Package leaflet: information for the user

Propecia 1 mg film-coated tablets

finasteride
Please read this leaflet carefully before taking this medicine
because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Propecia is and what it is used for
What you need to know before taking Propecia
How to take Propecia
Possible side effects
How to store Propecia
Contents of the pack and other information

1. What Propecia is and what it is used for

Propecia contains the active substance finasteride.
Propecia should only be used in men.
Propecia is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in men aged 18 to 41 years. If, after reading this leaflet, you have any questions about male hair loss, please consult your doctor.
Male pattern hair loss is a common condition believed to be caused by a combination of genetic factors and a particular hormone called dihydrotestosterone (DHT). DHT contributes to shortening the growth phase of hair and to thinning of the hair.
On the scalp, Propecia specifically reduces levels of DHT by inhibiting an enzyme (type II 5-alpha-reductase) that converts testosterone into DHT. Only men with mild to moderate, but not complete, hair loss can expect benefit from using Propecia. In most men treated with Propecia for 5 years, progression of hair loss has been slowed, and at least half of these men also experienced some degree of improvement in hair growth.

2. What you should know before taking Propecia

Do not take Propecia

if you are a woman (because this medicine is intended for men only, see Pregnancy). Clinical studies have shown that Propecia is not effective in women with hair loss
if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Propecia.
Effect on Prostate-Specific Antigen (PSA)
Propecia may affect a blood test called PSA (prostate-specific antigen) used to monitor prostate cancer. If you undergo a PSA test, you must inform your doctor or pharmacist that you are taking Propecia, as Propecia reduces PSA levels.
Effects on fertility
Infertility has been reported in men who have taken finasteride for a prolonged period and who had other risk factors that may affect fertility. After discontinuation of finasteride, normalization or improvement in semen quality has been reported. No long-term clinical studies in men have been conducted on the effects of finasteride on fertility.
Breast cancer
See section 4.
Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Propecia. If you experience any of these symptoms, stop taking Propecia and contact your doctor as soon as possible for further advice.
In some patients, sexual dysfunction has been reported, which may contribute to mood changes, including suicidal thoughts. If you experience symptoms of sexual dysfunction, contact your doctor for further advice. Your doctor may consider discontinuing treatment (see section 4 below for more information on these side effects).
A patient reminder card with the above information is provided in the Propecia packaging.
Children and adolescents
Propecia must not be used in children. There are no data demonstrating the efficacy or safety of finasteride in children under 18 years of age.
Other medicines and Propecia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Propecia is indicated only for the treatment of male pattern hair loss in men. For effects on male fertility, see section 2.

Women must not use Propecia due to the risk during pregnancy.
If you are a pregnant woman or a woman who could potentially become pregnant, do not handle crushed or broken Propecia tablets.
If the active ingredient in Propecia is absorbed following oral intake or through the skin by a woman who is pregnant with a male fetus, this may result in the male fetus being born with abnormalities of the genital organs.
If a pregnant woman comes into contact with the active ingredient in Propecia, she must consult a doctor.
Propecia tablets are film-coated to prevent contact with the active ingredient during normal handling.

Consult your doctor or pharmacist if you have any questions.
Driving and using machines
There are no data indicating that Propecia impairs your ability to drive or operate machinery.
Propecia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.
Propecia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Propecia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet per day. The tablets can be taken with or without food.
Your doctor can help you assess whether Propecia is effective for you. It is important to take Propecia for the length of time prescribed by your doctor. Propecia only works over the long term when used continuously.

If you take more Propecia than you should
If you take too many tablets by mistake, contact your doctor immediately. Propecia does not work faster or better if taken more than once a day.

If you forget to take Propecia
Do not take a double dose to make up for the missed tablet.

If you stop taking Propecia
It may take a period of 3 to 6 months for the full effect to develop. It is important that you continue taking Propecia for as long as your doctor recommends. If you stop treatment with Propecia, you are likely to lose the hair that has regrown within 9 to 12 months.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects have generally been temporary with continued treatment or resolved upon discontinuation of treatment.
Stop taking Propecia and contact your doctor immediately if you experience any of the following symptoms:
swelling of the lips, face, tongue, and throat; difficulty swallowing; swellings under the skin (urticaria), difficulty breathing, or suicidal thoughts.

You must immediately report to your doctor any changes in breast tissue such as lumps, pain, enlargement of breast tissue, or nipple discharge, as these changes may be signs of a serious condition, such as breast cancer.

Uncommon (may affect up to 1 in 100 people):

decreased sexual desire
difficulty in achieving an erection
problems with ejaculation such as reduced amount of semen released
depression

Not known: frequency cannot be estimated from the available data

allergic reactions such as skin rash and itching
swelling or tenderness of the breast
testicular pain
presence of blood in the semen
increased heart rate
persistent difficulty in obtaining an erection after stopping treatment
persistent reduction in sexual drive after stopping treatment
persistent ejaculation problems after stopping treatment
male infertility and/or poor semen quality
elevated liver enzymes
anxiety
suicidal thoughts

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Propecia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Propecia contains

The active substance is finasteride. Each tablet contains 1 mg of finasteride.
The other components are: Tablet core: monohydrate lactose 110.4 mg (see section 2), microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate, sodium docusate, magnesium stearate. Coating: talc, hypromellose, hydroxypropylcellulose, titanium dioxide (colour E171), yellow iron oxide and red iron oxide (colour E172).

Description of the appearance of Propecia and contents of the pack

Propecia film-coated tablets are supplied in blisters.
The tablets are film-coated, convex, reddish-brown, octagonal, and marked with “P” on one side and “Propecia” on the other side.
Pack sizes: 7, 28, 30, 84 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
This medicinal product is authorised in Austria, Finland, France, Germany, Greece, Italy,
Luxembourg, the Netherlands, Portugal, Spain and Sweden under the name Propecia.