FINASTERIDE TARBIS 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride Tarbis 1 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are 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 taking Finasteride Tarbis
3. How to take Finasteride Tarbis
4. Possible side effects
5. Storage of Finasteride Tarbis
6. Package Contents and Additional Information

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

This medication contains the active ingredient finasteride.

Finasteride is for use in men only.

This medication is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in men between 18 and 41 years old. If you have any questions about male pattern hair loss after reading this package leaflet, consult your doctor.

Male pattern hair loss is a common disorder that is believed 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 making the hair thinner.

In the scalp, finasteride blocks an enzyme (5-alpha-reductase 2) that converts testosterone to DHT, thereby specifically reducing the levels of this hormone. Only men with mild to moderate hair loss, but not complete hair loss, can expect to benefit from the use of finasteride. In many men treated with finasteride for 5 years, the progression of hair loss was slower, and in at least half of these cases, hair growth also improved in some way.

2. What you need to know before taking Finasteride Tarbis

Do not take Finasteride Tarbis:

• if you are a woman (because this medication is for men, see the section on pregnancy). Clinical trials have shown that finasteride has no effect in women with hair loss.
• if you are allergic (hypersensitive) to finasteride or any of the other components of this medication (listed in section 6).

Warnings and Precautions

• Consult your doctor or pharmacist before starting to take this medication.

Effects on Prostate-Specific Antigen (PSA)

This medication may affect a blood test called PSA (Prostate-Specific Antigen) for detecting prostate cancer. If you need to undergo a PSA test, you should inform your doctor or nurse that you are taking this medication, as it decreases PSA levels.

Effects on Fertility

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

Breast Cancer

See section 4.

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, stop taking finasteride and consult your doctor as soon as possible.

Children and Adolescents

Finasteride should not be used in children. There are no data to demonstrate the efficacy and safety of finasteride in children under 18 years old.

Other Medications and Finasteride Tarbis

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

Pregnancy, Breastfeeding, and Fertility

Finasteride is intended for the treatment of male pattern hair loss in men only. For effects on fertility in men, see section 2.

• Women should not use finasteride due to the risk during pregnancy.
• Pregnant women should not touch crushed or broken finasteride tablets.
• If a pregnant woman with a male fetus absorbs finasteride after ingesting it orally or through the skin, her son may be born with genital anomalies.
• If a pregnant woman comes into contact with finasteride, she should consult a doctor.
• The tablets of Finasteride Tarbis are film-coated to prevent contact with the active ingredient during normal use.

In case of doubt, ask your doctor.

Driving and Using Machines

There are no data to indicate that finasteride affects the ability to drive or use machines.

Finasteride Tarbis contains Lactose

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

Finasteride Tarbis contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free"

3. How to take Finasteride Tarbis

Follow the instructions for administration of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. The tablets can be taken with or without food.

Your doctor will help you determine if finasteride works for you. It is essential to take this medication for the entire time your doctor indicates. Finasteride only works in the long term if its administration is maintained.

If you take more Finasteride Tarbis than you should

If you take too many tablets by mistake, go to the doctor immediately. Finasteride will not work faster or better by taking more than one tablet per day.

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 medication and the amount ingested

If you forget to take Finasteride Tarbis

Do not take a double dose to make up for forgotten doses.

If you stop taking Finasteride Tarbis

To appreciate the effect, it may be necessary to take the medication for 3 to 6 months. It is essential that you continue taking finasteride for the entire period indicated by your doctor. If you stop taking finasteride, you will likely lose the hair you gained in the 9 to 12 months following treatment discontinuation.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

In general, the side effects of continued treatment have been transient and disappeared when treatment was discontinued.

Stop taking this medication and inform your doctor immediately if you experience any of the following symptoms: swelling of the lips, face, tongue, and throat; difficulty swallowing; lumps under the skin (urticaria) and difficulty breathing.

You should inform your doctor immediately about any changes in breast tissue, such as lumps, pain, breast enlargement, 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

• difficulty achieving an erection
• decreased sex drive
• ejaculation problems, including a decrease in the amount of semen ejaculated
• depression

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

• allergic reactions, including rash and itching
• breast sensitivity and swelling
• testicular pain
• blood in the semen
• rapid heartbeat
• persistent difficulty achieving an erection after discontinuing treatment
• persistent decreased sex drive after discontinuing treatment
• persistent ejaculation problems after discontinuing treatment
• male infertility and/or low-quality semen
• elevated liver enzymes
• anxiety

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Finasteride Tarbis

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

Do not use this medication after the expiration date stated on the packaging after 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 wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Finasteride Tarbis 1 mg film-coated tablets EFG

• The active ingredient is finasteride. Each tablet contains 1 mg of finasteride.
• The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate, sodium docusate, magnesium stearate.

Coating: hypromellose (E464), titanium dioxide (E171), talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of Finasteride Tarbis 1 mg film-coated tablets EFG and Package Contents

Film-coated tablet

Round tablets, 7 x 7 mm, film-coated, brown in color, engraved with an "H" on one side and the number "36" on the other.

The tablets of Finasteride Tarbis 1 mg film-coated tablets EFG are available in blister packs of 28, 84, and 98 units.

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

Germany Finasterid Amarox 1 mg Filmtabletten

Spain Finasterida Tarbis 1 mg comprimidos recubiertos con película EFG

France Finasteride Amarox 1 mg comprimé pelliculé

Italy Finasterida Amarox

Portugal Finasterida Amarox

United Kingdom Finasteride 1 mg film-coated tablets

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

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/