Uralex

Package Leaflet: Information for the Patient

Uralex, 5 mg, Tablets

Oxybutynin Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, 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, pharmacist, or nurse.
• 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 not mentioned in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Uralex and what is it 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 is Uralex and what is it used for

Uralex tablets contain the active substance oxybutynin hydrochloride. It belongs to two groups of medicines called anticholinergic and antispasmodic medicines. It causes relaxation of the bladder muscle and prevents sudden contractions of the bladder muscle, which helps control urination. Uralex can be used to treat:

Adults:

Frequent urgent urination or loss of control over urination (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 urination of large amounts),
• Nocturnal enuresis, when other treatment methods have not helped.

2. Important information before taking Uralex

When not to take Uralex

• -if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you have a disease called myasthenia gravis, which causes muscle weakness and rapid fatigue,
• if you have increased eye pressure (glaucoma),
• if you have a gastrointestinal obstruction (stomach or intestine), intestinal perforation, or the intestines do not work properly,
• if you have severe ulcerative colitis (inflammatory bowel disease) or toxic megacolon (enlarged colon),
• if you have a blockage that makes it difficult to urinate (e.g., an enlarged prostate),
• if you frequently urinate at night due to heart or kidney disease.

If you think any of the above applies to you, do not take the medicine. Before taking the medicine, consult your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Uralex, consult your doctor or pharmacist if you have any of the following conditions:

• You have kidney or liver problems,
• You are 65 years of age or older,
• The person taking the medicine is a child,
• You have a disease called autonomic neuropathy, such as Parkinson's disease,
• You have hyperthyroidism (an overactive thyroid gland),
• You have heart disease or high blood pressure,
• You have irregular heartbeat and (or) increased or rapid heartbeat,
• You have an enlarged prostate,
• You have gastrointestinal disorders,
• You have indigestion or heartburn caused by a hiatus hernia (a part of the stomach is displaced through the esophageal hiatus of the diaphragm) and (or) are taking medicines such as bisphosphonates, as anticholinergic medicines may cause or worsen esophagitis.

Oxybutynin must be used with caution in elderly patients due to the risk of side effects that affect cognitive function, thinking ability, and memory. Since oxybutynin may cause angle-closure glaucoma (increased eye pressure), patients should be informed of the need for immediate medical attention in case of vision loss or eye pain. Oxybutynin may reduce saliva production, which can lead to tooth decay or fungal infections of the mouth. Therefore, it is essential to maintain good oral hygiene while taking this medicine. Regular dental check-ups are recommended during long-term treatment. If you are taking medicines for angina (nitrates) that need to be dissolved under the tongue, it is essential to wet your mouth with your tongue or a small amount of water before taking such a tablet. If oxybutynin is used in a hot climate, there is a risk of heat stroke due to reduced sweating. If you experience symptoms such as hallucinations, agitation, disorientation, and sleep disturbances, consult your doctor.

Children

Under 5 years

Uralex is not recommended for children under 5 years of age. If you have any doubts or think any of the above applies to you, do not take the medicine. Before taking the medicine, consult your doctor or pharmacist.

Uralex and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription and herbal medicines. Uralex may affect the action of other medicines, and other medicines may affect the action of Uralex. In particular, inform your doctor about taking:

• atropine, atropine-like compounds (used to treat spasms), and other anticholinergic medicines (used to treat stomach disorders such as irritable bowel syndrome)
• prochlorperazine, chlorpromazine, or other phenothiazine derivatives, clozapine, or other antipsychotic medicines (used to treat psychosis)
• haloperidol, benperidol, or other butyrophenone derivatives (used to treat certain mental illnesses)
• amitriptyline, imipramine, dosulepin, or other tricyclic antidepressant medicines (used to treat depression)
• amantadine (used to treat Parkinson's disease or to treat and prevent 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)
• antihistamine medicines (used to treat allergic reactions)
• metoclopramide or domperidone (medicines that affect gut motility, used to treat nausea)
• cholinesterase inhibitors (used to treat Alzheimer's disease)

Uralex with food, drink, and alcohol

Oxybutynin may cause drowsiness and blurred vision. Drowsiness may be increased when consuming alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine should not be used during pregnancy unless absolutely necessary. Small amounts of oxybutynin pass into breast milk. For this reason, it is not recommended to take the medicine during breastfeeding.

Driving and using machines

The medicine may cause blurred vision or drowsiness. This should be taken into account if you need to maintain concentration, e.g., when driving or operating machinery.

Uralex contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Uralex

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Swallow the tablets with a glass of water. Do not take the decision to change the dose yourself. If you feel that the action of the medicine is too strong or too weak, consult your doctor.

Adults

The recommended initial dose is 2.5 mg three times a day. Your doctor may decide to increase the dose to a maximum of 5 mg four times a day.

Elderly patients

The recommended initial dose is 2.5 mg twice a day. Your doctor may decide to increase the dose to 5 mg twice a day.

Children (5 years and older)

The recommended initial dose is 2.5 mg twice a day. Your doctor may decide to increase the dose depending on body weight (0.3 or 0.4 mg/kg body weight per day) up to:

Age: Dose

5-9 years: 2.5 mg three times a day

9-12 years: 5 mg twice a day

Over 12 years: 5 mg three times a day

If the medicine is given to treat nocturnal enuresis, the last dose should be taken before bedtime. Swallow the tablet whole with a glass of water. Do not change the dose yourself; inform your doctor if you think the action of the medicine is too weak or too strong.

Overdose of Uralex

In case of overdose or accidental ingestion by a child, immediately contact your doctor or go to the hospital. Take the empty package or the remaining tablets with you to inform the doctor what medicine has been taken. Taking too many tablets can be very dangerous. Symptoms of overdose include: restlessness, agitation, flushing, mild pain, and dizziness. The heartbeat may become very fast, irregular, and strong. There may be breathing problems, numbness, and coma.

Missed dose of Uralex

If you miss a dose, take it 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 treatment with Uralex

Continue taking the medicine for as long as your doctor has prescribed. Do not stop taking the medicine even if you feel better. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Uralex can cause side effects, although not everybody gets them. Stop taking the medicine and contact your doctor or go to the hospital immediately if you experience any of the following symptoms:

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

Contact your doctor immediately if:

• you experience blurred vision, loss of vision, or eye pain, as these may be symptoms of glaucoma (increased eye pressure).

Tell your doctor or pharmacist if any of the following side effects get worse or last more than a few days:

Reporting side effects

If you experience any side effects, including those not mentioned in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Uralex

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month. Do not store above 30°C. Store in the original package to protect from moisture. 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 Uralex contains

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

What Uralex looks like and contents of the pack

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

Marketing authorization holder and manufacturer

Marketing authorization 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

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Country: Medicinal product name

France

Ireland

Poland

Sweden

United Kingdom (Northern Ireland)

Oxybutynin hydrochloride Accord 5mg film-coated tablet

Oxybutynin hydrochloride 2.5mg/5mg tablets

Uralex

Oxybutynin Accord

Oxybutynin hydrochloride 2.5mg/5 mg tablets

Date of last revision of the leaflet: July 2023