EPROSARTAN

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 diuretics such as hydrochlorothiazide or a calcium channel blocker such as sustained release nifedipine has been shown to have an additive effect with eprosartan Eprosartan may be taken with or without food.

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 600mg.

Paediatric population:

Eprosartan is not recommended for use in children and adolescents due to lack of data on safety and efficacy.

Clinical Trials 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. g. rash, pruritus) Angioedema* General disorders and administration site reactions Asthenia (*) Did not occur in a higher frequency than in placebo Postmarketing experience 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 the available data (not known). 4). g. renal artery stenosis). Muskuloskeletal and connective tissue disorder Arthralgia Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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8). These patients presented with abdominal pain, nausea, vomiting and diarrhoea. Symptoms resolved after discontinuation of angiotensin II receptor antagonists. If intestinal angioedema is diagnosed, Eprosartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.

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. Renal impairment No dose adjustment is required in patients with mild to moderate renal insufficiency (creatinine clearance >30 ml/min).

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

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 at intervals during the course of therapy. If worsening of renal function is observed during therapy, treatment with eprosartan should be reassessed.

g. high dose diuretic therapy). These conditions should be corrected before commencing therapy. Coronary heart disease There is limited experience in patients with coronary heart disease. Aortic and mitral valve stenosis / hypertrophic cardiomyopathy.

As with other vasodilators, eprosartan should be used with caution in patients with aortic and mitral valve stenosis or hypertrophic cardiomyopathy. 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.

Primary hyperaldosteronism Patients with primary hyperaldosteronism are not recommended to be treated with eprosartan. Renal transplantation There is no experience in patients with recent kidney transplantation. Hyperkalaemia During treatment with other medicinal products which affect the renin-angiotensin-aldosterone system hyperkalaemia may occur, especially in the presence of renal impairment and/or heart failure.

Adequate monitoring of serum potassium in patients at risk is recommended. g. heparin, trimethoprim containing medicines) may lead to an increase in serum potassium and should therefore be co-administered cautiously with Eprosartan. Pregnancy Angiotensin II receptor blockers should not be initiated during pregnancy.

Unless continued angiotensin II receptor blocker therapy is considered essential, patients planning pregnancy should be changed to alternative anti- hypertensive treatments which have an established safety profile for use in pregnancy.

6). Other warnings and precautions As observed for angiotensin converting enzyme inhibitors, eprosartan and the other angiotensin II receptor blockers are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. 6). Severe hepatic impairment. 1).