Oxybutynin medice

Package leaflet: Information for the patient

Oxybutynin Medice, 1 mg/ml, solution for bladder instillation
Oxybutynine hydrochloride
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Oxybutynin Medice is and what it is used for

What Oxybutynin Medice contains
Oxybutynin Medice is a solution containing a drug called oxybutynine hydrochloride. It works by reducing the tone of the bladder muscles and stopping sudden muscle contractions. This helps control urination.
Oxybutynin Medice solution is intended for direct instillation into the bladder (administration into the urinary bladder) via a tube called a catheter.

What Oxybutynin Medice is used for

• Oxybutynin Medice is used in children aged 6 years and above and in adults for the treatment of neurogenic detrusor overactivity associated with neurological disease, such as:

  • spinal cord injury
  • congenital spinal cord defect (spina bifida)

• Oxybutynin Medice is used only when symptoms of detrusor overactivity are not adequately controlled by oral administration of this type of medicine, and when the patient empties the bladder using a catheter.

Treatment with Oxybutynin Medice must be initiated and supervised by a physician specializing in the management of neurogenic detrusor overactivity.

2. Important information before using Oxybutynin Medice

This section contains information that should be read before starting
treatment with this medicine.
When not to use Oxybutynin Medice:

• if the patient is allergic to oxybutynin hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If the patient has a rare autoimmune disease called myasthenia gravis, which causes muscles to become weak and fatigued easily.
• If the patient has severe stomach or intestinal disease, e.g. severe ulcerative colitis or toxic megacolon (acute dilation of the large intestine).
• If the patient has glaucoma (increased pressure in the eyeballs, sometimes sudden and painful, with blurred vision or loss of vision). If glaucoma has occurred in the patient's family, the patient should inform their doctor.
• If the patient is receiving oxygen therapy.

Warnings and precautions
Before starting treatment with Oxybutynin Medice, consult a doctor if:

• the patient has a urinary tract infection. The patient may need to be prescribed antibiotics.
• the patient is over 65 years old, as they may be more sensitive to Oxybutynin Medice.
• the patient is taking sublingual nitrates (medicines placed under the tongue used to treat chest pain).
• the patient has gastrointestinal obstruction, as Oxybutynin Medice may slow down gastric and intestinal motility.
• the patient has a hiatus hernia or heartburn (gastroesophageal reflux).
• the patient has a neurological disorder called autonomic neuropathy, which affects involuntary body functions, including heart rate, blood pressure, sweating, and digestion.
• the patient has problems with memory, speech, or thinking abilities.
• the patient has hyperthyroidism, which may cause increased appetite, weight loss, or sweating.
• the patient has narrowing of blood vessels supplying blood and oxygen to the heart.
• the patient has heart problems that may cause shortness of breath or ankle swelling.
• the patient has irregular and/or rapid heartbeat.
• the patient has high blood pressure.
• the patient has an enlarged prostate gland.

Oxybutynin Medice may reduce saliva production, leading to tooth decay,
gum disease, or fungal infection of the mouth (oral candidiasis).
Caution should be exercised when using Oxybutynin Medice during hot weather or if the
patient has a fever. The patient should stay in the shade and avoid physical activity
during the hottest part of the day. This is because Oxybutynin Medice reduces sweating,
which may lead to heat exhaustion or heat stroke.
Oxybutynin Medice and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take.
Using Oxybutynin Medice at the same time as other medicines with similar
side effects, such as dry mouth, constipation, and drowsiness, may
increase the frequency and severity of these side effects.
The active substance in Oxybutynin Medice is oxybutynin hydrochloride, which may slow
gastrointestinal motility and thereby affect the absorption of other oral medicines.
Taking this medicine together with other medicines may enhance the effects of oxybutynin hydrochloride.
In particular, inform the doctor if the patient is taking any of the following
medicines:

• bisphosphonates (used to treat osteoporosis) and other medicines that may cause or worsen oesophageal inflammation.
• ketoconazole, itraconazole, or fluconazole (used to treat fungal infections).
• erythromycin, a macrolide antibiotic (used to treat bacterial infections).
• biperiden, levodopa, or amantadine (used to treat Parkinson's disease).
• antihistamines (used to treat allergies such as hay fever).
• phenothiazines, butyrophenones, or clozapine (used to treat psychiatric disorders).
• tricyclic antidepressants (used to treat depression).
• dipyridamole (used to treat blood clotting disorders).
• quinidine (used to treat heart rhythm disorders).
• atropine and other anticholinergic medicines (used to treat gastrointestinal disorders such as irritable bowel syndrome).

Oxybutynin Medice and alcohol
Oxybutynin Medice may cause drowsiness or blurred vision. Drinking alcohol
may worsen drowsiness.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult her doctor before using this medicine.
Pregnancy
Oxybutynin Medice should not be used during pregnancy unless advised by a doctor.
Breastfeeding
Oxybutynin Medice is not recommended during breastfeeding.
Driving and operating machinery
Oxybutynin Medice may cause drowsiness or blurred vision. Extreme caution should be exercised
when driving or operating machinery.

3. How to use Oxybutynin Medice

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor.
Dosage
Your doctor will determine the correct dose of Oxybutynin Medice required to treat overactive bladder in the patient. Do not change the dose of this medicine on your own.
At the beginning of treatment, your doctor will regularly monitor the patient's bladder function and adjust the dose if necessary.
Adolescents (aged 12 years and older), adults, and elderly patients (aged 65 years and older)
The usual recommended starting dose is 10 ml of Oxybutynin Medice per day.
Children (6–12 years of age)
The usual recommended starting dose is 2 ml of Oxybutynin Medice per day.
If the patient has liver or kidney disease
Inform the doctor if the patient has any kidney or liver problems.
Method of administration
Your doctor will prescribe Oxybutynin Medice only if the patient or a family member (caregiver) has been trained in a procedure called "clean intermittent catheterisation" (CIC). This procedure is performed at least six times a day to help empty the bladder using a catheter.
The acronym CIC stands for "Clean Intermittent Catheterisation":

• Clean: as free from germs as possible
• Intermittent: performed regularly several times a day
• Catheterisation: using a catheter (a type of thin tube) to remove urine from the bladder

Your doctor will train the patient and/or a family member (caregiver) in performing the CIC procedure and administering Oxybutynin Medice.
The procedure is carried out as follows:

1. Prepare a clean, germ-free area for the procedure.
2. Insert a single-use sterile catheter into the bladder according to your doctor's instructions.
3. Completely empty the bladder using the catheter.
4. Remove the syringe from the blister pack.
5. Remove the cap from the syringe.
6. Screw a graduated reducing connector with luer-lock onto the tip of the syringe.
7. Connect the catheter to the syringe using the graduated reducing luer-lock connector.
8. Continuously pressing the syringe plunger, inject the required amount of solution into the bladder.
9. If the patient's dose is less than the content of one syringe (10 ml), any unused solution remaining in the syringe should be returned to the pharmacy for proper disposal.
10. Remove the catheter.

The injected solution remains in the bladder until the next catheterisation.
Each syringe is for single use only. The urinary catheter, graduated reducing luer-lock connector, and any unused medicine must be discarded after use.
Use of a higher than recommended dose of Oxybutynin Medice
If a dose higher than prescribed by the doctor is accidentally administered, empty the bladder immediately using a catheter.
Overdose may cause symptoms such as restlessness, dizziness, speech and vision disturbances, muscle weakness, or rapid heartbeat.
If any of these symptoms occur, contact your doctor or the nearest hospital immediately.
Missed dose of Oxybutynin Medice
If the patient forgets to administer the dose at the usual time, administer the normal dose at the next scheduled catheterisation. However, if it is almost time for the next dose, skip the missed dose.
Do not administer a double dose to make up for a missed dose.
If in doubt, always consult your doctor.
Stopping treatment with Oxybutynin Medice
If the patient stops taking Oxybutynin Medice, symptoms of overactive bladder may return or worsen. If the patient is considering stopping treatment, they should always consult their doctor first.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most commonly occurring adverse reactions are typical for this type of medicine and include dry mouth, drowsiness and constipation.
The following adverse reactions have been reported with the use of oxybutynin chloride, although not all have been reported in connection with intravesical administration. The frequency of these adverse reactions is unknown (cannot be estimated from available data):
Discontinue use of Oxybutynin Medice and (or) contact your doctor immediately if:

• the patient experiences (severe) allergic reaction causing swelling of the face or throat (angioedema)*
• the patient has reduced sweating leading to overheating in hot conditions (heat stroke)*
• the patient experiences sudden eye pain with blurred vision or loss of vision (acute angle-closure glaucoma)*

Inform your doctor or pharmacist if any of the following adverse reactions worsen or persist for more than a few days:
Kidneys

• urinary tract infection
• presence of bacteria in urine without causing symptoms
• urgency (sudden need to urinate)
• presence of protein in urine
• presence of blood in urine
• pain during instillation of solution into the bladder
• disturbances in urination or difficulty initiating urination

Psychiatric disorders

• seeing or hearing non-existent stimuli (hallucinations)
• cognitive impairment
• excessive anxiety and restlessness (hyperactivity)
• agitation*
• loss of consciousness or confusion
• sleep disturbances
• agoraphobia (e.g. fear of leaving home, entering shops, being in crowds or public places)
• inability to concentrate
• anxiety*
• nightmares*
• excessive suspicion and distrust of others (paranoia)*
• symptoms of depression*
• dependence on oxybutynin (in patients with history of drug or psychoactive substance abuse)*

Consciousness

• disorientation
• loss of consciousness
• apathy
• feeling of fatigue
• drowsiness
• feeling of dizziness or vertigo

Eyes

• dry eye syndrome
• abnormal sensation in the eye
• impaired ability of the eye to focus from distant to near objects, which may cause blurred vision, double vision, eye strain
• blurred vision*
• increased intraocular pressure*

Cardiac and vascular disorders

• regular but abnormally rapid heart rate (supraventricular tachycardia)
• irregular heartbeat (arrhythmia)*
• low blood pressure

Skin disorders

• sudden facial flushing
• rash
• reduced sweating
• night sweats
• itchy rash with bumps (urticaria)*
• dry skin*
• increased sensitivity of the skin to sunlight (photosensitivity)*

Gastrointestinal disorders

• constipation
• dry mouth
• abdominal discomfort
• lower abdominal pain or abdominal pain
• nausea
• indigestion
• diarrhoea
• vomiting*
• loss of appetite (anorexia)*
• decreased appetite*
• difficulty swallowing (dysphagia)*
• burning sensation in the oesophagus (heartburn)*
• abnormal distension (swelling) accompanied by pain, nausea or vomiting (pseudobstruction)*
• altered taste sensation
• increased thirst

General disorders

• chest discomfort
• feeling of cold
• headache
• nervous system disorder (anticholinergic syndrome)
• seizures
• elevated blood levels of a hormone called prolactin. In women, this may lead to menstrual cycle disturbances or spontaneous milk discharge from the breasts. In men, disturbances in sexual desire or erectile function and increased breast tissue may occur.

* The above adverse reactions have also been reported with this type of medicine. However, it is not known whether they will occur with the use of the prescribed medicine Oxybutynin Medice.
One patient experienced oxygen deficiency during home oxygen therapy (see section 2 "When not to use Oxybutynin Medice").
Additional adverse reactions in children and adolescents
Children may be more sensitive to the effects of this medicinal product. They may experience adverse reactions, particularly affecting the central nervous system and psychiatric adverse reactions.
Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions 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
PL-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 helps provide more information on the safety of the medicine.

5. How to store Oxybutynin Medice

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
For single use only.
Any unused solution must be discarded immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Oxybutynin Medice contains
The active substance is oxybutynin hydrochloride.
1 ml of solution contains 1 mg of oxybutynin hydrochloride.
One pre-filled syringe with graduations containing 10 ml of sterile solution contains 10 mg of
oxybutynin hydrochloride.
The other ingredients are: hydrochloric acid, sodium chloride, solution (0.9%).

What Oxybutynin Medice looks like and contents of the pack
Oxybutynin Medice is a clear, colourless solution. It is supplied as a ready-to-use solution in a 10 ml
pre-filled syringe made of cyclic olefin copolymer, equipped with a plunger and a tip cap made of
bromobutyl synthetic rubber.
The pack contains 12, 96, or 96 (hospital pack) syringes and 12 or 96 sterile adapters respectively,
facilitating administration.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany
Tel.: +49 (0) 2371 937-0
Fax: +49 (0) 2371 937-106
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Velariq 1 mg/ml solution for intravesical use
Belgium Velariq 1 mg/ml oplossing voor intravesicaal gebruik / solution
intravésicale / Lösung zur intravesikalen Anwendung
Czech Republic Tarraconiq 1 mg/ml intravesical solution
Germany Velariq 1 mg/ml Lösung zur intravesikalen Anwendung
Luxembourg Velariq 1 mg/ml Lösung zur intravesikalen Anwendung
Netherlands Velariq 1 mg/ml oplossing voor intravesicaal gebruik
Poland Oxybutynin Medice
Portugal Velariq 1 mg/ml solução intravesical
Sweden Velarmediq 1 mg/ml intravesikal lösning
Slovakia Velariq 1 mg/ml intravezikálny roztok