PROSCAR 5 mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet attached to the packaging: information for the user
3. PROSCAR, 5 mg, film-coated tablets
   1. You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Proscar and what is it used for
5. Important information before taking Proscar
   1. What you need to know before and while taking Proscar
   2. When not to take Proscar
   3. Warnings and precautions
   4. Mood changes and depression
   5. Children
   6. Proscar and other medicines
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Proscar contains lactose monohydrate
   10. Proscar contains sodium
6. How to take Proscar
   1. Taking Proscar in patients with kidney or liver problems
   2. Taking Proscar in elderly patients
   3. Taking more Proscar than prescribed
   4. Missing a dose of Proscar
7. Possible side effects
   1. You should immediately inform your doctor about any changes in breast tissue, such as lumps, pain, enlargement, or discharge from the nipples, as these may be signs of serious disorders, such as breast cancer.
   2. Reporting side effects
8. How to store Proscar
9. Contents of the pack and other information
   1. What Proscar contains
   2. Marketing authorization holder and manufacturer
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. Date of last revision of the leaflet: 07/2024

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

PROSCAR, 5 mg, film-coated tablets

Finasteride
THIS MEDICINE IS FOR USE IN MEN ONLY

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Proscar and what is it used for

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

2. Important information before taking Proscar

What you need to know before and while taking Proscar

If your sexual partner is pregnant or may be pregnant, you should avoid exposing her to your semen, which may contain small amounts of the medicine.

When not to take Proscar

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

Proscar is not indicated for use in women.

Warnings and precautions

Before starting Proscar, you should discuss it with your doctor.
You should inform your doctor about all diseases you have now or have had in the past, as well as any allergies.
Benign prostatic hyperplasia is a condition that develops over many years. In some patients, relief of symptoms occurs soon after starting therapy. However, it may be necessary to take the medicine for at least 6 months to see a significant improvement. Regardless of whether symptoms improve, taking Proscar may reduce the risk of acute urinary retention and the need for surgical treatment. To monitor the progress of treatment, you should remain under regular medical supervision.
Benign prostatic hyperplasia is not a tumor, nor does it lead to the development of a tumor, but these conditions can occur together. Only your doctor can properly assess your symptoms and their likely cause.
Taking Proscar may affect the results of the PSA (prostate-specific antigen) test. Therefore, before having this test, you should inform your doctor that you are taking Proscar.
Proscar is indicated only for men for the treatment of benign prostatic hyperplasia.

Mood changes and depression

Patients taking Proscar 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.

Children

Proscar is not indicated for use in children.

Proscar and other medicines

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

Pregnancy and breastfeeding

Pregnancy
Women who are pregnant or may be pregnant should not take Proscar. They should also not touch crushed or broken Proscar tablets. If the active substance of Proscar enters the body (by mouth or through skin contact) of 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 Proscar, she should inform her doctor. Proscar tablets are film-coated, which prevents direct contact with the active substance, provided that the tablets are not damaged or crushed.
More information on this can be provided by your doctor.
Breastfeeding
Proscar is not indicated for use in women.
It is not known whether finasteride passes into human milk.

Driving and using machines

There is no data indicating that Proscar affects the ability to drive or use machines.

Proscar contains lactose monohydrate

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

Proscar contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Proscar

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor.
The recommended dose is one 5 mg tablet per day, regardless of meals.
The medicine should be taken orally.
You should remember that benign prostatic hyperplasia is a process that takes many years to develop before symptoms are noticed. Proscar may relieve symptoms and allow control of the disease if taken regularly over a long period.

Taking Proscar in patients with kidney or liver problems

No dose adjustment is required in patients with renal impairment of any degree or liver problems.

Taking Proscar in elderly patients

No dose adjustment is required in elderly patients.

Taking more Proscar than prescribed

If you have taken more tablets than prescribed, you should immediately contact your doctor.

Missing a dose of Proscar

You should take Proscar as prescribed by your doctor. However, if you miss a dose, do not take an extra tablet. The next day, you should return to the dosing schedule prescribed by your doctor.
If you have any further doubts about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Proscar 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 (amount of semen). This does not affect normal sexual function.

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

• rash,
• ejaculation disorders,
• breast tenderness or enlargement. Frequency not known(cannot be estimated from the available data): You should stop taking Proscar and immediately contact your doctor if you experience any of the following symptoms (angioedema): swelling of the face, lips, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.
• allergic reactions: swelling of the lips, tongue, throat, and face,
• depression,
• persistent decreased libido after stopping treatment,
• blood in semen,
• palpitations,
• liver function changes, which may be seen in blood tests,
• itching, hives,
• testicular pain,
• inability to achieve an erection persisting after stopping the medicine,
• ejaculation disorders persisting after stopping the medicine,
• male infertility and/or poor semen quality (after stopping the medicine, improvement in semen quality has been reported),
• rarely, development of breast cancer,
• anxiety,
• suicidal thoughts.

You should immediately inform your doctor about any changes in breast tissue, such as lumps, pain, enlargement, or discharge from the nipples, as these may be signs of serious disorders, such as breast cancer.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of 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 .
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 Proscar

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C, protected from light.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should 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 Proscar contains

• The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate type A, docusate sodium, magnesium stearate, yellow iron oxide (E 172).
• Coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), talc, indigo carmine (E 132). The pack contains 28 or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: + 48 22 105 50 01
[email protected]

Manufacturer/Importer:

Merck Sharp & Dohme B.V., Waarderweg 39, Haarlem, 2031BN, Netherlands
Organon Heist bv, Industriepark 30, 2220 Heist-op-den-Berg, Belgium

Date of last revision of the leaflet: 07/2024