Package Leaflet: Information for the User

Finasteride MABO 1 mg Film-Coated Tablets EFG

Finasteride

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

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

2. What you need to know before you start taking Finasteride MABO

3. How to take Finasteride MABO

4. Possible side effects

5. Storage of Finasteride MABO

6. Contents of the pack and additional information

Finasterida MABO contains the active ingredient finasteride.

Finasterida MABO is for exclusive use in males.

Finasterida MABO is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in males 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 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 specifically reduces DHT levels by blocking an enzyme (Type II 5-alpha-reductase) that converts testosterone to DHT.Only males with mild to moderate hair loss, but not complete, can expect a benefit from the use of finasteride. In many of the males treated with Finasterida MABO over 5 years, the progression of hair loss became slower, and at least in half of those males, the hair growth also improved in some way.

Do not take Finasterida MABO:

• if you are a woman (because this medication is for men, see Pregnancy section). Clinical trials have shown that finasteride is not effective in women with hair loss.
• if you are allergic to the active ingredient (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)

Finasteride may affect a blood test called Prostate-Specific Antigen (PSA) for detecting prostate cancer. If you have had a PSA test, you must inform your doctor or pharmacist that you are taking Finasterida MABO, 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 could affect fertility. Normalization or improvement of semen quality has been reported after stopping 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 this medication. If you experience any of these symptoms, stop taking finasteride and consult your doctor as soon as possible for medical advice.

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.

Finasterida MABO with other medications

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

Pregnancy, breastfeeding, and fertility

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

• Women cannot use finasteride due to the risk of 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 the active ingredient of 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 the active ingredient of finasteride, she should consult a doctor.
• Finasteride tablets are coated to prevent contact with the active ingredient during normal handling.

In case of doubt, ask your doctor.

Driving and operating machinery

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

Finasterida MABO contains lactose

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

Finasterida MABO contains sodium

This medication contains less than 23 mg of sodium (1mmol) per dose unit; that is, 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 Finasterida MABO is effective for you. It is essential to take Finasterida MABO for the entire time your doctor indicates. Finasterida MABO only acts in the long term if its administration is maintained.

If you take more Finasterida MABO than you should

If you accidentally take too many tablets, go to your doctor immediately. Finasterida MABO will not act faster or better by taking more than one tablet per day.

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Finasterida MABO

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

If you interrupt the treatment with Finasterida MABO

To appreciate the effect, it may be necessary to take the medication for 3 to 6 months. It is essential that you try to take Finasterida MABO for the entire period of time indicated by your doctor. If you stop taking Finasterida MABO, you will probably lose the hair you have gained in the 9 to 12 months following the interruption of treatment.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects have been, normally, transient with continued treatment or have disappeared when treatment is interrupted.

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

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

Rare: may affect up to 1 in 100 people

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

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

• allergic reactions including rash and itching
• breast tenderness and sensitivity
• testicular pain
• rapid heart rate
• persistent difficulty achieving an erection after stopping treatment
• persistent decrease in libido after stopping treatment
• persistent ejaculation problems after stopping treatment
• male infertility and/or poor semen quality
• elevated liver enzymes
• anxiety

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Finasteride MABO

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

Tablet core:lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch,carboxymethyl sodium starch (type A, from potato), sodium docusate, 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 contents of the packaging

• Finasteride MABO coated tablets are provided in blisters.
• The tablets are coated, round, brown in color, engraved with‘H’ on one face and ‘36’ on the other.
• Packaging sizes: 28 or 98 tablets.
• Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada (Madrid)

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

Last review date of this leaflet:July 2019

The 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/)