Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Treatment of the functional symptoms of benign prostatic hypertrophy (BPH).
For information on use in acute urinary retention (AUR) related to BPH see sections 4.2 and 5.1.
Xatral XL should be swallowed whole (see section 4.4).
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.
Efficacy of Xatral XL has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore Xatral XL is not indicated for use in the paediatric population.
In case of overdosage, the patient should be hospitalised, kept in the supine position, and conventional treatment of hypotension should take place.
In case of significant hypotension, the appropriate corrective treatment may be a vasoconstrictor that acts directly on vascular muscle fibres.
Alfuzosin is not dialysable because of its high degree of protein binding.
Shelf life: 3 years.
No special precautions for storage.
Store in the original container.
Boxes with 10, 30, 50, 100 and 500 tablets in pvc/foil blister strips.
Not all pack sizes may be marketed.
No special requirements.
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