Uronezyr

Package leaflet: Information for the patient

Uronezyr, 5 mg, coated tablets
Finasteride
THIS MEDICINAL PRODUCT IS INTENDED FOR USE IN MEN ONLY
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Uronezyr is and what it is used for

Uronezyr belongs to a group of medicines called 5α-reductase inhibitors.
These medicines reduce the size of the prostate gland in men.
Uronezyr is used in the treatment and management of benign (i.e. non-cancerous) enlargement of the prostate gland (known as Benign Prostatic Hyperplasia, BPH). It reduces the risk of sudden inability to pass urine (known as acute urinary retention) and the need for surgical treatment.
Uronezyr should be given to patients with an enlarged prostate gland (prostate volume above approximately 40 cm³).
BPH is a benign enlargement of the prostate gland, commonly occurring in men over 50 years of age. The prostate is located at the neck of the bladder and surrounds the urethra. Enlargement therefore leads to disturbances in urination. In benign prostate enlargement (BPH), the following symptoms may occur:

• frequent urination, especially at night,
• sudden urge to urinate,
• difficulty starting urination,
• interrupted, weak urine stream,
• feeling of incomplete bladder emptying or residual urine.

In some men, BPH may 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 using Uronezyr

When not to use Uronezyr

• if the patient is 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 breastfeeding"),
• in children.

Warnings and precautions
Before starting Uronezyr, discuss this with your doctor, pharmacist, or nurse.

• Treatment with Uronezyr should begin after consultation with a urologist.
• Before starting therapy, obstruction of the urinary tract caused by a certain type (trilobed) of prostate enlargement must be ruled out.
• To detect prostate cancer early, a check-up examination should be performed before starting treatment and regularly during treatment with Uronezyr.
• If the patient has or has had a large amount of residual urine in the bladder after urination and/or significantly reduced urine flow, close monitoring for urinary tract obstruction is required.
• If the patient has or has had impaired liver function, blood concentrations of finasteride may be increased.
• If the patient's sexual partner is pregnant or may be pregnant, the patient should avoid exposing the partner to contact with his semen, which may contain small amounts of the medicine.
• If the patient has had or currently undergoes PSA testing (a test used to detect prostate cancer), the doctor should be informed about finasteride use. Finasteride may affect blood levels of the substance measured in the PSA test.
• Any changes in breast gland tissue, such as lumps, pain, breast enlargement, or nipple discharge, should be reported to the doctor immediately, as these may be symptoms of a serious condition, such as breast cancer.

Mood changes and depression
Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients taking finasteride at a dose of 5 mg. If any of these symptoms occur, treatment with Uronezyr should be discontinued immediately and medical advice should be sought without delay.

Children
Uronezyr must not be used in children. There is lack of data on the efficacy or safety of finasteride in children.

Uronezyr and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding

Uronezyr is intended for use in men only.

Pregnancy
Women who are pregnant or planning to become pregnant, or who are breastfeeding, must not handle the tablets, especially if they are broken or crushed. Finasteride inhibits the conversion of the male sex hormone testosterone to dihydrotestosterone – the active hormone produced in the prostate. If finasteride is absorbed through the skin or taken orally by a woman expecting a male child, the baby may be born with malformations of the genital organs.

Crushed or broken coated tablets of Uronezyr must not be handled by women, particularly medical assistants who are at risk if they are pregnant or may be pregnant, because dermal absorption (skin absorption) of finasteride cannot be ruled out, and thus there is a potential risk to a male fetus.

Uronezyr tablets are coated, which prevents contact with the active ingredient during normal handling, provided the tablets are not broken or crushed.

If the patient's sexual partner is pregnant or may be pregnant, the patient should either avoid exposing the partner to contact with his semen (e.g. by using a condom) or discontinue treatment with finasteride. If a pregnant partner comes into contact with Uronezyr, medical advice should be sought.

Breastfeeding
It is unknown whether finasteride passes into human breast milk.

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

Uronezyr contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Uronezyr contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Uronezyr

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Unless otherwise instructed by the physician, the usual dose is 1 coated tablet of Uronezyr (5 mg
finasteride) once daily.
Doses higher than recommended have not demonstrated further efficacy and have not been studied.
Therefore, the recommended dose is also the maximum dose.

Combination therapy with a medicine containing doxazosin as the active substance
The treating physician will determine the dosing regimen for doxazosin (an α-receptor antagonist).
The recommended dosing regimen is as follows:

• 1 coated tablet of Uronezyr (5 mg finasteride) once daily.

Doxazosin:

• Week 1: 1 mg doxazosin once daily.
• Week 2: 2 mg doxazosin once daily.
• Week 3: 4 mg doxazosin once daily.
  From week 4 onwards: 4 mg or 8 mg doxazosin once daily.

Dose escalation to at least 4 mg of doxazosin is necessary to reduce the risk of clinical progression of benign prostatic hyperplasia (BPH).

Patients with hepatic impairment
There is no data available on the use of finasteride in patients with hepatic impairment (see also "Warnings and precautions").

Patients with renal impairment
Appropriate studies have shown that dose adjustment is not necessary when creatinine clearance is above 9 ml/min/1.73 m². The use of Uronezyr has not been studied in patients undergoing hemodialysis.

Elderly patients
The elimination rate of finasteride is slightly reduced in patients over 70 years of age. Dose adjustment is not necessary.

How and when to take the coated tablets
Take one coated tablet once daily, swallowed whole.

Taking the coated tablets with food and drink
Uronezyr may be taken on an empty stomach or with food, accompanied by an adequate amount of fluid.

Overdose of Uronezyr
There is no specific antidote or recommended treatment for finasteride overdose. Never take more coated tablets than prescribed by your doctor. If an overdose has occurred, consult your doctor immediately.

Missed dose of Uronezyr
Do not take a double dose if you have forgotten to take the previous dose. Continue treatment with one tablet of Uronezyr per day.

Stopping Uronezyr
Benign prostatic hyperplasia is a chronic progressive condition. In some patients, symptom relief occurs shortly after starting therapy. However, treatment for at least 6 months may be necessary to achieve significant improvement. Regardless of symptom improvement, continued use of Uronezyr may reduce the risk of acute urinary retention and the need for surgical intervention. To monitor treatment progress, the patient should remain under continuous medical supervision.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, stop taking Uronezyr
and contact your doctor immediately:
Allergic reactions

• swelling of the face, lips, tongue, or throat (angioedema)
• difficulty swallowing
• urticaria (itchy, oozing skin rash) and breathing difficulties.

The following adverse reactions have been reported with the use of Uronezyr:
Common (may occur in 1 to 10 out of 100 people)

• impotence (inability to achieve erection)
• decreased sexual desire (libido)
• reduced ejaculate volume (semen).

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

• ejaculation disorders (ejaculation problems)
• rash
• breast tenderness
• breast enlargement
• isolated cases of nipple discharge and breast nodules have been reported as part of gynecomastia, which required surgical removal in individual patients.

Frequency unknown (frequency cannot be estimated from available data)

• depression
• anxiety
• palpitations
• itching (urticaria)
• increased liver enzyme activity
• testicular pain
• blood in semen
• sexual disorders (erectile dysfunction and ejaculation disorders) that do not resolve after discontinuation of treatment
• decreased sexual desire (libido) that persisted after stopping treatment
• infertility and/or poor semen quality
• suicidal thoughts.

Normalization or improvement in semen quality has been observed after discontinuation of finasteride treatment.
Additionally, in clinical trials and post-marketing surveillance, cases of male breast cancer have been reported (see section 2. Warnings and precautions).
Laboratory tests
When measuring prostate-specific antigen (PSA) levels, it should be taken into account that finasteride reduces PSA values by approximately 50%.
Combination treatment with doxazosin
The following adverse reactions were observed more frequently when finasteride was used concomitantly with doxazosin, an α-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 of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Uronezyr

Keep this medicine out of sight and reach of children.
There are no special requirements for storage conditions.
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 stated month.
Medicines must 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 Uronezyr contains
The active substance is finasteride. One coated tablet contains 5 mg of finasteride.
The other ingredients are: monohydrate lactose (200 M), microcrystalline cellulose (PH 102),
pregelatinized corn starch (1500), sodium carboxymethyl starch (type A), sodium lauryl sulfate, magnesium stearate.
Coating:
Opadry Blue 03A80928:
HPMC 2910/Hypromellose 6 cP, titanium dioxide (E 171), talc, indigo carmine (E 132), aluminium lake, yellow iron oxide (E 172).

What Uronezyr looks like and contents of the pack
Coated tablet.
Blue, round coated tablets, embossed with "H" on one side and "37" on the other.
Uronezyr is available in blister packs containing: 28, 30, 90 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
ul. 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 Nuremberg
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Finasterid Heumann 5 mg Filmtabletten
Poland Uronezyr