Finasteride Biorga 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Finasteride Biorga 1 mg film-coated tablets EFG

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 could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Finasteride Biorga is and what it is used for
2. What you need to know before taking Finasteride Biorga
3. How to take Finasteride Biorga
4. Possible side effects
5. How to store Finasteride Biorga
6. Contents of the pack and other information

1. What Finasteride Biorga is and what it is used for

Finasteride Biorga contains the active substance finasteride.

Finasteride Biorga is for use in males only.

Finasteride is used for the treatment of the early stages of male pattern hair loss (also known as androgenic alopecia) in men 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 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 hair to become thinner.

In the scalp, finasteride 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 can expect benefit from using Finasteride Biorga. In many men treated with finasteride for 5 years, 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 starting to take Finasteride Biorga

Do not take Finasteride Biorga

• If you are a woman (because this medicine is for men only, see Pregnancy section). Clinical trials have shown that Finasteride Biorga 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 Finasteride Biorga.

Effects on Prostate-Specific Antigen (PSA)

Finasteride Biorga may affect a blood test known as PSA (Prostate-Specific Antigen) used to detect prostate cancer. If you have had a PSA test, you must inform your doctor or pharmacist that you are taking finasteride, 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 alterations and depression

Mood alterations such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with finasteride. If you experience any of these symptoms, stop taking finasteride and consult your doctor as soon as possible for medical advice.

Sexual dysfunction has been reported in some patients, which may contribute to mood disturbances, including suicidal thoughts. If you experience symptoms of sexual dysfunction, contact your doctor for additional medical advice. Your doctor may consider discontinuing treatment (see section 4 below for more information on these adverse effects).

A patient information card is provided with the Finasteride Biorga packaging, reminding you of the information above.

Children and adolescents

Finasteride 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 Finasteride Biorga with other medicines

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

Taking Finasteride Biorga with food, drinks or alcohol

Finasteride Biorga can be taken with or without food.

Pregnancy, breastfeeding and fertility

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

• Women must not use finasteride due to the risk during pregnancy.

• Women who are or may be pregnant must also avoid touching crushed or broken tablets.

• If a pregnant woman carrying a male fetus absorbs the active ingredient of Finasteride Biorga orally or through the skin, her child may be born with abnormalities of the genital organs.

• If a woman comes into contact with the active ingredient of Finasteride Biorga, she should consult a doctor.

• Finasteride Biorga tablets are film-coated to prevent contact with the active ingredient during normal handling.

If in doubt, ask your doctor.

Driving and use of machines

There are no data indicating that Finasteride Biorga affects the ability to drive or use machines.

Finasteride Biorga contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Finasteride Biorga contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Finasterida Biorga

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 may be taken with or without food.

Your doctor will help determine whether Finasterida Biorga is effective in your case. It is important to take Finasterida Biorga for as long as your doctor recommends. Finasterida Biorga only works long-term if treatment is maintained.

If you take more Finasterida Biorga than you should

If you take too many tablets by mistake, go to the doctor immediately. Finasterida Biorga will not work faster or better if you take more than one tablet a day.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medication and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Finasterida Biorga

Do not take a double dose to make up for missed doses.

If you stop taking Finasterida Biorga

It may be necessary to take the medicine for 3 to 6 months before an effect is seen. It is important that you try to take finasteride for the entire period of time indicated by your doctor. If you stop taking finasteride, 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 stopped.

Stop taking Finasteride Biorga 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), and difficulty breathing
• suicidal thoughts

You must immediately inform your doctor 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 illness, such as breast cancer.

Uncommon: may affect up to 1 in 100 people

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

Frequency not known: frequency cannot be estimated from available data

• allergic reactions including rash and itching
• breast tenderness or enlargement
• testicular pain
• blood in the semen
• rapid heartbeat
• persistent difficulty in obtaining 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 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride Biorga

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Finasteride Biorga

• The active substance is finasteride. Each tablet contains 1 mg of finasteride.

• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E-460), pregelatinized maize starch, sodium starch glycolate type A derived from potato starch, sodium lauryl sulfate, magnesium stearate (E-470b).

Coating: talc, hypromellose (E-464), propylene glycol, titanium dioxide (E-171), yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the product and contents of the pack

Film-coated tablet.

Finasteride Biorga 1 mg tablets are orange-pink in colour, round, and marked with "F1" on one side.

Finasteride Biorga is available in blister packs containing 28 and 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

LABORATOIRES BAILLEUL S.A.,
14-16 Avenue Pasteur
L-2310 Luxembourg
Luxembourg

Manufacturer

Kern Pharma, S.L.
Polígono Ind. Colón II,
Venus 72
08228 Terrassa (Barcelona)
SPAIN

Or

Laboratoire AJC Pharma
Usine de Fontaury
16120 Châteauneuf sur Charente
FRANCE

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

Date of the last revision of this leaflet: November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es/.