Finasteride Teva-Ratiopharm 1 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Finasteride Teva-ratiopharm 1 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Finasteride Teva-ratiopharm contains the active substance called finasteride.

Finasteride for use in males only.

Finasteride is used for the treatment of early stages of male pattern hair loss (also known as androgenetic alopecia) in men aged 18 to 41 years. If, after reading this leaflet, you have any questions about male pattern hair loss, please consult your doctor.

Male pattern hair loss is a common condition 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 to hair miniaturization.

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 to moderate, but not complete, hair loss may expect benefit from using finasteride. In most men treated with finasteride for 5 years, progressive hair loss was slowed, and at least half of these men experienced some degree of improvement in hair growth.

2. What you need to know before taking Finasteride Teva-ratiopharm

Do not take Finasteride Teva-ratiopharm

• if you are a woman (because this medicine is only for men, see also “Pregnancy, breastfeeding and fertility”). Clinical studies have shown that finasteride is ineffective in the treatment of hair loss in women
• if you are allergic to finasteride or to any of the other ingredients of Finasteride Teva-ratiopharm (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Finasteride Teva-ratiopharm.

Effects on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test known as PSA (Prostate-Specific Antigen) used to detect prostate cancer. If you have had a PSA test, you must inform your doctor or pharmacist that you are taking Finasteride, as it reduces PSA levels.

Mood alterations and depression

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

In some patients, sexual dysfunction has been reported, which may contribute to mood alterations, 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).

An information card for patients is provided with the Finasteride 1 mg packaging, which reminds of the above information.

Taking Finasteride Teva-ratiopharm with other medicines

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

Finasteride can generally be taken together with other medicines.

Taking Finasteride Teva-ratiopharm with food and drink

Finasteride Teva-ratiopharm may be taken with food and drink.

Pregnancy, breastfeeding and fertility

• Finasteride is only indicated for the treatment of male pattern hair loss in men.
• Women must not use Finasteride due to the risk during pregnancy.
• If you are a woman who is pregnant or could be pregnant, do not handle crushed or broken Finasteride tablets.
• If the active ingredient finasteride is absorbed orally or through the skin by a woman pregnant with a male fetus, this may cause the male baby to be born with abnormalities of the genital organs.
• A doctor should be consulted if a pregnant woman comes into contact with the active ingredient finasteride.
• The tablets are film-coated to prevent contact with the active ingredient during normal handling.

If your partner is pregnant or could be pregnant, you should avoid exposing her to your semen (e.g. by using a condom).

Infertility has been reported in men who took finasteride for a prolonged period and who had other risk factors that could affect fertility. Normalization or improvement in semen quality has been reported after stopping finasteride treatment. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.

Talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

There are no data indicating that finasteride affects the ability to drive or operate machinery.

Finasteride Teva-ratiopharm 1 mg tablets contain lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Finasteride Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is one tablet daily.

The tablets may be taken with or without food.

Your doctor will help you determine whether Finasteride is working for you. It is important to take Finasteride for the length of time prescribed by your doctor. Finasteride can only work in the long term if you continue taking it.

Use in children and adolescents

Finasteride Teva-ratiopharm must not be used in children. There are no data demonstrating efficacy and safety in children under 18 years of age.

If you take more Finasteride Teva-ratiopharm than you should

If you take too many tablets by mistake, consult your doctor immediately. Finasteride does not work faster or better if you take more than one tablet per day.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Finasteride Teva-ratiopharm

Take the next dose as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Finasteride Teva-ratiopharm

It may take 3 to 6 months for the full effect to develop. It is important to take Finasteride for the length of time prescribed by your doctor. If you stop treatment with finasteride, any improvement achieved in hair thickness may be lost within 9 to 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 may cause adverse effects, although not everyone experiences them.

Adverse effects have generally been temporary during continued treatment or have disappeared after treatment was stopped.

Stop taking Finasteride and contact your 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 (wheals)
• Difficulty breathing

You should 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.

Uncommon (may affect up to 1 in 100 people)

• decreased sexual desire,
• difficulty in achieving an erection,
• problems with ejaculation, such as a decrease in the amount of semen,
• depression

Frequency unknown (cannot be estimated from available data)

• allergic reactions including rash and itching,
• breast tenderness or enlargement,
• testicular pain,
• blood in the semen,
• increased heart rate,
• anxiety,
• persistent difficulty in achieving an erection after stopping treatment,
• persistent decrease in sexual desire after discontinuation of treatment,
• persistent problems with ejaculation after discontinuation of treatment,
• male infertility and/or poor semen quality,
• increased liver enzymes.

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 Teva-ratiopharm

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Finasteride Teva-ratiopharm:

• The active substance is finasteride.

• The other components (excipients) are: lactose monohydrate, pregelatinized starch (from maize), sodium lauryl sulfate, sodium starch glycolate type A (from potato), povidone, microcrystalline cellulose, magnesium stearate, hypromellose 6 cP (E464), titanium dioxide (E171), macrogol 6000, macrogol 400, iron oxide red (E172) and iron oxide yellow (E172).

Appearance of the product and contents of the pack

Finasteride Teva-ratiopharm 1 mg are brown, film-coated, round tablets, marked with “FNT1” on one side and plain on the other.

The product is available in blister packs (transparent PVC/PVdC/Aluminium) containing 7, 28, 30, 50 (hospital pack), 84, 98 and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 – Madrid

Spain

Manufacturer:

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

MERCKLE GMBH

Ludwig-Merckle-Strasse, 3

D-89143 Blaubeuren, Germany

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

This medicinal product is authorised in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

United Kingdom: Finasteride 1 mg Film-Coated Tablets

Denmark: Finasteride “Teva” filmovertrukne tabletter 1 mg

Spain: Finasterida Teva-ratiopharm 1 mg comprimidos recubiertos con película EFG

France: FINASTERIDE TEVA 1 mg, comprimé pelliculé

Netherlands: Finasteride 1 mg Teva, filmomhulde tabletten

Portugal: Finasterida Teva-ratiopharm

Date of the most recent revision of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/74035/P_74035.html