FINASTERIDE TARBIS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride Tarbis 5 mg film-coated tablets EFG

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

• Keep this package 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 package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Finasteride Tarbis and what is it 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 in the treatment and control of benign prostatic hyperplasia (BPH), as it reduces the risk of you developing an inability to urinate (acute urinary retention) and needing surgical intervention.

2. What you need to know before you take Finasteride Tarbis

Do not take Finasteride Tarbis:

• if you are allergic to finasteride or 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 a minor

Warnings and precautions

Talk to your doctor or pharmacist before taking Finasteride Tarbis.

• if you have kidney problems
• if you have problems emptying your bladder completely or reduced urine 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 can be signs of a serious disease, such as breast cancer. If you notice any of these changes, you should inform your doctor immediately.

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

If you need to undergo a blood test known as "PSA", you should inform your doctor that you are taking finasteride, as this medicine 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. If you experience any of these symptoms, talk to your doctor as soon as possible.

Other medicines and Finasteride Tarbis

Finasteride is not expected to interact with other medicines. Tell your doctor before taking other medicines at the same time.

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

Using Finasteride Tarbis with food, drinks, and alcohol

Finasteride can 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 potentially become pregnant, you should avoid exposing her to your semen, as it may contain a tiny amount of the drug.

Pregnant women or women who may become pregnant should not handle crushed or broken Finasteride Tarbis tablets.

If a pregnant woman with a male fetus absorbs finasteride after oral ingestion or through the skin, her child may be born with genital anomalies. The tablets are film-coated, which prevents direct contact as long as the tablets are not crushed or broken.

Driving and using machines

There is no evidence to suggest that finasteride affects the ability to drive or use machines.

Finasteride Tarbis contains lactose

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

Finasteride Tarbis contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Finasteride Tarbis

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. 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 should be swallowed whole and not crushed or broken. They can be taken with or without food.

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

If you take more Finasteride Tarbis than you should

Consult a doctor immediately, the emergency department of the nearest hospital, or the nearest poison control center for medical advice.

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

If you forget to take Finasteride Tarbis

Do not take a double dose to make up for forgotten doses. Take the next dose when it is due.

If you stop taking Finasteride Tarbis

Although you may notice some improvement after a short period, it may be necessary to continue treatment for at least 6 months. Do not change or stop the dose without consulting your doctor first.

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

4. Possible side effects

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

Stop taking Finasteride 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 difficulty breathing. These may be symptoms of an allergic reaction, which is reported as an unknown frequency (i.e., its frequency cannot be estimated from the available data).

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

• Reduced semen volume
• Impotence
• Decreased libido

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

• Rash
• Ejaculation problems after stopping the medication
• Breast tenderness or enlargement

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

• Itching, hives
• Palpitations (abnormal heart rhythm)
• Increased liver enzymes (levels evaluated by a blood test)
• Testicular pain
• Impotence after stopping treatment
• Male infertility and/or poor semen quality
• Depression
• Persistent decreased libido that may continue after stopping treatment
• Anxiety

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

Combination therapy with doxazosin

The following side effects have been reported more frequently when finasteride was used in combination with the alpha-blocker 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 side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: http://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 Tarbis 5 mg film-coated tablets EFG

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

The other ingredients are:

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

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

Appearance of the product and pack contents

Film-coated tablet

Round tablets, 7 mm in diameter, film-coated, blue in color, engraved with an "H" on one side and "37" on the other.

Finasteride tablets are available in blister packs of 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

Netherlands

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

Germany Finasterid Amarox 5 mg film-coated tablets

Denmark Finasterid Amarox 5 mg film-coated tablets

Spain Finasterida Tarbis 5 mg film-coated tablets EFG

France Finasteride Amarox 5 mg film-coated tablets

Italy Finasterida Amarox

Netherlands Finasteride Amarox 5 mg film-coated tablets

Portugal Finasterida Amarox

United Kingdom Finasteride 5 mg film-coated tablets

Sweden Finasteride Amarox 5 mg film-coated tablets

United Kingdom Finasteride 5 mg film-coated tablets

Date of the last revision of this package leaflet: March 2020.

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/