ANDROSTATIN 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Androstatin, 1 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
3. What is Androstatin and what is it used for
   1. Indications for Use
4. Important Information Before Taking Androstatin
   1. When Not to Take Androstatin:
   2. Warnings and Precautions
   3. Effect on Prostate-Specific Antigen (PSA)
   4. Breast Cancer
   5. Mood Changes and Depression
   6. Children and Adolescents
   7. Androstatin and Other Medicines
   8. Androstatin with Food and Drink
   9. Pregnancy, Breastfeeding, and Fertility
   10. Driving and Using Machines
   11. Androstatin Contains Lactose Monohydrate
   12. Androstatin Contains Sodium
5. How to Take Androstatin
   1. Use in Children and Adolescents
   2. Overdose
   3. Missed Dose
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store Androstatin
8. Contents of the Pack and Other Information
   1. What Androstatin Contains
   2. What Androstatin Looks Like and Contents of the Pack
   3. Marketing Authorisation Holder and Manufacturer
   4. Date of Last Revision of the Package Leaflet:

Package Leaflet: Information for the Patient

Androstatin, 1 mg, Film-Coated Tablets

Finasteridum

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, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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, pharmacist, or nurse. See section 4.

THIS MEDICINE IS FOR USE IN MEN ONLY

Table of Contents of the Package Leaflet:

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

1. What is Androstatin and what is it 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 concentration in the body of the product
of testosterone metabolism, which contributes to male pattern hair loss (androgenetic). The medicine inhibits
the process of miniaturization of hair follicles on the head, leading to reversal of the hair loss process.
The best treatment results are achieved in men with mild to moderate hair loss.
Finasteride has no effect on the treatment of androgenetic alopecia in women.

Indications for Use

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 prevent further hair loss.
The medicine can only be used in men.
Androstatin is not intended for use in women, children, and adolescents.

2. Important Information Before Taking Androstatin

When Not to Take 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 taking finasteride or other 5α-reductase type II inhibitors for the treatment of benign prostatic hyperplasia or other conditions.

Warnings and Precautions

Before starting treatment with Androstatin, discuss it with your doctor or pharmacist.

Effect on Prostate-Specific Antigen (PSA)

Inform your doctor that you are taking Androstatin if your prostate-specific antigen (PSA) blood levels are being checked.
Before evaluating the PSA test results, your doctor should consider doubling the PSA level in men taking Androstatin.

Breast Cancer

See section 4.

Mood Changes and Depression

Mood changes, such as depressive mood and depression, as well as suicidal thoughts, have been reported in patients taking Androstatin.
If you experience any of these symptoms, stop taking Androstatin and immediately consult your doctor for further medical advice.

Children and Adolescents

Androstatin is contraindicated in children and adolescents.
There are no data on the efficacy or safety of finasteride in children and adolescents under 18 years of age.

Androstatin and Other Medicines

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

Androstatin with Food and Drink

The medicine can be taken with or without food, as food does not affect the absorption of the medicine.
Swallow the tablet with water.

Pregnancy, Breastfeeding, and Fertility

Pregnancy
Finasteride is contraindicated in women.
Taking Androstatin is contraindicated in women who are pregnant or suspected to be pregnant.
Handling damaged or crushed tablets can cause absorption of the medicine through the skin and lead to developmental abnormalities in male fetuses.
Women who are pregnant or suspected to be pregnant, as well as women of childbearing age, should not handle crushed or damaged Androstatin tablets.
Androstatin tablets are film-coated, which prevents direct contact with the medicine, provided that the tablets are not damaged or crushed.
Breastfeeding
Androstatin is contraindicated in women.
Taking Androstatin 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 Androstatin affects the ability to drive and use machines.

Androstatin Contains Lactose Monohydrate

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

Androstatin Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is essentially 'sodium-free'.

3. How to Take Androstatin

Take this medicine always as directed by your doctor. If you are not sure, ask 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 Androstatin for as long as your doctor recommends, as the medicine only works after a longer period of time. 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 will cause the effects to disappear within 9 to 12 months.

Use in Children and Adolescents

Androstatin should not be used in children and adolescents.

Overdose

In case of overdose, contact your doctor immediately.

Missed Dose

Do not take a double dose to make up for a missed dose.

4. Possible Side Effects

Like all medicines, Androstatin can cause side effects, although not everybody gets them.
Side effects that may be associated with the use of Androstatin include decreased interest in sex and difficulty in achieving an erection.
Stop taking Androstatin and immediately consult your doctor if you experience any of the following symptoms (angioedema): swelling of the face, tongue, or throat; difficulty swallowing; hives; and difficulty breathing.
Immediately report any changes in breast tissue, such as lumps, pain, enlargement of the breast, or discharge from the nipples, to your doctor, as they 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(cannot be estimated from the available data)

• allergic reactions, including rash, itching,
• 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 disorders after discontinuation of treatment,
• infertility,
• increased liver enzyme activity,
• male breast cancer,
• anxiety.

If you experience an allergic reaction, stop taking Androstatin and immediately consult your doctor.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Androstatin

Keep the medicine out of the sight and reach of children.
Store in 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Androstatin Contains

• The active substance of the medicine is finasteride (Finasteridum).Each film-coated tablet contains 1 mg of finasteride.
• The other ingredients are: tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, hydroxypropyl cellulose; 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 of OPA/Aluminum/PVC/Aluminum, in a cardboard box.
The pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Date of Last Revision of the Package Leaflet: