Package leaflet: Information for the patient

Finpros 5 mg, coated tablets
Finasteride
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Finpros is and what it is used for
Important information before taking Finpros
How to take Finpros
Possible side effects
How to store Finpros
Contents of the pack and other information

1. What Finpros is and what it is used for

Finpros belongs to a group of medicines called 5-alpha-reductase inhibitors. These work by
reducing the size of the prostate gland in men.
Finpros is used for the treatment and inhibition of progression of benign (non-cancerous)
enlargement of the prostate gland.

2. Important information before using Finpros

When not to use Finpros

if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6),
in women (see also section "Pregnancy and breastfeeding") or children.

Warnings and precautions
Please consult your doctor or pharmacist before using Finpros:

if the patient has liver function disorders.
if the patient experiences difficulty completely emptying the bladder or significantly impaired urine flow, the doctor should thoroughly examine the patient before starting Finpros to exclude other urinary tract obstructions.
if the patient needs to undergo a blood test called prostate-specific antigen (PSA) measurement, he should inform the doctor or nurse about taking this medicine, as finasteride may affect test results.

If a sexual partner is or may be pregnant, exposure to semen possibly containing small amounts of the medicine should be avoided (see also "Pregnancy and breastfeeding").
Mood changes and depression
Mood changes such as depressive mood and depression, and less frequently suicidal thoughts, have been reported in patients taking Finpros. If any of these symptoms occur, treatment with Finpros should be discontinued immediately and the patient should seek medical advice from a doctor without delay.
Children
Finpros must not be used in children.
Finpros with other medicines
Tell 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.
Finpros can generally be taken with other medicines.
Finpros with food and drink
Finpros can be taken with or without food.
Pregnancy and breastfeeding
Finpros is intended for use in men only.
If a sexual partner is or may be pregnant, exposure to semen possibly containing small amounts of the medicine should be avoided.
Pregnant women or women who may become pregnant must not handle crushed or broken Finpros tablets.
Skin absorption or oral intake of finasteride by a pregnant woman carrying a male fetus may result in birth defects of the male genital organs.
The tablets are film-coated, which prevents contact with finasteride in intact tablets that have not been broken or crushed.
Driving and using machines
There is no evidence indicating any influence of Finpros on the ability to drive or operate machinery.
Finpros contains lactose and sodium
If the patient has an intolerance to certain sugars, consult a doctor before starting this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free."

3. How to use Finpros

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose is 1 tablet per day.
The tablet should be swallowed whole; do not split or crush it. The medicine may be taken with or without food.
Although improvement is often seen within a short time, continued treatment for at least 6 months may be necessary. Do not change the dose or stop treatment without consulting your doctor.
Your doctor may prescribe Finpros together with another medicine (e.g. doxazosin) to help control BPH.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.
Taking more Finpros than prescribed
Contact your doctor immediately, go to the nearest hospital emergency department or poison control center for advice.
Missed dose of Finpros
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Finpros and contact your doctor immediately if any of the following adverse reactions occur:

swelling of the face, tongue or throat,
difficulty swallowing,
hives and breathing difficulties. The above adverse reactions may be symptoms of an allergic reaction, such as angioedema, reported as an adverse reaction of unknown frequency (frequency cannot be estimated from available data).

Other adverse reactions:
Frequent adverse reactions (may occur in up to 1 in 10 patients):

inability to achieve erection,
decreased libido,
reduced semen volume.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

rash,
tenderness and/or enlargement of the breasts,
difficulty in achieving ejaculation.

Adverse reactions of unknown frequency (frequency cannot be estimated from available data):

depression,
anxiety,
suicidal thoughts,
decreased libido, which may persist after discontinuation of treatment,
palpitations (awareness of strong heart beat),
changes in liver function tests observed in blood tests,
itching, hives,
testicular pain,
blood in semen,
erectile dysfunction, which may persist after discontinuation of treatment,
ejaculation disorders, which may persist after discontinuation of treatment,
infertility and/or poor semen quality. Improvement in semen quality has been observed after discontinuation of treatment.

Patients should immediately inform their doctor of any changes in the breasts, such as lumps, breast pain, breast enlargement or nipple discharge, as these may be symptoms of a serious disease, such as breast cancer.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Finpros

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special precautions for storage are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Finpros contains

The active substance is finasteride. Each coated tablet contains 5 mg of finasteride.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, pregelatinized maize starch, glyceryl lauryl macrogols, sodium carboxymethyl starch (type A), magnesium stearate in the tablet core; the tablet coating contains hypromellose 6 cps, macrogol 6000, titanium dioxide (E 171), indigo carmine (E 132), and aluminium lacquer. See section 2 "Finpros contains lactose and sodium".

What Finpros looks like and contents of the pack
Finpros coated tablets are blue, round, biconvex, with the imprint "F5",
7 mm in diameter.
Pack sizes: 28, 30, 60 or 90 coated tablets in blisters, packed in a cardboard carton.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Actavis hf., Reykjavikurvegur 78, IS-220 Hafnarfjördur, Iceland
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Czech Republic, Poland, Slovakia, Sweden, Hungary

Finpros