Package leaflet: Information for the user

Androster, 5 mg, 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, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. 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.

Leaflet contents

What Androster is and what it is used for
What you need to know before taking Androster
How to take Androster
Possible side effects
How to store Androster
Contents of the pack and other information

1. What Androster is and what it is used for

Androster belongs to a group of medicines called 5-alpha-reductase inhibitors. These work by reducing the size of the prostate gland in men.
Androster is indicated for the treatment and control of benign prostatic hyperplasia. It reduces the size of the enlarged prostate gland, improves urine flow, relieves symptoms associated with benign prostatic hyperplasia, and reduces the risk of acute urinary retention and the need for surgical treatment.

2. Important information before using Androster

When not to use Androster

if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6)
in women (see also "Pregnancy and breastfeeding")
in children.

Warnings and precautions
Before starting treatment with Androster, discuss this with your doctor or pharmacist.

if the patient has difficulty completely emptying the bladder or significantly reduced urine flow. In such cases, the patient should undergo a thorough examination before starting Androster treatment to rule out urinary tract obstruction.
if the patient has impaired liver function. In these patients, finasteride plasma concentrations may increase.

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Any changes in the breast area, such as lumps, pain, breast enlargement, or any nipple discharge occurring during treatment should be reported to a doctor immediately, as they may be symptoms of a serious condition, such as breast cancer.
Before starting finasteride treatment and periodically during therapy, the doctor should perform a digital rectal examination ( per rectum ) and, if necessary, measure serum prostate-specific antigen (PSA) levels.
If the patient needs to have a blood test called PSA, they should inform the doctor or nurse about taking Androster, as this medicine may affect the test result.
Mood changes and depression
Mood changes such as depressive mood and depression, and less frequently suicidal thoughts, have been reported in patients taking Androster. If any of these symptoms occur, seek immediate medical advice from a doctor.
Androster with other medicines
No significant interactions with other medicines have been reported.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Androster with food and drink
Androster can be taken with or without food.
Pregnancy and breastfeeding
Androster is indicated for use in men only.
Pregnant women or women of childbearing potential 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 baby may be born with incompletely developed genital organs.
The tablets are film-coated, which protects against contact with the active substance provided the tablets are not crushed or broken.
If the patient's sexual partner is or may be pregnant, exposure to the patient's semen, which may contain trace amounts of the medicine, should be avoided.
It is not known whether finasteride passes into human milk.
Driving and operating machinery
There are no data indicating that Androster could affect the ability to drive or operate machinery.
Androster contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Androster

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
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The recommended dose is 1 tablet per day (equivalent to 5 mg of finasteride).
The tablet may be taken either on an empty stomach or with food. The tablet should be swallowed whole; it must not be divided or chewed.
Your doctor will determine how long you should take Androster. Do not discontinue treatment prematurely,
as symptoms may recur.
Dosage in hepatic impairment
There is no data available on the use of Androster in patients with impaired liver function
(see also "Warnings and precautions").
Dosage in renal impairment
Dosage adjustment is not necessary. Studies with Androster have not been conducted in patients undergoing hemodialysis.
Dosage in elderly patients
Dosage adjustment is not necessary.
If you feel that the effect of Androster is too strong or too weak, consult your doctor.
Taking more Androster than recommended
If you take more Androster than recommended, or if a child swallows the medicine, contact your doctor immediately.
Missed dose of Androster
If you miss a dose of Androster, take it as soon as possible, unless it is almost time for the next dose. In that case, continue treatment as prescribed by your doctor.
Do not take a double dose to make up for a missed dose.
Stopping Androster
Although improvement may be noticeable within a short time, continued treatment for at least 6 months may be necessary. Do not change the dose or stop taking this medicine without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most commonly occurring adverse reactions are impotence and decreased libido.
These effects usually occur at the beginning of treatment and are transient in most patients during continued treatment.
Treatment with Androster should be discontinued and immediate medical advice sought if the patient notices any of the following symptoms (angioedema): swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties.
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Common (may occur in up to 1 in 10 people):

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

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

breast tenderness or breast enlargement
ejaculation disorders
skin rash.

Unknown (frequency cannot be estimated from available data):

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

During clinical studies and post-marketing surveillance, cases of male breast cancer have been observed.
Finasteride may affect PSA test results.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 to provide more information on the safety of the medicine.

5. How to store Androster

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
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. Such measures will help protect the environment.
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6. Contents of the pack and other information

What Androster contains

The active substance is finasteride. Each coated tablet contains 5 mg of finasteride.
The excipients in the tablet core are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, sodium lauryl sulfate, sodium carboxymethyl starch (type A), magnesium stearate. The coating contains hypromellose, microcrystalline cellulose, and polyethylene glycol 8 stearate (type I).

What Androster looks like and contents of the pack
Androster coated tablets are white, round, biconvex, 7 mm in diameter, with an imprint of
“F” and “5” on one side.
Blister packs (PVC/PVDC/Aluminium) containing 30 or 90 coated tablets, in a cardboard box.
Marketing Authorisation 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 more detailed information about the medicinal product and its names in the Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
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