Patient Information Leaflet: Information for the Patient

Finasteride ratiopharm 1 mg Film-Coated Tablets

Read this 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. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Finasteride ratiopharmFinasteride ratiopharm

3.How to take Finasteride ratiopharm

4.Possible side effects

5.Storage of Finasteride ratiopharm

6.Contents of the pack and additional information

Finasterida is only for use in men and should not be taken by women or children.

Finasterida ratiopharm contains an active ingredient called finasteride. Finasteride is used for the treatment of the early stages of male pattern hair loss(also known as androgenetic alopecia)in men aged18 to41 years. If after reading this leaflet, you have any questions aboutmale pattern hair loss,consult your doctor.

Male pattern hair loss is a common condition that is thought to be caused by a combination of genetic factors and a particular hormone, called dihydrotestosterone (DHT).DHTcontributes to shortening the growth phase of hair andits reduction.

In the scalp, finasteride specifically reduces DHT levels by blocking an enzyme (5-alpha-reductase, type II) that converts testosterone into DHT. Only men with mild or moderate hair loss, but not complete, can expect to benefit from the use of Finasterida ratiopharm. In most men treated with finasteride for 5 years, the progressive hair loss was slower, and at least half of these men experiencedsome type of improvement in hair growth.

Do not takeFinasterida ratiopharm

• if you are allergic to finasteride or any of the other ingredients of this medication (listed in section 6),
• if you are a woman (also see “pregnancy, breastfeeding and fertility”). Studies have shown that finasteride is ineffective in treating hair loss (androgenetic alopecia) in women.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Finasterida ratiopharm.

Women

Pregnant women or women who may become pregnant should not touch broken or crushed finasteride tablets. There is a possibility that finasteride may be absorbed through the skin, which can interfere with the external development of male genitalia in the embryo. If a pregnant woman comes into contact with finasteride (the active ingredient), she should inform her doctor.

Effects on prostate-specific antigen (PSA)

Finasteride tablets may affect the blood test for prostate-specific antigen (PSA) for prostate cancer screening. If you are to have a blood test to control your prostate gland, inform your doctor that you are taking finasteride because this medication reduces PSA levels.

The serum determination of prostate-specific antigen should be carried out before starting treatment with finasteride and during treatment.

Mood changes and depression

Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasterida ratiopharm. If you experience any of these symptoms, stop taking Finasterida ratiopharm and consult your doctor as soon as possible.

Children and adolescents

Children under 18 years old should not take Finasterida ratiopharm. There is no evidence of efficacy and safety in children and adolescents under 18 years old.

Taking Finasterida ratiopharm with other medications

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

Finasteride does not normally interfere with other medications.

Taking Finasterida ratiopharm with food and drink

Finasterida ratiopharm can be taken with or without food.

Pregnancy, breastfeeding and fertility

This medication is for the treatment of male pattern hair loss, only in men.

Women should not take finasteride.

Pregnancy

Pregnant women who are or may become pregnant should not handle finasteride tablets, especially if they are broken or crushed. If a pregnant woman with a male fetus absorbs finasteride through the skin or ingests it, the child may be born with genital organ malformations.

The tablets are coated, which helps to prevent contact with finasteride during normal use, as long as the tablets are not broken or crushed.

Fertility

Cases of infertility have been described in men who take finasteride for a long period and have other factors that may affect fertility. Normalization or improvement of semen quality has been described after discontinuation of finasteride. No long-term studies have been conducted on the effects of finasteride on male fertility.

Driving and operating machinery

There is no evidence to suggest that finasteride affects the ability to drive and operate machinery.

Finasterida ratiopharm contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Finasterida ratiopharm contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt, consult with your doctor or pharmacist.

Tablet intake:Swallow the tablets whole with a little water. Do not crush or break them. You can take the tablets with food or on an empty stomach.

The normal dose for all patients is 1 tablet per day, unless your doctor tells you otherwise.

Follow exactly the administration instructions as indicated by your doctor.Do not change the dose or stop taking this medication without consulting your doctor first.

Finasterida does not work faster or better if you take more than 1 tablet per day. To achieve an increase in hair thickness or reduce hair loss, you need to take this medication every day for3 to6 months or more. You and your doctor will then determine if the treatment with finasterida has benefited you. No changes are needed in your normal daily hair care during treatment with finasterida.

If you feel that the effect of finasterida is too weak or too strong, please consult with your doctor or pharmacist.

IfYou Take MoreFinasteridaratiopharmThan You Should

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediatelyor call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to TakeFinasteridaratiopharm

Do not take a double dose to compensate for the missed doses.

Take your tablet at the usual time and continue with the treatment as normal.

If You Interrupt Treatment withFinasteridaratiopharm

To maintain the benefit of treatment, it is recommended to continue using this medication. If you interrupt treatment with finasterida, any increase achieved in hair thickness may be lost within 9 or 12 months.

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

Like all medications, Finasterida ratiopharm may cause adverse effects, although not everyone will experience them.

Adverse effects have usually been temporary with continued treatment or have disappeared once treatment has been discontinued.

Stop using this medication and contact a doctor immediately if you experience any of the following symptoms (angioedema):swelling of the lips, face, tongue, or throat; difficulty swallowing; lumps under the skin (urticaria) and difficulty breathing.

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 disease, such as breast cancer.

Other adverse effects:

Rare (may affect up to 1 in 100 people)

• decreased libido,
• difficulty achieving an erection,
• problems with ejaculation, such as a decrease in semen volume
• depression

Unknown frequency(cannot be estimated from available data)

• allergic reactions such as skin rash and pruritus
• breast tenderness or enlargement
• testicular pain,
• blood in semen
• increased heart rate
• anxiety
• after discontinuation of prolonged treatment
• • difficulty achieving an erection
  • decreased interest in sex
  • ejaculation problems
• male infertility and/or poor semen quality
• increased liver enzymes

Reporting Adverse Effects

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

Keepthis medicationout ofsight and reach of children.

This medication does not require special conditions for conservation.

Do not usethis medicationafter the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

HDPE containers and LDPE screw cap:

Use within 4 months after the first opening of the plastic container.

Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Finasterida ratiopharm 1 mg tablets:

- The active ingredient is finasteride. Each tablet contains 1 mg of finasteride.

- The other components (excipients) are:

Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch,lauril macrogolglycerides,sodium glycolate (type A) (from potato) and magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E-171), iron oxide red and yellow (E-172) and macrogol 6,000.

Appearance of the product and contents of the package

Finasterida ratiopharm 1 mg are brown-red film-coated, round, biconvex tablets, marked with “F1” on one side.

Finasterida ratiopharm 1 mg film-coated tablets are available in

Blister (Aluminum/PVC; Aluminum/Aluminum)

Package sizes:

7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 180 tablets.

Unit dose blister:

Package sizes:

28 x 1, 30 x 1, 50 x 1, 98 x 1, 100 x 1 tablets.

HDPE bottles and LDPE screw cap

Package sizes:

100, 250, 500 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11,

Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Or

Actavis Group PTC ehf.

Dalshraun 1

220 Hafnarfjördur

Iceland

This medicine is authorized in the member states of the European Economic Area with the following names:

France:Finastéride ratiopharm 1 mg, film-coated tablet

Luxembourg:Finasterid-ratiopharm®1 mg Filmtabletten

Spain:Finasterida ratiopharm 1 mg film-coated tablets EFG

Last review date of this leaflet: October 2022

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