Finpros

Document: Finpros film-coated tablet ENG PL change

Package leaflet: Information for the patient

Finpros 5 mg film coated tablets

Finasteride

Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Finpros is and what it is used for

2. What you need to know before you take use Finpros

3. How to take Finpros

4. Possible side effects

5. How to store Finpros

6. 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. They act by reducing the size of the prostate gland in men.

Finpros is used in the treatment and control of benign (not cancerous)enlargement of the prostate.

2. What you need to know before you take Finpros

Do not take Finpros:

if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
if you are a woman (see also Pregnancy and breast-feeding) or a child.

Warnings and precautions

Talk to your doctor or pharmacist before takingFinpros.

If you have reduced liver function.
If you have difficulty emptying your bladder completely or a greatly reduced flow of urine, your doctor should examine you thoroughly before you start taking Finpros to exclude other obstructions in the urinary tract.
If you need to have a blood test called “PSA”. Make sure you tell your doctor or nurse first since finasteride may alter the results of the test.

If your sexual partner is or may potentially be pregnant, you should avoid exposing her to your semen which could contain a tiny amount of the drug (see also Pregnancy and breast-feeding).

Children

Finpros should not be used in children.

Other medicines and Finpros

Tellyour doctor or pharmacist if you are taking,have recently taken or might take any other medicines.

Finpros tablets can normally be taken with other medicines.

Finpros with food and drink

Finpros can be taken with or without food.

Pregnancy and breast-feeding

Finpros is only intended for men.

If your sexual partner is or may potentially be pregnant, you should avoid exposing her to your semen which could contain a tiny amount of the drug.

Women who are pregnant or may become pregnant should not handle broken or crushed Finpros tablets.If finasteride is absorbed through the skin or taken by mouth by a woman pregnant with a male foetus, the child may be born with malformed genital organs. The tablets are film-coated, which prevents contact with finasteride provided the tablets are not broken or crushed.

Driving and using machines

There is no evidence to suggest that Finpros affects the ability to drive or use machines.

Finpros contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Finpros

Always take this medicine exactly as your doctor or pharmacist has told you. Checkwith your doctor or pharmacist if you are not sure.

The usual dose is 1 tablet daily.

The tablet should be swallowed whole and should not be broken or crushed. It may be taken with or without food.

Although an improvement is often noticed after a short time, it may be necessary to continue the treatment for at least 6 months. Do not alter the dose or stop treatment without asking your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you take more Finpros than you should

Immediately contact a doctor, the nearest hospital casualty department or the centre for poison information for advice.

If you forget to take Finpros

Do not take a double dose to make up for a forgotten dose. Just take the next one when it is due.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Finpros and contact your doctor immediately if you develop any of the following symptoms:

swelling of the face, tongue or throat,
difficulty swallowing
urticaria and difficulty breathing.

Other side effects:

Common(may affect up to 1 in 10 people)

inability to obtain an erection

reduced sex drive,
reduced ejaculatory volume.

Uncommon(may affect up to 1 in 100 people)

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

Unkonwn frequency(frequency cannot be estimated from the available data)

allergic reactions such as swelling of the face and lips,
depression
Decrease in sex drive that may continue after stopping the medication
palpitation (feeling your heartbeat),
changes in the way your liver is working, which can be shown by a blood test,
itching, urticaria (hives),
testicular pain,
an inability to have an erection which may continue after stopping the medication,
male infertility and/or poor quality of semen.

You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such as breast cancer.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possibleside effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Finpros

Keep this medicine out of the sightand reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Finpros contains

The active substance is finasteride. Each film-coated tablet contains 5 milligrams finasteride.
The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, lauroyl macrogolglycerides, sodium starch glycolate, magnesium stearate. The tablet coating contains hypromellose, macrogol 6000, titanium dioxide (E 171) and indigo carmine aluminium lake (E 132).

What Finpros looks like and contents of the pack

Finpros is a blue, round, biconvex tablet marked "F5". The diameter is 7 mm.

Boxes containing 7, 14, 28, 30, 49, 50, 60, 90, 98, 100 or 300 tablets in blisters.

Plastic bottles containing 10, 30, 50, 100 or 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Actavis hf., Reykjavikurvegur 78, IS-220 Hafnarfjördur, Iceland.

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic	Finpros
Estonia	Finpros
Hungary	Finpros
Latvia	Finster
Lithuania	Finster
Poland	Finpros
Slovak Republic	Finpros
Sweden	Finpros

This leaflet was last revised in 17 November 2014