Finaster

Package Leaflet: Information for the Patient

FINASTER, 5 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 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Finaster and what is it used for

Finasteride, the active substance of Finaster, is a 5-alpha reductase inhibitor, an enzyme that converts testosterone (male sex hormone) into a more potent dihydrotestosterone (DHT). Finaster reduces the volume of the prostate gland.
Finaster is used to treat a condition called benign prostatic hyperplasia (prostate gland enlargement, which can cause difficulty urinating).
Finaster is indicated for the treatment of benign prostatic hyperplasia to:

• relieve symptoms,
• reduce the risk of acute urinary retention,
• reduce the risk of needing surgical treatment, including transurethral resection of the prostate (TURP) and prostatectomy (surgical removal of the prostate gland).

FINASTER IS FOR USE IN MEN ONLY

2. Important information before taking Finaster

If your sexual partner is pregnant or may become pregnant, you should avoid exposing her to your semen, which may contain small amounts of the medicine.
Tell your doctor about any diseases you have or have had, and about any allergies.

When not to take Finaster

• if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6),
• in women who are pregnant or may become pregnant.

Finaster is not indicated for use in women or children.

Warnings and precautions

Before taking Finaster, discuss with your doctor:

• if you have or may have a urinary tract infection, prostate cancer, decreased bladder tension, neurogenic disorders. The symptoms of these diseases are similar to those of benign prostatic hyperplasia, so they should be ruled out before starting treatment with finasteride.
• if you have a large amount of residual urine and/or severe urinary outflow obstruction, with a risk of uropathy caused by urinary tract obstruction.

Benign prostatic hyperplasia is a disease that develops over many years. In some patients, relief of symptoms occurs soon after starting treatment. However, it may be necessary to take the medicine for at least 6 months to achieve significant improvement. Regardless of whether symptoms improve, taking Finaster may reduce the risk of acute urinary retention and the need for surgical treatment. To monitor the progress of treatment, the patient should remain under constant medical supervision.
Benign prostatic hyperplasia is not a tumor, nor does it lead to the development of a tumor, but these diseases can occur simultaneously. Only a doctor can properly assess the symptoms and their likely cause.
Taking Finaster may affect the results of the PSA (prostate-specific antigen) test. Therefore, before undergoing this test, tell your doctor that you are taking Finaster.
Finaster is indicated only for men for the treatment of benign prostatic hyperplasia.
Mood changes and depression
Patients taking Finaster have reported mood changes, such as depressive mood and depression, and less frequently, suicidal thoughts. If you experience any of these symptoms, seek medical advice immediately.

Children

Finaster is contraindicated in children.

Finaster and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Finaster usually does not affect the action of other medicines taken.

Finaster 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 and breastfeeding

Pregnancy
Finaster is contraindicated in pregnant women and women of childbearing age. Pregnant women and women of childbearing age should not handle crushed or broken Finaster tablets. If the active substance of the medicine is absorbed (after oral administration or through skin contact) by a pregnant woman carrying a male fetus, it may cause developmental disorders of the genital organs in the fetus. If a pregnant woman comes into contact with the active substance of Finaster, she should inform her doctor. The tablets of Finaster are film-coated, which, during normal use, protects against contact with the active substance of the medicine, provided the tablet is not crushed or broken.
More information on this can be provided by your doctor.
Breastfeeding
It is not known whether finasteride passes into human milk.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

Finaster contains lactose

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

3. How to take Finaster

Take this medicine always as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
The recommended dose of Finaster is 5 mg (1 tablet) once a day.
Remember that benign prostatic hyperplasia is a process that takes many years to develop before symptoms appear. Finaster may relieve symptoms and control the progression of the disease if taken regularly for a long time.

Taking Finaster in patients with renal and/or hepatic impairment

No dose adjustment is required in patients with renal and/or hepatic impairment.

Taking Finaster in elderly patients

No dose adjustment is necessary in elderly patients.

Taking more than the recommended dose of Finaster

If you take more tablets than recommended, contact your doctor immediately.

Missing a dose of Finaster

Take Finaster as directed by your doctor. However, if you miss a dose, do not take a double dose to make up for the missed dose.
If you have any further questions about taking Finaster, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Finaster can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people):

• decreased libido,
• impotence (inability to achieve an erection),
• decreased semen volume. This does not affect normal sexual function.

In some cases, these symptoms may disappear during treatment. However, if side effects persist, tell your doctor, who may decide to stop taking Finaster.
Uncommon(may affect up to 1 in 100 people):

• breast tenderness and/or enlargement,
• rash,
• ejaculation disorders.

Frequency not known(frequency cannot be estimated from available data):
Stop taking Finaster and contact your doctor immediately if you experience any of the following symptoms (angioedema):
Swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing

• allergic reactions: swelling of the lips, tongue, throat, and face,
• itching, hives,
• palpitations (rapid or irregular heartbeat),
• increased liver enzyme activity (abnormal blood test result),
• depression,
• persistent decreased libido after stopping treatment,
• testicular pain,
• erectile dysfunction and ejaculation disorders, which may persist after stopping treatment,
• male infertility and/or poor semen quality. Improvement in semen quality has been observed after stopping finasteride treatment,
• rarely, development of breast cancer,
• anxiety.

Immediately report to your doctor any changes in breast tissue, such as lumps, pain, breast enlargement, or discharge from the nipples, as they may be symptoms of serious disorders, such as breast cancer.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Finaster

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use Finaster after the expiry date stated on the carton. 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.

6. Contents of the pack and other information

What Finaster contains

The active substance is 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, macrogol 3350, titanium dioxide.

What Finaster looks like and contents of the pack

Finaster is a white, round, film-coated tablet with a smooth surface.
Blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box, containing 30, 60, 90, or 120 tablets.

Marketing authorization 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 leaflet:

• 18.09.2020