BESAVAR XL

Besavar XL tablets should be swallowed whole.

BPH:

The recommended dose is one 10mg tablet to be taken once daily after a meal.

AUR:

In patients 65 years and older, one 10 mg tablet daily after a meal to be taken from the first day of catheterisation. The treatment should be administered for 3-4 days, 2-3 days during catheterisation and 1 day after its removal. In this indication no benefit has been established in patients under 65 years of age or if treatment is extended beyond 4 days.

1). Therefore, alfuzosin is not indicated for use in the paediatric population.

Classification of expected frequencies:

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). 4) • General disorders and administration site conditions Common: asthenia Uncommon: flushes, oedema, chest pain • Gastro-intestinal disorders Common: nausea, abdominal pain Uncommon: diarrhoea, dry mouth Not known: vomiting • Hepatobiliary disorders Not known: hepatocellular injury, cholestatic liver disease • Nervous system disorders Common: faintness/dizziness, headache Uncommon: syncope, vertigo, malaise, drowsiness • Reproductive system and breast disorders Not known: priapism • Respiratory, thoracic and mediastinal disorders Uncommon: rhinitis • Skin and subcutaneous tissue disorders Uncommon: rash, pruritus Very rare: urticaria, angioedema • Vascular disorders Uncommon: hypotension (postural), flushing • Blood and lymphatic system disorders Not known: neutropenia, thrombocytopenia 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Warnings As with all alpha-1 blockers in some subjects, in particular patients receiving antihypertensive medications or nitrates, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration.

In such cases, the patient should lie down until the symptoms have completely disappeared. These effects are transient, occur at the beginning of treatment and do not usually prevent the continuation of treatment. 8). The risk of developing hypotension and related adverse reactions may be greater in elderly patients.

The patient should be warned of the possible occurrence of such events. As with all alpha1-receptor blockers, alfuzosin should be used with caution in patients with acute cardiac failure. Care should be taken when Besavar XL is administered to patients who have had a pronounced hypotensive response to another alpha-1-blocker.

Treatment should be initiated gradually in patients with hypersensitivity to alpha-1- blockers. 5). Blood pressure should be monitored regularly, especially at the beginning of treatment. Patients with congenital QTc prolongation, with a known history of acquired QTc prolongation or who are taking drugs known to increase the QTc interval should be evaluated before and during the administration of alfuzosin.

5). g. itraconazole and clarithromycin) and a temporary interruption of alfuzosin treatment is recommended if treatment with such medicinal products is initiated. Prolonged erections and priapism have been reported with alpha-1 blockers including alfuzosin in post marketing experience.

8). Precautions In coronary patients, the specific treatment for coronary insufficiency should be continued. If angina pectoris reappears or worsens Besavar XL should be discontinued. As there are no clinical safety data available in patients with severe renal impairment (creatinine clearance < 30ml/min), Besavar XL 10mg tablets should not be administered to this patient group.

1). • History of orthostatic hypotension. • Combination with other -alpha-1 receptor blockers. 5). • Hepatic insufficiency.