FINASTERIDE

6). Androgenetic alopecia The recommended dosage is 1 mg daily. Finasteride may be taken with or without food. There is no evidence that an increase in dosage will result in increased efficacy. Efficacy and duration of treatment should continuously be assessed by the treating physician.

Generally, three to six months of once daily treatment are required before evidence of stabilisation of hair loss can be expected. Continuous use is recommended to sustain benefit. If treatment is stopped, the beneficial effects begin to reverse by six months and return to baseline by 9 to12 months.

No data are available on the concomitant use of Finasteride and topical minoxidil in male pattern hair loss. Use in renal insufficiency No adjustment in dosage is required in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 ml/min), as pharmacokinetic studies did not indicate any change in the disposition of finasteride.

4). Use in the elderly No dosage adjustment is required in elderly patients. 6 Fertility, pregnancy and lactation). ‘Finasteride’ tablets are coated to prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

The adverse reactions during clinical trials and/or post-marketing use are listed in the table below.

Frequency of adverse reactions is determined as follows:

Very Common (≥ 1/10); Common (≥ 1/100, ≤1/10); Uncommon (≥ 1/1,000, ≤ 1/100); Rare (≥ 1/10,000, ≤ 1/1,000); Very rare (< 1/10,000); not known (cannot be estimated from the available data). The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.

System Organ Class Frequency: adverse reaction Immune system disorders Not known:

Hypersensitivity reactions, including rash, pruritus, urticaria and angioedema (swelling of the lips, tongue, throat and face). Psychiatric disorders Uncommon*: decreased libido Uncommon: depression†.

Not known:

Anxiety. suicidal ideation Cardiac disorders Not known: palpitation Hepatobiliary disorders Not known: increased hepatic enzymes Reproductive system and breast disorders Uncommon *: Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate).

Not known:

Breast tenderness and enlargement, testicular pain, haematospermia, infertility**. 4. * Incidences presented as difference from placebo in clinical studies at Month 12. † This adverse reaction was identified through post-marketing surveillance but the incidence in randomized controlled Phase III clinical trials (Protocols 087, 089 and 092) was not different between finasteride and placebo.

Side effects, which usually have been mild, generally have not required discontinuation of therapy. Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3,200 men. In three 12-month, placebo-controlled, double-blind, multicentre studies of comparable design, the overall safety profiles of Finasteride 1 mg and placebo were similar.

Paediatric population Finasteride should not be used in children. There are no data demonstrating efficacy or safety of finasteride in children under the age of 18. 5 ng/ml at month 12. Doubling the PSA level in men taking Finasteride should be considered before evaluating this test result.

Effects on fertility See

1. 1 ‘Pharmacodynamic properties’. • Finasteride is not indicated for use in women or children and adolescents. • Finasteride 1 mg should not be taken by men who are taking finasteride 5 mg or any other 5α- reductase inhibitor for benign prostatic hyperplasia or any other condition.