Finapil

Package Leaflet: Information for the User

Finapil, 1 mg, Film-Coated Tablets

Finasteride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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. 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, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

THIS MEDICINE IS FOR USE IN MEN ONLY.

Table of Contents of the Package Leaflet

• 1. What is Finapil and what is it used for
• 2. Important information before taking Finapil
• 3. How to take Finapil
• 4. Possible side effects
• 5. How to store Finapil
• 6. Contents of the pack and other information

1. What is Finapil and what is it used for

Finapil is a film-coated tablet containing the active substance finasteride. Finasteride inhibits the activity of 5α-reductase type II, an enzyme involved in the metabolism of testosterone. In men with androgenetic alopecia, finasteride reduces the concentration in the body of the product of testosterone metabolism, which contributes to male pattern hair loss (androgenetic alopecia). The medicine slows down the process of miniaturization of hair follicles on the head, leading to a reversal of the hair loss process. The best treatment results are achieved in men with mild to moderate hair loss. Finasteride does not show efficacy in the treatment of androgenetic alopecia in women.

Indications for Use

Finapil is indicated for the treatment of male pattern hair loss (androgenetic alopecia). It is used in men to increase hair growth and prevent further hair loss. The medicine can only be used in men. The medicine is not intended for use in women, children, and adolescents.

2. Important Information Before Taking Finapil

When Not to Take Finapil:

• in women,
• if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6),
• in men taking finasteride or other 5α-reductase type II inhibitors for the treatment of benign prostatic hyperplasia or other conditions.

Benign prostatic hyperplasia.

Warnings and Precautions

Before starting to take Finapil, discuss it with your doctor or pharmacist. Mood changes and depression. Patients taking Finapil have reported mood changes, such as depressive mood and depression, and less frequently, suicidal thoughts. If any of these symptoms occur, you should stop taking Finapil and immediately consult a doctor for further medical advice.

Effect on Prostate-Specific Antigen (PSA)

You should inform your doctor about taking Finapil if you are going to have a blood test to measure the level of prostate-specific antigen (PSA). Before evaluating the PSA test results, your doctor should consider doubling the PSA level in men taking Finapil.

Breast Cancer

See section 4.

Children and Adolescents

Finapil should not be used in children and adolescents. There are no data on the efficacy or safety of finasteride in children and adolescents under 18 years of age.

Finapil and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, Breastfeeding, and Fertility

Pregnancy. Finapil is contraindicated in women. The use of Finapil is contraindicated in women who are or may be pregnant. Handling damaged or crushed tablets can lead to the absorption of the medicine through the skin and cause developmental disorders in male fetuses. Women who are or may be pregnant, as well as women of childbearing age, should not handle crushed or damaged Finapil tablets. The tablets of Finapil are film-coated, which prevents direct contact with the medicine, provided that the tablets are not damaged or crushed. Breastfeeding. Finapil is contraindicated in women. The use of Finapil is contraindicated during breastfeeding. Fertility. There are no data on the effect on fertility in humans. Cases of infertility have been reported in men taking finasteride for a long time, who had other risk factors for fertility. However, no studies have been conducted on the effect of finasteride on fertility in men.

Driving and Using Machines

There are no data indicating that Finapil affects the ability to drive or use machines.

Finapil Contains Lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

Finapil Contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to Take Finapil

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist. The recommended dose is 1 mg (1 tablet) once a day. The medicine should be taken orally with or without food. It is important to take Finapil for as long as your doctor recommends, as the medicine only works after a longer period. To increase hair growth and prevent further hair loss, it is necessary to take the medicine every day for at least 3 months. To maintain the treatment results, it is recommended to continue taking the medicine without interruption. Stopping the medicine leads to a loss of its effect within 9 to 12 months.

Taking More Than the Recommended Dose of Finapil

In case of taking more tablets than recommended, you should immediately consult a doctor.

Missing a Dose of Finapil

Do not take a double dose to make up for a missed dose. If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Finapil can cause side effects, although not everybody gets them. The side effects associated with taking Finapil may include decreased interest in sex and difficulty achieving an erection. You should stop taking Finapil and immediately consult a doctor if you experience any of the following symptoms (angioedema): swelling of the face, lips, tongue, or throat; difficulty swallowing; hives; and difficulty breathing. You should immediately inform your doctor about any changes in breast tissue, such as lumps, pain, enlargement of the breast, or discharge from the nipples, as these may be symptoms of a serious disease, such as breast cancer. Uncommon(may affect up to 1 in 100 people)

• decreased libido,
• erectile dysfunction,
• ejaculation disorders (e.g., decreased semen volume),
• depression.

Frequency Not Known(frequency cannot be estimated from the available data)

• allergic reactions, including rash, itching, hives, angioedema (including swelling of the lips, tongue, throat, and face),
• breast tenderness and/or enlargement,
• testicular pain,
• blood in semen,
• palpitations,
• persistent erectile dysfunction after discontinuation of treatment,
• persistent decreased libido after discontinuation of treatment,
• persistent ejaculation disorder after discontinuation of treatment,
• infertility,
• increased liver enzyme activity,
• male breast cancer,
• anxiety,
• suicidal thoughts.

If you experience an allergic reaction, you should stop taking the medicine and immediately consult a doctor.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Finapil

Keep the medicine out of the sight and reach of children. There are no special precautions for storage. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Finapil Contains

• The active substance of the medicine is finasteride. One tablet contains 1 mg of finasteride.
• The other ingredients are:

Core: lactose monohydrate, microcrystalline cellulose, maize starch, sodium carboxymethyl cellulose type A, lauryl macrogolglycerides, magnesium stearate. Coating: hypromellose 6cp, titanium dioxide (E 171), macrogol 6000, iron oxide red (E 172), iron oxide yellow (E 172).

What Finapil Looks Like and Contents of the Pack

Finapil is a reddish-brown, round, biconvex film-coated tablet. The medicine is available in PVC/Aluminum or Aluminum/Aluminum blisters in a cardboard box containing 28 or 98 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

SUN-FARM Sp. z o.o., ul. Dolna 21, 05-092 Łomianki, tel. +48 22 350 66 69.

Manufacturer

mibe GmbH Arzneimittel, Münchener Strasse 15, 06796 Brehna, Germany.

Date of Last Revision of the Package Leaflet: