Finasteride Teva-Ratiopharm 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Finasteride Teva-ratiopharm 5 mg film-coated tablets EFG

finasteride

Read the entire 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

The active substance in Finasteride Teva-ratiopharm is finasteride, which belongs to a group of medicines called 5-alpha reductase inhibitors. These medicines work by reducing the size of the prostate in men.

Finasteride Teva-ratiopharm is used in the treatment and management of benign enlargement of the prostate (benign prostatic hyperplasia – BPH). This medicine reduces the enlarged prostate, improves urinary flow and symptoms caused by BPH, and reduces the risk of acute urinary retention and the need for surgical intervention.

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

Do not take Finasteride Teva-ratiopharm:

• If you are allergic to finasteride or to any of the other ingredients of this medicine listed in section 6.
• If you are pregnant or could be pregnant. Finasteride Teva-ratiopharm is not indicated for use in women. Special caution is required for women who are or may be pregnant and who may handle Finasteride Teva-ratiopharm (see “Pregnancy, breastfeeding and fertility”).

Finasteride Teva-ratiopharm is not recommended for use in children.

IF IN DOUBT, ALWAYS CONSULT YOUR DOCTOR OR PHARMACIST

Warnings and precautions

Talk to your doctor or pharmacist before taking Finasteride Teva-ratiopharm if:

• You have a large urinary residual volume and/or a significantly reduced urinary flow. In such cases, you should be closely monitored for possible urinary tract obstruction.
• You have impaired liver function. Plasma levels of finasteride may be increased in these patients.
• Your sexual partner is or could be pregnant, you must avoid exposing her to your semen, which may contain a minute amount of the medicine.

Breast cancer

Inform your doctor immediately about any changes in your breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be signs of a serious condition, including breast cancer.

Effect on prostate-specific antigen (PSA)

Before starting treatment with finasteride and during treatment, you should undergo a clinical examination (including digital rectal examination) and measurement of serum prostate-specific antigen (PSA) levels. This medicine decreases PSA levels; therefore, this should be taken into account when making a differential diagnosis.

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, consult your doctor as soon as possible.

Other medicines and Finasteride Teva-ratiopharm

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

No significant interactions with other medicines have been identified.

Pregnancy, breastfeeding and fertility

Finasteride Teva-ratiopharm is intended for use in men only.

If you are pregnant or could be pregnant, do not handle crushed or broken tablets of Finasteride Teva-ratiopharm. If finasteride is absorbed through the skin or ingested by a pregnant woman carrying a male fetus, the male fetus may be born with genital abnormalities. Finasteride tablets are coated to prevent contact with the active substance, provided the tablets are not broken or crushed.

When a patient’s sexual partner is or may become pregnant, the patient should avoid exposing her to semen (e.g., by using a condom) or discontinue treatment with finasteride. It is unknown whether this medicine is excreted in breast milk.

Driving and use of machines

There are no data suggesting that Finasteride Teva-ratiopharm may affect the ability to drive or operate machinery.

Finasteride Teva-ratiopharm contains lactose

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

Finasteride Teva-ratiopharm contains sodium

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

3. How to take Finasteride Teva-ratiopharm

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet daily (equivalent to 5 mg of finasteride).

The tablets may be taken either on an empty stomach or with food. The tablets should be swallowed whole and must not be split or crushed.

Although improvement may be seen within a short period of time, treatment for at least 6 months may be necessary to determine whether a satisfactory response to treatment has been achieved.

Your doctor will determine the duration of treatment with Finasteride Teva-ratiopharm. Do not stop treatment prematurely, as symptoms may reappear.

Patients with hepatic impairment

There is no experience with the use of Finasteride Teva-ratiopharm in patients with liver insufficiency (see also section 2 “Warnings and precautions”).

Patients with renal impairment

Dose adjustment is not required. The use of Finasteride Teva-ratiopharm in patients undergoing hemodialysis has not been studied.

Elderly patients

Dose adjustment is not required.

Tell your doctor or pharmacist if you feel that the effect of Finasteride Teva-ratiopharm is too strong or too weak.

If you take more Finasteride Teva-ratiopharm than you should

If you take more Finasteride Teva-ratiopharm than you should, or if a child has accidentally taken the medicine, contact your doctor or pharmacist immediately or call the Poison Information Service: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Finasteride Teva-ratiopharm

If you forget to take a dose of Finasteride Teva-ratiopharm, take it as soon as you remember, unless it is almost time for your next dose; in that case, continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

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 can cause adverse effects, although not everyone gets them.

Allergic reactions

If you have had an allergic reaction, stop taking this medicine and see your doctor immediately. Signs may include:

• Swelling of the lips, face, tongue or throat
• Difficulty swallowing
• Skin rash, itching, lumps under the skin (rash)
• Difficulty breathing

Other side effects:

Frequent (may affect up to 1 in 10 patients)

• Difficulty in achieving an erection (impotence)
• You may have less desire for sex
• Decrease in the amount of semen released during sex. This decrease in semen volume does not appear to affect normal sexual function.

These adverse effects may disappear over time if you continue taking Finasteride Teva-ratiopharm. If not, they usually disappear when you stop taking Finasteride Teva-ratiopharm.

Uncommon (may affect up to 1 in 100 patients)

• Rash
• Breast swelling or tenderness
• Problems with ejaculation which may continue after stopping the medicine

Not known (frequency cannot be estimated from available data)

• Anxiety
• Palpitations (feeling your heartbeat)
• Changes in liver function, which may be seen in blood tests
• Testicular pain
• Male infertility and/or poor semen quality. Cases of improvement in semen quality after stopping treatment have been reported.
• Depression
• Decreased interest in sex, which may continue after stopping treatment
• Problems with erection and ejaculation which may continue after stopping treatment
• Blood in the semen
• Suicidal thoughts

You should inform your doctor of any changes in breast tissue such as lumps, pain, enlargement or nipple discharge, as these could be symptoms of something more serious, such as breast cancer.

Finasteride may affect laboratory PSA test results.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Finasteride Teva-ratiopharm

• The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other components (excipients) are monohydrate lactose, microcrystalline cellulose, sodium starch glycolate (type A) (from potato, gluten-free), pregelatinized starch (from maize), povidone, magnesium stearate, sodium lauryl sulfate, hypromellose (E464), titanium dioxide (E171), macrogol 6000, macrogol 400, Indigo Carmine Aluminium Lake (E132).

Appearance of the product and contents of the container

Finasteride Teva-ratiopharm are blue, capsule-shaped, film-coated tablets, marked with "FNT5" on one side.

Finasteride Teva-ratiopharm is available in packs of 14, 15, 20, 28, 30, 50, 50x1 (hospital pack), 56, 60, 84, 90, 98, 100 or 120 tablets.

Finasteride Teva-ratiopharm is also available in HDPE bottles with polypropylene screw cap containing 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer responsible

Pharmachemie B.V.

Swensweg 5, Postbus 552,

2003 RN Haarlem

The Netherlands

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Teva Operations Poland Sp. z o.o.

Ul. Mogilska 80

31-546 Kraków,

Poland

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

Date of the last review of this leaflet: October 2025

“Detailed and up-to-date information on this medicinal product 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 medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70122/P_70122.html

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