Oxibutinin Medice

Leaflet accompanying the packaging: patient information

Oxybutynin Medice, 1 mg/ml, solution for bladder instillation

Oxybutynin hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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 packaging and other information

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

What Oxybutynin Medice contains

Oxybutynin Medice is a solution containing the active substance oxybutynin hydrochloride. It works by reducing bladder muscle tension and preventing sudden muscle contractions. This helps control urination.

What Oxybutynin Medice is used for

• Oxybutynin Medice is used in children from 6 years of age and in adults to treat overactive bladder associated with a neurological condition, such as:
• spinal cord injury
• congenital spinal cord condition (spina bifida)
• Oxybutynin Medice is used only when the symptoms of overactive bladder are not well controlled with oral medication and the patient empties their bladder using a catheter.

Therapy with Oxybutynin Medice must be started and supervised by a doctor specializing in the treatment of overactive bladder caused by neurological disorders.

2. Important information before using Oxybutynin Medice

In this section, you will find information that you need to know before you start using 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 easy fatigue and muscle weakness.
• if the patient has severe stomach or intestinal disease, such as severe ulcerative colitis or toxic megacolon (acute colonic dilation).
• if the patient has glaucoma (increased pressure in the eyeballs, sometimes sudden and painful, with blurred vision or loss of vision). If there is a history of glaucoma in the patient's family, they should inform their doctor.
• if the patient is receiving oxygen therapy.

Warnings and precautions

Before starting treatment with Oxybutynin Medice, the patient should consult their doctor if:

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

Oxybutynin Medice may reduce the amount of saliva produced, leading to tooth decay, gum disease, or fungal infection of the mouth (oral thrush). The patient should be cautious when using Oxybutynin Medice during hot weather or if they have a fever. They should stay in the shade and avoid strenuous activities during the hottest part of the day. This is because Oxybutynin Medice reduces the amount of sweat produced, which can lead to heat exhaustion or heat stroke.

Oxybutynin Medice and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• bisphosphonates (used to treat osteoporosis) and other medicines that may cause or worsen esophageal inflammation
• ketokonazole, 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)
• phenothiazine, butyrophenones, or clozapine (used to treat mental illnesses)
• 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 stomach disorders, such as irritable bowel syndrome)

Oxybutynin Medice and alcohol

Oxybutynin Medice may cause drowsiness or blurred vision. Consuming alcohol may increase drowsiness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine.

Driving and using machines

Oxybutynin Medice may cause drowsiness or blurred vision. The patient should be cautious when driving or operating machinery.

3. How to use Oxybutynin Medice

This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor.

Dose

The doctor will calculate the correct dose of Oxybutynin Medice needed to treat the patient's overactive bladder. The patient should not change the dose of the medicine themselves.

Administration

The doctor will prescribe Oxybutynin Medice to the patient only if the patient or their family members (caregivers) have been trained in a procedure called "intermittent catheterization" (Clean Intermittent Catheterisation, CIC). This procedure involves emptying the bladder using a catheter at least six times a day.

The procedure is performed as follows:

• 1. Prepare a sterile area for the procedure.
• 2. Insert a single-use sterile catheter into the bladder according to the 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 the graduated, tapered Luer-lock connector onto the end of the syringe.
• 7. Connect the catheter to the syringe using the graduated, tapered Luer-lock connector.
• 8. Without interrupting, press the syringe plunger to inject the required amount of solution into the bladder.
• 9. If the patient's dose is less than the contents of one syringe (10 ml), the unused remainder of the solution in the syringe should be returned to the pharmacy for disposal.
• 10. Remove the catheter.

The injected solution remains in the bladder until the next catheterization. Each syringe is for single use only. The urinary catheter, graduated, tapered Luer-lock connector, and unused medicine should be discarded.

What to do if more Oxybutynin Medice is used than prescribed

If more Oxybutynin Medice is used than prescribed, the bladder should be emptied immediately using a catheter.

What to do if a dose of Oxybutynin Medice is missed

If the patient forgets to use a dose at the usual time, they should use the normal dose during the next catheterization cycle. However, if it is almost time for the next dose, the missed dose should be skipped.

What to do if treatment with Oxybutynin Medice is stopped

If the patient stops using Oxybutynin Medice, their overactive bladder symptoms may return or worsen. If the patient is considering stopping treatment, they should always consult their doctor.

4. Possible side effects

Like all medicines, Oxybutynin Medice can cause side effects, although not everybody gets them. The most common side effects are typical for this type of medicine and include dry mouth, drowsiness, and constipation.

If the patient experiences any of the following, they should stop using Oxybutynin Medice and/or consult their doctor immediately:

• severe allergic reaction causing swelling of the face or throat (angioedema)
• reduced sweating leading to overheating when it is hot (heat stroke)
• sudden eye pain with blurred vision or loss of vision (glaucoma)

The patient should tell their doctor or pharmacist if any of the following side effects get worse or last more than a few days:

Kidneys and urinary tract

• urinary tract infection
• bacteria in the urine without symptoms
• urinary urgency (sudden need to urinate)
• protein in the urine
• blood in the urine
• pain during injection of the solution into the bladder
• urination disorders or difficulty starting urination

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine.

Psychiatric disorders

• seeing or hearing things that are not there (hallucinations)
• cognitive disorders
• excessive restlessness and agitation (hyperactivity)
• agitation
• confusion or altered state of consciousness
• sleep disorders
• agoraphobia (e.g., fear of leaving home, entering shops, being in crowds, and public places)
• inability to concentrate
• anxiety
• nightmares
• excessive suspicion and mistrust of others (paranoia)
• symptoms of depression
• oxybutynin dependence (in patients with a history of drug or substance abuse)

Nervous system

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

Eyes

• dry eye syndrome
• abnormal sensation in the eye
• inability of the eye to focus on objects at different distances, which can cause blurred vision, double vision, eye strain
• blurred vision
• increased eye pressure

Heart and blood vessels

• rapid but not abnormal heart rate (supraventricular tachycardia)
• irregular heart rate (arrhythmia)
• low blood pressure

Skin and subcutaneous tissue

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

Gastrointestinal tract

• constipation
• dry mouth
• abdominal discomfort
• lower abdominal pain or stomach pain
• nausea
• indigestion
• diarrhea
• vomiting
• loss of appetite (anorexia)
• decreased appetite
• difficulty swallowing (dysphagia)
• heartburn (esophagitis)
• abnormal bloating (obstruction) with accompanying pain and nausea or vomiting (pseudobstruction)
• change in taste
• increased thirst

General disorders

• chest discomfort
• feeling of cold
• headache
• anticholinergic syndrome (a condition caused by blocked transmission of nerve impulses)
• seizures
• increased levels of a hormone called prolactin in the blood. In women, this can disrupt the normal menstrual cycle or cause spontaneous milk production. In men, it can cause decreased libido, impotence, or gynecomastia (enlargement of breast tissue).

* The above side effects have also been reported for this type of medicine. However, it is not known whether they will occur with the prescribed Oxybutynin Medice.

Additional side effects in children and adolescents

Children may be more sensitive to the effects of this medicine. They may experience side effects, particularly in the central nervous system and psychiatric disorders.

Reporting side effects

If the patient experiences any side effects, including any 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, 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. Side effects can also be reported to the marketing authorization holder.

5. How to store Oxybutynin Medice

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month.

There are no special precautions for storing the medicine.

For single use only.

Unused solution should be discarded immediately.

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

6. Contents of the packaging 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 a graduated scale contains 10 ml of sterile solution, which contains 10 mg of oxybutynin hydrochloride.

The other ingredients are hydrochloric acid, sodium chloride, and a 0.9% solution.

What Oxybutynin Medice looks like and contents of the pack

Oxybutynin Medice is a clear, colorless solution.

It is supplied in a 10 ml pre-filled syringe made of cycloolefin copolymer, with a plunger and a tip cap made of synthetic bromobutyl rubber.

The packaging includes a tray containing 12, 96, or 96 (hospital packaging) syringes and corresponding 12 or 96 sterile adapters to facilitate administration.

Not all pack sizes may be marketed.

Marketing authorization 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, Email: info@medice.de

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Velariq 1 mg/ml Lösung zur intravesikalen Anwendung

Belgium: Velariq 1 mg/ml oplossing voor intravesicaal gebruik / solution intravésicale / Lösung zur intravesikalen Anwendung

Czech Republic: Tarraconiq 1 mg/ml intravezikální roztok

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

Date of last revision of the leaflet:12/2021