Finamef

Package Leaflet: Information for the Patient

Finamef, 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Finamef and what is it used for

The active substance of Finamef is finasteride, which belongs to a group of medicines called 5-alpha-reductase inhibitors. Its action is to reduce the size of the prostate gland in men.
Finamef is used to treat and control benign prostatic hyperplasia (BPH). It reduces the size of the enlarged prostate gland, improves urine flow, and alleviates symptoms associated with BPH, as well as reduces the risk of acute urinary retention and the need for surgical intervention.

2. Important information before taking Finamef

When not to take Finamef:

Finamef is not recommended for use in children.
IN CASE OF DOUBT, ALWAYS CONSULT A DOCTOR OR PHARMACIST.

Warnings and precautions

Before starting Finamef, discuss it with your doctor or pharmacist.

Breast cancer
Inform your doctor immediately if you notice any changes in breast tissue, such as lumps, pain, or discharge from the nipple, as these may be symptoms of a serious condition such as breast cancer.
Effect on prostate-specific antigen (PSA)
Before taking Finamef and during treatment, the patient should undergo a physical examination and laboratory tests (including a rectal examination) and should have their prostate-specific antigen (PSA) levels measured.
This medicine lowers PSA levels in the blood, which should be taken into account in differential diagnosis.
Mood changes and depression
Patients taking Finamef have reported mood changes, such as depressive mood and depression, and less frequently, suicidal thoughts. If any of these symptoms occur, consult a doctor for further medical advice.

Finamef and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No significant clinical interactions have been found.

Pregnancy, breastfeeding, and fertility

Finamef is intended for use in men only.

If a pregnant woman or a woman who may be pregnant comes into contact with crushed or

broken Finamef tablets.If a pregnant woman with a male fetus absorbs finasteride through the skin or takes it orally, there is a risk that the child may be born with deformed genitalia. Finamef tablets are film-coated, so there is no contact with the active substance unless the tablet is crushed or broken.
If the patient's sexual partner is pregnant or may be pregnant, they should avoid exposure to semen (e.g., by using a condom) or stop taking finasteride.
It is not known whether this medicine passes into breast milk.

Driving and using machines

There is no data indicating that Finamef affects the ability to drive or operate machinery.

Finamef contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Finamef

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 (equivalent to 5 mg of finasteride).
Finamef film-coated tablets can be taken with or without food. The tablets should be swallowed whole, do not divide or crush them.
Despite the possibility of rapid clinical improvement, to properly assess the effectiveness of treatment, the medicine should be taken for at least 6 months.
Your doctor will tell you how long to take Finamef. Do not stop taking the medicine without consulting your doctor, as the symptoms of the disease may return.
Liver function disorders
There is no experience with the use of Finamef in patients with liver function disorders (see also "Warnings and precautions").
Kidney function disorders
No dose adjustment is necessary.
No studies have been conducted with Finamef in patients undergoing hemodialysis.
Elderly patients
No dose adjustment is necessary.
If you feel that the effect of Finamef is too strong or too weak, consult your doctor or pharmacist.

Taking more than the recommended dose of Finamef

If you have taken more than the recommended dose of Finamef or if you think a child has accidentally taken the medicine, contact your doctor immediately.

Missing a dose of Finamef

If you miss a dose of Finamef, take the missed dose as soon as you remember, unless it is almost time for your next dose. In this case, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Finamef can cause side effects, although not everybody gets them.
Allergic reactions

If an allergic reaction occurs, stop taking the medicine and contact your doctor immediately.

symptoms may include:

• swelling of the lips, face, tongue, and throat
• difficulty swallowing
• skin rash, itching, hives
• difficulty breathing

Other side effects:

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

• difficulty achieving an erection (impotence)
• decreased sex drive
• decreased semen volume during ejaculation. The decrease in semen volume does not appear to affect normal sexual function. The above side effects may disappear after some time in patients continuing treatment with Finamef. If the symptoms do not disappear while taking the medicine, they usually disappear after stopping Finamef.

Uncommon (may affect up to 1 in 100 people)

• skin rash
• breast tenderness or swelling
• ejaculation disorders, which may persist after stopping the medicine

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

• anxiety
• palpitations (feeling of heartbeats)
• liver function changes, which may be visible in blood tests
• testicular pain
• male infertility and (or) poor semen quality. Improvement in semen quality has been observed after stopping treatment
• depression
• decreased sex drive, which may persist after stopping treatment
• erectile dysfunction and ejaculation disorders, which may persist after stopping treatment
• blood in the semen

Inform your doctor immediately if you notice any changes in breast tissue, such as lumps, pain, or discharge from the nipple, as these may be symptoms of a serious condition such as breast cancer.
Finasteride may affect the results of prostate-specific antigen (PSA) measurement.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Finamef

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blister, and bottle after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after "Lot".
Do not store above 30°C.
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 Finamef contains

• The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), maize starch, pregelatinized maize starch, povidone K30, magnesium stearate, sodium lauryl sulfate, hypromellose 6cp, titanium dioxide (E171), macrogol 6000, macrogol 400, indigo carmine (E132).

Finamef film-coated tablets are blue, capsule-shaped, with "FNT5" engraved on one side.
Finamef is available in blisters in packs of 28, 30, 60, 90, or 105 tablets and in an HDPE container with a polypropylene cap containing 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00
Poland

Manufacturer:

Pharmachemie B.V.
Swensweg 5, Postbus 552
2003 RN Haarlem
Netherlands
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków

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

Belgium
Finasteride Teva 5 mg film-coated tablets
Denmark
Finasteride Teva 5 mg
Estonia
Finasteride Teva
France
Finasteride Teva 5 mg, film-coated tablet
Hungary
Finasterid-TEVA 5 mg film tablet
Italy
FINASTERIDE Teva Italia 5 mg film-coated tablets
Latvia
Finasteride Teva 5 mg film-coated tablets
Lithuania
Finasteride Teva 5 mg film-coated tablets
Netherlands
Finasteride 5 mg Teva
Poland
Finamef
Portugal
Finasterida-Teva
Spain
Finasterida Teva-ratiopharm 5 mg film-coated tablets EFG
Sweden
Finasteride Teva 5 mg film-coated tablet

Date of revision of the leaflet: August 2024