FINASTERIDE RATIOPHARM 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Finasteride ratiopharm 1 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you

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

Contents of the Package Leaflet:

1. What is Finasteride ratiopharm and what is it used for
2. What you need to know before taking Finasteride ratiopharm
3. How to take Finasteride ratiopharm
4. Possible side effects
5. Storage of Finasteride ratiopharm
6. Package contents and additional information

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

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

Finasteride ratiopharm contains the active ingredient finasteride. Finasteride is used to treat the early stages of male pattern hair loss (also known as androgenetic alopecia) in men between 18 and 41 years old. If you have any questions about male pattern hair loss after reading this package leaflet, consult your doctor.

Male pattern baldness is a common condition that is thought to be caused by a combination of genetic factors and a particular hormone, called dihydrotestosterone (DHT). DHT contributes to shortening the hair growth phase and reducing hair density.

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

2. What you need to know before taking Finasteride ratiopharm

Do not takeFinasteride 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 (see also "Pregnancy, Breastfeeding, and Fertility"). Clinical 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 Finasteride ratiopharm.

Women

Pregnant women or women who may become pregnant should not handle 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 the genitals in a male fetus. 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 going to have a blood test to check your prostate, inform your doctor that you are taking finasteride, as this medication decreases PSA levels.

The determination of prostate-specific antigen in serum should be performed 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 Finasteride ratiopharm. If you experience any of these symptoms, stop taking Finasteride ratiopharm and consult your doctor as soon as possible.

Children and Adolescents

Children under 18 years old should not take Finasteride ratiopharm. There is no data to demonstrate the efficacy and safety of finasteride in children and adolescents under 18 years old.

Taking Finasteride ratiopharm with Other Medications

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

Finasteride does not normally interfere with other medications.

Taking Finasteride ratiopharm with Food and Drink

Finasteride 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 or women who may become pregnant should not handle broken or crushed finasteride tablets. If a pregnant woman absorbs finasteride through the skin or ingests it, the baby may be born with genital malformations.

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

Fertility

There have been reports of infertility in men taking finasteride for a long time and having other factors that may affect fertility. There have been reports of normalization or improvement of semen quality after discontinuation of finasteride. No long-term studies have been conducted on the effects of finasteride on male fertility.

Driving and Using Machines

There is no data to suggest that finasteride affects the ability to drive and use machines.

Finasteride ratiopharm contains Lactose

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

Finasteride ratiopharm contains Sodium

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

3. How to Take Finasteride ratiopharm

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist.

Tablet Administration:The tablets should be swallowed whole with a little water. They should not be crushed or broken. You can take the tablets with food or on an empty stomach.

The normal dose for all patients is one tablet per day, unless your doctor indicates otherwise.

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

Finasteride does not work faster or better if you take more than one tablet per day. To achieve an increase in hair density or reduce hair loss, you need to take this medication every day for 3 to 6 months or more. You and your doctor will then determine if treatment with finasteride has benefited you. No changes are needed in your normal daily hair care during treatment with finasteride.

If you think the effect of finasteride is too weak or too strong, please consult your doctor or pharmacist.

If you take moreFinasteride ratiopharmthan you should

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 medication and the amount ingested.

If you forget to takeFinasteride ratiopharm

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

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

If you stop takingFinasteride ratiopharm

To maintain the benefit of the treatment, continuous use of this medication is recommended. If you stop taking finasteride, any increase in hair density achieved may be lost within 9 to 12 months.

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

4. Possible Side Effects

Like all medications, Finasteride ratiopharm can cause side effects, although not everyone will experience them.

Side effects are usually temporary with continued treatment or disappear once treatment is stopped.

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 should immediately inform your doctor of any changes 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.

Other side effects:

Uncommon (may affect up to 1 in 100 people)

• decreased sexual desire,
• difficulty having an erection,
• problems with ejaculation, such as a decrease in semen volume
• depression

Frequency not known(cannot be estimated from available data)

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

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Finasteride ratiopharm

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the packaging after the abbreviation EXP. The expiration date is the last day of the month indicated.

HDPE containers and LDPE screw caps:

Use within 4 months after opening the plastic container.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Finasteride ratiopharm 1 mg film-coated tablets:

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

• The other ingredients (excipients) are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (from corn), lauryl macrogolglycerides, sodium starch glycolate (type A) (from potato), and magnesium stearate.

Coating of the tablet: hypromellose, titanium dioxide (E-171), red and yellow iron oxide (E-172), and macrogol 6000.

Appearance of the Product and Package Contents

Finasteride ratiopharm 1 mg are film-coated tablets of brown-red color, round, biconvex, marked with "F1" on one side.

Finasteride ratiopharm 1 mg film-coated tablets are available in:

Blister packs (Aluminum/PVC; Aluminum/Aluminum)

Package sizes:

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

Unit dose blisters:

Package sizes:

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

HDPE containers and LDPE screw caps

Package sizes:

100, 250, 500 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11,

Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Or

Actavis Group PTC ehf.

Dalshraun 1

220 Hafnarfjördur

Iceland

This medication is authorized in the Member States of the European Economic Area under the following names:

France: Finasteride ratiopharm 1 mg, film-coated tablet

Luxembourg: Finasterid-ratiopharm 1 mg film-coated tablets

Spain: Finasteride ratiopharm 1 mg film-coated tablets EFG

Date of the last revision of this package leaflet: October 2022

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