Uprox Xr

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Uprox XR

0.4 mg, prolonged-release tablets

Tamsulosin hydrochloride

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Uprox XR and what is it used for
• 2. Important information 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 is Uprox XR and what is it used for

The active substance of Uprox XR is tamsulosin. Tamsulosin is a selective alpha-adrenergic receptor antagonist. Tamsulosin reduces the tension of the smooth muscles of the prostate and urethra, facilitating the flow of urine through the urethra and urination. Additionally, tamsulosin reduces the feeling of pressure on the bladder. Uprox XR is used to treat symptoms of lower urinary tract disorders associated with benign prostatic hyperplasia (enlargement of the prostate). These symptoms include difficulty urinating (weak stream), urinating in drops, pressure on the bladder, and increased frequency of urination both at night and during the day.

2. Important information before taking Uprox XR

When not to take Uprox XR:

• if you are 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 breathing, and/or itching and rash (angioedema),
• if you have severe liver impairment,
• if you experience dizziness or fainting when changing position from lying down to sitting or standing.

Warnings and precautions

Before starting treatment with Uprox XR, discuss it with your doctor.

• Regular medical check-ups are necessary to determine the degree of development of the disease being treated.
• Rarely, as with other medicines in the same group, fainting may occur. If symptoms such as dizziness or weakness occur, sit or lie down until they pass.
• If you have severe kidney disease, inform your doctor.
• If you are scheduled to undergo eye surgery for cataracts or increased eye pressure (glaucoma), inform your ophthalmologist that you have taken, are taking, or plan to take Uprox XR. The specialist will then be able to take appropriate precautions regarding treatment and surgical techniques. Ask your doctor if you should stop taking Uprox XR or temporarily discontinue it in connection with cataract surgery or surgical treatment of increased eye pressure (glaucoma).

Children and adolescents

Uprox XR should 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

Taking Uprox XR with other medicines in the same group (alpha-adrenergic receptor antagonists) may cause unintended lowering of blood pressure. Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. It is especially important to tell your doctor if you are taking medicines that may reduce the excretion of Uprox XR from the body, such as ketoconazole (an antifungal medicine) or erythromycin (an antibiotic).

Uprox XR with food and drink

Uprox XR can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Uprox XR is not indicated for use in women. There have been reports of ejaculation disorders in men. This means that semen does not flow through the urethra but instead flows back into the bladder (retrograde ejaculation) or the volume of ejaculate (semen) is reduced or does not occur. This phenomenon is not a threat.

Driving and using machines

The effect of Uprox XR on the ability to drive and use machines has not been proven. However, you should be aware of the possibility of dizziness - in such cases, do not perform tasks that require attention.

3. How to take Uprox XR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is one tablet once a day. Uprox XR can be taken with or without food, preferably at the same time every day. Swallow the tablet whole, do not chew or crush it. Uprox XR is usually prescribed for long-term use. The effect on the bladder and urination persists during long-term treatment with Uprox XR.

Taking more Uprox XR than prescribed

Taking too many Uprox XR tablets may lead to unintended lowering of blood pressure and increased heart rate with a feeling of weakness. If you have taken too many Uprox XR tablets, contact your doctor immediately.

Missing a dose of Uprox XR

If you miss a dose of Uprox XR, you can take the tablet later that day. If you do not take the 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, the symptoms of the disease may return. Therefore, you should take Uprox XR for as long as your doctor has prescribed, even if the symptoms of the disease have disappeared. Stopping treatment should always be discussed with your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Uprox XR can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience any of the following side effects (may be a sign of an allergic reaction):

• hives (urticaria),
• swelling of hands, feet, mouth, tongue, or throat, and/or difficulty breathing.

If you experience dizziness or weakness while taking Uprox XR, sit or lie down until the symptoms pass.

Frequently (less than 1 in 10, but more than 1 in 100 people (1-10%)):

• dizziness, especially when changing position from lying down to sitting or standing,
• ejaculation disorders, absence of ejaculation, retrograde ejaculation (meaning that semen does not flow through the urethra but instead flows back into the bladder. This phenomenon is not a threat).

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

• headache,
• palpitations (heart beating faster than usual),
• low blood pressure, felt when changing position from lying down to sitting or standing, and sometimes associated with dizziness,
• runny nose or stuffy nose,
• diarrhea or constipation,
• nausea or vomiting,
• allergic reactions (rash, itching, localized skin inflammation),
• feeling weak (asthenia).

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

• fainting,
• feeling weak, sudden swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and rash, often as a result of an allergic reaction (angioedema).

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

• inflammatory condition with blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (Stevens-Johnson syndrome),
• undesirable, painful, and prolonged erection, in which case immediate treatment should be sought (priapism).

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

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

If you are scheduled to undergo eye surgery for cataracts or increased eye pressure (glaucoma) and have taken or are taking Uprox XR, consider that the pupil may not dilate properly and the iris (colored, round part of the eye) may become flaccid during the procedure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Uprox XR

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of that month. Store in the original package to protect from light. 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 Uprox XR contains

• The active substance is tamsulosin in the form of tamsulosin hydrochloride.
• The other ingredients are:

Core of the tablet:

Hypromellose, microcrystalline cellulose, carbomer, colloidal anhydrous silica, iron oxide red (E 172), magnesium stearate.

Coating of the tablet:

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 dividing line, 9 mm in diameter, with "T9SL" on one side and "0,4" on the other. Blister packs in a carton. One pack contains 30, 60, or 90 prolonged-release tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Recordati Polska sp. z o.o. Al. Armii Ludowej 26 00-609 Warsaw

Manufacturer:

Synthon BV Microweg 22 6545 CM Nijmegen Netherlands Synthon Hispania S.L. Castelló, 1 Sant Boi de Llobregat 08830 Barcelona Spain

Date of last revision of the leaflet: 07/2023