Vesoxx

Leaflet accompanying the packaging: information for the user

Vesoxx

1 mg/ml, solution for bladder instillation

Oxybutynin hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Vesoxx and what is it used for

What Vesoxx contains

Vesoxx is a solution containing the active substance oxybutynin hydrochloride. It works by reducing the tension of the bladder muscle and preventing sudden muscle contractions. This allows for control over urination. The Vesoxx solution is intended for direct injection into the bladder (intravesical administration) through a tube called a catheter.

What Vesoxx is used for

Vesoxx is used in children from 6 years of age and in adults to treat an overactive bladder associated with a neurological disorder (such as spinal cord injury or spina bifida, a congenital spinal cord defect). Vesoxx is used only when the symptoms of an overactive bladder are not well controlled or when there are severe side effects when taking this type of medicine orally, and if the patient empties their bladder using a catheter. Therapy with Vesoxx must be initiated and supervised by a doctor specializing in the treatment of overactive bladder caused by neurological disorders.

2. Important information before using Vesoxx

This section contains information that you should read before starting to use this medicine.

When not to use Vesoxx

• 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 weakness and fatigue of the muscles.
• If the patient has severe stomach or intestinal disease, such as severe ulcerative colitis or toxic megacolon (acute colonic dilatation).
• 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, the doctor should be informed.
• If the patient has difficulty urinating or incomplete emptying of the bladder during urination.
• If the patient frequently urinates at night due to heart or kidney disease.
• If the patient is undergoing oxygen therapy.

Warnings and precautions

Before starting to use Vesoxx, you should 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 Vesoxx
• the patient is taking sublingual nitrates (medicines placed under the tongue used to treat chest pain)
• the patient has gastrointestinal obstruction, as Vesoxx may slow down gastric and intestinal peristalsis
• the patient has a hiatus hernia or heartburn
• the patient has a nervous disorder called autonomic neuropathy, which affects the involuntary functions of the body, including heart rate, blood pressure, sweating, and digestion
• the patient has memory, speech, or thinking problems
• the patient has hyperthyroidism, which can cause increased appetite, weight loss, or sweating
• the patient has narrowing of the blood vessels supplying blood and oxygen to the heart
• the patient has heart rhythm disorders that can cause shortness of breath or swelling of the ankles
• the patient has irregular and/or rapid heartbeat
• the patient has high blood pressure
• the patient has an enlarged prostate gland

Vesoxx may reduce the amount of saliva produced, leading to tooth decay, gum disease, or fungal infection of the mouth (oral thrush). Oxybutynin may cause a type of glaucoma. If blurred vision, loss of vision, or eye pain occurs, you should contact your doctor immediately. During treatment, you should have your vision and intraocular pressure checked from time to time. You should be careful when using Vesoxx during hot weather or if you have a fever. You should stay in the shade and avoid sports activities during the hottest part of the day. This is because Vesoxx reduces the amount of sweat produced, which can lead to heat exhaustion or heat stroke.

Children and adolescents

Vesoxx should not be used in children under 6 years of age.

Vesoxx and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking and any medicines they plan to take. Using Vesoxx at the same time as taking 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 of Vesoxx, oxybutynin hydrochloride, may slow down the peristalsis of the gastrointestinal tract and thus affect the absorption of other oral medicines. Using this medicine with other medicines may enhance the effect of oxybutynin hydrochloride. In particular, the doctor should be informed if the patient is taking any of the following medicines:

• biphosphonates (used to treat osteoporosis) and other medicines that may cause or worsen esophageal 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)
• 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)
• cholinesterase inhibitors (used to treat dementia or certain muscle diseases)

Medicines used to treat angina pectoris (chest pain due to reduced blood flow to the heart), which should dissolve under the tongue, may dissolve less under the tongue due to dry mouth. Therefore, it is recommended to moisten the mouth before taking Vesoxx.

Vesoxx and alcohol

Vesoxx may cause drowsiness or blurred vision. Consuming alcohol may enhance drowsiness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor before using this medicine. Pregnancy If the doctor has not prescribed it, Vesoxx should not be used during pregnancy. Breastfeeding Vesoxx should not be used during breastfeeding.

Driving and using machines

Vesoxx may cause drowsiness or blurred vision. You should be careful when driving or operating machinery.

Vesoxx contains sodium

This medicine contains 3.56 mg of sodium (the main component of table salt/food salt) per milliliter. This corresponds to 0.18% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Vesoxx

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor.

Dose

The doctor will calculate the correct dose of Vesoxx needed to treat the patient's overactive bladder. You should not change the dose of the medicine yourself. At the start of treatment, the doctor will regularly check the patient's bladder function and adjust the dose of the medicine if necessary.

Adolescents (12 years and older), adults, and elderly patients (65 years and older)

The recommended initial dose is usually 10 ml of Vesoxx per day.

Children (6-12 years)

The recommended initial dose of Vesoxx is usually 0.1 mg/kg body weight and is administered in the morning. For example, in children with a body weight of 20 kg, the initial dose is 2 mg (2 ml).

If the patient has liver or kidney disease

The patient should inform their doctor if they have liver or kidney disease.

Method of administration

The doctor will prescribe Vesoxx to the patient only if the patient or their family members (caregiver) have been familiarized with the procedure called "intermittent catheterization" (CIC - Clean Intermittent Catheterization). This procedure is performed at least six times a day to facilitate emptying of the bladder using a catheter. The abbreviation CIC comes from the name "Clean Intermittent Catheterisation":

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

The doctor will train the patient and/or their family member (caregiver) to perform the CIC procedure and administer Vesoxx.

The procedure is performed as follows:

• 1. Disinfect your hands as shown on the packaging of the disinfectant. Open the packaging of the ampoule-syringe at the designated place.
• 2. Remove the ampoule-syringe from the packaging. Remove the cap by gently twisting it.
• 3. TIP: If a smaller amount is prescribed than the contents of the syringe, expel the excess amount before administration, unless the user takes responsibility for using the remaining amount in the syringe (see point 5) (unused medicinal product or its waste should be disposed of in accordance with national regulations. For environmental protection, do not dispose of medicines in sewage).
• 4. Put the syringe back into the packaging without touching the tip.
• 5. Disinfect your hands and start catheterization. (Instructions are available at: www.farco.de/isk).
• 6. Completely empty the bladder through the catheter and make sure the catheter is still in the bladder before starting administration.
• 7. Remove the ampoule-syringe from the packaging again and connect it to the catheter.
• 8. Administer the contents of the ampoule-syringe into the bladder by pressing the syringe plunger. Remove the ampoule-syringe along with the catheter for disposal.
• 9. Unused medicinal product or its waste should be disposed of in accordance with national regulations. For environmental protection, do not dispose of medicines in sewage.

The injected solution remains in the bladder until the next catheterization. Each syringe is intended for single use. The urinary catheter and unused medicine should be discarded.

Using a higher dose of Vesoxx than recommended

If a dose higher than prescribed by the doctor is accidentally administered, the bladder should be emptied immediately using a catheter. Overdose may cause symptoms such as: restlessness, dizziness, speech and vision disorders, muscle weakness, or rapid heartbeat. If at least one of these symptoms occurs, you should contact your doctor or the nearest hospital as soon as possible.

Missing a dose of Vesoxx

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 the next dose is approaching, the missed dose should be skipped. A double dose should not be used to make up for a missed dose. In case of doubts, the patient should always consult their doctor.

Stopping use of Vesoxx

If the patient stops taking Vesoxx, the symptoms of an overactive bladder may return or worsen. If the patient is considering stopping treatment, they should always consult their doctor. In case of any further doubts about using the medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Vesoxx 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. The following side effects have been reported in connection with the use of oxybutynin hydrochloride, although not all of them have been reported in connection with intravesical use. The frequency of these side effects is unknown (cannot be determined from the available data):

You should stop using Vesoxx and/or contact your doctor immediately if:

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

You should inform your doctor or pharmacist if any of the following side effects worsen or last longer than a few days:

Kidneys

• 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

Psychiatric disorders

• seeing or hearing non-existent stimuli (hallucinations)
• cognitive disorders
• excessive restlessness and agitation (hyperactivity)
• agitation*
• confusion or altered state of consciousness
• sleep disorders
• agoraphobia (e.g., fear of leaving the house, entering shops, being in a crowd, and public places)
• inability to concentrate
• anxiety*
• nightmares*
• excessive suspicion and mistrust of others (paranoia)*
• symptoms of depression*
• dependence on oxybutynin (in patients with a history of drug or psychoactive substance abuse)*

Consciousness

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

Eyes

• dry eye syndrome
• abnormal sensation in the eye
• inability of the eye to accommodate from distant to near objects, which may cause blurred vision, double vision, eye fatigue
• blurred vision*
• increased eye pressure*

Heart and blood vessels

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

Skin disorders

• 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 disorders

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

General disorders

• discomfort in the chest
• feeling of cold
• headache
• neurological disorder (anticholinergic syndrome)
• seizures
• increased levels of a hormone called prolactin in the blood. In women, this may cause disruption of the normal menstrual cycle or spontaneous milk flow from the breasts. In men, it may cause sexual dysfunction or breast tissue enlargement.

* The above side effects have also been reported for this type of medicine. However, it is not known whether they will occur when using the prescribed Vesoxx. In one patient, oxygen deficiency occurred during home oxygen therapy (see section 2 "When not to use Vesoxx").

Additional side effects in children and adolescents

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

Reporting side effects

If the patient experiences any side effects, including any side effects 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 2-222 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. Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vesoxx

The medicine should be stored out of sight and reach of children. Do not use the medicine after the expiry date, which is stated on the label of the syringe and the carton after the statement "Expiry date" (EXP). The expiry date refers to the last day of the specified month. There are no special precautions for storage temperature. If the medicine is not used immediately, the user is responsible for the storage time and conditions before administration. Medicines should not be disposed of in household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vesoxx contains

• The active substance is oxybutynin hydrochloride.

1 ml of the solution contains 1 mg of oxybutynin hydrochloride. One ampoule-syringe with a graduated scale containing 10 ml of sterile solution contains 10 mg of oxybutynin hydrochloride.

• Other ingredients are hydrochloric acid diluted (10%), sodium chloride, and water for injections.

What Vesoxx looks like and contents of the packaging

Vesoxx is a clear, colorless solution. It is supplied in a ready-to-use solution in a 10 ml ampoule-syringe with a plunger and a tip made of synthetic bromobutyl rubber. The carton contains 100 ampoule-syringes for direct connection to standard catheter systems. The carton contains 12 ampoule-syringes for direct connection to standard catheter systems. Not all pack sizes may be marketed.

Marketing authorization holder

FARCO-PHARMA GmbH Gereonsmühlengasse 1-11 50670 Köln Germany E-mail: [email protected]

Manufacturer

Klosterfrau Berlin GmbH Motzener Strasse 41 12277 Berlin Germany

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:

Austria:

Vesoxx 1 mg/ml Lösung zur intravesikalen Anwendung

Belgium:

Vesoxx 1 mg/ml

Czech Republic:

Vesoxx

Spain:

VESOLOX 1 mg/ml solución intravesical

Netherlands:

VESOLOX 1 mg/ml oplossing voor intravesicaal gebruik

Luxembourg:

Vesoxx 1 mg/ml

Germany:

Vesoxx 1 mg/ml Lösung zur intravesikalen Anwendung

Poland:

Vesoxx

Portugal:

Vesoxx 1 mg/ml

Slovakia:

Vesoxx 1 mg/ml

Sweden:

Vesoxx 1 mg/ml intravesikal lösning

United Kingdom (Northern Ireland):

Vesoxx 1 mg/ml intravesical solution

Italy:

Vesoxx 1 mg/ml, soluzione endovescicale

Date of last revision of the leaflet: January 2025

Information intended for healthcare professionals only: Dosage The initial dose selection should be performed by a neurourologist under close urodynamic control. There are no established rules for the dosage regimen, as there are significant individual differences in bladder pressure and the dose required to alleviate symptoms of neurogenic overactive bladder. The dosage regimen (dose and timing) should therefore be determined individually based on the patient's needs. Individual doses are used to sufficiently control urodynamic parameters (maximum detrusor pressure <40 cm h2o) to completely inhibit neurogenic overactive bladder. during intravesical oxybutynin treatment, urodynamic parameters should be monitored at regular intervals, as recommended by the treating physician. children and adolescents safety efficacy of hydrochloride have not been established in under 6 years age. doses different age groups dose recommendations are based on percentiles body weight (table 1). table 1: groups< p>

Recommended daily initial dose

Recommended total daily dose [mg]

Age group Age [years] [mg]

Children

• 6 - 12 Dose selected individually, see
• 2 - 30

below (information is

• 3)

Adolescents

• 12 - 18 10
• 10 - 40

Adults

• 19 - 65 10
• 10 - 40

over 65

• 10 - 30 Elderly patients

If higher doses are required than the initial dose, the dose should be gradually increased until the neurogenic overactive bladder is sufficiently controlled to allow for careful monitoring of both efficacy and safety. The required daily maintenance doses can be divided into several administrations (Tables 2 and 3). Assuming six intermittent catheterizations of the bladder (CIC) per day, the following dosage regimen is recommended: Table 2: Recommended dosage regimen (children aged 6 to 12 years)

Dose per administration [mg]

Daily dose [mg]

CIC 1 CIC 2 CIC 3 CIC 4 CIC 5 CIC 6

2

2

5

5

10

5

• 5

15

5

• 5
• 5

20

10

• 10

30

10

• 10
• 10

Table 3: Recommended dosage regimen for initial doses of 10 mg (adolescents from 12 years, adults, and elderly patients)

Dose per administration [mg]

Daily dose [mg]

CIC 1 CIC 2 CIC 3 CIC 4 CIC 5 CIC 6

10

5

• 5

20

10

• 10

30

10

• 10
• 10

40

10 10 10

• 10

Children (aged 6 to 12 years) The dose is selected individually. The initial dose is 0.1 mg/kg body weight and is administered intravesically in the morning. The dose can be adjusted after one week of treatment. The smallest effective dose should be chosen. The daily dose can be increased to 30 mg to achieve the desired effect, provided that the side effects are tolerated. No more than 10 mg should be administered as a single dose. The safety and efficacy of oxybutynin hydrochloride have not been established in children under 6 years of age. Elderly patients (over 65 years) As with other anticholinergic medicines, caution should be exercised in frail and elderly patients, especially if doses higher than 30 mg per day are required. Renal or hepatic impairment Vesoxx should be used with caution in patients with renal or hepatic impairment. The use of this medicinal product in these patients should be closely monitored, and dose reduction may be required.