Leaflet: Information for the user

Maxpil 1 mg film-coated tablets EFG

Finasteride

Read this 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, 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.

1. What is Maxpil and what it is used for

2. What you need to know before starting to take Maxpil

3. How to take Maxpil

4. Possible side effects

5. Storage of Maxpil

6. Contents of the pack and additional information

Maxpil is used fortreatment of the initial stages of male pattern hair loss(also known as androgenetic alopecia).

Do not take Maxpil

• If you are allergic to finasteride or any of the other components of this medication (listed in section 6).
• If you are a woman (see “Pregnancy, breastfeeding and fertility”).
• If you are a child.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Maxpil.

Be especially careful if you have difficulty emptying your bladder completely or if the flow of urine 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.

Taking Maxpil with other medications

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

Maxpil tablets can be taken normally with other medications.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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 ingesting it orally or through the skin, her child may be born with genital organ abnormalities. The tablets are coated to prevent contact with finasteride, as long as the tablets are not broken or crushed.

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 been in contact with finasteride, consult a doctor.

Driving and operating machines

There is no indication that finasteride affects the ability to drive vehicles or operate machines.

Important information about some of the components of Maxpil

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

Use in athletes

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

Blood tests

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

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

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

Tablets should beswallowed wholeandshould not be broken or crushed.It can be takenwith or without food.

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

If you take more Maxpilthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Maxpil

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

If you interrupt treatment with Maxpil

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

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

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

Stop taking Maxpil and immediately inform your doctor if any of the following symptoms of an allergic reaction appear:swelling of the face, tongue, or lips, or urticaria (skin rash with itching).

Reproductive System and Breast Disorders

Frequent (may affect between 1 and 10 in every 100 patients): impotence (inability to initiate and maintain an erection) and decreased semen volume during sexual intercourse.

Infrequent (may affect between 1 and 10 in every 1,000 patients): ejaculation disorders, breast growth, and increased breast sensitivity.

Rare (may affect between 1 and 10 in every 10,000 patients): testicular pain.

Psychiatric Disorders

Frequent (may affect between 1 and 10 in every 100 patients): decreased libido.

Infrequent (may affect between 1 and 10 in every 1,000 patients): depression.

Unknown frequency (cannot be estimated from available data:anxiety.

Skin and Subcutaneous Tissue Disorders

Infrequent (may affect between 1 and 10 in every 1,000 patients): skin rash.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box and blister after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe changes in the appearance of the tablets.

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 collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Maxpil 1 mg tablets

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

- The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, lauroglycerides, carboxymethylstarch sodium (type A) from potato, magnesium stearate, hypromellose (E464), titanium dioxide (E171), yellow and red iron oxide (E172), and macrogol 6000.

Appearance of the product and contents of the packaging

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

Packaging of 28 and 98 tablets.

Holder of the marketing authorization

Laboratorios Viñas, S.A.

Provenza, 386

08025-Barcelona

Responsible for manufacturing

Actavis hf or Actavis Group PTC ehf

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Islandia

Last review date of this leaflet: August 2018

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/