Patient Information Leaflet

Antiprost, 5 mg, film-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, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What Antiprost is and what it is 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 in the treatment and management of benign prostatic hyperplasia (BPH). It reduces
the size of the enlarged prostate, improves urine flow, and relieves BPH-related symptoms. It also reduces
the risk of acute urinary retention and the need for surgical treatment.

2. Important information before using Antiprost

When not to use Antiprost:

if the patient is allergic to finasteride or to 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 Antiprost, consult a doctor or pharmacist.

In patients with a large amount of residual urine and/or significantly reduced urinary flow. In such cases, the patient should be carefully monitored for urinary tract obstruction.
In patients with impaired liver function. In these patients, finasteride plasma concentrations may be increased.
If the patient develops changes in the breasts, such as lumps, pain, breast enlargement in men (gynecomastia), or nipple discharge.

Mood changes and depression
Mood changes, including depressive mood and depression, and rarely suicidal thoughts, have been reported in patients taking Antiprost. If any of these symptoms occur, medical advice should be sought immediately.
A physical examination (including per rectum, i.e. digital rectal examination) and measurement of serum prostate-specific antigen (PSA) levels should be performed before starting finasteride treatment and during treatment.

Antiprost and other medicines
Inform 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.
No significant interactions with other medicines have been identified.

Pregnancy and breastfeeding
Antiprost is intended for use in men only.
If the patient's sexual partner is pregnant or may be pregnant, the patient 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 must not handle broken or crushed Antiprost tablets. If finasteride is absorbed through the skin or taken orally by a woman expecting a male child, the baby may be born with malformations of the genital organs. The tablets are film-coated, which prevents contact with finasteride as long as the tablets are not broken or crushed.

Driving and operating machinery
There are no data suggesting that Antiprost affects the ability to drive or operate machinery.

Antiprost contains lactose.
This medicine contains 75 mg of lactose monohydrate per tablet. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to take Antiprost

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The recommended dose is 1 tablet once daily (corresponding to 5 mg of finasteride).
The coated tablets may be taken on an empty stomach or with food. The tablets should be swallowed
whole and must not be divided or crushed.
Although improvement may be noticed within a short period of time, treatment may need to continue
for at least six months to objectively assess whether therapeutic improvement has been achieved.
Your doctor will inform you how long you should continue taking Antiprost. Do not stop treatment prematurely,
as symptoms may recur.
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 renal function disorders
Dose adjustment is not necessary. Studies on the use of Antiprost in patients undergoing hemodialysis
have not been conducted.
Elderly patients
Dose adjustment is not necessary.
If you feel that the effect of Antiprost is too strong or too weak, you should inform your doctor or pharmacist.
Taking more Antiprost than recommended
If you take more Antiprost than recommended, or if the medicine is accidentally ingested by a child,
you should contact your doctor immediately.
Missing a 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 that case, continue taking the medicine as prescribed. Do not take a double dose to make up for
a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most common adverse effects are impotence and reduced sexual desire.
These effects usually occur at the beginning of treatment but typically do not last long in most
patients if treatment is continued.

Common (may affect up to 1 in 10 people):

decreased libido (reduced sexual desire)
impotence
reduced ejaculate 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 10,000 people):

breast discharge, breast nodules.

Unknown frequency (cannot be estimated from available data):

palpitations
itching
urticaria (hives)
hypersensitivity reactions; discontinue use of Antiprost and contact a doctor immediately if any of the following symptoms occur (angioedema): swelling of the lips, tongue, or throat; difficulty swallowing; hives and breathing difficulties
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 in semen quality has been reported after discontinuation of finasteride.
depression
persistent decreased libido after stopping treatment
anxiety
suicidal thoughts.

Finasteride may affect laboratory PSA test results.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Antiprost

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the cardboard packaging
and blister 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
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 coated tablet contains 5 mg of finasteride.
The other ingredients are:
tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized maize starch, sodium carboxymethyl starch (type A), magnesium stearate, sodium lauryl sulfate.
tablet coating: hypromellose, microcrystalline cellulose, polyglycol 8 stearate (type I).

What Antiprost looks like and contents of the pack
Antiprost tablets are white, round, biconvex, coated tablets with a diameter of 7 mm, marked with "F" and "5" on one side.
PVC/PVDC/Aluminium blisters: 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For more detailed information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Finland: Finasterid Orion
Poland: Antiprost