Finasteride Mabo 1 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Finasteride MABO 1 mg film-coated tablets EFG
Finasteride
Read the entire 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, 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 could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Finasteride MABO is and what it is used for
- What you need to know before taking Finasteride MABO
- How to take Finasteride MABO
- Possible side effects
- How to store Finasteride MABO
- Contents of the pack and other information
1. What Finasteride MABO is and what it is used for
Finasteride MABO contains the active substance finasteride.
Finasteride MABO is for use in males only.
Finasteride MABO 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, please consult your doctor.
Male-pattern hair loss is a common condition believed to be caused by a combination of genetic factors and a specific hormone called dihydrotestosterone (DHT). DHT contributes to shortening the hair's growth phase and causes the hair to become thinner.
In the scalp, finasteride specifically reduces levels of DHT by blocking an enzyme (type II 5-alpha-reductase) that converts testosterone into DHT. Only men with mild to moderate, but not complete, hair loss may expect benefit from using finasteride. In many men treated with Finasteride MABO for 5 years, progression of hair loss slowed, and in at least half of these men, hair growth also improved to some extent.
2. What you need to know before taking Finasteride MABO
Do not take Finasteride MABO:
- if you are a woman (because this medicine is for men only, see Pregnancy section). Clinical trials have shown that finasteride is not effective in women with hair loss.
- if you are allergic to the active substance (finasteride) or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take this medicine.
Effects on Prostate-Specific Antigen (PSA)
Finasteride may affect a blood test known as PSA (Prostate-Specific Antigen) used to detect prostate cancer. If you have had a PSA test, you must inform your doctor or pharmacist that you are taking Finasteride MABO, as it reduces PSA levels.
Effects on fertility
Infertility has been reported in men who took finasteride for a long time and who had other risk factors that could affect fertility. Normalization or improvement in semen quality has been reported after stopping treatment with finasteride. 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 changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with this medicine. If you experience any of these symptoms, stop taking finasteride and consult your doctor as soon as possible for medical advice.
In some patients, sexual dysfunction has been reported, which may contribute to mood disturbances, 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 is provided with the packaging of this medicine, reminding you of the information above.
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.
Taking Finasteride MABO with other medicines
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 for the treatment of male-pattern hair loss exclusively 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 must not handle crushed or broken finasteride tablets.
- If a pregnant woman carrying a male fetus absorbs the active ingredient of finasteride orally or through the skin, her child may be born with abnormalities of the genital organs.
- If a pregnant woman comes into contact with the active ingredient of finasteride, she must consult a doctor.
- Finasteride tablets are film-coated to prevent contact with the active ingredient during normal handling.
If in doubt, ask your doctor.
Driving and using machines
There are no data indicating that this medicine affects the ability to drive or operate machinery.
Finasteride MABO 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 MABO contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per dose unit; hence, it is essentially “sodium-free”.
3. How to take Finasteride MABO
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is one tablet daily. The tablets can be taken with or without food.
Your doctor will help determine whether Finasteride MABO is effective in your case. It is important to take Finasteride MABO for the entire duration indicated by your doctor. Finasteride MABO only works long-term if treatment is maintained.
If you take more Finasteride MABO than you should
If you accidentally take too many tablets, contact your doctor immediately. Finasteride MABO will not work faster or better if you take more than one tablet per day.
Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.
If you forget to take Finasteride MABO
Do not take a double dose to make up for missed doses.
If you stop taking Finasteride MABO
It may take 3 to 6 months to notice the effect of the medicine. It is important that you try to take Finasteride MABO for the entire period indicated by your doctor. If you stop taking Finasteride MABO, you will likely lose the hair you 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.
Adverse effects have usually been temporary during continued treatment or disappeared when treatment was stopped.
Stop taking finasteride and inform your doctor immediately if you experience any of the following symptoms: swelling of the lips, face, tongue, or throat; difficulty swallowing; lumps under the skin (hives), difficulty breathing, or suicidal thoughts.
Inform your doctor immediately of any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be signs of a serious illness, such as breast cancer.
Uncommon: may affect up to 1 in 100 people
- reduced sexual desire
- difficulty achieving an erection
- problems with ejaculation, including a decrease in the amount of ejaculated semen
- depression
Frequency not known: frequency cannot be estimated from the available data
- allergic reactions including rash and itching
- breast tenderness and enlargement
- testicular pain
- rapid heartbeat
- persistent difficulty in achieving an erection after stopping treatment
- persistent decrease in sexual desire after stopping treatment
- persistent ejaculation problems after stopping treatment
- male infertility and/or poor semen quality
- 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Finasteride MABO
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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Finasterida MABO
- The active substance is finasteride. Each tablet contains 1 mg of finasteride.
- The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized starch (from maize), sodium carboxymethyl starch (type A, from potato), docusate sodium, and magnesium stearate.
Coating: Opadry Brown 03A86790 (talc, hydroxypropylmethyl cellulose 2910/hypromellose (E-464), titanium dioxide (E-171), yellow iron oxide (E-172), and red iron oxide (E-172)).
Appearance of the product and package contents
- Finasterida MABO film-coated tablets are supplied in blisters.
- The tablets are film-coated, round, brown in colour, marked with 'H' on one side and '36' on the other.
- Package sizes: 28 or 98 tablets.
- Only certain package sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
MABO-FARMA S.A.
Calle Vía de los Poblados 3,
Edificio 6, 28033, Madrid,
Spain.
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Date of latest revision of this leaflet: October 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)