Each tablet contains 2.5mg alfuzosin hydrochloride. Excipients: Each tablet contains 61 mg lactose anhydrous.

Film-coated tablets. White round, film coated tablet for oral administration marked Xatral 2.5 on one side.

Treatment of the functional symptoms of benign prostatic hypertrophy.

Alfuzosin Hydrochloride 2.5mg 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.

Renal insufficiency

In patients with renal insufficiency, as a precaution, it is recommended that the dosing be started at Alfuzosin Hydrochloride 2.5mg Tablets twice daily adjusted according to clinical response.

Hepatic insufficiency

In patients with mild to moderate hepatic insufficiency, it is recommended that therapy should commence with a single dose of Alfuzosin Hydrochloride 2.5mg Tablets/day to be increased to Alfuzosin Hydrochloride 2.5mg Tablets twice daily according to clinical response.

Lactose

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

• Hypersensitivity to the active substance or to any of the excipients (see section 6.1 List of excipients).

• History of orthostatic hypotension.

• Combination with other alpha-1 receptorblockers.

• Severe hepatic insufficiency.

Warnings

The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated withalpha1-blockers.Although the risk of this event with alfuzosin appears very low, ophthalmic surgeons should be informed in advance of cataract surgery of current or part use of alpha-1-blockers, as IFIS may lead to increased procedural complications. Care should be taken when alfuzosin is administered to patients who have had a pronounced hypotensive response to another alpha1-blocker.

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 and do not usually prevent the continuation of treatment after adjustment of the dose. 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.

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.

Precautions

Treatment should be initiated gradually in patients with hypersensitivity to alpha-1-blockers. Alfuzosin Hydrochloride 2.5mg Tablets should be administered carefully to patients being treated with antihypertensives. Blood pressure should be monitored regularly, especially at the beginning of treatment.

In patients with coronary insufficiency specific anti-anginal therapy should be continued, but if the angina reappears or worsens Alfuzosin Hydrochloride 2.5mg Tablets should be discontinued.

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

Combinations contraindicated:

- Alpha-1-receptor blockers (see section 4.3 Contraindications))

Combinations to be taken into account:

- Antihypertensive drugs (see section 4.4 Special warnings and precautions for use)

- Nitrates (see section 4.4 Special warnings and precautions for use)

- Potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir since blood levels are increased.

The administration of general anaesthetics to patients receiving Alfuzosin Hydrochloride 2.5mg Tablets could cause profound hypotension. It is recommended that Alfuzosin Hydrochloride 2.5mg Tablets be withdrawn 24 hours before surgery.

Other forms of interaction

No pharmacodynamic or pharmacokinetic interaction has been observed in healthy volunteers between alfuzosin and the following drugs: warfarin, digoxin, hydrochlorothiazide and atenolol.

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).

• Cardiac disorders

Uncommon: tachycardia, palpitations

Very rare: angina pectoris in patients with pre-existing coronary artery disease 

Not known: atrial fibrillation

• Eye disorders

Uncommon: vision abnormal

Not known: intraoperative floppy iris syndrome

• General disorders and administration site conditions

Common: asthenia, malaise

Uncommon:, oedema, chest pain

• Gastro-intestinal disorders

Common: nausea, abdominal pain, 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

• 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, angiœdema

• Vascular disorders

Common: hypotension (postural)

Uncommon: flushing

• Blood and lymphatic system disorders

Not known: neutropenia

Winthrop Pharmaceuticals UK Ltd

POM

11 November 2011