Propecia 1 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Propecia 1 mg film-coated tablets
finasteride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- 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 ingredient finasteride.
Propecia is for use in males only.
Propecia is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in men aged 18 to 41. If, after reading this leaflet, you have any questions about male pattern hair loss, 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 hair growth phase and causes the hair to become thinner.
In the scalp, Propecia specifically reduces levels of DHT by blocking an enzyme (type II 5-alpha-reductase) that converts testosterone to DHT. Only men with mild to moderate, but not complete, hair loss may expect benefit from using Propecia. In many men treated with Propecia for 5 years, the progression of hair loss slowed, and in at least half of these men, hair growth also improved to some extent.
2. What you need to know before taking Propecia
Do not take Propecia
- if you are a woman (because this medicine is intended for men only; see Pregnancy section). Clinical trials have shown that Propecia is not effective in women with hair loss.
- if you are allergic to the active substance (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 starting to take Propecia.
Effects on Prostate-Specific Antigen (PSA)
Propecia may affect a blood test known as PSA (Prostate-Specific Antigen), which is used to detect prostate cancer. If you have had a PSA test, you must inform your doctor or pharmacist that you are taking Propecia, as it reduces PSA levels.
Effects on fertility
Infertility has been reported in men who took finasteride for a prolonged period and who had other risk factors that could affect fertility. Normalization or improvement in semen quality has been reported after discontinuation of finasteride treatment. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
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 consult your doctor as soon as possible for medical advice.
In some patients, sexual dysfunction has been reported, which may contribute to mood disturbances, including suicidal thoughts. If you experience symptoms of sexual dysfunction, contact your doctor for further medical advice. Your doctor may consider discontinuing treatment (see section 4 for more information on these adverse effects).
A patient information card is provided with the Propecia packaging, summarizing the above information.
Children and adolescents
Propecia must not be used in children. There are no data demonstrating the efficacy and safety of finasteride in children under 18 years of age.
Taking Propecia with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding and fertility
Propecia is intended 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.
- Women who are or may be pregnant must not handle crushed or broken Propecia tablets.
- If a pregnant woman absorbs the active ingredient of Propecia orally or through the skin, a male fetus may be born with abnormalities of the genital organs.
- If a pregnant woman comes into contact with the active ingredient of Propecia, she must consult a doctor.
- Propecia tablets are film-coated to prevent contact with the active ingredient during normal handling.
If in doubt, ask your doctor.
Driving and using machines
There are no data indicating that Propecia affects the ability to drive or operate machinery.
Propecia contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Propecia contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., essentially “sodium-free”.
3. How to take Propecia
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
The recommended dose is one tablet daily. The tablets can be taken with or without food.
Your doctor will help you determine whether Propecia is effective in your case. It is important to take Propecia for as long as your doctor recommends. Propecia only works long-term if treatment is maintained.
If you take more Propecia than you should
If you take too many tablets by mistake, contact your doctor immediately. Propecia will not work faster or better if you take more than one tablet a day.
Contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20 immediately, indicating the medication and the amount taken. It is recommended to bring the medication packaging and leaflet to the healthcare professional.
If you forget to take Propecia
Do not take a double dose to make up for forgotten doses.
If you stop taking Propecia
It may take 3 to 6 months of treatment before an effect is noticeable. It is important to try to take Propecia for the entire period recommended by your doctor. If you stop taking Propecia, you will likely lose the hair you have gained within 9 to 12 months after stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects have usually been temporary during continued treatment or disappeared when treatment was discontinued.
Stop taking Propecia and inform your doctor immediately if you experience any of the following symptoms: swelling of the lips, face, tongue, or throat; difficulty swallowing; lumps under the skin (hives), difficulty breathing, or suicidal thoughts.
Inform your doctor immediately of any changes in breast tissue, such as lumps, pain, enlargement of breast tissue, or nipple discharge, as these may be signs of a serious condition, such as breast cancer.
Uncommon: may affect up to 1 in 100 people
- reduced sexual desire
- difficulty achieving erection
- problems with ejaculation, including a decrease in the amount of semen ejaculated
- depression
Frequency not known: frequency cannot be estimated from available data
- allergic reactions including rash and itching
- breast tenderness and enlargement
- testicular pain
- blood in the semen
- rapid heartbeat
- persistent difficulty in achieving erection after stopping treatment
- persistent decrease in sexual desire after stopping treatment
- persistent ejaculation problems after stopping treatment
- male infertility and/or poor semen quality
- elevated liver enzymes
- anxiety
- suicidal thoughts
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Propecia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Propecia
- The active substance is finasteride. Each tablet contains 1 mg of finasteride.
- The other components are:
Tablet core: lactose monohydrate (110.4 mg) (see section 2), microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), sodium docusate, magnesium stearate.
Coating: talc, hypromellose, hydroxypropyl cellulose, titanium dioxide (colour E-171), yellow and red iron oxide (colour E-172).
Appearance of the product and contents of the pack
- Propecia film-coated tablets are supplied in blisters.
- The tablets are film-coated, convex, octagonal, cinnamon-coloured, engraved with the logo 'P' on one side and 'PROPECIA' on the other.
- Pack sizes: 7, 28, 30, 84 or 98 tablets.
- Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Tel.: 915911279
Manufacturer
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria, Finland, France, Germany, Greece, Italy, Luxembourg, The Netherlands, Portugal, Spain and Sweden: Propecia.
Date of the most recent revision of this leaflet: 11/2025.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)