Package leaflet: Information for the user

PROSCAR, 5 mg, film-coated tablets
Finasteride
THIS MEDICINAL PRODUCT IS INTENDED FOR USE IN MEN ONLY
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet as 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 personally. Do not pass it on to others. It may harm other people, 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.

Contents of the leaflet:

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

1. What Proscar is and what it is used for

Finasteride, the active substance in Proscar, is a 5-alpha-reductase inhibitor, an enzyme that converts testosterone (a male sex hormone) into the more potent dihydrotestosterone (DHT). Proscar reduces the volume of the prostate gland.
Proscar is used in a condition called benign prostatic hyperplasia. The prostate gland, located near the urinary bladder, has become enlarged, causing difficulties in urination.
Proscar 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).

2. Important information before using Proscar

What you should know before and during treatment with Proscar
If the patient's sexual partner is pregnant or suspected of being pregnant,
exposure to the patient's semen, which may contain small amounts of the drug, should be avoided.

When Proscar must not be used

if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6),
in pregnant women and women of childbearing potential.

Proscar is not indicated for use in women.

Warnings and precautions

Before starting Proscar, discuss this with your doctor.
Inform your doctor about any current or past medical conditions and allergies.
Benign prostatic hyperplasia is a condition that develops over a long period of time. In some patients, symptoms may improve shortly after starting therapy. However, treatment with the medicine for at least 6 months may be necessary to achieve a significant improvement. Regardless of whether symptoms improve, treatment with Proscar may reduce the risk of acute urinary retention and the need for surgical intervention. To monitor treatment progress, the patient should remain under continuous medical supervision.
Benign prostatic hyperplasia is not cancer and does not lead to cancer; however, both conditions may coexist. Only a doctor can properly assess symptoms and their likely cause.
Treatment with Proscar may affect the results of the PSA test (prostate-specific antigen). Therefore, before undergoing this test, inform your doctor that you are taking Proscar.
Proscar is indicated for use in men only, for the treatment of benign prostatic hyperplasia.

Mood changes and depression
Mood changes such as depressive mood and depression, and less frequently suicidal thoughts, have been reported in patients taking Proscar. If any of these symptoms occur, seek immediate medical advice from your doctor.

Children
Proscar is not indicated for use in children.

Proscar with other medicines
Inform your doctor about all medicines currently used, recently taken, or planned to be taken. Proscar generally does not affect the action of other concomitantly used medicines.

Pregnancy and breastfeeding

Pregnancy
Pregnant women and women of childbearing potential must not use Proscar. They should also not handle crushed or broken Proscar tablets. If the active ingredient of the medicine enters the body (by oral administration or through skin contact) of a woman expecting a male child, it may cause developmental abnormalities of the fetal genital organs. Any case of exposure of a pregnant woman to the active ingredient of Proscar should be reported to a doctor. Proscar tablets are coated, which prevents direct contact with the active ingredient, provided that the tablets are not damaged or crushed. More information on this subject can be obtained from your doctor.

Breastfeeding
Proscar is not indicated for use in women.
It is unknown whether finasteride is excreted in human milk.

Driving and operating machinery
There are no data indicating that Proscar has an effect on the ability to drive or operate machinery.

Proscar contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Proscar contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Proscar

This medicine should always be used exactly as your doctor has instructed. If you are unsure,
you should consult your doctor.
The recommended dose is one 5 mg tablet daily, regardless of meals.
The medicine should be taken orally.
Please remember that benign prostatic hyperplasia is a condition that progresses slowly over many
years before symptoms become noticeable. Proscar may relieve symptoms and help control the
course of the disease, provided it is taken regularly over a prolonged period.
Use of Proscar in patients with impaired kidney and/or liver function
Dosage adjustment is not required in patients with any degree of renal and/or hepatic impairment.
Use of Proscar in elderly patients
Dosage adjustment is not required in elderly patients.
Taking more Proscar than recommended
If you take more tablets than recommended, you should contact your doctor immediately.
Missing a dose of Proscar
Proscar should be taken as prescribed by your doctor. If a dose is missed, do not take an extra
tablet. Resume the prescribed dosing schedule the next day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Proscar may cause adverse reactions, although they do not occur in everyone.

Common (may occur in 1 to 10 out of 100 people):

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

In some cases, these symptoms may resolve during treatment. However, if adverse reactions persist, consult your doctor, who may decide to discontinue treatment with Proscar.

Uncommon (may occur in 1 to 10 out of 1,000 people):

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

Frequency not known (cannot be estimated from available data):
Treatment with Proscar should be discontinued and immediate medical advice sought if any of the following symptoms occur (angioedema):
swelling of the face, tongue or throat, difficulty swallowing, urticaria, and breathing difficulties.

allergic reactions: swelling of the lips, tongue, throat and face,
depression,
persistent decrease in libido after stopping treatment,
blood in semen,
palpitations,
changes in liver function, which may be observed in blood tests,
itching, urticaria,
testicular pain,
persistent inability to achieve erection after discontinuation of the drug,
persistent ejaculation disorders after discontinuation of the drug,
male infertility and/or poor semen quality (improvement in semen quality has been reported after discontinuation),
in rare cases, development of breast cancer,
anxiety,
suicidal thoughts.

Any changes observed in the breast tissue, such as lumps, pain, breast enlargement or nipple discharge, should be promptly reported to the treating physician, as they may indicate serious conditions such as breast cancer.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 to provide more information on the safety of the medicine.

5. How to store Proscar

Keep this medicine out of the sight and reach of children.
Store below 30°C and protect from light.
Do not use this medicine after the expiry date stated on the cardboard box after:
Expiry date (EXP). 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
what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Proscar contains

The active substance is finasteride. Each coated tablet contains 5 mg of finasteride.
Other ingredients are: monohydrate lactose, microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch type A, sodium docusate, magnesium stearate, yellow iron oxide (E 172).
Coating composition: hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), talc, indigotine (E 132).

Packaging contains 28 or 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warszawa
Tel.: + 48 22 306 57 64
[email protected]
Manufacturer/Importer:
Merck Sharp & Dohme B.V., Waarderweg 39, Haarlem, 2031BN, The Netherlands
Organon Heist bv, Industriepark 30, 2220 Heist-op-den-Berg, Belgium