FINASTERIDE TEVA-RATIOPHARM 1 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet: Information for the Patient

Finasteride Teva-ratiopharm 1 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Finasteride Teva-ratiopharm contains the active substance finasteride.

Finasteride for use in men 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, ask 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). DHT contributes to shortening the growth phase of hair and decreasing hair density.

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

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

Do not takeFinasteride Teva-ratiopharm

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Finasteride Teva-ratiopharm.

Effects on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test called PSA (Prostate-Specific Antigen) for detecting prostate cancer. If you have had a PSA test, you should inform your doctor or pharmacist that you are taking Finasteride, as it decreases PSA levels.

Mood changes and depression

Mood changes, 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.

Taking Finasteride Teva-ratiopharm with other medicines

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

Finasteride can usually be taken with other medicines.

Taking Finasteride Teva-ratiopharm with food and drink

Finasteride Teva-ratiopharm can be taken with or without food.

Pregnancy, breastfeeding and fertility

• Finasteride is for the treatment of male pattern hair loss in men only.
• Womenmust notuseFinasteride, due to the risk inpregnancy.
• Ifyou are a woman who ispregnant ormay be pregnant,do nothandle crushed or brokenFinasteridetablets.
• If the active substance of Finasteride is absorbed after oral use or through the skin by a pregnant woman carrying a male fetus, this may cause the male fetus to be born with abnormalities of the genital organs.
• A doctor should be consulted if a pregnant woman comes into contact with the active substance of Finasteride.
• The tablets are film-coated to prevent contact with the active substance during normal use.

If your partner is or may be pregnant, you should avoid exposing her to your semen (for example, by using a condom).

Infertility has been reported in men who took finasteride for a long time and had other risk factors that could affect fertility. Normalization or improvement of semen quality has been reported after discontinuation of finasteride treatment. No long-term clinical studies on the effect of finasteride on male fertility have been conducted.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

There is no evidence to suggest that Finasteride affects the ability to drive and use machines.

Finasteride Teva-ratiopharm 1 mg film-coated tablets contain lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Finasteride Teva-ratiopharm

Take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

The recommended dose is one tablet a day.

The tablets can be taken with or without food.

Your doctor will help you determine if Finasteride is working for you. It is important to take Finasteride for the time your doctor has prescribed. Finasteride can only work over the long term if you continue to take it.

Use in children and adolescents

Finasteride Teva-ratiopharm should not be used in children. There is no evidence of the efficacy and safety of finasteride in children under 18 years.

If you take more Finasteride Teva-ratiopharm than you should

If you take too many tablets by mistake, talk to your doctor immediately. Finasteride will not work faster or better if you take more than one tablet a day.

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

If you forget to take Finasteride Teva-ratiopharm

Take the next one 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 or 6 months for the full effect to develop. It is important to take Finasteride for the time your doctor has prescribed. If you stop taking finasteride, any increase in hair density may be lost within 9 to 12 months.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects usually have been temporary with continued treatment or have disappeared after discontinuation of treatment.

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
• Dificulty swallowing
• Lumps under the skin (hives)
• Dificulty 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 may be signs of a serious disease, such as breast cancer.

Uncommon (may affect up to 1 in 100 people)

• decreased sex drive,
• difficulty getting an erection,
• problems with ejaculation, such as a decrease in semen volume,
• depression

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

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

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. 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 which is stated on the carton after the abbreviation EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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 further information

Composition of Finasteride Teva-ratiopharm:

• The active substance is finasteride.

• The other ingredients (excipients) are: lactose monohydrate, pregelatinized starch (from maize), sodium lauryl sulfate, sodium starch glycolate type A (from potato), povidone, microcrystalline cellulose, magnesium stearate, hypromellose 6cP (E464), titanium dioxide (E-171), macrogol 6,000, macrogol 400, red iron oxide (E172), and yellow iron oxide (E-172).

Appearance of the product and pack contents

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108 – Madrid

Spain

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi ùt 13, 4042 Debrecen

Hungary

or

MERCKLE GMBH

Ludwig-Merckle-Strasse, 3

D-89143 Blaubeuren, Germany

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

This medicine is authorized in the Member States of the European Economic Area 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

This leaflet was approved in May 2023

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/ p/74035/P_74035.html