Finxta

Package leaflet: Information for the user

Finxta, 5 mg, film-coated tablets
Finasteride
MEDICINAL PRODUCT FOR USE IN MEN ONLY
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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Finxta is and what it is used for

Finasteride, the active substance in Finxta, is an inhibitor of 5-alpha reductase, an enzyme that converts testosterone (a male sex hormone) into the more potent dihydrotestosterone (DHT). Finxta causes a reduction in the size of the prostate gland.

Finxta is used in a condition called benign prostatic hyperplasia (BPH). In this condition, the prostate gland, located near the urinary bladder, enlarges and causes difficulty in urination.

Finxta is indicated for the treatment of benign prostatic hyperplasia to:

• relieve symptoms,
• reduce the risk of acute urinary retention,
• reduce the risk of needing surgical treatment, including transurethral resection of the prostate (TURP) and prostatectomy (surgical removal of the prostate gland).

2. Important information before using Finxta

What you need to know before and during treatment with Finxta
If the patient's sexual partner is pregnant or suspected of being pregnant,
exposure to the patient's semen, which may contain small amounts of the drug, should be avoided.

When not to use Finxta

• if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6),
• in pregnant women and women of childbearing potential.

Finxta is not indicated for use in women.

Warnings and precautions

Before starting treatment with Finxta, discuss this with your doctor.
Inform your doctor about all current or past medical conditions and any allergies.
Benign prostatic hyperplasia is a slowly progressive condition. In some patients, symptoms may improve shortly after starting treatment. However, treatment with Finxta may need to be continued for at least 6 months before a significant improvement is observed. Regardless of whether symptoms improve, continued use of Finxta may reduce the risk of acute urinary retention and the need for surgical treatment. To monitor treatment progress, the patient should remain under regular medical supervision.
Benign prostatic hyperplasia is not cancer and does not lead to cancer, but both conditions may coexist. Only a doctor can properly assess symptoms and their likely cause.
Treatment with Finxta may affect PSA (prostate-specific antigen) test results. Therefore, inform your doctor that you are taking Finxta before undergoing this test.
Finxta is indicated only in men for the treatment of benign prostatic hyperplasia.

Mood changes and depression
Mood changes such as depressive mood and depression, and rarely suicidal thoughts, have been reported in patients taking Finxta. If any of these symptoms occur, seek immediate medical advice from your doctor.

Children
Finxta is not indicated for use in children.

Finxta and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Finxta usually does not affect the action of other concomitantly used medicines.

Pregnancy and breastfeeding

Pregnancy
Pregnant women and women of childbearing potential must not take Finxta. They should also not handle crushed or broken Finxta tablets. If the active substance of the medicine passes into the body of a pregnant woman (by oral administration or through skin contact), it may cause developmental abnormalities of the genital organs in a male fetus. Inform your doctor if a pregnant woman has been exposed to the active substance of Finxta. Finxta tablets are film-coated, which prevents direct contact with the active substance, provided the tablets are not damaged or crushed.
For further information, consult your doctor.

Breastfeeding
Finxta is not indicated for use in women.
It is unknown whether finasteride passes into human milk.

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

Finxta contains lactose
This medicine contains lactose. If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Finxta

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is one 5 mg tablet per day, regardless of food intake.
The medicine should be taken orally. The coated tablets should be swallowed whole. They must not be divided or crushed.
It should be remembered that benign prostatic hyperplasia is a process that progresses over many years before symptoms become apparent. Finxta may relieve symptoms and allow control of the disease progression, provided it is taken regularly over a prolonged period.
Use of Finxta in patients with renal and/or hepatic impairment
Dosage adjustment is not required in patients with any degree of renal and/or hepatic impairment.
Use of Finxta in elderly patients
Dosage adjustment is not required in elderly patients.
If you feel that the effect of Finxta is too strong or too weak, consult your doctor or pharmacist.
Taking more Finxta than recommended
If you have taken more tablets than recommended, contact your doctor immediately.
Missing a dose of Finxta
Finxta should be taken as directed by your doctor. However, if a dose is missed, do not take an additional tablet. Resume the prescribed dosing schedule the next day. 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.

Common (may occur in 1 to 10 out of 100 people)

• Decreased libido,
• Erectile dysfunction (inability to achieve penile erection),
• Reduced ejaculate volume (amount of semen). This does not affect sexual function.

In some cases, these symptoms may resolve during treatment. However, if adverse symptoms persist, you should consult your doctor, who may decide to discontinue the use of Finxta.

Uncommon (may occur in 1 to 10 out of 1,000 people)

• Rash,
• Disorders of semen emission,
• Enlargement and/or tenderness of the breasts.

Unknown (frequency cannot be estimated from the available data)

Discontinue use of Finxta and contact your doctor immediately if any of the following symptoms occur (angioedema): swelling of the face, tongue or throat, difficulty swallowing, urticaria, and breathing difficulties.

• Hypersensitivity reactions: swelling of lips, tongue, throat and face,
• Depression,
• Persistent decreased libido after discontinuation of treatment,
• Blood in semen,
• Palpitations,
• Changes in liver function, which may be observed in blood tests,
• Itching, urticaria,
• Testicular pain,
• Persistent inability to achieve penile erection after stopping the medicine,
• Persistent disorders of semen emission after stopping the medicine,
• Male infertility and/or poor semen quality (improvement in semen quality has been reported after discontinuation of the medicine),
• In rare cases, development of breast cancer,
• Anxiety.

Any changes observed in breast tissue, such as lumps, pain, breast enlargement or nipple discharge, should be reported immediately to the treating physician, as they may be signs of a serious illness, e.g. breast cancer.

Reporting of adverse effects

If any adverse effects occur, including those 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Finxta

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the outer carton and the blister after:
"Expiry date (EXP)" and on the blister after: "EXP". The expiry date refers to the last day of the stated month.
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 package and other information

What Finxta contains

• The active substance is finasteride. One coated tablet contains 5 mg of finasteride.
• The other ingredients in the tablet core are: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, sodium carboxymethyl starch (type A), magnesium stearate, sodium lauryl sulphate. The tablet coating contains hypromellose, microcrystalline cellulose, polyglycol 8 stearate (type I).

What Finxta looks like and contents of the pack:
Finxta is a white, round, biconvex coated tablet with a diameter of 7 mm,
imprinted with the characters "F" and "5" on one side.
PVC/PVDC/Aluminium blisters containing: 15, 28, 30, 50, 98 and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
Tel. 22 206 84 50

Manufacturer:
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate
Hal Far BBG3000
Malta