Prescribing Information - UK

Xatral® / Xatral® XL (alfuzosin hydrochloride)

Presentation: Xatral XL tablets containing 10 mg alfuzosin hydrochloride in a prolonged release formulation. Xatral tablets containing 2.5mg alfuzosin hydrochloride.

Indication: Symptomatic relief of Benign Prostatic Hypertrophy (BPH). For information on use in Acute Urinary Retention (AUR) related to BPH see dosage.

Dosage: Initial dose should be taken before bedtime.
BPH: Adults
Xatral XL - one tablet to be taken daily after a meal. Tablet should be swallowed whole.
Xatral - one tablet (2.5mg) three times daily increasing to four tablets per day if required. BPH: Elderly and treated hypertensive patients
Xatral XL - no dose adjustment required.
Xatral - one tablet (2.5mg) twice daily (morning and evening).
BPH: Renal insufficiency
Xatral XL - no dose adjustment required in patients with mild to moderate renal impairment. Experience in patients with severe renal impairment is limited and cautious use in these patients is recommended.
Xatral - one tablet (2.5mg) twice daily (morning and evening) adjusted according to clinical response.
BPH: Hepatic insufficiency Mild to moderate: single dose of Xatral 2.5mg per day, increasing to 2.5mg twice daily according to clinical response.
AUR related to BPH:
Xatral XL. In patients 65 years and older, one 10mg tablet daily after a meal from first day of catheterisation for 3-4 days (2-3 days during catheterisation and 1 day after catheter removal). In this indication, no benefit has been established in patients younger than 65 years or if treatment extended beyond 4 days.

Contraindications: Hypersensitivity to alfuzosin, history of orthostatic hypotension, co-administration with other alpha-blockers, severe hepatic insufficiency (Xatral), hepatic insufficiency (Xatral XL).

Warnings: Postural hypotension with or without symptoms may occur in some subjects, in particular, patients receiving antihypertensive medications. These effects are transient and do not usually prevent continuation of treatment following dose adjustment.

Precautions: Initiate treatment gradually in patients who have shown hypersensitivity to alpha blockers and in patients taking anti-hypertensive drugs. Continue specific anti-anginal therapy in patients with coronary insufficiency. Discontinue Xatral XL or Xatral if angina reappears or worsens. Withdraw 24 hours before surgery.

Interactions: Use of Xatral and Xatral XL with general anaesthetics could cause profound hypotension. It is recommended to withdraw therapy 24 hours prior to surgery. Use with nitrates is a combination to be taken into account.

Side effects:
Xatral XL: Commonly observed side effects: faintness, dizziness, headache, nausea, abdominal pain and asthenia Uncommon side effects: vertigo, malaise, drowsiness, palpitations, hypotension (postural), syncope. diarrhoea, dry mouth, rash, pruritus, flushes, oedema and chest pain

Xatral: Commonly observed side effects: faintness, dizziness, vertigo, malaise, headache, hypotension (postural), nausea, abdominal pain, diarrhoea, dry mouth and asthenia Uncommon side effects: drowsiness, abnormal vision, tachycardia, palpitations, syncope, rhinitis, rash, pruritus, flushes, oedema and chest pain

Xatral XL & Xatral: Very rarely: aggravation or recurrence of angina pectoris. Although only reported in isolated cases with alfuzosin, occurrence of priapism can not be excluded as it is generally accepted as being attributable to all other alpha adrenoreceptor blockers.