Uprox

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Uprox

0.4 mg, prolonged-release hard capsules

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Uprox and what is it used for

The active substance of Uprox is tamsulosin. Tamsulosin is a selective alpha-1 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 is used to treat the 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

When not to take Uprox:

• 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 breathing, and/or itching and rash (angioedema),
• if the patient has severe liver impairment,
• if the patient experiences dizziness or fainting when sitting or standing up quickly.

Warnings and precautions

Before starting to take Uprox, the patient should discuss it with their doctor.

• Regular medical check-ups are necessary to determine the progression 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, the patient should sit or lie down until the symptoms pass.
• If the patient has severe kidney disease, they should inform their doctor.
• If the patient is scheduled to undergo eye surgery for cataracts or increased eye pressure (glaucoma), they should inform their ophthalmologist that they have taken, are taking, or plan to take Uprox. The specialist will then be able to take appropriate precautions regarding treatment and surgical techniques. The patient should ask their doctor if they should stop taking Uprox or temporarily discontinue it in connection with cataract surgery or surgical treatment of increased eye pressure (glaucoma).

Children and adolescents

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

Uprox and other medicines

Taking Uprox with other medicines in the same group (alpha-1 adrenergic receptor antagonists) may cause unintended lowering of blood pressure. The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

It is especially important to inform the doctor if the patient is taking medicines that may reduce the elimination of Uprox from the body, such as ketoconazole (an antifungal medicine) or erythromycin (an antibiotic).

Uprox with food and drink

Uprox should be taken after breakfast or the first meal of the day.

Pregnancy, breastfeeding, and fertility

Uprox is not indicated for use in women.

Driving and using machines

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

3. How to take Uprox

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

The recommended dose is 1 capsule once a day. Uprox should be taken after breakfast or the first meal of the day.

The capsule should be swallowed whole and not chewed or crushed.

Uprox is usually prescribed for long-term use. The effect on the bladder and urination is maintained during long-term use of Uprox.

Taking more Uprox than prescribed

Taking too many Uprox capsules may lead to unintended lowering of blood pressure and increased heart rate with a feeling of weakness. If the patient has taken too many Uprox capsules, they should contact their doctor immediately.

Missing a dose of Uprox

If a dose of Uprox is missed, the patient can take the capsule later that day. If the patient has not taken the Uprox capsule on a given day, they should continue treatment according to the previous dosing schedule.

The patient should not take a double dose to make up for a missed dose (capsule).

Stopping Uprox treatment

If treatment is stopped prematurely, the symptoms of the disease may return. Therefore, Uprox should be taken for as long as prescribed by the doctor, even if the symptoms of the disease have disappeared.

Stopping treatment should always be consulted with the doctor.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should contact their doctor or go to the hospital immediately if they experience any of the following side effects (may be a sign of an allergic reaction):

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

If the patient experiences dizziness or a feeling of weakness while taking Uprox, they should sit or lie down until the symptoms pass. Common (less than 1 in 10, but more than 1 in 100 people (1-10%)):

• dizziness, especially when sitting or standing up,
• ejaculation disorders, absence of ejaculation, retrograde ejaculation (which means that semen does not flow through the urethra but 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, e.g., 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 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 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 and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (Stevens-Johnson syndrome),
• unwanted, painful, and prolonged erection, in which case immediate treatment should be sought (priapism).

Unknown(frequency cannot be estimated from the available data):

• blurred vision,
• vision disorders,
• 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 the patient is scheduled to undergo eye surgery for cataracts or increased eye pressure (glaucoma) and has taken or is taking Uprox, the patient should consider that their pupil may not dilate properly, and the iris (the colored, round part of the eye) may become floppy during the procedure.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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, 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, more information can be collected on the safety of the medicine.

5. How to store Uprox

The medicine should be stored out of 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 the month.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Uprox contains

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

Capsule composition:

microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Capsule shell:

gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Uprox looks like and contents of the pack

Uprox is orange-olive prolonged-release hard capsules. The capsules contain white or almost white pellets.

The capsules are packaged in PVC/PE/PVDC/Aluminum blisters in a cardboard box. One pack contains 30, 60, or 90 prolonged-release capsules.

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