ALFUZOSIN HYDROCHLORIDE

5mg tablets should be swallowed whole. The first dose should be given just before bedtime. Adults The usual dose is one tablet three times daily. The dose may be increased to a maximum of 4 tablets (10mg) per day depending on the clinical response.

Elderly and treated hypertensive patients As a routine precaution when prescribing alfuzosin to elderly patients (aged over 65 years) and the treated hypertensive patient, the initial dose should be 1 tablet in the morning and 1 tablet in the evening.

5mg tablets twice daily adjusted according to clinical response. 5mg Tablets twice daily according to clinical response. 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, malaise 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, vertigo, headache Uncommon: drowsiness, syncope Not known: cerebral ischemic disorders in patients with underlying cerebrovascular disturbances • 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 Common: hypotension (postural) Uncommon: 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.

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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 Alfuzosin 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. 5 mg tablets should be discontinued. Although the risk of this event with alfuzosin appears very low, ophthalmic surgeons should be informed in advance of cataract surgery of current or past use of alpha-1-blockers, as IFIS may lead to increased procedural complications.

5 mg tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium free’

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