MAXPIL 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Maxpil 1 mg film-coated tablets EFG

Finasteride

Read this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What is Maxpil and what is it used for
2. What you need to know before you take Maxpil
3. How to take Maxpil
4. Possible side effects
5. Storage of Maxpil
6. Contents of the pack and further information

1. What is Maxpil and what is it used for

Maxpil is used to treat the early stages of male pattern hair loss(also known as androgenetic alopecia).

2. What you need to know before you take Maxpil

Do not take Maxpil

• if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman (see “Pregnancy, breast-feeding and fertility”).
• if you are a child.

Warnings and precautions

Consult your doctor or pharmacist before starting Maxpil.

Be particularly careful if you have difficulty emptying your bladder completely or if your urine flow is very reduced.

Your doctor should examine you before you start taking finasteride to rule out other obstructions in the urinary tract.

Mood changes and depression

Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Maxpil. If you experience any of these symptoms, stop taking Maxpil and consult your doctor as soon as possible.

Sexual dysfunction has been reported in some patients, which may contribute to mood changes, 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 for more information on these side effects).

A patient information card is provided with the Maxpil packaging, which reminds you of the above information.

Taking Maxpil with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Maxpil tablets can be taken normally with other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Women who are or may be pregnant should not handle crushed or broken finasteride tablets.If a pregnant woman with a male fetus absorbs finasteride after oral ingestion or through the skin, her baby may be born with genital anomalies. The tablets are coated to prevent contact with finasteride, as long as the tablets are not crushed or broken.

If your partner is or may become pregnant, you should avoid exposure to semen, which may contain a small amount of the drug, by using a condom. If you think a pregnant woman has come into contact with finasteride, she should consult a doctor.

Driving and using machines

There is no evidence to suggest that finasteride affects your ability to drive or operate machinery.

Important information about some of the ingredients of Maxpil

This medicine contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Use in athletes

Patients should be warned that this medicine contains finasteride, which may produce a positive result in doping tests.

Blood tests

Maxpil tablets may affect the results of a blood test called PSA. If you have had a PSA test, tell your doctor that you are taking finasteride.

3. How to take Maxpil

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor again.

The usual dose is1 mg (1 tablet) per day.

The tablets should be swallowed wholeand not crushed or broken.They can be taken with or without food.

Your doctor will help you determine if finasteride is working for you. It is important to take this medicine for as long as your doctor tells you. Finasteride only works over the long term if you continue to take it.

If you take more Maxpilthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Maxpil

Do not take a double dose to make up for forgotten doses. Just take the next tablet at the usual time.

If you stop taking Maxpil

Although improvement can often be seen in a short time, it may be necessary to continue treatment for at least 6 months. Do not change the dose or stop treatment without consulting your doctor first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Maxpil can cause side effects, although not everybody gets them.

Stop taking Maxpil and tell your doctor immediately if you get any of the following symptoms of an allergic reaction:swelling of the face, tongue, or lips, or hives (itchy skin rash).

Stop taking Maxpil and tell your doctor if you experience:

Suicidal thoughts

Frequency not known:

Suicidal thoughts

Disorders of the reproductive system and breast

Common (may affect up to 1 in 10 people):impotence (inability to initiate and maintain an erection) and decreased semen volume.

Uncommon (may affect up to 1 in 100 people):ejaculation disorders, breast tenderness, and enlargement.

Rare (may affect up to 1 in 1,000 people):testicular pain.

Psychiatric disorders

Common (may affect up to 1 in 10 people):decreased libido.

Uncommon (may affect up to 1 in 100 people):depression.

Frequency not known (cannot be estimated from the available data):anxiety.

Disorders of the skin and subcutaneous tissue

Uncommon (may affect up to 1 in 100 people):skin rash.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Maxpil

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Do not use this medicine if you notice any change in the appearance of the tablets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Maxpil 1 mg tablets

• The active substance is finasteride. Each tablet contains 1 mg of finasteride.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, lauroyl macrogolglycerides, sodium carboxymethylcellulose (type A) potato, magnesium stearate, hypromellose (E464), titanium dioxide (E171), yellow and red iron oxide (E172), and macrogol 6000.

Appearance and packaging

Maxpil 1 mg are round, biconvex tablets, reddish-brown in color, engraved with “F1”.

Pack sizes: 28 and 98 tablets.

Marketing authorisation holder

Laboratorios Viñas, S.A.

Provenza, 386

08025-Barcelona

Manufacturer

Actavis hf or Actavis Group PTC ehf

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Date of last revision of this leaflet:September 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/