FINASTERIDE BIORGA 1 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Finasteride Biorga 1 mg film-coated tablets EFG

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 side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

Finasteride Biorga contains the active ingredient 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 androgenetic alopecia) in men aged 18 to 41.

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 growth phase of hair and making hair thinner.

In the scalp, finasteride 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 Finasteride Biorga. In many men treated with finasteride 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 Finasteride Biorga

Do not take Finasteride Biorga

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

Effects on Prostate-Specific Antigen (PSA)

Finasteride Biorga 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 finasteride, 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 finasteride. If you experience any of these symptoms, stop taking finasteride and consult your doctor as soon as possible for medical advice.

Children and adolescents

Finasteride 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 Finasteride Biorga with other medications

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

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 in males only. For effects on fertility in men, see section 2.

• Women should not use finasteride due to the risk of pregnancy.
• Pregnant women or women who may become pregnant should not handle crushed or broken tablets.

• If a pregnant woman with a male fetus absorbs the active ingredient of Finasteride Biorga after ingesting it orally or through the skin, her child may be born with genital anomalies.

• If a woman comes into contact with the active ingredient of Finasteride Biorga, she should consult a doctor.
• The tablets of Finasteride Biorga 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 Finasteride Biorga affects the ability to drive or use machines.

Finasteride Biorga 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.

3. How to take Finasteride Biorga

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 Finasteride Biorga is effective in your case. It is essential to take finasteride for the entire time your doctor indicates. Finasteride only works in the long term if its administration is maintained.

If you take more Finasteride Biorga than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and package leaflet of the medication to the healthcare professional.

If you forget to take Finasteride Biorga

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

If you stop taking Finasteride Biorga

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 finasteride for the entire period indicated by your doctor. If you stop taking finasteride, you will likely lose the hair you gained in the 9 to 12 months following treatment discontinuation.

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 discontinued.

Stop taking Finasteride Biorga 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, breast tissue enlargement, 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 sex drive
• 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 available data

• allergic reactions, including rash and itching
• breast tenderness and enlargement
• testicular pain
• rapid heartbeat
• persistent difficulty having an erection after discontinuing treatment
• persistent decrease in sex drive after discontinuing treatment
• persistent problems with ejaculation after discontinuing treatment
• male infertility and/or poor semen quality
• elevated liver enzymes
• anxiety

Reporting side effects:

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

5. Storage of Finasteride Biorga

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

This medication does not require special storage conditions.

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.

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

6. Package contents and additional information

Composition of Finasteride Biorga

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

• The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E-460), pregelatinized corn starch, sodium starch glycolate type A (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 package contents

Film-coated tablet.

The tablets of Finasteride Biorga 1 mg are orange-pink, round, and have "F1" engraved on one side.

Finasteride Biorga is available in blister packs of 7, 28, 30, 84, and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

LABORATOIRES BAILLEUL S.A.,

14-16 Avenue Pasteur Luxembourg

L-2310

Luxembourg.

Manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II,

Venus 72

08228 Terrassa (Barcelona)

Spain

Or

Laboratoire AJC Pharma

Usine de Fontaury

16120 CHATEAUNEUF SUR CHARENTE

FRANCE

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

Date of the last revision of this package leaflet: September 2019

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