Androster

Package Leaflet: Information for the User

Androster, 5 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 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Androster and what is it used for

Androster belongs to a group of medicines called 5-alpha-reductase inhibitors. Their action is to reduce the size of the prostate gland in men.
Androster is indicated for the treatment and control of benign prostatic hyperplasia. It causes a reduction in the size of the enlarged prostate gland, improvement in urine flow, relief of symptoms associated with benign prostatic hyperplasia, reduction in the risk of acute urinary retention, and the need for surgical treatment.

2. Important information before taking Androster

When not to take Androster

• in women (see also "Pregnancy and breast-feeding")
• in children.

Warnings and precautions

Before taking Androster, discuss it with your doctor or pharmacist.

PL/H/0140/001/II/033
1
You should immediately report to your doctor any changes in the breast, such as lumps, pain, enlargement of the breast, or any discharge from the nipple that occurs during treatment, as they may be symptoms of a serious disease, such as breast cancer.
Before starting finasteride treatment and periodically during therapy, your doctor should perform a digital rectal examination (per rectum) and, if necessary, determine the level of prostate-specific antigen (PSA) in the blood.
If you need to have a blood test called PSA, you should inform your doctor or nurse that you are taking Androster, as it may affect the test result.
Mood changes and depression
Patients taking Androster have reported mood changes, such as depressive mood and depression, and less frequently, suicidal thoughts. If you experience any of these symptoms, you should immediately consult your doctor for further medical advice.

Androster and other medicines

No significant interactions with other medicines have been found.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Androster with food and drink

Androster can be taken with or without food.

Pregnancy and breast-feeding

Androster is indicated only for men.

Women who are pregnant or may become pregnant should not handle crushed or broken

Androster tablets. If finasteride is absorbed through the skin or ingested by a pregnant woman carrying a male fetus, the child may be born with abnormally developed genital organs.
The tablets have a coating that protects against contact with the active substance, provided they are not crushed or broken.
If your partner is pregnant or may become pregnant, you should avoid exposing her to your semen, which may contain small amounts of the medicine.
It is not known whether finasteride passes into human milk.

Driving and using machines

There are no data to suggest that Androster may affect your ability to drive or use machines.

Androster contains lactose and sodium

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Androster

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
PL/H/0140/001/II/033
2
The recommended dose is one tablet a day (which corresponds to 5 mg of finasteride).
The tablet can be taken with or without food. The tablet should be swallowed whole and not divided or chewed.
Your doctor will determine how long you need to take Androster. Do not stop taking the medicine without consulting your doctor, as symptoms may return.

Dosage in liver function disorders

There are no data on the use of Androster in patients with impaired liver function (see also "Warnings and precautions").

Dosage in kidney function disorders

No dose adjustment is necessary. No studies have been conducted with Androster in patients undergoing hemodialysis.

Dosage in elderly patients

No dose adjustment is necessary.
If you feel that the effect of Androster is too strong or too weak, you should consult your doctor.

Taking more than the recommended dose of Androster

If you take more Androster than you should or if a child accidentally swallows the medicine, you should immediately consult your doctor.

Missing a dose of Androster

If you miss a dose, take it as soon as possible, unless it is already time for your next dose. In this case, continue treatment as directed by your doctor.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Androster

Although improvement is noticeable after a short time, continued treatment may be necessary for at least 6 months. Do not change the dose or stop taking the medicine without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Androster can cause side effects, although not everybody gets them.
The most common side effects are impotence and decreased libido.
These effects usually occur at the beginning of treatment and are transient in nature for most patients during continued treatment.
You should stop taking Androster and immediately contact your doctor if you experience any of the following symptoms (angioedema): swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.
PL/H/0140/001/II/033
3
Common(may affect up to 1 in 10 people):

• reduced semen volume
• decreased libido
• difficulty achieving an erection (impotence).

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

• breast tenderness or enlargement
• ejaculation disorders
• skin rash.

Rare(may affect up to 1 in 1,000 people):

• depression
• irregular or rapid heartbeat
• increased liver enzyme activity
• testicular pain
• blood in semen
• itching, hives
• hypersensitivity reactions, such as swelling of the lips, tongue, throat, and face
• persistent difficulty achieving an erection after stopping treatment
• decreased libido persisting after stopping treatment
• suicidal thoughts
• ejaculation disorders persisting after stopping treatment
• male infertility or poor semen quality (improvement in semen quality has been observed after stopping treatment)
• anxiety. Normalization and improvement of semen quality have been observed after stopping treatment.

During clinical trials and after the product was marketed, male breast cancer has been reported.
Finasteride may affect the results of PSA tests.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Androster

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.
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.
PL/H/0140/001/II/033
4

6. Contents of the pack and other information

What Androster contains

• The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, maize starch, sodium lauryl sulfate, carboxymethylcellulose sodium (type A), magnesium stearate. The coating contains hypromellose, microcrystalline cellulose, and macrogol 8 stearate (type I).

What Androster looks like and contents of the pack

Androster film-coated tablets are white, round, biconvex, 7 mm in diameter, with "F" and "5" embossed on one side.
PVC/PVDC/Aluminum blisters containing 30 or 90 film-coated tablets, in a cardboard box.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
Siegfried Malta Ltd.
HHF070 Hal Far Industrial Estate
Hal Far BBG3000
Malta

For further information on the medicine and its names in the Member States of the European Economic Area, please contact the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, phone (22) 345 93 00.

Date of last revision of the leaflet: May 2025

PL/H/0140/001/II/033
5