FINASTERIDE

Posology The recommended dosage is one 1 mg tablet daily. The medicinal product 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 to 12 months.

6 – “Fertility, pregnancy and lactation”). The tablets are coated to prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. Patients with renal impairment No dosage adjustment is required in patients with renal insufficiency.

No data are available on the concomitant use of Finasteride tablets and topical minoxidil in male pattern hair loss.

The adverse reactions during clinical trials and/or post-marketing use are listed in the table below: The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.

System Organ Class 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 available data) Immune system disorders Hypersensitivity reactions, including rash, pruritus, urticaria and angioedema (swelling of the lips, tongue, throat and face) Cardiac disorders Palpitation Psychiatric disorders 1Decreased libido, Depression†, Anxiety, Suicidal Ideation Hepatobiliar y disorders Increased hepatic enzymes Reproductiv e system and breast disorders 1Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate) Breast tenderness and enlargement (gynecomastia), testicular pain, haematospermia, infertility2.

4. † This adverse reaction was identified through post-marketing surveillance but the incidence in randomised controlled Phase III clinical trials (Protocols 087, 089, and 092) was not different between finasteride and placebo. Side effects, which have usually 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 and placebo were similar.

1% of 934 men treated with placebo. 8% vs. 7%). 4% of men treated with placebo. Resolution of these side effects occurred in men who discontinued therapy with finasteride and in many who continued therapy. The effect of finasteride on ejaculate volume was measured in a separate study and was not different from that seen with placebo.

Paediatric population Finasteride 1 mg Film-Coated Tablets 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 1 mg should be considered before evaluating this test result.

6 – “Fertility, pregnancy and lactation”. Hepatic impairment The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied. Breast cancer Breast cancer has been reported in men taking finasteride 1 mg during the post- marketing period.

Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps, pain, gynaecomastia, or nipple discharge. Mood alterations and depression Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 1 mg.

Patients should be monitored for psychiatric symptoms and if these occur, treatment with finasteride should be discontinued and the patient advised to seek medical advice. Lactose intolerance Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Finasteride 1 mg Film-Coated Tablets contain sodium This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

This medicinal product is contraindicated in women. 1 - “Pharmacodynamic Properties”. 1 This medicinal product is not indicated for use in women or children and adolescents. Finasteride 1 mg Film-Coated Tablets should not be taken by men who are taking any other finasteride-containing products or any other 5α-reductase inhibitors for benign prostatic hyperplasia or any other condition.