Finasteride Tarbis 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Finasteride Tarbis 5 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

This medicine contains the active substance finasteride, which belongs to a group of medicines known as 5-alpha reductase inhibitors, whose action reduces the size of the prostate in men.

This medicine is used for the treatment and management of benign (non-cancerous) enlargement of the prostate (benign prostatic hyperplasia or BPH), as it reduces the risk that you will develop an inability to urinate (acute urinary retention) and require surgical intervention.

2. What you need to know before starting Finasteride Tarbis

Do not take Finasteride Tarbis:

• if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
• if you are a woman (see “Pregnancy, breastfeeding and fertility”)
• if you are under 18 years of age

Warnings and precautions

Talk to your doctor or pharmacist or nurse before starting to take Finasteride Tarbis.

• if you have kidney problems
• if you have difficulty completely emptying your bladder or reduced urinary flow; your doctor should examine you carefully before you start taking Finasteride Tarbis, to rule out other urinary tract obstructions.
• if you notice changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be signs of a serious condition, such as breast cancer. If you notice any of these changes, you must inform your doctor immediately.

If your sexual partner may be pregnant or could potentially become pregnant, you must avoid exposing her to your semen, as it may contain a tiny amount of the medicine (see also “Pregnancy, breastfeeding and fertility”).

If you need to have a blood test known as “PSA”, you must inform your doctor or nurse that you are taking finasteride, because this medicine lowers 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. If you experience any of these symptoms, consult your doctor as soon as possible.

Other medicines and Finasteride Tarbis

Finasteride is not usually associated with interactions with other medicines. Inform your doctor before taking any other medicines at the same time.

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

Use of Finasteride Tarbis with food, drinks and alcohol

Finasteride may be taken with or without food.

Pregnancy, breastfeeding and fertility

Finasteride is for use in men only.

If your sexual partner may be pregnant or could potentially become pregnant, you must avoid exposing her to your semen, as it may contain a tiny amount of the medicine.

Women who are or may be pregnant must not handle crushed or broken Finasteride Tarbis tablets.

If a pregnant woman absorbs finasteride orally or through the skin while carrying a male fetus, her child may be born with abnormalities of the genital organs. The tablets are film-coated, which prevents direct contact as long as the tablets are not broken or crushed.

Driving and use of machines

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

Finasteride Tarbis contains lactose

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

Finasteride Tarbis contains sodium

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

3. How to take Finasterida Tarbis

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one tablet per day (equivalent to 5 mg of finasteride).

The film-coated tablets must be swallowed whole and must not be split or crushed. They may be taken with or without food.

Your doctor may prescribe finasteride together with another medicine (called doxazosin) to help you better control your BPH.

If you take more Finasterida Tarbis than you should

Contact a doctor immediately, go to the nearest hospital emergency department, or contact your local poison center for medical advice.

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

If you forget to take Finasterida Tarbis

Do not take a double dose to make up for forgotten doses. Take the next dose at the scheduled time.

If you stop taking Finasterida Tarbis

Although some improvement is often noticed after a short period, treatment may need to be continued for at least 6 months. Do not change or stop the dose without first consulting your doctor.

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.

Stop taking Finasterida Tarbis and inform your doctor immediately if you experience any of the following symptoms (angioedema): swelling of the face, tongue, and throat; difficulty swallowing; hives; and breathing difficulties. These may be symptoms of an allergic reaction, which has been reported as an adverse effect of unknown frequency (i.e. the frequency cannot be estimated from the available data).

Frequent (may affect up to 1 in 10 people):

• Reduced volume of ejaculated semen
• Inability to achieve an erection (impotence)
• Decreased sexual desire

Uncommon (may affect up to 1 in 100 people):

• Rash
• Ejaculation problems after stopping the medication
• Swelling or discomfort in the breasts

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

• Pruritus (itching), urticaria
• Palpitations (abnormal heart rate)
• Increased liver enzymes (levels assessed by blood test)
• Testicular pain
• Inability to achieve an erection after stopping treatment
• Male infertility and/or low-quality semen
• Depression
• Persistent decrease in sexual desire that may continue after stopping treatment
• Anxiety
• Suicidal thoughts

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

Combination therapy with doxazosin

The following adverse effects have been reported more frequently when finasteride was used together with the alpha-blocker known as doxazosin: asthenia 16.8% (placebo 7.1%), postural hypotension 17.8% (placebo 8.0%), dizziness 23.2% (placebo 8.1%), and ejaculation disorders 14.1% (placebo 2.3%).

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 through the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride Tarbis

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Finasterida Tarbis 5 mg film-coated tablets EFG

The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.

The other components are:

Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate from potato, sodium docusate, and magnesium stearate.

Coating: hypromellose (E464), titanium dioxide (E171), indigo carmine aluminium lake (E132), talc, and yellow iron oxide (E172).

Appearance of the product and contents of the container

Film-coated tablet

Round, blue film-coated tablets, 7 mm in diameter, marked with an 'H' on one side and the number '37' on the other.

Finasteride tablets are available in blister packs containing 15, 28, 30, 50, 90, 98 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany Finasterid Amarox 5 mg Filmtabletten

Denmark Finasterid Amarox 5 mg Filmovertrukne tabletter

Spain Finasterida Tarbis 5 mg comprimidos recubiertos con película EFG

France Finasteride Amarox 5 mg comprimé pelliculé

Italy Finasterida Amarox

The Netherlands Finasteride Amarox 5 mg filmomhulde tabletten

Portugal Finasterida Amarox

United Kingdom Finasteride 5 mg film-coated tablets

Sweden Finasteride Amarox 5 mg Filmdragerad tablett

United Kingdom Finasteride 5 mg film-coated tablets

Date of the most recent revision of this leaflet: December 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/