Finapil

Package leaflet: Information for the user

Finapil, 1 mg, coated tablets
Finasteride
Please read this leaflet carefully before using this medicine, because it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

MEDICINE FOR USE IN MEN ONLY.
Leaflet contents

1. What Finapil is and what it is used for
2. What you need to know 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 Finapil is and what it is used for

Finapil is a coated tablet containing the active substance finasteride. Finasteride
inhibits the activity of type II 5α-reductase, an enzyme involved in the metabolism
of testosterone. In men with androgenetic alopecia, finasteride reduces the body's
concentration of a testosterone metabolite that contributes to male-pattern (androgenic) hair loss.
The drug inhibits the process of miniaturization of hair follicles on the scalp, thereby reversing the hair loss process.
The best treatment outcomes are achieved in men with mild to moderate hair loss.
Finasteride has not been shown to be effective in the treatment of androgenetic alopecia in women.

Indications
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.
This medicine may be used only in men.
It is not intended for use in women, children, or adolescents.

2. Information before using Finapil

When not to use 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 using finasteride or other type II 5α-reductase inhibitors for the treatment of mild benign prostatic hyperplasia or other conditions.

Warnings and precautions

Before starting treatment with Finapil, discuss this with your doctor or pharmacist.

Mood changes and depression

In patients taking Finapil, mood changes such as depressive mood and depression have been reported, and suicidal thoughts less frequently. If any of these symptoms occur, treatment with Finapil should be discontinued and medical advice should be sought immediately.

In some patients, sexual dysfunction has been reported, which may contribute to mood changes, including suicidal thoughts. If symptoms of sexual dysfunction occur, medical advice should be sought. The doctor may consider discontinuing treatment (see section 4 below for further information on these adverse effects).

A Patient Warning Card reminding of the above has been included in the Finapil packaging.

Effect on prostate-specific antigen (PSA)

Inform your doctor that you are taking Finapil when undergoing blood tests to measure prostate-specific antigen (PSA) levels. Before interpreting PSA test results, the doctor should consider doubling the PSA value in men taking Finapil.

Breast cancer

See section 4.

Children and adolescents

Finapil should not be used in children and adolescents. There is a lack of data on the efficacy or safety of finasteride in children and adolescents under 18 years of age.

Finapil with other medicines

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

Pregnancy, breastfeeding and fertility

Pregnancy

Finapil is contraindicated in women.

Finapil must not be used during pregnancy or if pregnancy is suspected.

Handling crushed or damaged tablets may result in absorption of the medicine through the skin and may lead to developmental abnormalities in male fetuses.

Pregnant women, women who may be pregnant, and women of childbearing age must not handle crushed or damaged Finapil tablets.

Finapil tablets are film-coated, which prevents direct contact with the active substance, provided the tablets are not damaged or crushed.

Breastfeeding

Finapil is contraindicated in women.

Finapil must not be used during breastfeeding.

Fertility

There is a lack of data on the effect on fertility in humans.

Cases of infertility have been reported in men taking finasteride for a long time, who also had other risk factors affecting fertility. However, no studies have been conducted on the effect of finasteride on male fertility.

Driving and using machines

There are no data indicating that Finapil affects the ability to drive or operate machinery.

Finapil contains lactose

If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Finapil contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to use Finapil

This medicine should always be taken exactly as directed by the physician. In case of doubts, consult a doctor or pharmacist.
The recommended dose is 1 mg (1 tablet) once daily. The medicine should be taken orally, with or without food.
It is important to take Finapil for as long as your doctor has instructed, since the medicine works only after a prolonged period. To increase hair growth and prevent further hair loss, daily use of the medicine is necessary—for at least 3 months. To maintain treatment results, continuous use of the medicine is recommended. Discontinuation of the medicine leads to reversal of its effects within 9 to 12 months.
Taking more Finapil than recommended
If more tablets than recommended have been taken, contact a doctor immediately.
Missing a dose of Finapil
Do not take a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects associated with the use of this medicine may include reduced interest in sex and difficulty achieving an erection.

Discontinue use of Finapil and seek immediate medical attention if any of the following symptoms occur (angioedema): swelling of the face, lips, tongue or throat; difficulty swallowing; hives; or breathing difficulties.

Any changes observed in breast tissue, such as lumps, pain, breast enlargement or nipple discharge, should be promptly reported to the treating physician, as they may be signs of a serious illness such as breast cancer.

Discontinue use of Finapil and consult a doctor if any of the following occur:

• Suicidal thoughts

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

• Decreased libido
• Erectile dysfunction
• Ejaculation disorders, e.g. reduced ejaculate volume (amount of semen)
• Depression

Frequency unknown (frequency cannot be estimated from available data):

• Allergic reactions, including rash, itching, hives, angioedema (including swelling of lips, tongue, throat and face)
• Breast enlargement and/or tenderness
• Testicular pain
• Blood in semen
• Palpitations
• Persistent erectile dysfunction after discontinuation of treatment
• Persistent decreased libido after discontinuation of treatment
• Persistent ejaculation disorders after discontinuation of treatment
• Infertility
• Increased liver enzyme activity
• Breast cancer in men
• Anxiety
• Suicidal thoughts

If allergic reactions occur, discontinue use of the medicine and inform your doctor immediately.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Finapil

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

6. Contents of the pack and other information

What Finapil contains

• The active substance is finasteride. One tablet contains 1 mg of finasteride.
• Other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized maize starch, sodium carboxymethyl starch type A, glyceryl macrogol ricinoleate, magnesium stearate.
  Coating: hypromellose 6 cP, titanium dioxide (E 171), polyethylene glycol 6000, iron oxide red (E 172), iron oxide yellow (E 172).

What Finapil looks like and contents of the pack
Finapil is a brownish-red, round, biconvex coated tablet.
The medicine is available in PVC/Aluminum or Aluminum/Aluminum blisters in a cardboard box containing 28 or 98 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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