FINASTERIDE VIATRIS 1 mg FILM-COATED TABLETS

2. What you need to know before you take Finasteride Viatris

Do not take Finasteride Viatris:

• If you are allergic to finasteride or 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 breastfeeding). Finasteride has been shown to be ineffective for the treatment of hair loss (androgenetic alopecia) in clinical studies with 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 plan to have a child (be a father), as this medicine may affect fertility or male sexual activity (see section "Fertility" below in this leaflet).

During treatment

This medicine may affect the results of a blood test to detect changes in the prostate, including the appearance of prostate cancer. If you are going to have a blood test, remind your doctor, nurse or healthcare professional that you are taking this medicine.

It has also been observed that finasteride increases the risk of changes in the breast (such as breast tenderness or enlargement) in men taking this medicine. Immediately inform your doctor if you notice changes in the breast area, such as lumps, pain, swelling, nipple discharge, as these can be symptoms of serious diseases 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.

Children and adolescents

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

Other medicines and Finasteride Viatris

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

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

Pregnancy

Finasteride is indicated only for men. If a woman takes finasteride during pregnancy, it may affect the normal development of the male fetus's sexual organs. Pregnant women should not handle crushed or broken tablets, due to the risk of absorption of finasteride.

Finasteride has also been found in the semen of men taking it. If your sexual partner is pregnant or thinks she may be pregnant, you should use a condom to avoid exposing her to your semen, as it may contain finasteride. If you have any questions, consult your doctor.

Fertility

If you plan to have a child (be a father), consult your doctor or pharmacist before starting to take finasteride, as this medicine may affect fertility or male sexual activity. See section 4 "Possible side effects" of this leaflet for more information on side effects you may experience.

Breastfeeding

Finasteride is not indicated for women. It is not known whether it can pass into breast milk.

Driving and using machines

In principle, finasteride does not affect the ability to drive or use machines.

Finasteride Viatris contains lactose monohydrate and sodium

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

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

3. How to take Finasteride Viatris

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:

Adults

One tablet daily by mouth, with or without food.

It may take up to six months before some patients notice an improvement. Long-term use is recommended. If treatment is stopped, the beneficial effect will start to disappear after 6 months and will disappear completely within 9-12 months.

Taking more than one tablet daily does not increase the efficacy of the medicine.

Patients with liver problems

There is 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 Finasteride Viatris than you should

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

If you forget to take Finasteride Viatris

If you forget to take finasteride, do not take a double dose to make up for the forgotten doses. Take the next dose when it is due.

If you stop taking Finasteride Viatris

If you stop taking finasteride, you will probably lose the hair you have regained during the 12 months following the stop.

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.

Generally, these side effects were temporary with continued treatment or disappeared when treatment was stopped.

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

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

• Swelling of the face, lips, tongue or throat.
• Dificulty swallowing.
• Skin rash, itching, lumps under the skin (hives).
• Dificulty breathing.

Tell your doctor immediately if you experience any of the following symptoms:

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

The following side effects have also been reported:

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

• Decreased libido.
• Erectile dysfunction.
• Ejaculation disorders, such as decreased ejaculate volume.
• Depression.

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

• Testicular pain.
• Blood in the semen.
• Tachycardia (increased heart rate).
• Dificulty having an erection after stopping treatment.
• Infertility has been reported in men taking finasteride for long periods and who had risk factors that could affect fertility. After stopping treatment, normalization or improvement of semen quality has been observed. Long-term clinical trials on the effect of finasteride on male fertility have not been conducted.
• Liver changes that can be detected by blood tests.
• Anxiety.

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 leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Finasteride Viatris

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

Do not take this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from light.

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 other information

Composition of Finasteride Viatris

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

Appearance and packaging

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Spain Finasteride Viatris 1 mg film-coated tablets EFG

France Finasteride Mylan 1 mg, film-coated tablet

Italy Finasteride Mylan Generics Italia

Netherlands Finasteride Mylan 1 mg, film-coated tablet

United Kingdom Finasteride 1 mg Film-Coated Tablet

Date of last revision of this leaflet:May 2020

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