Finasterid Stada 5 mg tabletki povlekane

Leaflet attached to the packaging: patient information

Finasterid Stada 5 mg film-coated tablets

(Finasteridum)

Read the 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 to a specific person. 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 any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Finasterid Stada and what is it used for

The active substance in Finasterid Stada is finasteride. Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors. These medicines work by reducing the size of the prostate gland in men.
Finasterid Stada is used to treat and control benign prostatic hyperplasia (BPH).

2. Important information before taking Finasterid Stada

When not to take Finasterid Stada

• If the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• If the patient is a woman (see also "Pregnancy and breastfeeding" in this section).
• If the patient is a child.

Warnings and precautions

Before taking Finasterid Stada, the patient should discuss it with their doctor, pharmacist, or nurse.

• If the patient has reduced liver function.
• If the patient has difficulty emptying their bladder or has a significantly reduced urine flow. In such cases, the patient should be thoroughly examined by a doctor to rule out other causes of urinary tract narrowing.
• If the patient's sexual partner is or may become pregnant, they should avoid exposure to semen (e.g., by using a condom), which may contain small amounts of the medicine (see also section 2 "Pregnancy and breastfeeding").

The patient should immediately inform their doctor about any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, which may indicate a serious disease, such as breast cancer.
Before starting treatment with finasteride and periodically during treatment, the doctor will likely perform some simple tests to rule out the possibility of prostate cancer. This may include a digital rectal examination and a blood test to measure the level of prostate-specific antigen (PSA).
If the patient is to have a blood test to measure the level of PSA, they should inform their doctor or nurse, as finasteride may affect the results of this test.
Mood changes and depression
Patients taking Finasterid Stada have reported mood changes, such as depressive mood and depression, and less frequently, suicidal thoughts. If any of these symptoms occur, the patient should immediately consult their doctor for further medical advice.

Finasterid Stada and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Finasterid Stada can be normally taken with other medicines, but the patient should inform their doctor before starting to take another medicine.

Finasterid Stada with food

Finasterid Stada can be taken with or without food.

Pregnancy and breastfeeding

Finasterid Stada is intended for men only and should not be taken by women (see section 2 "When not to take Finasterid Stada").
Women who are pregnant or may become pregnant should not handle crushed or broken Finasterid Stada tablets. If a pregnant woman, carrying a male fetus, absorbs finasteride through the skin or takes it orally, the child may be born with genital abnormalities.
The tablets containing finasteride are film-coated, which protects against contact with the active substance during normal use, as long as the tablet is not crushed or broken.
If a pregnant woman has come into contact with crushed or broken Finasterid Stada tablets, she should consult a doctor.
If the patient's sexual partner is pregnant or may become pregnant, they should avoid exposure to the patient's semen, which may contain small amounts of the medicine (e.g., by using a condom).
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

There are no data to suggest that Finasterid Stada impairs the ability to drive or operate machinery.

Finasterid Stada contains lactose and sodium.

Lactose: if the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Sodium: this medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, which is considered "sodium-free".

3. How to take Finasterid Stada

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is one tablet per day.
The tablet should be swallowed whole and not crushed or chewed. The medicine can be taken with or without food.

Taking more than the recommended dose of Finasterid Stada

If the patient takes more than the recommended dose of Finasterid Stada 5 mg or if a child accidentally swallows the medicine, they should consult a doctor or go to the hospital.

Missing a dose of Finasterid Stada

The patient should not take a double dose to make up for a missed dose. The next dose should be taken at the usual time.

Stopping treatment with Finasterid Stada

Although improvement is often seen after a short period, it may be necessary to continue treatment for at least 6 months.
The patient should not change the dose or stop treatment without consulting their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Finasterid Stada can cause side effects, although not everybody gets them.

The patient should stop taking Finasterid Stada and immediately consult their doctor if they experience any of the following symptoms of angioedema (frequency not known (cannot be estimated from the available data)):

• Swelling of the face, tongue, and lips or throat,
• Difficulty swallowing
• Hives,
• Difficulty breathing.

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

• Impotence and decreased libido. These side effects usually occur at the beginning of treatment, are mostly temporary, and disappear when treatment is continued.
• Decreased semen volume.

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

• Breast tenderness and (or) breast enlargement.
• Difficulty ejaculating.
• Rash

Rare (may affect up to 1 in 10,000 people):
Nipple discharge, breast lumps.
Unknown (frequency cannot be estimated from the available data):

• Increased liver enzyme activity
• - Heart palpitations (palpitations).
• Impotence that does not disappear after stopping the medicine.
• Infertility and (or) poor semen quality.
• Depression.
• Decreased libido that does not disappear after stopping the medicine.
• Testicular pain.
• Itching (pruritus), hives.
• Anxiety.

The patient should immediately consult their doctor if they experience any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be symptoms of a serious disease, such as breast cancer.
Reporting side effects
If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Finasterid Stada

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Finasterid Stada contains

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

What Finasterid Stada looks like and contents of the pack

Finasterid Stada is a white, round, biconvex, film-coated tablet with the letter "F" and the number "5" embossed on one side of the tablet. The diameter is 7 mm.
The tablets are packaged in PVC/PVDC/Aluminum blisters in a cardboard box, containing 30, 90, 105, 100, or 120 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel, Germany

Manufacturer:

STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel, Germany
Eurogenerics NV, Heizel Esplanade b 22, 1020 Brussels, Belgium
Kern Pharma S.L., Venus 72, 08228 Terrassa-Barcelona, Spain
Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany
PharmaCoDane ApS, Marielundsvej 46A, DK-2730 Herlev, Denmark
STADA Arzneimittel GesmbH, Muthgasse 36/2, 1190 Vienna, Austria
Siegfried Malta Ltd., HHF070 Hal Far Industrial Estate, Hal Far BBG3000, Malta

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

Austria:
Finasterid 'Stada' 5 mg – Filmtabletten
Belgium:
Finasteride EG 5 mg filmomhulde tabletten
Denmark:
Finasterid „Stada“
Germany:
Finasterid AL 5 mg Filmtabletten
Iceland
Finasterid Stada 5 mg filmuhúðuð tafla
Italy:
Finasteride EG 5 mg compresse rivestite con film
Luxembourg:
FINASTERIDE - EG
Poland:
Finasterid STADA 5 mg tabletki powlekane
Sweden:
Finasterid Stada 5 mg filmdragerad tablett

Date of last revision of the leaflet: 19.03.2020