FINASTERIDE AUROVITAS 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride Aurovitas 1 mg film-coated tablets EFG

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

• Finasteride Aurovitas 1 mg film-coated tablets contain the active ingredient finasteride.
• Finasteride is for use in men only.
• Finasteride is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in men aged 18-41 years. If, after reading this package leaflet, you have any questions about male pattern hair loss, ask your doctor.
• Male pattern hair loss is a common condition 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 the hair and making the hair thinner.

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

Do not take Finasteride Aurovitas

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Finasteride Aurovitas.

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.

Effects on Prostate-Specific Antigen (PSA)

Finasteride 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, because it lowers PSA levels.

Effects on fertility

Infertility has been reported in men who took finasteride for a long time and who had other risk factors that could affect fertility. Normalization or improvement of semen quality has been reported after discontinuation of finasteride treatment. No long-term clinical studies on the effect of finasteride on male fertility have been conducted.

Breast cancer

See section 4.

Children and adolescents

Finasteride should not be used in children. There is no evidence of the efficacy and safety of finasteride in children under 18 years of age.

Other medicines and Finasteride Aurovitas

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

Pregnancy, breastfeeding, and fertility

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

• Women must not use finasteride due to the risk of pregnancy.
• Do not handle crushed or broken finasteride tablets if you are a pregnant woman or could be pregnant.
• If a pregnant woman with a male fetus absorbs the active ingredient of Finasteride Aurovitas after oral ingestion or through the skin, her son could be born with genital anomalies.
• If a pregnant woman comes into contact with the active ingredient of Finasteride Aurovitas, she should consult a doctor.
• The tablets of Finasteride Aurovitas are film-coated to prevent contact with the active ingredient during normal handling.

If you are in doubt, ask your doctor.

Driving and using machines

There are no data to suggest that finasteride affects the ability to drive or use machines.

Finasteride Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Finasteride Aurovitas contains sodium

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

3. How to take Finasteride Aurovitas

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

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

Your doctor will help you determine if this medicine works for you. It is important to take finasteride for the entire period of time your doctor indicates. Finasteride only works in the long term if its administration 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 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 medicine and the amount ingested.

If you forget to take Finasteride Aurovitas

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

If you stop taking Finasteride Aurovitas

To appreciate the 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 probably lose the hair you gained within 9 to 12 months after stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Stop taking finasteride 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, enlargement of breast tissue, or nipple discharge, as these can be signs of a serious disease, such as breast cancer.

Uncommon (may affect up to 1 in 100 people):

• decreased sexual desire,
• 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 the available data):

• allergic reactions including rash and itching,
• sensitivity and breast enlargement,
• testicular pain,
• blood in the semen,
• rapid heartbeat,
• persistent difficulty having 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 side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Information System: www.notificaRAM.es. By reporting side 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 which is stated on the carton, blister, and label of the bottle after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Finasteride Aurovitas

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

Core of the tablet:lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A) (derived from potato starch), pregelatinized maize starch, sodium docusate, magnesium stearate.

Coating of the tablet:hypromellose, hydroxypropyl cellulose, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Appearance and packaging of the product

Film-coated tablet.

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

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

Package sizes:

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

HDPE bottle: 30 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Finasterid Aurobindo 1 mg film-coated tablets

Spain: Finasterida Aurovitas 1 mg film-coated tablets EFG

France: FINASTERIDE ARROW LAB 1 mg, film-coated tablet

Italy: Finasteride Aurobindo Pharma Italia 1 mg film-coated tablets

Malta: Finasteride 1 mg film-coated tablets

Date of the last revision of this package leaflet:January 2025

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