Finasteride Aurovitas 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Finasteride Aurovitas 1 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

• Finasteride Aurovitas 1 mg film-coated tablets contain the active substance finasteride.
• Finasteride is for use in males only.
• Finasteride is used to treat male-pattern hair loss (also known as androgenetic alopecia) in men aged 18–41 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 specific hormone called dihydrotestosterone (DHT). DHT contributes to shortening the hair growth phase and causes the hair to become thinner.

In the scalp, finasteride specifically reduces DHT levels by blocking an enzyme (5-alpha-reductase Type II) that converts testosterone to DHT. Only men with mild to moderate, but not complete, hair loss can expect benefit from using finasteride. In many men treated with finasteride for 5 years, 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 starting to take Finasteride Aurovitas

Do not take Finasteride Aurovitas

• If you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
• If you are a woman (because this medicine is for men only, see Pregnancy section). Clinical trials have shown that finasteride is not effective in women with hair loss.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Finasteride Aurovitas.

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.

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

A patient information card reminding of the above information is provided with the Finasteride Aurovitas packaging.

Effects on Prostate-Specific Antigen (PSA)

Finasteride 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 long-term and who had other risk factors that could affect fertility. Normalization or improvement in semen quality has been reported after stopping treatment with finasteride. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.

Breast cancer

See section 4.

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.

Other medicines and Finasteride Aurovitas

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

Pregnancy, breastfeeding and fertility

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

• Women must not use finasteride due to the risk during pregnancy.
• Pregnant women or women who may be pregnant must not handle crushed or broken finasteride tablets.
• If a pregnant woman absorbs the active ingredient of Finasteride Aurovitas orally or through the skin, her male fetus could be born with abnormalities of the genital organs.
• If a pregnant woman comes into contact with the active ingredient of Finasteride Aurovitas, she must consult a doctor.
• Finasteride Aurovitas 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 affects the ability to drive or operate machinery.

Finasteride Aurovitas contains lactose

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

Finasteride Aurovitas contains sodium

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

3. How to take Finasteride Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet daily.
• The tablet can be taken with or without food.

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

If you take more Finasteride Aurovitas than you should

If you have taken too many tablets by mistake, contact your doctor immediately. Finasteride 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 number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Finasteride Aurovitas

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

If you stop taking Finasteride Aurovitas

To see maximum effect, it may be necessary to take the medicine for 3 to 6 months. 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 with continued treatment or disappeared when treatment was stopped.

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

You must inform your doctor immediately 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 libido;
• difficulty achieving an erection;
• problems with ejaculation, including reduced volume of ejaculated semen;
• depression.

Frequency not known (frequency cannot be estimated from available data):

• allergic reactions including rash and itching;
• tenderness and enlargement of the breasts;
• testicular pain;
• blood in the semen;
• rapid heartbeat;
• persistent difficulty in 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;
• suicidal thoughts.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride Aurovitas

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton, blister, and label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

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. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Finasteride Aurovitas

• The active substance is finasteride. Each film-coated tablet contains 1 mg of finasteride.
• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylstarch (type A) (derived from potato starch), pregelatinized maize starch, sodium docusate, magnesium stearate.

Tablet coating: hypromellose, hydroxypropyl cellulose, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and contents of the pack

Film-coated tablet.

Brown, octagonal, biconvex film-coated tablets, engraved with "J" on one side and "81" on the other.

Finasteride Aurovitas film-coated tablets are available in opaque white PVC/PE/PVdC/Aluminum blister packs and in high-density polyethylene (HDPE) bottles with polypropylene caps containing silica gel as desiccant.

Pack sizes:

Blister pack: 28, 56, 84 and 98 film-coated tablets.

HDPE bottle: 30 and 1000 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16 D

28036, Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Finasterid Aurobindo 1 mg Filmtabletten

Spain: Finasterida Aurovitas 1 mg comprimidos recubiertos con película EFG

France: FINASTERIDE ARROW LAB 1 mg, comprimé pelliculé

Italy: Finasteride Aurobindo Pharma Italia 1 mg compresse rivestite con film

Malta: Finasteride 1 mg film-coated tablets

Date of the most recent revision of this leaflet: October 2025

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