance <60 ml/min), the daily dose should not exceed 600 mg.

Paediatric population Eprosartan is not recommended for use in children or adolescents due to lack of data on safety and efficacy. Method of administration For oral use. Eprosartan may be taken with or without food.

The most commonly reported adverse drug reactions of patients treated with eprosartan are headache and unspecific gastrointestinal complaints, occurring in approximately 11% and 8%, respectively, of patients. Adverse reactions have been ranked under headings of frequency 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), not known (cannot be estimated from the available data).

g. g. rash, pruritus) Musculoskeletal and connective tissue disorders Arthralgia General disorders and administration site disorders Asthenia *Did not occur in a higher frequency than in placebo. In addition to those adverse events reported during clinical trials the following side effects have been reported spontaneously during postmarketing use of eprosartan.

A frequency cannot be estimated from available data (not known). g. renal artery stenosis). 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.

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Hepatic impairment When eprosartan is used in patients with mild to moderate hepatic impairment, special care should be exercised due to the fact that there is limited experience in this patient population. Risk of renal impairment No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min).

Caution is recommended for use in patients with creatinine clearance < 30 ml/min or in patients undergoing dialysis. g. patients with severe cardiac insufficiency (NYHA class IV), bilateral renal artery stenosis, or renal artery stenosis of a solitary kidney) have risks of developing oliguria and/or progressive azotaemia and in rare cases acute renal failure during treatment with an angiotensin converting enzyme inhibitor (ACE-inhibitors).

These events are more likely to occur in patients treated concomitantly with a diuretic. Angiotensin II receptor blockers, such as eprosartan, have not had adequate therapeutic experience to determine if there is a similar risk of developing renal function compromise in these susceptible patients.

When eprosartan is to be used in patients with renal impairment, renal function should be assessed before starting treatment with eprosartan and regularly during treatment. If worsening of renal function is observed during therapy, treatment with eprosartan should be reassessed.

The following precautions are based on experience from other drugs belonging to the same class and ACE-inhibitors. 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. 6). Severe hepatic impairment. Haemodynamically significant bilateral renovascular disease or severe stenosis of a single functioning kidney. 1).