Patient Information Leaflet

Androstatin, 1 mg, film-coated tablets
Finasteride

Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
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 side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

MEDICINE FOR USE IN MALES ONLY
Leaflet Contents:

What Androstatin is and what it is used for
Important information before taking Androstatin
How to take Androstatin
Possible side effects
How to store Androstatin
Contents of the pack and other information

1. What Androstatin is and what it is used for

Androstatin contains 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 levels of a metabolite of testosterone
that contributes to male-pattern (androgenic) hair loss. The medicine inhibits the process of
miniaturization of scalp hair follicles, thereby reversing hair loss.
Best treatment results are achieved in men with mild to moderate hair loss.
Finasteride has not shown efficacy in the treatment of androgenetic alopecia in women.
Indications
Androstatin is indicated for the treatment of male-pattern hair loss (androgenetic alopecia) in men.
It is used in men to increase hair growth and to prevent further hair loss.
This medicine may be used only in men.
Androstatin is not intended for use in women, children, or adolescents.

2. Important information before using Androstatin

When not to use Androstatin:

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

Warnings and precautions
Before starting treatment with Androstatin, discuss this with your doctor or pharmacist.
Mood changes and depression
Mood changes such as depressed mood, depression, and less frequently suicidal thoughts have been reported in patients taking Androstatin. If any of these symptoms occur, treatment with Androstatin should be discontinued and medical advice should be sought immediately.
Some patients have reported sexual dysfunction, 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 Androstatin packaging.
Effect on prostate-specific antigen (PSA)
Inform your doctor that you are taking Androstatin if undergoing blood tests to measure prostate-specific antigen (PSA) levels. Before interpreting PSA test results, your doctor should consider doubling the PSA value in men taking Androstatin.
Breast cancer
See section 4.
Children and adolescents
Use of Androstatin is contraindicated 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.
Androstatin with other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Androstatin with food and drink
Androstatin can be taken during or independently of meals, as food does not affect drug absorption. The tablet should be taken with water.
Pregnancy, breastfeeding and fertility
Pregnancy
Finasteride is contraindicated in women.
Use of Androstatin is contraindicated in pregnant women or when pregnancy is suspected.
Handling crushed or damaged tablets may result in drug absorption through the skin and may lead to developmental abnormalities in male fetuses.
Pregnant women or women who may be pregnant, as well as women of childbearing potential, should not handle crushed or damaged Androstatin tablets.
Androstatin tablets are film-coated, which prevents direct contact with the drug, provided the tablets are not damaged or crushed.
Breastfeeding
Androstatin is contraindicated in women.
Use of Androstatin is contraindicated during breastfeeding.
Effect on 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 prolonged periods, in whom other risk factors affecting fertility were present. However, no studies have been conducted on the effect of finasteride on male fertility.
Driving and operating machinery
There are no data indicating that Androstatin affects the ability to drive or operate machinery.
Androstatin contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Androstatin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to use Androstatin

This medicine should always be used as directed by a physician. If in doubt, consult your
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 continue taking Androstatin for as long as directed by your doctor, as the medicine
only works over an extended period. To increase hair growth and prevent further hair loss, it is
necessary to use the medicine daily for at least 3 months. To maintain treatment results, continuous
use of the medicine is recommended. Discontinuation of the medicine will result in the loss of its effects
within 9 to 12 months.
Use in children and adolescents
Androstatin must not be used in children and adolescents.
Use of a higher than recommended dose of Androstatin
If more tablets than recommended have been taken, contact your doctor immediately.
Missed dose of Androstatin
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions associated with the use of this medicine may include reduced interest in sex and difficulty achieving an erection.

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

Discontinue use of Androstatin and contact your doctor if any of the following occur:
⦁ Suicidal thoughts.

Any changes noticed in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, should be promptly reported to your doctor, as they may be symptoms of a serious illness, such as breast cancer.

Uncommon (may occur in up to 1 in 100 people)

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

Frequency not known (cannot be estimated from available data)

Allergic reactions, including rash, itching,
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 Androstatin and inform your doctor immediately.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Androstatin

Keep this medicine out of sight and reach of children.
Store at a temperature below 25 °C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 Androstatin contains

The active substance is finasteride (Finasteridum). Each coated tablet contains 1 mg of finasteride.
Other ingredients: tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, hydroxypropylcellulose; tablet coating: talc, polyvinyl alcohol (partially hydrolyzed), macrogol 3000, titanium dioxide (E171), quinoline yellow lake (E104), indigo carmine lake (E132).

What Androstatin looks like and contents of the pack
Androstatin is blue, round, film-coated tablets with a smooth surface.
Blisters made of OPA/Aluminum/PVC/Aluminum foil, packed in a cardboard box.
The pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company
Ostrzykowizna 14A
05-170 Zakroczym
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106
09.09.2025