4.1. Therapeutic indications

'Propecia' is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss.

'Propecia' is not indicated for use in women or children and adolescents.

4.2. Posology and method of administration

Posology

The recommended dosage is one 1 mg tablet daily. 'Propecia' 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.

Method of administration

Crushed or broken tablets of 'Propecia' should not be handled by women when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus (see section 4.6 Fertility, pregnancy and lactation). 'Propecia' 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 'Propecia' and topical minoxidil in male pattern hair loss.

4.3. Contraindications

Contraindicated in women: see section 4.6 'Fertility, pregnancy and lactation' and section 5.1 'Pharmacodynamic properties'.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

'Propecia' is not indicated for use in women or children and adolescents.

'Propecia' should not be taken by men who are taking 'Proscar' (finasteride 5 mg) or any other 5α-reductase inhibitor for benign prostatic hyperplasia or any other condition.

4.4. Special warnings and precautions for use

Paediatric population

'Propecia' should not be used in children. There are no data demonstrating efficacy or safety of finasteride in children under the age of 18.

Effects on Prostate Specific Antigen (PSA)

In clinical studies with 'Propecia' in men 18-41 years of age, the mean value of serum prostate-specific antigen (PSA) decreased from 0.7 ng/ml at baseline to 0.5 ng/ml at month 12. Doubling the PSA level in men taking 'Propecia' should be considered before evaluating this test result.

Effects on fertility

See section 4.6 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, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium‑free'.

4.5. Interaction with other medicinal products and other forms of interaction

Finasteride is metabolised primarily via, but does not affect, the cytochrome P450 3A4 system. Although the risk for finasteride to affect the pharmacokinetics of other drugs is estimated to be small, it is probable that inhibitors and inducers of cytochrome P450 3A4 will affect the plasma concentration of finasteride. However, based on established safety margins, any increase due to concomitant use of such inhibitors is unlikely to be of clinical significance.

Interaction studies have only been performed in adults

4.6. Fertility, pregnancy and lactation

Pregnancy

'Propecia' is contra-indicated for use in women due to the risk in pregnancy. Because of the ability of type II 5α-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone (DHT) in some tissues, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman.

Exposure to finasteride: risk to male foetus

A small amount of finasteride, less than 0.001% of the 1 mg dose per ejaculation, has been detected in the seminal fluid of men taking 'Propecia'. Studies in Rhesus monkeys have indicated that this amount is unlikely to constitute a risk to the developing male foetus (see Section 5.3).

During continual collection of adverse experiences, post-marketing reports of exposure to finasteride during pregnancy via semen of men taking 1 mg or higher doses have been received for eight live male births, and one retrospectively-reported case concerned an infant with simple hypospadias. Causality cannot be assessed on the basis of this single retrospective report and hypospadias is a relatively common congenital anomaly with an incidence ranging from 0.8 to 8 per 1000 live male births. In addition, a further nine live male births occurred during clinical trials following exposure to finasteride via semen, during pregnancy, and no congenital anomalies have been reported.

Breast-feeding

It is not known whether finasteride is excreted in human milk.

Fertility

Long-term data on fertility in humans are lacking, and specific studies in subfertile men have not been conducted. The male patients who were planning to father a child were initially excluded from clinical trials. Although, animal studies did not show relevant negative effects on fertility, spontaneous reports of infertility and /or poor seminal quality were received post-marketing. In some of these reports, patients had other risk factors that might have contributed to infertility. Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride.

4.7. Effects on ability to drive and use machines

Propecia has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

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 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 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, 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 disorder:

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**.

**see section 4.4.

* 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 randomised 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 'Propecia' and placebo were similar. Discontinuation of therapy due to any clinical adverse experience occurred in 1.7% of 945 men treated with 'Propecia' and 2.1% of 934 men treated with placebo.

In these studies, the following drug-related adverse experiences were reported in ≥1% of men treated with 'Propecia': decreased libido ('Propecia', 1.8% vs. placebo, 1.3%) and erectile dysfunction (1.3%, 0.7%). In addition, decreased volume of ejaculate was reported in 0.8% of men treated with 'Propecia' and 0.4% of men treated with placebo. Resolution of these side effects occurred in men who discontinued therapy with 'Propecia' and in many who continued therapy. The effect of 'Propecia' on ejaculate volume was measured in a separate study and was not different from that seen with placebo.

By the fifth year of treatment with 'Propecia', the proportion of patients reporting each of the above side effects decreased to <0.3%.

Finasteride has also been studied for prostate cancer risk reduction at 5 times the dosage recommended for male pattern hair loss. In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, of whom 9060 had prostate needle biopsy data available for analysis, prostate cancer was detected in 803 (18.4%) men receiving finasteride 5 mg and 1147 (24.4%) men receiving placebo. In the finasteride 5 mg group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) 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.

In addition, the following have been reported in post-marketing use: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorder) after discontinuation of treatment with 'Propecia'; male breast cancer (see 4.4 Special warnings and precautions for use).

Drug-related sexual undesirable effects were more common in the finasteride 1 mg-treated men than the placebo-treated men, with frequencies during the first 12 months of 3.8% vs 2.1%, respectively. The incidence of these effects decreased to 0.6% 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months (n=71) did not result in dose-related undesirable effects.

No specific treatment of overdosage with 'Propecia' is recommended.