Label: information for the patient

Finasteride Viatris 1 mg film-coated tablets EFG

Read this label carefully before starting to take this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What isFinasteride Viatrisand for what it is used

2.What you need to knowbeforestarting totakeFinasteride Viatris

3.How to takeFinasteride Viatris

4.Possible adverse effects

5.Storage ofFinasteride Viatris

6. Contents of the package andadditional information

Finasterida belongs to a group of medicationsknown as5-alpha reductase inhibitors. It can be used to treat male pattern hair loss in men.

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

Finasterida specifically reduces the levels of DHT in the scalp, which causes hair loss in men. In this way, finasterida helps to reverse the process of baldness and prevent additional hair loss.

Do not take Finasterida Viatris:

• If you are allergic to finasteride or any of the other components of this medication (listed in section 6).
• If you are a child or adolescent.
• If you are a woman (also see 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 condition.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Finasterida Viatris:

• If you plan to have a child (father), as this medication may affect fertility or male sexual activity (see section "Fertility" below in this prospectus).

During treatment

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

It has also been observed that finasteride increases the risk of changes in the chest (breasts) of men taking this medication.Inform your doctor immediately if you notice changes in the chest area such as the appearance of lumps, pain, increased size, secretion in the nipples, as these may 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 medication and consult your doctor as soon as possible.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old.

Other medications and Finasterida Viatris

Finasteride generally does not interfere with other medications. However, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

Pregnancy

Finasteride is only indicated for men. If a woman takes it during pregnancy, it may affect the normal development of the male fetus's sexual organs. Pregnant women should not handle crushed or broken tablets, as there is a risk that the body may absorb 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, use a condom to avoid exposing her to semen, which may contain finasteride. If you have any doubts, consult your doctor.

Fertility

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

Breastfeeding

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

Driving and operating machinery

Finasteride generally does not affect the ability to drive or operate machinery.

Finasterida Viatris contains lactose monohydrate and sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 for some patients to notice an improvement. Prolonged use is recommended. If treatment is suspended, the beneficial effect will begin to disappear after six months and will be completely gone in the period of 9-12 months.

Taking more than one tablet daily does not increase the effectiveness of the medication.

Patients with liver problems

There have been no experiences of finasteride use 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 Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested), or go to the nearest hospital. Bring the packaging and remaining tablets with you.

If you forgot to take Finasterida Viatris

If you forgot to take finasteride, do not take a double dose to compensate for the missed doses. Take the next dose when it is due.

If you interrupt treatment with Finasterida Viatris

If you stop taking finasteride, it is likely that you will lose the hair you have regained over the next 12 months.

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

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

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

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

Stop taking this medicine and inform your doctor immediately, or go to the nearest emergency center, 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.

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

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

The following side effects have also been reported:

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

• Decreased libido.
• Erectile dysfunction.
• Problems with ejaculation, such as decreased ejaculation volume.
• Depression.

Unknown frequency (frequency cannot be estimated from available data):

• Testicular pain.
• Blood in semen.
• Tachycardia (increased heart rate).
• Difficulty achieving an erection after treatment interruption.
• Cases of infertility have been reported in men who took finasteride for long periods of time and had risk factors that could affect fertility. After treatment interruption, 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 through blood tests.
• Anxiety.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not take this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Finasterida Viatris

• The active ingredient isfinasterida.Each film-coated tablet contains1 mg of finasterida.
• The other components are: docusato sódico, estearato de magnesio,celulosa microcristalina, lactosa monohidrato, almidón de maíz pregelatinizado (cornstarch), carboximetilalmidón sódico de patata (potato starch), povidona. The coating ofthe tabletcontainsóxido de hierro amarilloand rojo (E-172),dióxido de titanio(E-171),hipromelosa,talco e hidroxipropilcelulosa.

Appearance of the product and contents of the package

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

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

69800Saint-Priest

France

or

Mylan Hungary Kft

H-2900 Komarom

Mylan utca 1

Hungary

You can request more information about this medicine by contacting 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 Member States of the EEE with the following names:

SpainFinasterida Viatris 1 mg film-coated tablets EFG

FranceFinasteride Mylan 1 mg, coated tablet

ItalyFinasteride Mylan Generics Italia

NetherlandsFinasteride Mylan 1 mg, film-coated tablets

United KingdomFinasteride 1 mg Film-Coated Tablet

Last review date of this prospectus:May 2020

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