Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK
‘Proscar’ is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in patients with an enlarged prostate to:
The recommended adult dose is one 5 mg tablet daily, with or without food.
‘Proscar’ can be administered alone or in combination with the alpha-blocker doxazosin (see section 5.1 ‘Pharmacodynamic properties’).
Although early improvement in symptoms may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. Thereafter, treatment should be continued long term.
No dosage adjustment is required in the elderly or in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 ml/min).
There are no data available in patients with hepatic insufficiency.
‘Proscar’ is contra-indicated in children.
No specific treatment of overdosage with ‘Proscar’ is recommended. Patients have received single doses of ‘Proscar’ up to 400 mg and multiple doses of ‘Proscar’ up to 80 mg/day for up to three months without any adverse effects.
Three years.
Do not store above 30°C. Store in the original package.
Opaque PVC/PE/PVDC blisters lidded with aluminium foil; packs of 28 tablets.
Women should not handle crushed or broken ‘Proscar’ Tablets when they are or may potentially be pregnant (see 'Contra-indications, ‘Pregnancy and lactation’, Exposure to finasteride – risk to male foetus).
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