Package leaflet: Information for the user

Uprox
0,4 mg, modified-release capsules, hard
Tamsulosin hydrochloride
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Uprox is and what it is used for
What you need to know before taking Uprox
How to take Uprox
Possible side effects
How to store Uprox
Contents of the pack and other information

1. What Uprox is and what it is used for

The active substance in Uprox is tamsulosin. Tamsulosin is a selective alpha-adrenergic receptor antagonist. Tamsulosin reduces the tone of smooth muscles in the prostate gland and urethra, facilitating urine flow through the urethra and urination. In addition, tamsulosin reduces the sensation of urgency to urinate.
Uprox is used in the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), dribbling when urinating, urgency to urinate, and increased frequency of urination both during the 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 hepatic impairment,
if the patient experiences dizziness or fainting upon rapid sitting or standing.

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

Periodic medical examinations are necessary to monitor the progression of the disease being treated.
Rarely, as with other drugs in the same class, fainting may occur. If symptoms such as dizziness or feeling of weakness appear, the patient should sit or lie down until symptoms subside.
If the patient has been diagnosed with severe kidney disease, inform the doctor.
If the patient is scheduled for a surgical procedure due to cataract or increased intraocular pressure (glaucoma), inform the ophthalmologist that Uprox has been used in the past, is currently being used, or is planned for use. The specialist can then take appropriate precautions regarding suitable treatment and surgical techniques. Ask the doctor whether to delay starting Uprox or temporarily discontinue it prior to cataract removal or surgical treatment of increased intraocular pressure (glaucoma).

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

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

Uprox with food and drink
Uprox should be taken after breakfast or after the first meal of the day.

Pregnancy, breastfeeding and fertility
Uprox is not indicated for use in women.

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

3. How to take Uprox

This medicine should always be taken as directed by the physician. If in doubt, consult a
doctor or pharmacist.
The recommended dose is 1 capsule once daily. Uprox should be taken after breakfast or after the first
meal of the day.
The capsule should be swallowed whole and must not be chewed or crushed.
Uprox is usually prescribed for long-term use. Its effect on the bladder and urination persists during prolonged treatment with Uprox.
Taking more Uprox than recommended
Taking too many Uprox capsules may lead to undesirable lowering of blood pressure and increased heart rate with a feeling of weakness. If too many Uprox capsules have been taken, contact a doctor immediately.
Missing a dose of Uprox
If a dose of Uprox is missed, the capsule may be taken later on the same day. If the patient did not take the Uprox capsule on a given day, treatment should be continued according to the previous dosing schedule.
Do not take a double dose to make up for a missed dose (capsule).
Stopping Uprox treatment
If treatment is stopped prematurely, symptoms of the disease may return. Therefore, Uprox should be taken for as long as the doctor has prescribed, even if symptoms have subsided.
Any decision to discontinue treatment should always be discussed with a doctor.
If there are any further questions regarding the use of this medicine, consult a 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
(they may be symptoms of an allergic reaction):

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

If you experience dizziness or feel faint while taking Uprox, 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 sitting down or standing up,
ejaculation disorders, absence of ejaculation, or retrograde ejaculation (meaning semen does not exit through the urethra but flows backward 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 a faster-than-normal heartbeat),
low blood pressure, for example when changing position from lying down to sitting or standing, sometimes associated with dizziness,
nasal congestion or a stuffy nose,
diarrhoea or constipation,
nausea or vomiting,
allergic reactions (rash, itching, localised 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 localised 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%)):

inflammation and 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 eye surgery due to cataract or increased intraocular pressure (glaucoma), and the patient is currently taking or has previously taken Uprox, 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 flaccid 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Uprox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton after "Expiry date (EXP)" and on the blister after: "EXP". The expiry date refers to the last day of the stated month.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 contents: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc. Capsule shell: gelatin, indigotine (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 an orange-olive modified-release hard capsule. The capsules contain white or almost white pellets.
The capsules are packed in PVC/PE/PVDC/Aluminium blisters in a cardboard box. Each pack contains 30, 60 or 90 modified-release capsules.

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