PROPECIA 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Propecia 1 mg film-coated tablets

finasteride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Propecia and what is it used for
2. What you need to know before taking Propecia
3. How to take Propecia
4. Possible side effects
5. Storage of Propecia
6. Package contents and additional information

1. What is Propecia and what is it used for

Propecia contains the active ingredient finasteride.

Propecia is for use in men only.

Propecia is used to treat male pattern hair loss (also known as androgenetic alopecia) in men aged 18 to 41 years. If, after reading this package leaflet, you have any questions about male pattern hair loss, consult your doctor.

Male pattern hair loss is a common disorder that is thought 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 making the hair thinner.

In the scalp, Propecia specifically reduces DHT levels by blocking an enzyme (Type II 5-alpha-reductase) that converts testosterone to DHT. Only men with mild to moderate hair loss, but not complete hair loss, can expect a benefit from using Propecia. In many men treated with Propecia for 5 years, the progression of hair loss slowed down, 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 medication is for men, see section Pregnancy). Clinical trials have shown that Propecia is not effective in women with hair loss.
• if you are allergic to the active ingredient (finasteride) or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Propecia.

Effects on Prostate-Specific Antigen (PSA)

Propecia may affect a blood test called PSA (Prostate-Specific Antigen) for detecting prostate cancer. If you have had a PSA test, you should inform your doctor or pharmacist that you are taking Propecia, as it decreases PSA levels.

Effects on fertility

Infertility has been reported in men who took finasteride for a long time and had other risk factors that could affect fertility. Normalization or improvement of semen quality has been reported after discontinuing finasteride treatment. No long-term clinical studies have been conducted on the effect of finasteride on male 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 consult your doctor as soon as possible for medical advice.

Children and adolescents

Propecia should not be used in children. There are no data to demonstrate the efficacy and safety of finasteride in children under 18 years of age.

Taking Propecia with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Pregnancy, breastfeeding, and fertility

Propecia is intended for the treatment of male pattern hair loss in men only. For effects on fertility in men, see section 2.

• Women should not use Propecia due to the risk of pregnancy.
• Pregnant women should not handle crushed or broken Propecia tablets.
• If a pregnant woman with a male fetus absorbs the active ingredient of Propecia after ingesting it orally or through the skin, her son may be born with genital anomalies.
• If a pregnant woman comes into contact with the active ingredient of Propecia, she should consult a doctor.
• Propecia tablets are film-coated to prevent contact with the active ingredient during normal handling.

In case of doubt, ask your doctor.

Driving and using machines

There are no data to indicate that Propecia affects the ability to drive or use machines.

Propecia contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Propecia contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Propecia

Follow the exact instructions for administration of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. The tablets can be taken with or without food.

Your doctor will help you determine if Propecia is effective in your case. It is essential to take Propecia for the entire time your doctor indicates. Propecia only works in the long term if its administration is maintained.

If you take more Propecia than you should

If you take too many tablets by mistake, go to the doctor immediately. Propecia will not work faster or better by taking more than one tablet per day.

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to take the package and package leaflet of the medication 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

To appreciate the effect, it may be necessary to take the medication for 3 to 6 months. It is essential that you try to take Propecia for the entire period indicated 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects have usually been transient with continued treatment or have disappeared when treatment is interrupted.

Stop taking Propecia and inform your doctor immediately if you experience any of the following symptoms: swelling of the lips, face, tongue, and throat; difficulty swallowing; lumps under the skin (hives) and difficulty breathing.

You should inform your doctor immediately of any change in breast tissue, such as lumps, pain, increased breast tissue, or nipple discharge, as these may be signs of a serious disease, such as breast cancer.

Uncommon: may affect up to 1 in 100 people

• decreased sexual desire
• difficulty achieving an erection
• problems with ejaculation, including a decrease in the amount of semen ejaculated
• depression

Frequency not known: frequency cannot be estimated from the available data

• allergic reactions, including rash and itching
• breast tenderness and enlargement
• testicular pain
• blood in the semen
• rapid heartbeat
• persistent difficulty having an erection after stopping treatment
• persistent decrease in sexual desire after stopping treatment
• persistent problems with ejaculation after stopping treatment
• male infertility and/or poor semen quality
• elevated liver enzymes
• anxiety
• suicidal thoughts

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Propecia

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Propecia

• The active ingredient is finasteride. Each tablet contains 1 mg of finasteride.
• The other ingredients are:

Core of the tablet: lactose monohydrate (110.4 mg) (see section 2), microcrystalline cellulose, pregelatinized starch (from corn), sodium starch glycolate (from potato), sodium docusate, magnesium stearate.

Coating: talc, hypromellose, hydroxypropyl cellulose, titanium dioxide (color E-171), yellow and red iron oxide (color E-172).

Appearance of the product and package contents

• Propecia film-coated tablets are provided in blisters.
• The tablets are film-coated, convex, octagonal, brown in color, engraved with the logo 'P' on one side and 'PROPECIA' on the other.
• Package sizes: 7, 28, 30, 84, or 98 tablets.
• Not all package 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

Netherlands

This medication is authorized in the Member States of the European Economic Area under the following names:

Austria, Finland, France, Germany, Greece, Italy, Luxembourg, Netherlands, Portugal, Spain, and Sweden: Propecia.

Date of the last revision of this package leaflet:07/2024.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)