Uronezir

Package Leaflet: Information for the Patient

Uronexir, 5 mg, Film-Coated Tablets

Finasteride
THIS MEDICINE IS FOR USE IN MEN ONLY

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 you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or any other side effects not mentioned in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Uronexir and what is it used for

Uronexir belongs to a group of medicines called 5-alpha reductase inhibitors.
These medicines reduce the size of the prostate gland in men.
Uronexir is used to treat and control benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate gland.
It reduces the risk of sudden inability to pass urine (known as acute urinary retention) and the need for surgery.
Uronexir should be given to patients with an enlarged prostate gland (prostate volume above approximately 40 cm³).
BPH is a non-cancerous enlargement of the prostate gland that often occurs in men over 50 years of age.
The prostate gland is located in the passage between the bladder and the urethra and surrounds it.
Enlargement can lead to urinary problems. With BPH, the following symptoms may occur:

• frequent urination, especially at night,
• sudden need to urinate,
• difficulty starting to empty the bladder,
• interrupted, weak urine flow,
• urine retention or feeling that the bladder cannot be completely emptied.

In some men, BPH can lead to serious complications, such as urinary tract infections, complete blockage of urine flow (acute urinary retention), and the need for surgical intervention.

2. Important information before taking Uronexir

When not to take Uronexir

• if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6),
• in women,
• if a woman is pregnant or may be pregnant (see also "Pregnancy and breast-feeding"),
• in children.

Warnings and precautions

Before taking Uronexir, discuss it with your doctor, pharmacist, or nurse.

• Treatment with Uronexir should be started after consultation with a urologist.
• Before starting therapy, it is necessary to rule out urinary tract obstruction caused by a certain type (trilobed) of prostate enlargement.
• To detect prostate cancer early, you should undergo a control examination before treatment and regularly during treatment with Uronexir.
• If you have or have had a large amount of urine retention in the bladder after urination and/or significantly reduced urine flow, you should be closely monitored for urinary tract narrowing.
• If you have or have had liver function disorders, the concentration of finasteride in the blood may be increased.
• If your sexual partner is pregnant or may be pregnant, you should avoid exposing your partner to contact with your semen, which may contain small amounts of the medicine.
• If you have or have had a PSA test (a test used to detect prostate cancer), you should inform your doctor about taking finasteride. Finasteride may affect the concentration of the substance being tested in the blood, PSA.
• You should immediately report to your doctor any changes in the breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be symptoms of a serious condition, such as breast cancer.

Mood changes and depression

In patients taking finasteride at a dose of 5 mg, depressive mood, depression, and less frequently suicidal thoughts have been reported. If any of these symptoms occur, you should stop taking Uronexir and immediately consult your doctor for further medical advice.

Children

Uronexir should not be used in children. There is no data on the efficacy or safety of finasteride in children.

Uronexir 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.

Pregnancy and breast-feeding

Uronexir is intended for use in men only.

Pregnancy
Women who are pregnant or planning to become pregnant, or are breast-feeding, should not touch the tablets, especially if they are broken or crushed. Finasteride inhibits the conversion of the male sex hormone testosterone to dihydrotestosterone - an active hormone produced in the prostate. If finasteride is absorbed through the skin or taken orally by a pregnant woman expecting a male child, the child may be born with genital deformities.
Broken or crushed Uronexir film-coated tablets should not be handled by women, especially medical assistants, who are at risk if they are pregnant or may become pregnant, as it cannot be excluded that finasteride may be absorbed through the skin, and thus pose a risk to the unborn male child.
The Uronexir tablets are film-coated, which will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
If your sexual partner is pregnant or may be pregnant, you should either avoid exposing your partner to contact with your semen (e.g., by using a condom) or stop taking finasteride. If your partner, who is pregnant, comes into contact with Uronexir, you should consult your doctor.
Breast-feeding
It is not known whether finasteride passes into human milk.

Driving and using machines

There is no data suggesting that Uronexir affects the ability to drive or use machines.

Uronexir contains lactose monohydrate

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

Uronexir contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Uronexir

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Unless your doctor has told you otherwise, the usual dose is one 5 mg Uronexir film-coated tablet per day.
Doses higher than recommended have not shown any further increase in efficacy and have not been studied. Therefore, the recommended dose is also the maximum dose.

Combination therapy with a medicine containing doxazosin

Your doctor will determine the dosage of doxazosin (an alpha-receptor antagonist).
The recommended dosage is:

• One 5 mg Uronexir film-coated tablet per day.

Doxazosin:

• Week 1: 1 mg of doxazosin per day.
• Week 2: 2 mg of doxazosin per day.
• Week 3: 4 mg of doxazosin per day. From week 4: 4 mg or 8 mg of doxazosin per day.

Increasing the dose to at least 4 mg of doxazosin is necessary to reduce the risk of clinical progression of BPH.

Patients with liver function disorders

There is no data on the use of finasteride in patients with liver function disorders (see also "Warnings and precautions").

Patients with kidney function disorders

Studies have shown that there is no need to adjust the dosage when the creatinine clearance is above 9 ml/min/1.73 m². No studies have been conducted on the use of Uronexir in patients undergoing hemodialysis.

Elderly patients

The elimination rate of finasteride is slightly decreased in patients over 70 years of age. There is no need to adjust the dosage.

How and when to take the film-coated tablets?

Take one film-coated tablet once a day, swallowing it whole.

Taking the film-coated tablets with food and drink

Uronexir can be taken with or without food, with a sufficient amount of liquid.

What to do if you take more Uronexir than you should

There is no specific recommended treatment for overdose with finasteride. Never take more tablets than your doctor has prescribed. If you have taken too many tablets, consult your doctor immediately.

What to do if you forget to take Uronexir

Do not take a double dose to make up for a forgotten dose. Continue treatment with one Uronexir tablet per day.

What to do if you stop taking Uronexir

Benign prostatic hyperplasia is a condition that develops over a long time. In some patients, relief of symptoms occurs soon after starting treatment. However, it may be necessary to take the medicine for at least 6 months to achieve significant improvement. Regardless of whether symptoms improve, taking Uronexir may reduce the risk of acute urinary retention and the need for surgical intervention. To monitor the progress of treatment, you should remain under constant medical supervision.
If you have any further questions about taking 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.

If you experience any of the following symptoms, stop taking Uronexir and contact your doctor immediately:

Allergic reactions

• swelling of the face, lips, tongue, and throat (angioedema)
• difficulty swallowing
• hives (itching, blistering skin rash) and difficulty breathing.

The following side effects have been reported with Uronexir:
Common(may affect up to 1 in 10 people)

• impotence (inability to achieve an erection)
• decreased libido (sex drive)
• decreased semen volume.

Uncommon(may affect up to 1 in 100 people)

• ejaculation disorders (ejaculation failure)
• rash
• breast tenderness
• breast enlargement
• single cases of nipple discharge and breast lumps as part of gynecomastia, which were surgically removed in individual patients.

Frequency not known(frequency cannot be estimated from the available data)

• depression
• anxiety
• palpitations
• itching (hives)
• increased liver enzyme activity
• testicular pain
• blood in semen
• sexual disorders (erectile dysfunction and ejaculation disorders) that do not resolve after stopping treatment
• decreased libido (sex drive) that persists after stopping treatment
• infertility and/or poor semen quality.

Normalization or improvement in semen quality has been observed after stopping finasteride treatment.
Additionally, cases of male breast cancer have been reported in clinical trials and after the medicine was marketed (see section 2. Warnings and precautions).
Laboratory tests
When determining the level of prostate-specific antigen (PSA), it should be taken into account that under the influence of finasteride, the PSA value is reduced by about 50%.

Combination therapy with doxazosin

The following side effects were observed more frequently when finasteride was taken together with doxazosin, an alpha-receptor antagonist: asthenia 16.8% (placebo 7.1%), orthostatic hypotension 17.8% (placebo 8%), dizziness 23.2% (placebo 8.1%), and ejaculation disorders 14.1% (placebo 2.3%).

Reporting side effects

If you experience any side effects, or any other side effects not mentioned in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Uronexir

Keep this medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging and on the label after EXP. The expiry date refers to the last day of the 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 pack and other information

What Uronexir contains

The active substance is finasteride. One film-coated tablet contains 5 mg of finasteride.
The other ingredients are: lactose monohydrate (200 M), microcrystalline cellulose (PH 102), corn starch, sodium carboxymethylcellulose (type A), sodium docusate, magnesium stearate.
Coating:
Opadry Blue 03A80928:
HPMC 2910/Hypromellose 6 cP, titanium dioxide (E 171), talc, indigo carmine (E 132), aluminum lake, yellow iron oxide (E 172).

What Uronexir looks like and contents of the pack

Film-coated tablet.
The film-coated tablets are blue, round, with "H" embossed on one side and "37" on the other side.
Uronexir is available in blisters containing: 28, 30, 90, or 120 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
Tel.: +48 22 855 40 93

Manufacturer/Importer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany

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

Germany
Finasterid Heumann 5 mg Filmtabletten
Poland
Uronexir
Date of last revision of the leaflet:August 2024