Uprox xr

Package leaflet: Information for the user

Uprox XR
0.4 mg, prolonged-release tablets
Tamsulosin hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 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 or pharmacist. See section 4.

Table of contents

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

1. What Uprox XR is and what it is used for

The active substance in Uprox XR is tamsulosin. Tamsulosin is a selective alpha-1 adrenergic receptor antagonist. Tamsulosin reduces the tone of smooth muscles in the prostate gland and urethra, facilitating urine flow through the urethra and urination. Additionally, tamsulosin reduces the sensation of urinary urgency.
Uprox XR is used in the treatment of symptoms of lower urinary tract related to benign prostatic hyperplasia (benign enlargement of the prostate gland). These symptoms include difficulty in urination (weak stream), dribbling after urination, urinary urgency, and increased frequency of urination both during the day and at night.

2. Important information before taking Uprox XR

When not to take Uprox XR:

• if the patient is allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest as sudden swelling of soft tissues (e.g. throat or tongue), difficulty in breathing and/or itching and rash (angioedema),
• if the patient has severe hepatic impairment,
• if the patient experiences dizziness or fainting upon changing position from lying down to sitting or standing.

Warnings and precautions
Before starting treatment with Uprox XR, discuss this with your doctor.

• Periodic medical examinations are necessary to monitor the progression of the disease being treated.
• Rarely, as with other medicines in the same class, fainting may occur. If symptoms such as dizziness or feeling weak occur, the patient should sit or lie down until symptoms subside.
• If the patient has severe kidney disease, this should be reported to the doctor.
• If the patient is scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma), the ophthalmologist must be informed that the patient has previously taken, currently takes, or plans to take Uprox XR. The specialist can then take appropriate precautions regarding suitable treatment and surgical techniques. Please consult your doctor whether you should refrain from starting Uprox XR or temporarily discontinue its use prior to cataract removal or surgical treatment of increased intraocular pressure (glaucoma).

Children and adolescents
Uprox XR must not be used in children and adolescents under 18 years of age, as it is not effective in this population.

Uprox XR and other medicines
Concomitant use of Uprox XR with other medicines from the same class (alpha-adrenergic receptor antagonists) may lead to unintended lowering of blood pressure.
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
It is especially important to inform the doctor about concomitant use of medicines that may reduce the elimination of Uprox XR from the body, e.g. ketoconazole (a medicine used to treat fungal infections), erythromycin (an antibiotic).

Uprox XR with food and drink
Uprox XR can be taken regardless of meals.

Pregnancy, breastfeeding and fertility
Uprox XR is not indicated for use in women.
Cases of ejaculation disorders in men have been reported. This means that semen does not exit through the urethra but instead flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced or ejaculation does not occur. This phenomenon is not dangerous.

Driving and operating machinery
The effect of Uprox XR on the ability to drive and operate machinery has not been established.
However, one should be aware of the possibility of dizziness occurring; in such a case, activities requiring attention should not be performed.

3. How to take Uprox XR

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The recommended dose is 1 tablet once daily. Uprox XR can be taken regardless of meals,
preferably at the same time each day.
The tablet should be swallowed whole and must not be chewed or crushed.
Uprox XR is usually prescribed for long-term use. The effect on the bladder and urination is maintained during prolonged treatment with Uprox XR.
Taking more Uprox XR than recommended
Taking too many Uprox XR tablets may lead to undesirable lowering of blood pressure and increased heart rate with a feeling of weakness. If too many Uprox XR tablets have been taken, contact your doctor immediately.
Missing a dose of Uprox XR
If a dose of Uprox XR is missed, the tablet may be taken later the same day. If the patient did not take the Uprox XR tablet on a given day, continue treatment according to the previous dosing schedule.
Do not take a double dose to make up for a missed dose (tablet).
Stopping Uprox XR treatment
If treatment is stopped prematurely, symptoms of the disease may return. Therefore, Uprox XR should be taken for as long as your doctor has prescribed, even if symptoms have improved.
Any decision to discontinue treatment should always be discussed with your doctor.
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.
You should contact your doctor immediately or go to hospital if any of the following adverse effects occur
(these may be symptoms of an allergic reaction):

• maculopapular rash (urticaria),
• swelling of the hands, feet, lips, tongue or throat and (or) difficulty breathing.

If you experience dizziness or feeling weak while taking Uprox XR, you should sit or lie down until the symptoms subside.
Common (less than 1 in 10 but more than 1 in 100 people (1-10%)):

• dizziness, particularly when changing position from lying to sitting or standing,
• ejaculation disorders, absence of ejaculation, retrograde ejaculation (meaning semen does not exit through the urethra but flows back into the bladder. This phenomenon is not dangerous).

Uncommon (more than 1 in 1,000 but less than 1 in 100 people (0.1-1%)):

• headache,
• palpitations (awareness of rapid heartbeat),
• low blood pressure, felt for example when changing position from lying to sitting or standing, sometimes associated with dizziness,
• nasal congestion or stuffy nose,
• diarrhoea or constipation,
• nausea or vomiting,
• allergic reactions (rash, itching, local skin inflammation),
• feeling of weakness (asthenia).

Rare (more than 1 in 10,000 but less than 1 in 1,000 people (0.01-0.1%)):

• fainting,
• feeling of weakness, sudden localized swelling of soft tissues (e.g. throat or tongue), difficulty breathing and (or) itching and rash, often due to an allergic reaction (angioedema).

Very rare (less than 1 in 10,000 people (<0.01%)):

• inflammatory condition with blister formation on the skin and (or) mucous membranes of the lips, eyes, mouth, nostrils or genital organs (Stevens-Johnson syndrome),
• unwanted, painful and prolonged erection requiring immediate treatment (priapism).

Not known (frequency cannot be estimated from available data):

• blurred vision,
• visual disturbances,
• nosebleeds,
• itchy, pink-red spots on the limbs (erythema multiforme),
• red, scaly skin (exfoliative dermatitis),
• irregular, abnormal heartbeat (atrial fibrillation, arrhythmia, tachycardia),
• difficulty breathing (dyspnoea),
• dry mouth.

If a patient is scheduled for a surgical procedure due to lens opacity (cataract) or
increased intraocular pressure (glaucoma), and the patient is currently taking or has previously taken Uprox XR,
it should be considered that the patient's pupil may not dilate properly and the iris (the coloured, circular
part of the eye) may become floppy during the procedure.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions, 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, website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Uprox XR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after "EXP" and on the blister after "EXP". The expiry date refers to the last day of the specified month.
Store in the original packaging in order to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Uprox XR contains

• The active substance is tamsulosin in the form of tamsulosin hydrochloride.
• Other components are: Tablet core: Hypromellose, microcrystalline cellulose, carbomer, colloidal anhydrous silica, red iron oxide (E 172), magnesium stearate. Tablet coating: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, magnesium stearate.

What Uprox XR looks like and contents of the pack
Prolonged-release tablet. White, round tablet without a break line, 9 mm in diameter, marked
“T9SL” on one side and “0.4” on the other side.
Blisters in a cardboard box. One pack contains 30, 60 or 90 prolonged-release tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
Poland

Manufacturer:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

Synthon Hispania S.L.
Castelló, 1
Sant Boi de Llobregat
08830 Barcelona
Spain