PATIENT INFORMATION LEAFLET

Finasterida Biorga 1 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Finasterida Biorgacontains the active ingredient finasteride.

Finasterida Biorga is for exclusive use in males.

Finasteride is used for the treatment of the early stages 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 that is 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 makes the hair thinner.

In the scalp, finasteride specifically reduces DHT levels by blocking an enzyme (5-alpha-reductase type II) that converts testosterone to DHT. Only males with mild to moderate hair loss, but not complete, can expect a benefit from using Finasterida Biorga. In many of the males treated with finasteride over 5 years, the progression of hair loss became slower, and at least half of those males also experienced some improvement in hair growth.

Do not take Finasterida Biorga

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

Effects on Prostate-Specific Antigen (PSA)

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

Effects on fertility

Fertility problems have 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 stopping 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.No data demonstrate the efficacy and safety of finasteride in children under 18 years old.

Finasterida Biorga and other medications

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

Finasterida Biorga and food, drinks, or alcohol

Finasterida 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 males.See section 2 for effects on male fertility.

• Women cannot use finasteride due to the risk of pregnancy.
• Women who are or may be pregnant should not touch crushed or broken tablets.

• If a pregnant woman with a male fetus absorbs the active ingredient of Finasterida Biorga after oral ingestion or through the skin, her child may be born with genital organ abnormalities.

• If a woman comes into contact with the active ingredient, she should consult a doctor.
• Finasterida Biorga tablets are coated to prevent contact with the active ingredient during normal handling.

Ask your doctor if you are unsure.

Driving and operating machinery

No data indicate that Finasterida Biorga affects the ability to drive or operate machinery

Finasterida Biorga contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for 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. Tablets can be taken with or without food.

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

If you take more Finasterida Biorga than you should

If you accidentally take too many tablets, go to your doctor immediately. Finasterida Biorga will not act 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Finasterida Biorga

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

If you interrupt treatment with Finasterida Biorga

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

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

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

Adverse effects have been, normally, transient with continued treatment or have disappeared when treatment is interrupted.

Stop taking Finasterida Biorga and immediately inform your doctor 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 immediately inform your doctor 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

Frequencyunknown: the frequency cannot be estimated from the available data

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

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 of 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.

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Finasteride Biorga

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

• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E-460), pregelatinized cornstarch, 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 packaging

Coated tablet.

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

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

Not all packaging sizes may be marketed.

Marketing authorization holder

LABORATOIRES BAILLEUL S.A.,

14-16 Avenue Pasteur Luxembourg

L-2310

Luxembourg.

Responsible for manufacturing

Kern Pharma, S.L.

Polígono Ind. Colón II,

Venus 72

08228 Terrassa (Barcelona)

Spain

O

Laboratoire AJC Pharma

Usine de Fontaury

16120 CHATEAUNEUF SUR CHARENTE

FRANCE

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

Last review date of this leaflet: September 2019

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