Maxpil 1 mg film-coated tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Maxpil 1 mg film-coated tablets EFG
Finasteride
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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Leaflet contents
- What Maxpil is and what it is used for
- What you need to know before taking Maxpil
- How to take Maxpil
- Possible side effects
- How to store Maxpil
- Contents of the pack and other information
1. What Maxpil is and what it is used for
Maxpil is used to treat the early stages of male pattern hair loss (also called androgenetic alopecia).
2. What you need to know before taking Maxpil
Do not take Maxpil
- if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
- if you are a woman (see “Pregnancy, breastfeeding and fertility”).
- if you are a child.
Warnings and precautions
Talk to your doctor or pharmacist before you start taking Maxpil.
Take special care if you have difficulty completely emptying your bladder or if your urine flow is very low.
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.
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, reminding of the above information, is provided with the Maxpil packaging.
Taking Maxpil with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Maxpil tablets can normally be taken with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Women who are or may be pregnant must not handle crushed or broken finasteride tablets. If a pregnant woman carrying a male fetus absorbs finasteride orally or through the skin, her baby may be born with abnormalities of the genital organs. The tablets are coated to prevent contact with finasteride, provided the tablets are not broken or crushed.
If your partner is or may become pregnant, you must avoid exposing her to semen, which may contain a small amount of the drug, by using a condom. If you think a pregnant woman has been exposed to finasteride, you must consult a doctor.
Driving and using machines
There are no data indicating that finasteride affects the ability to drive or operate machinery.
Important information about some of the ingredients of Maxpil
This medicine contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Use in athletes
Patients should be advised that this medicine contains finasteride, which may result in a positive finding in doping control tests.
Blood tests
Maxpil tablets may affect the results of a blood test called PSA. If you have had a PSA test, inform your doctor that you are taking finasteride.
3. How to take Maxpil
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.
The usual dose is 1 mg (1 tablet) per day.
The tablets should be swallowed whole and must not be split or crushed. They may 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 recommends. Finasteride only works over the long term if treatment is maintained.
If you take more Maxpil than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Maxpil
Do not take a double dose to make up for missed doses. Simply take the next tablet at your usual time.
If you stop taking Maxpil
Although improvement is often observed within a short period, treatment may need to be continued for at least 6 months. Do not change the dose or stop treatment without first consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Maxpil may cause adverse effects, although not everybody gets them.
Stop taking Maxpil and inform your doctor immediately if you experience any of the following symptoms of an allergic reaction: swelling of the face, tongue or lips, or hives (itchy rash on the skin).
Stop taking Maxpil and contact your doctor if you experience:
Suicidal thoughts
Frequency not known:
Suicidal thoughts
Reproductive system and breast disorders
Common (may affect between 1 and 10 out of 100 patients): impotence (inability to initiate or maintain an erection) and decreased amount of semen ejaculated during sexual activity.
Uncommon (may affect between 1 and 10 out of 1,000 patients): ejaculation disorders, breast enlargement and increased breast sensitivity.
Rare (may affect between 1 and 10 out of 10,000 patients): testicular pain.
Psychiatric disorders
Common (may affect between 1 and 10 out of 100 patients): decreased sexual desire.
Uncommon (may affect between 1 and 10 out of 1,000 patients): depression.
Frequency not known (cannot be estimated from available data): anxiety.
Skin and subcutaneous tissue disorders
Uncommon (may affect between 1 and 10 out of 1,000 patients): skin rash.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice any changes in the appearance of the tablets.
Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Maxpil 1 mg tablets
- The active substance is finasteride. Each tablet contains 1 mg of finasteride.
- The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, lauroyl macroglycerides, sodium carboxymethylstarch (type A) from potato, magnesium stearate, hypromellose (E464), titanium dioxide (E171), yellow and red iron oxides (E172), and macrogol 6000.
Appearance of the product and contents of the pack
Maxpil 1 mg are round, biconvex, reddish-brown tablets, engraved with "F1".
Pack sizes of 28 and 98 tablets.
Marketing Authorization Holder
Laboratorios Viñas, S.A.
Provenza, 386
08025-Barcelona
Manufacturer
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Date of the most recent revision of this leaflet: September 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/