ANTIPROST 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Antiprost, 5 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
3. What is Antiprost and what is it used for
4. Important information before taking Antiprost
   1. When not to take Antiprost:
   2. Warnings and precautions
   3. Antiprost and other medicines
   4. Pregnancy and breastfeeding
   5. Women who are pregnant or may be pregnant should not touch crushed or broken Antiprost tablets.
   6. Driving and using machines
   7. Antiprost contains lactose.
   8. Other excipients
5. How to take Antiprost
   1. Patients with liver function disorders
   2. Patients with kidney function disorders
   3. Elderly patients
   4. Overdose of Antiprost
   5. Missed dose of Antiprost
6. Possible side effects
   1. Reporting of side effects
7. How to store Antiprost
8. Contents of the pack and other information
   1. What Antiprost contains
   2. What Antiprost looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 06.03.2025

Package Leaflet: Information for the User

Antiprost, 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Antiprost and what is it used for

Antiprost belongs to a group of medicines called 5α-reductase inhibitors. These medicines reduce the size of the prostate gland in men.
Antiprost is used to treat and control benign prostatic hyperplasia (BPH). It reduces the size of the enlarged prostate gland, improves urine flow, and relieves symptoms associated with BPH. It also reduces the risk of acute urinary retention and the need for surgical treatment.

2. Important information before taking Antiprost

When not to take Antiprost:

• in women (see also “Pregnancy and breastfeeding”)
• in children.

Warnings and precautions

Before taking Antiprost, tell your doctor or pharmacist.

• If you have a large amount of residual urine and/or significantly reduced urine flow. In such cases, you should be closely monitored for urinary tract narrowing.
• If you have liver function disorders. In such patients, finasteride levels in the blood may be increased.
• If you experience breast changes, such as lumps, pain, breast enlargement in men (gynecomastia), or nipple discharge.

Mood changes and depression
Patients taking Antiprost 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.
A physical examination (including a rectal examination, i.e., a finger examination through the rectum) and a prostate-specific antigen (PSA) test should be performed before starting treatment with finasteride and during treatment.

Antiprost and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
No significant interactions with other medicines have been identified.

Pregnancy and breastfeeding

Antiprost is intended for men only.
If your sexual partner is or may be pregnant, you should avoid exposing her to contact with semen, which may contain a small amount of the medicine.

Women who are pregnant or may be pregnant should not touch crushed or broken Antiprost tablets.

The tablets are film-coated, which prevents contact with finasteride, as long as the tablets are not crushed or broken.If finasteride is absorbed through the skin or taken orally by a pregnant woman, the baby may be born with genital deformities.

Driving and using machines

There are no data suggesting that Antiprost affects the ability to drive or use machines.

Antiprost contains lactose.

This medicine contains 75 mg of lactose monohydrate in each tablet. If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

Other excipients

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

3. How to take Antiprost

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one tablet a day (corresponding to 5 mg of finasteride).
The film-coated tablets can be taken with or without food. The tablets should be swallowed whole, not divided or crushed.
Although improvement may be seen within a short period, treatment may need to be continued for at least six months to assess whether an improvement in treatment outcomes has been achieved.
Your doctor will tell you how long to take Antiprost. Do not stop taking the medicine too early, as symptoms may return.

Patients with liver function disorders

There is no experience with the use of Antiprost in patients with liver function disorders (see also “Warnings and precautions”).

Patients with kidney function disorders

No dose adjustment is necessary. No studies have been conducted on the use of Antiprost in patients undergoing hemodialysis.

Elderly patients

No dose adjustment is necessary.
If you feel that the effect of Antiprost is too strong or too weak, tell your doctor or pharmacist.

Overdose of Antiprost

If you take more than the recommended dose of Antiprost or if a child accidentally takes the medicine, contact your doctor immediately.

Missed dose of Antiprost

If you miss a dose of Antiprost, take it as soon as possible, unless it is almost time for the next dose. In this case, continue taking the medicine as directed. Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Antiprost 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 but usually do not last long in most patients if treatment is continued.
Common (may affect up to 1 in 10 people):

• decreased libido (decreased sex drive)
• impotence
• decreased semen volume
• drowsiness.

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

• ejaculation disorders
• breast tenderness, breast enlargement
• rash.

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

• nipple discharge, breast lumps.

Frequency not known (cannot be estimated from the available data):

• palpitations
• pruritus
• urticaria
• hypersensitivity reactions; stop taking Antiprost and contact your doctor immediately if you experience any of the following symptoms (angioedema): swelling of the face, lips, tongue, or throat; difficulty swallowing; urticaria and difficulty breathing
• increased liver enzyme activity
• testicular pain
• blood in semen
• erectile dysfunction, which may persist after discontinuation of treatment
• ejaculation disorders, which may persist after discontinuation of treatment
• male infertility and/or poor semen quality. Normalization or improvement of semen quality has been reported after discontinuation of finasteride.
• depression
• decreased libido persisting after discontinuation of treatment
• anxiety
• suicidal thoughts.

Finasteride may affect the results of PSA laboratory tests.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please 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
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 Antiprost

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 carton and blister after “Expiry date (EXP)”. 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 Antiprost contains

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

What Antiprost looks like and contents of the pack

Antiprost tablets are white, round, biconvex, film-coated, 7 mm in diameter, marked with “F” and “5” on one side.
PVC/PVDC/Aluminum blisters: 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer:

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Finland: Finasteride Orion
Poland:
Antiprost

Date of last revision of the leaflet: 06.03.2025