Leaflet: information for the user

Finasteride Tarbis 1 mg film-coated tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Finasteride Tarbis

4. Possible side effects

5. Storage of Finasteride Tarbis

6. Contents of the pack and additional information

This medication contains the active ingredient finasteride.

Finasteride is for exclusive use in men.

This medication is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in men 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 disorder, which is believed to be due to 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 into DHT, and thus reduces the levels of this hormone. Only men with mild to moderate hair loss, but not complete, can expect a benefit from the use of finasteride. In many of the men treated with finasteride over 5 years, the progression of hair loss was slower, and in at least half of those cases, it also improved in some way the hair growth.

Do not take Finasterida 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 on women with hair loss.

-if you are allergic (hypersensitive) to finasteride or to 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) to detect prostate cancer. If you have to undergo a PSA test, you must 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 is no evidence to demonstrate the efficacy and safety of finasteride in children under 18 years old.

Other medications and Finasterida Tarbis

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

Pregnancy, breastfeeding, and fertility

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

•Women cannot use finasteride due to the risk during pregnancy.

•Women who are or may be pregnant should not touch crushed or broken finasteride 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 organ abnormalities.

•If a pregnant woman comes into contact with finasteride, she should consult a doctor.

•Finasterida Tarbis tablets are coated to prevent contact with the active ingredient during normal use.

In case of doubt, ask your doctor.

Driving and operating machinery

There is no evidence to indicate that finasteride affects the ability to drive or operate machinery.

Finasterida Tarbis contains lactose

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

Finasterida Tarbis contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

If you take more Finasterida Tarbis than you should

If you accidentally take too many tablets, go to your doctor immediately. Finasteride will not act 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Finasterida Tarbis

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Finasterida Tarbis

To appreciate the effect, it may be necessary to take the medication for 3 to 6 months. It is essential to 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 the interruption of treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Generally, side effects from continued treatment have been transient and disappeared when treatment was discontinued.

Stop taking this medicine 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 must inform your doctor immediately of any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as they may be signs of a serious disease, such as breast cancer.

Rare:may affect up to 1 in 100 people

•difficulty achieving an erection

•decreased libido

•ejaculation problems, including a decrease in the amount of semen ejaculated

•depression

Unknown frequency:frequency cannot be estimated from available data

•allergic reactions including rash and itching

•breast tenderness and swelling

•testicular pain

•blood in semen

•rapid heart rate.

•persistent difficulty achieving an erection after discontinuing treatment

•persistent decrease in libido after discontinuing treatment

•persistent ejaculation problems after discontinuing treatment

•male infertility and/or low-quality semen

•elevated liver enzymes

•anxiety

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears 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 drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Finasterida Tarbis 1 mg film-coated tablets

-The active ingredient is finasteride. Each tablet contains 1 mg of finasteride.

-The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, 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 Finasterida Tarbis 1 mg film-coated tablets and contents of the package

Film-coated tablet

Round tablets of 7 x 7 mm, coated with a brown film, engraved with a ‘H’ on one face and with the number ‘36’ on the other.

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

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

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 with the following names:

GermanyFinasterid Amarox 1 mg Filmtabletten

SpainFinasterida Tarbis 1 mg film-coated tablets

FranceFinasteride Amarox 1 mg coated tablet

ItalyFinasterida Amarox

PortugalFinasterida Amarox

United KingdomFinasteride 1 mg film-coated tablets

Last review date of this leaflet: March 2020

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/