Finasteride Tarbis 1 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Finasteride Tarbis 1 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; do not pass it on to other people, 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 side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Finasteride Tarbis is and what it is used for
- What you need to know before taking Finasteride Tarbis
- How to take Finasteride Tarbis
- Possible side effects
- How to store Finasteride Tarbis
- 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.
Finasteride is for use in men only.
This medicine 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 further questions about male pattern hair loss, please consult your doctor.
Male pattern hair loss is a common condition believed to result from a combination of genetic factors and a particular hormone called dihydrotestosterone (DHT). DHT contributes to shortening the hair growth phase and causes the hair to become thinner.
In the scalp, finasteride blocks an enzyme (5-alpha-reductase type 2) that converts testosterone into DHT, thereby specifically reducing levels of this hormone. Only men with mild to moderate, but not complete, hair loss may expect benefit from using finasteride. In many men treated with finasteride for 5 years, progression of hair loss was slowed, and in at least half of these cases, hair growth also improved to some extent.
2. What you need to know before taking Finasterida Tarbis
Do not take Finasterida Tarbis:
- if you are a woman (because this medicine is for men only, see section on pregnancy). Clinical trials have shown that finasteride has no effect on hair loss in women.
- if you are allergic (hypersensitive) to finasteride or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- Consult your doctor or pharmacist before starting to take this medicine.
Effects on Prostate-Specific Antigen (PSA)
This medicine may affect a blood test known as PSA (Prostate-Specific Antigen) used to detect prostate cancer. If you are due to have a PSA test, you must inform your doctor or nurse that you are taking this medicine, as it decreases PSA levels.
Effects on fertility
Infertility has been reported in men who took finasteride for a prolonged period and who had other risk factors that could affect fertility. Normalization or improvement in semen quality has been reported after discontinuation of finasteride treatment. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
Breast cancer
See section 4.
Mood alterations and depression
Mood alterations, 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.
In some patients, sexual dysfunction has been reported, which may contribute to mood alterations, including suicidal thoughts. If you experience symptoms of sexual dysfunction, contact your doctor for further medical advice. Your doctor may consider discontinuing treatment (see section 4 below for more information on these adverse effects).
A patient information card, summarizing the above information, is provided with the Finasterida Tarbis packaging.
Children and adolescents
Finasteride must not be used in children. There are no data demonstrating the efficacy and safety of finasteride in children under 18 years of age.
Other medicines and Finasterida Tarbis
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding and fertility
Finasteride is intended solely for the treatment of male-pattern hair loss in men. For effects on male fertility, see section 2.
- Women must not use finasteride due to the risk during pregnancy.
- Women who are or may be pregnant should not handle crushed or split finasteride tablets.
- If a pregnant woman absorbs finasteride orally or through the skin, a male fetus may be born with abnormalities of the genital organs.
- If a pregnant woman comes into contact with finasteride, she should consult a doctor.
- Finasterida Tarbis tablets are film-coated to minimize contact with the active ingredient during normal use.
If in doubt, ask your doctor.
Driving and use of machines
There are no data indicating that finasteride affects the ability to drive or operate machinery.
Finasterida 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.
Finasterida Tarbis contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.
3. How to take Finasterida Tarbis
Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 determine whether finasteride is effective in your case. It is important to take this medicine for as long as your doctor has indicated. Finasteride only works long-term if treatment is maintained.
If you take more Finasterida Tarbis than you should
If you take too many tablets by mistake, contact your doctor immediately. Finasteride will not work faster or better if you take more than one tablet per day.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 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 missed doses.
If you stop taking Finasterida Tarbis
It may be necessary to take the medicine for 3 to 6 months before an effect is seen. It is important 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 have gained within 9 to 12 months after stopping treatment.
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 experiences them.
In general, adverse effects associated with continued treatment have been temporary 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, or throat; suicidal thoughts; difficulty swallowing; lumps under the skin (urticaria); or difficulty breathing.
You must 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 disease, such as breast cancer.
Uncommon: may affect up to 1 in 100 people
- Difficulty achieving an erection
- Decreased sexual desire
- Ejaculation problems, including reduced volume of ejaculated semen
- Depression
Frequency not known: frequency cannot be estimated from available data
- Allergic reactions including rash and itching
- Breast tenderness and swelling
- Testicular pain
- Blood in the semen
- Rapid heartbeat
- Persistent difficulty achieving an erection after stopping treatment
- Persistent decrease in sexual desire after stopping treatment
- Persistent ejaculation problems after stopping treatment
- Male infertility and/or low-quality semen
- Elevated liver enzymes
- Anxiety
- Suicidal thoughts
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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Finasteride Tarbis Storage
Keep this medicine out of the sight and reach of children.
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.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Finasterida Tarbis 1 mg film-coated tablets EFG
- The active substance is finasteride. Each tablet contains 1 mg of finasteride.
- The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate from potato, docusate sodium, 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 EFG and contents of the pack
Film-coated tablet
Round tablets of 7 x 7 mm, film-coated in brown color, marked with an 'H' on one side and the number '36' on the other.
Finasterida Tarbis 1 mg film-coated tablets EFG are available in blister packs containing 28, 84, and 98 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 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 most recent review of this leaflet: December 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/