Prospect: Information for the patient

Finasteride Teva-ratiopharm 1 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine 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 prospect. See section 4.

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

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

3.How to take Finasteride Teva-ratiopharm

4.Possible adverse effects

5.Storage of Finasteride Teva-ratiopharm

6.Contents of the pack and additional information

Finasterida Teva-ratiopharm contains the active ingredient called finasteride.

Finasteride for exclusive use in males.

Finasteride is used for the treatment of the early stages of male pattern hair loss (also known as androgenetic alopecia) in males aged 18 to 41 years. If after reading this leaflet, you have any questions about male 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). DHT contributes to shortening the hair growth phase and decreasing the hair.

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 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.

Do not takeFinasterida Teva-ratiopharm

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

Warnings and precautions

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

Effects on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test called Prostate-Specific Antigen (PSA) to detect prostate cancer. If you have had a PSA test, you must inform your doctor or pharmacist that you are taking Finasterida, because 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 Finasterida Teva-ratiopharm. If you experience any of these symptoms, stop taking Finasterida Teva-ratiopharm and consult your doctor as soon as possible.

Taking Finasterida Teva-ratiopharm with other medicines

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

Finasteride generally can be taken with other medicines.

Taking Finasterida Teva-ratiopharm with food and drink

Finasterida Teva-ratiopharm can be taken with food and drinks.

Pregnancy, breastfeeding and fertility

• Finasteride is only for the treatment of male pattern hair loss in men only.
• Women should not use Finasterida, due to the risk in pregnancy.
• If you are a woman who is pregnant or may be pregnant, do not touch crushed or broken Finasterida tablets.
• If the active ingredient of Finasterida is absorbed after oral use or through the skin by a pregnant woman of a male baby, this may cause the male baby to be born with abnormalities of the sexual organs.
• Consult a doctor if a pregnant woman comes into contact with the active ingredient of Finasterida.
• The tablets are coated to prevent contact with the active ingredient during normal use.

If your partner is or may be pregnant, you must 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 stopping finasteride treatment. No long-term clinical studies have been conducted on the effect of finasteride on male fertility.

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

No data indicate that Finasterida affects the ability to drive and use machines.

Finasterida Teva-ratiopharm 1 mg tablets contain lactose and sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult with your doctor or pharmacist if you have any doubts.

The recommended dose is one tablet per day.

Tablets can be taken with or without food.

Your doctor will help you determine if Finasterida is working for you. It is essential to take Finasterida for the time your doctor has prescribed. Finasterida can only act in the long term if you continue taking it.

Use in children and adolescents

Finasterida Teva-ratiopharm should not be used in children. There are no data to demonstrate the efficacy and safety of children under 18 years old.

If you take more Finasterida Teva-ratiopharm than you should

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

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

If you forgot to take Finasterida Teva-ratiopharm

Take the next one as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Finasterida Teva-ratiopharm

It may take 3 or 6 months for the full effect to develop. It is essential to take Finasterida for the time your doctor has prescribed. If you interrupt the treatment with finasterida, any increase in hair thickness may be lost within 9 or 12 months.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

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
• Swollen lumps under the skin (hives)
• Difficulty breathing

You should inform your doctor immediately of any change in breast tissue, such as lumps, pain, breast tissue enlargement, or nipple discharge, as these may be signs of a serious disease, such as breast cancer.

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, including rash and itching
• Breast tenderness or enlargement
• Testicular pain
• Blood in semen
• Increased heart rate
• Anxiety
• Persistent difficulty achieving an erection after discontinuing treatment
• Persistent decrease in libido after discontinuing treatment
• Persistent problems with ejaculation after discontinuing treatment
• Male infertility and/or poor semen quality
• Increased liver enzymes.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not require special storage conditions.

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

Composition of Finasterida Teva-ratiopharm:

- The active ingredient is finasteride.

- The other components (excipients) are: lactose monohydrate, pregelatinized starch (from maize), sodium laurilsulfate, sodium starch glycolate type A (from potato), povidone, microcrystalline cellulose, magnesium stearate, hypromellose 6cP (E464), titanium dioxide (E-171), macrogol 6.000, macrogol 400, iron oxide red (E172), and iron oxide yellow (E-172).

Appearance of the product and contents of the package

Finasterida Teva-ratiopharm 1 mg arefilm-coated tablets with a brown color, rounded shape, marked with “FNT1” on one side and smooth on the other.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Teva Pharma, S.L.U.

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

Alcobendas, 28108 – Madrid

Spain

Responsible for manufacturing

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

Netherlands

This medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

United Kingdom:Finasteride 1 mg Film-Coated Tablets

Denmark:Finasteride “Teva” filmovertrukne tabletter 1 mg

Spain:Finasterida Teva-ratiopharm 1 mg film-coated tablets

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 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/