Uralex

Package leaflet: Information for the patient

Uralex, 5 mg, tablets
Oxybutynini hydrochloridum
Please read the entire leaflet 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 further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Uralex is and what it is used for

Uralex tablets contain the active substance oxybutynini hydrochloridum (oxybutynin hydrochloride).
It belongs to two groups of medicines known as anticholinergics and antispasmodics.
It causes relaxation of the bladder muscles and prevents their sudden contractions, thus helping to control urination.
Uralex may be used in the treatment of:
Adults:
Frequent urgent need to urinate or loss of urinary control (urinary incontinence) caused by nerve damage.
Children aged 5 years and older:

• loss of control over urination,
• increased need to urinate or sudden urge to urinate (frequent passage of large amounts of urine),
• nocturnal enuresis (bedwetting), when other treatment methods have not helped.

2. Important information before using Uralex

When not to use Uralex

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient suffers from a disease called myasthenia gravis, which causes muscles to become weak and tire easily,
• if the patient has increased intraocular pressure (glaucoma),
• if the patient has gastrointestinal obstruction (stomach or intestine), intestinal perforation, or paralytic ileus,
• if the patient has severe ulcerative colitis (inflammatory bowel disease) or toxic megacolon (dilated colon),
• if the patient has an obstruction impairing the ability to pass urine (e.g. enlarged prostate),
• if the patient frequently passes urine at night due to heart or kidney disease.

If the patient believes any of the above situations apply, the medicine should not be taken.
Before using the medicine, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Uralex, consult a doctor or pharmacist.
If the patient has any of the following conditions, medical advice should be sought before starting treatment:

• The patient has kidney or liver problems,
• The patient is aged 65 years or older,
• The person intending to take the medicine is a child,
• The patient suffers from autonomic neuropathy, such as Parkinson's disease,
• The patient has overactive thyroid (hyperthyroidism),
• The patient has heart disease or high blood pressure,
• The patient experiences irregular heartbeat (palpitations) and/or increased or rapid heartbeat,
• The patient has benign prostatic hyperplasia (enlarged prostate),
• The patient has gastrointestinal disorders,
• The patient has indigestion or heartburn due to hiatal hernia (part of the stomach moves through the diaphragmatic opening) and/or is taking medications such as bisphosphonates, because anticholinergic medicines may cause or worsen oesophagitis.

Oxybutynin should be used with caution in elderly patients due to the risk of adverse effects affecting cognitive function, thinking ability, and memory.
Since oxybutynin may cause narrow-angle glaucoma (increased pressure inside the eye), patients should be advised to contact their doctor immediately if they experience loss of vision or eye pain.
Oxybutynin may reduce saliva production, which can lead to dental caries or fungal infections of the mouth. Therefore, it is important to maintain proper oral hygiene during treatment with this medicine. Regular dental check-ups are recommended during long-term treatment.
If the patient is taking medicines for angina pectoris (called nitrates), which should be dissolved under the tongue, it is important to moisten the mouth with the tongue or a small amount of water before taking such a tablet.
If oxybutynin is used in hot climates, there is a risk of heatstroke due to reduced sweating.
If the patient experiences symptoms such as hallucinations, agitation, disorientation, or sleep disturbances, medical advice should be sought.

Children

Under 5 years of age
Uralex is not recommended for use in children under 5 years of age.
If the patient has any doubts or believes any of the above situations apply, the medicine should not be taken. Before using the medicine, consult a doctor or pharmacist.

Uralex 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, including over-the-counter medicines and herbal remedies. Uralex may affect the action of other medicines, and other medicines may affect the action of Uralex.

Inform your doctor especially if taking:

• atropine, atropine-like compounds (used to treat spasms), or other anticholinergic medicines (used to treat gastrointestinal disorders such as irritable bowel syndrome),
• prochlorperazine, chlorpromazine, or other phenothiazine derivatives, clozapine, or other antipsychotics (medicines used to treat psychosis),
• haloperidol, benperidol, or other butyrophenone derivatives (medicines used to treat certain mental illnesses),
• amitriptyline, imipramine, dosulepin, or other tricyclic antidepressants (medicines used to treat depression),
• amantadine (used to treat Parkinson's disease or certain viral infections),
• levodopa, biperiden (used to treat Parkinson's disease),
• digoxin (used to treat heart conditions),
• dipyridamole (used to treat blood clotting problems),
• ketoconazole, itraconazole, or fluconazole (used to treat fungal infections),
• erythromycin or other macrolide antibiotics (used to treat bacterial infections),
• quinidine (used to treat heart conditions),
• antihistamines (used to treat allergic reactions),
• metoclopramide or domperidone (medicines affecting intestinal motility, used to treat nausea),
• cholinesterase inhibitors (used to treat Alzheimer's disease).

Uralex, food, drink, and alcohol

Oxybutynin may cause drowsiness and blurred vision. Drowsiness may be increased if alcohol is consumed at the same time.

Pregnancy, breastfeeding, and fertility

If a woman is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy unless absolutely necessary.
Small amounts of oxybutynin pass into breast milk. Therefore, use of this medicine during breastfeeding is not recommended.

Driving and operating machinery

This medicine may cause blurred vision or drowsiness. This should be taken into account when concentration is required, such as when driving or operating machinery.

Uralex contains lactose

If the patient has been told by a doctor that they have an intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to use Uralex

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The tablets should be swallowed with a glass of water.
Do not make independent decisions about changing the dosage. If you feel the medicine's effect
is too strong or too weak, consult your doctor.
Recommended dose
Adults
The recommended initial dose is 2.5 mg three times daily.
The doctor may decide to increase the dose up to the maximum dose of 5 mg four times daily.
Elderly patients
The recommended initial dose is 2.5 mg twice daily.
The doctor may decide to increase the dose to 5 mg twice daily.
Children (aged 5 years and older)
The recommended initial dose is 2.5 mg twice daily.
The doctor may decide to increase the dose according to body weight (0.3 or 0.4 mg/kg body weight/day),
up to a maximum of:
Age Dose
5–9 years 2.5 mg three times daily
9–12 years 5 mg twice daily
Over 12 years 5 mg three times daily
If the medicine is administered for the treatment of nocturnal enuresis, the last dose should be taken before
bedtime.
The tablet should be swallowed whole with a glass of water.
Do not change the dose independently. Inform your doctor if the patient feels the medicine's effect
is too weak or too strong.
Taking more Uralex than recommended
In case of overdose or accidental ingestion by a child, contact a doctor immediately or go to a hospital.
Bring the empty packaging of the medicine taken to inform the doctor which medicine was ingested.
Taking too many tablets may be very dangerous. Symptoms of overdose include:
anxiety, agitation, flushing, mild pain and dizziness. Heartbeat may become very fast, irregular and strong.
Breathing difficulties, numbness and coma may occur.
Missing a dose of Uralex
If a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose.
Do not take a double dose to make up for a missed dose.
Stopping Uralex treatment
Continue taking the medicine for as long as directed by your doctor. Do not stop taking the medicine,
even if you feel better.
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 everybody gets them.
You should stop taking the medicine and immediately contact a doctor or go to hospital
if the patient experiences any of the following symptoms:

• allergic reaction such as: rash, difficulty swallowing and breathing, swelling of the face, lips, throat or tongue

You should contact a doctor immediately if:

• the patient experiences blurred vision, loss of vision, or eye pain, as these may be symptoms of glaucoma (increased pressure in the eye).

You should tell your doctor or pharmacist if any of the following adverse reactions become severe
or last longer than a few days:

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continuous monitoring of the safety of the medicinal product.

5. How to store Uralex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store in the original packaging
to protect from moisture.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help
protect the environment.

6. Contents of the pack and other information

What Uralex contains
The active substance is oxybutynin hydrochloride. Each tablet contains 5 mg of oxybutynin hydrochloride.
The other ingredients are: microcrystalline cellulose, monohydrate lactose, talc, magnesium stearate.

What Uralex looks like and contents of the pack
White or almost white, odourless, uncoated tablet, convex on both sides, with a diameter of 7.9 mm, marked with "B" and "R" on either side of the break line on one side and smooth on the other.
The tablet can be divided into equal doses.
Uralex is available in blisters packed in cardboard boxes containing 6, 20, 21, 28, 30, 50, 56, 60, 84 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands
Accord Healthcare single member S.A.
64th Km National Road Athens,
Lamia, Schimatari,
32009, Greece

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

| Country | Name of the medicinal product | |---------|-------------------------------| | France | Oxybutynin hydrochloride Accord 5mg film-coated tablet | | Ireland | Oxybutynin hydrochloride 2.5mg/5mg tablets | | Poland | Uralex | | Sweden | Oxybutynin Accord | | United Kingdom (Northern Ireland) | Oxybutynin hydrochloride 2.5mg/5 mg tablets |