Finasteride Viatris 1 mg film-coated tablets EFG

Patient Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Finasteride Viatris 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, 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors. It can be used to treat male-pattern hair loss in men.

Your doctor has prescribed finasteride because you have male-pattern hair loss (also known as androgenetic alopecia). Finasteride prevents further hair loss in men. Men with mild to moderate hair loss, but not complete hair loss, may benefit from using finasteride. Finasteride blocks an important enzyme (type II 5-α-reductase) involved in the regulation of the hair follicle.

Finasteride specifically reduces levels of DHT in the scalp, which is responsible for hair loss in men. In this way, finasteride helps to reverse the balding process and prevent further hair loss.

2. What you need to know before you start taking Finasteride Viatris

Do not take Finasteride Viatris:

• If you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
• If you are a child or adolescent.
• If you are a woman (see also section Pregnancy and breast-feeding). Finasteride has been shown to be ineffective in the treatment of hair loss (androgenetic alopecia) in clinical studies in women.
• If you are already taking finasteride or any other 5-alpha-reductase inhibitor (such as dutasteride) for an enlarged prostate [benign prostatic hyperplasia (BPH)] or any other disorder.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Finasteride Viatris:

• If you are planning to have a child (to become a father), as this medicine may affect male fertility or sexual function (see section "Fertility" below in this leaflet).

During treatment

This medicine may affect the results of a blood test used to detect changes in the prostate, including the presence of prostate cancer. If you are scheduled for a blood test, remember to inform your doctor, nurse, or healthcare professional that you are taking this medicine.

It has also been observed that finasteride may increase the risk of changes in the male breast area. Inform your doctor immediately if you notice any changes in the breast area, such as lumps, pain, enlargement, or nipple discharge, as these may be symptoms of serious conditions such as breast cancer.

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 this medicine and consult your doctor as soon as possible.

In some patients, sexual dysfunction has been reported, which may contribute to mood disturbances, including suicidal thoughts. If you experience symptoms of sexual dysfunction, contact your doctor for further 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 Viatris packaging, which reminds you of the information above.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age.

Other medicines and Finasteride Viatris

Finasteride usually does not interfere with other medicines. However, inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

There is no available information on the use of finasteride together with topical minoxidil (applied to the skin) for male-pattern hair loss. The combination is not recommended.

Pregnancy

Finasteride is intended for use in men only. If taken by a woman during pregnancy, it may affect the normal development of the male fetus's sex organs. Pregnant women should not handle crushed or broken tablets due to the risk of absorption of finasteride through the skin.

Finasteride has also been found in the semen of men taking this medicine. If your sexual partner is pregnant or suspects she may be pregnant, you must use a condom to avoid exposing her to your semen, which may contain finasteride. If you have any doubts, consult your doctor.

Fertility

If you are planning to have a child (to become a father), consult your doctor or pharmacist before starting to take finasteride, as this medicine may affect male fertility or sexual function. See section 4 "Possible side effects" of this leaflet for more information about possible adverse effects.

Breast-feeding

Finasteride is not intended for use in women. It is unknown whether it passes into breast milk.

Driving and use of machines

In general, finasteride does not affect the ability to drive or operate machinery.

Finasteride Viatris contains lactose monohydrate and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., it is essentially "sodium-free".

3. How to take Finasterida Viatris

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

One tablet daily, taken orally, with or without food.

It may take up to six months before some patients notice an improvement. Prolonged use is recommended. If treatment is discontinued, the beneficial effect will begin to diminish after 6 months and will disappear completely within 9–12 months.

Taking more than one tablet per day does not increase the effectiveness of the medicine.

Patients with liver problems

There has been no experience with the use of finasteride in patients with liver problems.

Patients with kidney problems

No dose adjustment is required in patients with kidney problems.

If you take more Finasterida Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist, call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and the amount ingested), or go to the nearest hospital. Take the container and any remaining tablets with you.

If you forget to take Finasterida Viatris

If you forget to take finasteride, do not take a double dose to make up for the missed doses. Take the next dose at the scheduled time.

If you stop taking Finasterida Viatris

If you stop taking finasteride, you are likely to lose the hair you have regained within the following 12 months.

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.

Generally, these adverse effects were temporary during continued treatment or disappeared when treatment was stopped.

The following adverse effects are important and require immediate action if you experience any of them.

Stop taking this medicine and contact your doctor immediately, or go to the nearest emergency room, if you experience any of the following symptoms:

• Swelling of the face, lips, tongue, or throat.
• Difficulty swallowing.
• Skin rash, itching, lumps under the skin (urticaria).
• Difficulty breathing.
• Suicidal thoughts

If you experience any of the following symptoms, contact your doctor immediately:

• Swelling, pain, enlargement of breast tissue, or nipple discharge. These signs may indicate a serious condition, such as breast cancer.

The following adverse effects have also been reported:

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

• Decreased libido.
• Erectile dysfunction.
• Ejaculation problems, such as reduced ejaculate volume.
• Depression.

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

• Testicular pain.
• Blood in the semen.
• Tachycardia (increased heart rate).
• Difficulty achieving an erection after stopping treatment.
• Cases of infertility have been reported in men who took finasteride for long periods and who had risk factors that could affect fertility. After stopping treatment, normalization or improvement in semen quality has been observed. Long-term clinical trials on the effect of finasteride on male fertility have not yet been conducted.
• Liver abnormalities that may be detected through blood tests.
• 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride Viatris

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 CAD or EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and any unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Finasteride Viatris

• The active substance is finasteride. Each film-coated tablet contains 1 mg of finasteride.
• The other components are: sodium docusate, magnesium stearate, microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch (maize starch), sodium potato starch glycolate (potato starch), povidone. The tablet coating contains yellow and red iron oxide (E-172), titanium dioxide (E-171), hypromellose, talc and hydroxypropylcellulose.

Appearance of the product and contents of the pack

The medicine is marketed as film-coated, biconvex, round brown tablets, packaged in blisters of 7, 14, 28, 30, 60, 84, 90 and 98 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin – 13
Ireland

or

Mylan S.A.S.
ZAC des Gaulnes, 10 boulevard de Lattre de Tassigny
69330 Meyzieu
France

or

Mylan SAS
117, Allée des Parcs
69800 Saint-Priest
France

or

Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the EEA Member States under the following names:

Spain: Finasteride Viatris 1 mg film-coated tablets EFG
France: Finasteride Mylan 1 mg, comprimé pelliculé
Italy: Finasteride Mylan Generics Italia
Netherlands: Finasteride Mylan 1 mg, filmomhulde tabletten
United Kingdom: Finasteride 1 mg Film-Coated Tablet

Date of the most recent review of this leaflet: November 2025

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