FINASTERIDE

Posology The recommended dosage is one 1 mg tablet daily. 6). The film-coated tablets can either be taken on an empty stomach or with a meal. 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.

Dosage in renal insufficiency No dosage adjustment is required in patients with renal insufficiency. Dosage in hepatic insufficiency There are no data available in patients with hepatic insufficiency No data are available on the concomitant use of finasteride and topical minoxidil in male pattern hair loss.

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.

Immune system disorders:

Not known: Hypersensitivity reactions, such as rash, pruritus, urticaria and angioedema including 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 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.

3%. Finasteride has also been studied for prostate cancer risk reduction at 5 times the dosage recommended for male pattern hair loss. 4%) men receiving placebo. 4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs.

1%) men in placebo group. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (stage T1 or T2). The relationship between long-term use of Finasteride 5 mg and tumours with Gleason scores of 7-10 is unknown.

4 Special warnings and precautions for use). 1%, respectively. 6% in Finasteride 1 mg-treated men over the following four years. Approximately 1% of men in each treatment group discontinued due to drug related sexual adverse experiences in the first 12 months, and the incidence declined thereafter.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Paediatric population This medicine must 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 1mg should be considered before evaluating this test result.

This decrease in serum PSA concentrations needs to be considered, if during treatment with Finasteride Tablets 1mg, a patient requires a PSA assay. In this case doubling the PSA value should be considered before making a comparison with the results from untreated men.

Effects on fertility See section

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