IRBESARTAN

Posology The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better 24hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75years.

1). 5). In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. 1) Special Populations Patients with renal impairment: no dosage adjustment is necessary in patients with impaired renal function.

4). Patients with Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patientswith severe hepatic impairment. Older people: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the older people.

Paediatric population:

The safety and efficacy of Irbesartan in children aged 0 to 18has not been established. 2 but no recommendation on a posology can be made. Method of Administration For oral use

5%). 5%). The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment. , uncommon) but in excess of placebo. The following table presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received irbesartan.

Terms marked with a star (*) refer to the adverse reactions that were additionally reported in> 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo. 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) and not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions additionally reported from post–marketing experience are also listed. These adverse reactions are derived from spontaneous reports.

4) Reproductive system and breast disorders Uncommon sexual dysfunction Common fatigueGeneral disorders and administration site conditions Uncommon chest pain Investigations Very common Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.

4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group. 3% of the patients in the placebo group. 7%) in irbesartan treated subjects. None of these increases were associated with identifiable clinical musculoskeletal events.

7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed. 9%). 5%) and elevated CK values in 2% of child recipients.

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 medicinalproduct. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Intravascular volume depletion:

Symptomatic hypotension, especially after the first dose, may occur in patients whoare volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of irbesartan.

Renovascular hypertension:

There is an increased risk of severe hypotension and renal insufficiency when patientswith bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with drugs that affect the renin- angiotensin- aldosterone system.

While this is not documented with irbesartan, a similar effect should be anticipatedwith angiotensin-II receptor antagonists.

Renal impairment and kidney transplantation:

When irbesartan is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of irbesartan in patients with a recent kidneytransplantation.

Hypertensive patients with type 2 diabetes and renal disease:

The effects of irbesartan both on renal and cardiovascular events were not uniformacross all subgroups, in an analysis carried out in the study with patients with advanced renal disease. 1).

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 usedconcomitantly in patients with diabetic nephropathy.

Hyperkalemia:

As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalemia may occur during the treatment with irbesartan, especially inthe presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.

5).

Hypoglycaemia:

Irbesartan may include hypoglycaemia, particularly in diabetic patients. 5). 5).

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:

As with other vasodilators, special caution is indicated in patients suffering fromaortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Primary aldosteronism:

Patients with primary aldosteronism generally will not respond to antihypertensivemedicinal products acting through inhibition of the renin- angiotensin system. Therefore, the use of irbesartan is not recommended. g. 5). As with any anti- hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.

1).

Pregnancy:

Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti- hypertensive treatmentswhich have an established safety profile for use in pregnancy.

6). 2). 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, Irbesartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.

Information on sodium content This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that that is to say essentially ‘sodium-free’.

1. 6). 1).