Label: information for the user

Propecia 1 mg film-coated tablets

finasteride

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult 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, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What Propecia is and for what it is used

2. What you need to know before starting to take Propecia

3. How to take Propecia

4. Possible adverse effects

5. Storage of Propecia

6. Contents of the pack and additional information

Propecia contains the active ingredient finasteride.

Propecia is for exclusive use in males.

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

Male pattern hair loss is a common disorder 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 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 males with mild to moderate hair loss, but not complete, can expect a benefit from using Propecia. In many males treated with Propecia for 5 years, the progression of hair loss became slower, and at least half of those males also showed some improvement in hair growth.

Do not take Propecia

• If you are a woman (because this medication is for men, see Pregnancy section). 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 components 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 must 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 is no evidence to demonstrate the efficacy and safety of finasteride in children under 18 years old.

Propecia and other medications

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

Pregnancy, breastfeeding, and fertility

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

• Women cannot use Propecia due to the risk of pregnancy.
• Women who are or may be pregnant should not touch crushed or broken Propecia tablets.
• If a pregnant woman with a male fetus absorbs the active ingredient of Propecia after oral ingestion or through the skin, her child may be born with genital organ abnormalities.
• If a pregnant woman comes into contact with the active ingredient of Propecia, she should consult a doctor.
• Propecia tablets are coated to prevent contact with the active ingredient during normal handling.

In case of doubt, ask your doctor.

Driving and operating machinery

There is no evidence to indicate that Propecia affects the ability to drive or operate machinery.

Propecia contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him 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".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

If you take more Propecia than you should

If you accidentally take too many tablets, go to your doctor immediately. Taking more than one tablet per day will not make Propecia work faster or better.

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Propecia

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Propecia

To appreciate the effect, it may be necessary to take the medication for 3 to 6 months. It is essential to try to take Propecia for the entire period of time indicated by your doctor. If you stop taking Propecia, you will likely lose the hair you gained in the 9 to 12 months following the interruption of treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people experience them.

Adverse effects have been, normally, 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 must inform your doctor immediately of any change in breast tissue, such as lumps, pain, breast tissue enlargement, or nipple discharge, as these may be signs of a serious disease, such as breast cancer.

Rare: may affect up to 1 in 100 people

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

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

• allergic reactions, including rash and itching
• breast tenderness and swelling
• testicular pain
• blood in semen
• rapid heart rate
• persistent difficulty achieving an erection after stopping treatment
• persistent decrease in libido after stopping treatment
• persistent problems with ejaculation after stopping treatment
• male infertility and/or poor semen quality
• elevated liver enzymes
• anxiety
• suicidal thoughts

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. 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 through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Propecia

• The active ingredient 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 cornstarch, sodium starch glycolate, sodium docusate, magnesium stearate.

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

Appearance of the product and contents of the container

• Propecia film-coated tablets are provided in blisters.
• The tablets are film-coated, convex, octagonal, brown in color, and engraved with the logo ‘P’ on one face and ‘PROPECIA’ on the other.
• Container sizes: 7, 28, 30, 84, or 98 tablets.
• Not all container sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Responsible manufacturer

Organon Heist bv

Industriepark30

2220Heist-op-den-Berg

Belgium

Merck Sharp & Dohme B.V.

Waarderweg39

2031BN Haarlem

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

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

Last review date of this leaflet:07/2024.

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