VESOXX 1 mg/ml INTRAVESICAL SOLUTION

Introduction

Leaflet: information for the user

Vesoxx 1mg/ml intravesical solution

oxibutinina hydrochloride

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Vesoxx and what is it used for
2. What you need to know before taking Vesoxx
3. How to use Vesoxx
4. Possible side effects
5. Storage of Vesoxx
6. Package contents and additional information

1. What is Vesoxx and what is it used for

What is Vesoxx

Vesoxx is a solution that contains a medicine called oxibutinina hydrochloride. It works by relaxing the bladder muscles and stopping sudden muscle contractions (spasms). This helps control the evacuation of water (urine).

The Vesoxx solution must be injected directly into the bladder (via the intravesical route) through a small 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 caused by a neurological disease, such as:

• spinal cord injury;
• spina bifida (a congenital anomaly of the spinal cord).

• Vesoxx is used only when the overactive bladder cannot be controlled after taking this type of medication orally and if you are already emptying your bladder with the help of a catheter.

A doctor specializing in the treatment of overactive bladder caused by neurological disorders should initiate and supervise treatment with Vesoxx.

2. What you need to know before taking Vesoxx

The following section contains information that you should know beforestarting to use this medicine.

Do not use Vesoxx

• if you are allergic to oxibutinina hydrochloride or any of the other components of this medicine (listed in section 6);
• if you have a rare autoimmune disease called myasthenia gravis that makes the body's muscles weak and easily tired;
• if you have a severe intestinal or stomach disease, such as severe ulcerative colitis or toxic megacolon (a sudden enlargement of the intestine);
• if you have glaucoma (high pressure in the eyes, sometimes sudden and painful, accompanied by blurred vision or loss of vision). If you have a family history of glaucoma, inform your doctor;
• if you are receiving oxygen treatment.

Warnings and precautions

Consult your doctor before starting to use Vesoxx if:

• you have a urinary tract infection. Your doctor may need to prescribe you some antibiotics;
• you are over 65 years old, as you may be more sensitive to Vesoxx;
• you are taking sublingual nitrates (a medicine that is placed under the tongue to treat chest pain);
• you have a blockage in the digestive system, as Vesoxx can slow down intestinal and stomach movements;
• you have a tear in the stomach (hiatal hernia) or heartburn;
• you have a nervous system disorder called autonomic neuropathy that affects involuntary body functions, including heart rate, blood pressure, sweating, and digestion;
• you have memory, language, or thinking problems;
• you have an overactive thyroid gland that can cause increased appetite, weight loss, or sweating;
• you have a narrowing of the blood vessels that carry blood and oxygen to the heart;
• you have heart problems that can cause shortness of breath or swelling of the ankle;
• you have irregular and/or rapid heartbeats;
• you have high blood pressure
• you have an enlarged prostate.

Vesoxx may reduce the amount of saliva and cause tooth decay, gingivitis, or fungal infection of the mouth (oral candidiasis).

Caution should be exercised when using Vesoxx in hot weather or if you have a fever. You should, for example, stay away from the sun and avoid the midday hours to practice sports. The reason is that Vesoxx reduces the amount of sweat produced. This can cause heat stroke and heat exhaustion.

Other medicines and Vesoxx

Tell your doctor if you are taking, have recently taken, or may need to take any other medicine.

Taking Vesoxx at the same time as other medicines that have similar side effects, such as dry mouth, constipation, and drowsiness, may increase the frequency and severity of these side effects.

The active ingredient of Vesoxx is oxibutinina hydrochloride, which can slow down the functioning of the digestive tube and thus influence the absorption of other oral medicines; on the other hand, the use of this medicine together with other medicines may increase the effect of oxibutinina hydrochloride.

In particular, inform your doctor if you are taking any of the following medicines:

• Bisphosphonates (used to treat osteoporosis) or other medicines that can cause or worsen inflammation of the esophagus.
• 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 pollen allergy).
• Phenothiazines, butyrophenones, or clozapine (used to treat mental illnesses).
• Tricyclic antidepressants (used to treat depression).
• Dipyridamole (used to treat coagulation problems).
• Quinidine (used to treat abnormal heart rhythms).
• Atropine and other anticholinergics (used to treat stomach disorders such as irritable bowel syndrome).

Taking Vesoxx with alcohol

Vesoxx may cause drowsiness or blurred vision. Drowsiness may increase with alcohol consumption.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Do not use Vesoxx if you are pregnant, unless your doctor has indicated it.

Breastfeeding

It is not recommended to use Vesoxx during breastfeeding.

Driving and using machines

Vesoxx may cause drowsiness or blurred vision. Be especially careful when driving or using machinery.

3. How to use Vesoxx

Follow your doctor's instructions for administering this medicine exactly. If in doubt, consult your doctor again.

Dose

Your doctor will calculate the correct amount of Vesoxx needed to treat your overactive bladder. Do not change the dose on your own.

During the start of your treatment, your doctor will periodically check your bladder function and, if necessary, adjust the dose.

Adolescents (12 years and older), adults, and elderly people (over 65 years)

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

Children (6-12 years)

The recommended initial dose is usually 0.1 mg/kg body weight of Vesoxx in the morning, which corresponds to an equivalent amount in the initial dose of 2 mg (2 ml) for children with 20 kg body weight.

If you have liver or kidney problems

Tell your doctor if you have a liver or kidney problem.

Method of administration

Your doctor will only prescribe Vesoxx if you or your family members/caregiver are familiar with a procedure called "clean intermittent catheterization (CIC)". This is a technique that is performed at least 6 times a day to help you empty your bladder using a catheter.

CIC means clean intermittent catheterization.

• Catheterization: use of a catheter, a type of small tube, to drain urine from the bladder.
• Intermittent: performed periodically several times a day.
• Clean: as aseptic as possible.

Your doctor will explain to you and/or your family members/caregiver what the CIC procedure consists of and will teach you how to administer it with Vesoxx.

The syringe is intended for single use or, alternatively, dual use only under the administration of healthcare professionals. In the case of dual use, the syringe is intended to be used by a single patient. Each syringe must be used within 24 hours after opening.

The procedure is performed as follows:

1. Disinfect your hands as indicated on the disinfectant packaging. Open the packaging of the pre-filled syringe at the marked point.
2. Remove the pre-filled syringe from the packaging. Remove the cap by gently twisting it.
3. TIP: Before removing the seal cap, press the plunger to release the pressure point. This ensures that the syringe is handled easily and uniformly
   • In the case of dual use, the syringe can only be used a second time for the same patient and must be administered only by a specialized healthcare professional in a clean and controlled environment. If the healthcare professional decides to reuse the syringe, they must ensure that, after the first instillation, the catheter is discarded and a new sterile catheter is used for the second instillation with the same syringe. The healthcare professional must ensure that the plunger cap is securely placed on the syringe immediately after use and that the syringe is stored properly for future use. The syringe must be kept out of the reach of unauthorized persons. Only one pre-filled syringe should be used for re-use at a time. The syringe must be discarded after the second use (i.e., after 24 hours) and a new syringe must be used from then on. The healthcare professional will decide if re-use is possible.
4. Put the syringe back in its packaging with the adapter without touching the syringe tip.
5. Disinfect your hands and start catheterization. (Instructions can be found at: www.farco.de/isk).
6. Completely empty your bladder through the catheter and make sure the catheter is still in the bladder before starting the instillation.
7. Remove the pre-filled syringe from the packaging again and connect it to the catheter.
8. Introduce the contents of the pre-filled syringe into the bladder by pressing the syringe plunger. Remove the pre-filled syringe along with the catheter for disposal after single use or, if re-used, after the second use.
9. Any unused medicine or waste material must be disposed of in accordance with local regulations. For the sake of the environment, do not dispose of medicines in wastewater.

The injected solution remains in the bladder until the next catheterization.

The remaining unused medicine and the urethral catheter must be discarded.

If you use more Vesoxx than you should

If you accidentally use more than the prescribed dose, empty your bladder immediately through the catheter.

An overdose can cause symptoms such as agitation, dizziness, speech and vision disorders, muscle weakness, or faster heartbeats.

If you experience one or more of these symptoms, contact your doctor or go to the nearest hospital as soon as possible. You can also call the Toxicology Information Service, phone 91 562 04 20.

If you forget to use Vesoxx

If you forget to use a dose at the usual time, use the usual dose with the next catheterization. However, if it is almost time for the next dose, do not use the missed dose.

Do not use a double dose to make up for missed doses.

In case of doubt, always consult your doctor.

If you stop treatment with Vesoxx

If you stop treatment with Vesoxx, the symptoms and overactive bladder syndrome may return or worsen. Always consult your doctor if you are thinking of stopping treatment.

If you have any other questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The most frequently reported side effects are characteristic of this type of medicine and include dry mouth, drowsiness, and constipation.

The following side effects have been reported after using oxibutinina hydrochloride, although not all have been associated with intravesical use. The frequency of these side effects is unknown (cannot be estimated from the available data).

Stop treatment with Vesoxx and/or contact a doctor immediately if:

• you have a severe allergic reaction that causes swelling of the face or throat (angioedema)*;
• you notice a decrease in sweating, which can cause overheating in a hot environment (heat stroke)*;
• you have sudden eye pain accompanied by blurred vision or loss of vision (glaucoma)*.

If any of the following side effects worsen or last more than a few days, inform your doctor or pharmacist.

Kidneys

• urinary tract infection;
• appearance of bacteria in the urine that do not cause symptoms;
• urgent need to urinate (urinary urgency);
• proteins in the urine;
• blood in the urine;
• pain after injection (instillation) of the solution into the bladder;
• difficulty expelling urine or difficulty starting urination.

Mental disorders

• seeing or hearing things that do not really exist (hallucinations);
• cognitive disorders;
• restlessness and excessive movement (hyperactivity);
• agitation*;
• confusion or mental obtundation;
• difficulty sleeping;
• agoraphobia (e.g., fear of leaving home, entering a store, or being in a crowd or public places);
• inability to concentrate;
• anxiety*;
• nightmares*;
• suspecting and mistrusting others excessively (paranoia)*;
• symptoms of depression*;
• dependence on oxibutinina (in patients with a history of substance or drug abuse)*;

Consciousness

• disorientation;
• loss of consciousness;
• apathy;
• feeling of fatigue;
• drowsiness;
• feeling of dizziness or that the head is spinning.

Eyes

• dry eyes;
• abnormal sensation in the eye;
• inability of the eye to automatically change focus from distant to near objects, which can cause blurred vision, double vision, or tired eyes;
• blurred vision*;
• increased pressure in the eyes*.

Heart and blood vessel disorders

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

Skin

• facial flushing;
• rash;
• decreased sweating;
• night sweats;
• itching, hives (urticaria)*;
• dry skin*;
• skin that is more sensitive to the sun (photosensitivity)*.

Digestive problems

• constipation;
• dry mouth;
• abdominal discomfort;
• pain in the lower or upper abdomen;
• nausea;
• indigestion;
• diarrhea;
• vomiting*;
• loss of appetite (anorexia)*;
• decreased appetite*;
• difficulty swallowing (dysphagia)*;
• heartburn*;
• abnormal distension/swelling with pain and nausea or vomiting (pseudo-obstruction)*;
• change in taste;
• thirst.

General disorders

• chest discomfort;
• feeling of cold;
• headache;
• nervous system disease (anticholinergic syndrome);
• seizures;
• increased levels of a hormone called prolactin in the blood. Women may experience changes in normal menstrual periods or spontaneous milk production. Men may experience changes in libido or erection problems and an increase in breast tissue.

• These side effects have also been reported for this type of medicine. However, it is unknown whether these side effects will also occur with Vesoxx.

A patient presented with oxygen deficiency during home treatment with oxygen (see section 2 "Do not use Vesoxx").

Other side effects in children and adolescents

Children may be more sensitive to the effects of this medicine, especially to psychiatric and central nervous system side effects.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Vesoxx

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the syringe and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature. The syringe should be discarded 24 hours after first opening and a new one used.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Vesoxx

• The active substance is oxybutynin hydrochloride.

1 ml of solution contains 1 mg of oxybutynin hydrochloride.

A pre-filled graduated syringe with 10 ml of sterile solution contains 10 mg of oxybutynin hydrochloride.

• The other ingredients are hydrochloric acid, sodium chloride, and water for injectable preparations.

Appearance and Package Contents of the Product

Vesoxx is a clear and colorless solution.

It is presented in a ready-to-use solution in a 10 ml pre-filled polypropylene syringe with a synthetic bromobutyl rubber piston and a protector.

Box of 100 pre-filled syringes for direct connection to a standard catheter system.

Box of 12 pre-filled syringes for direct connection to standard catheter systems.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

FARCO-PHARMA GmbH

Gereonsmühlengasse 1-11

50670 Cologne

Germany

Manufacturer

Klosterfrau Berlin GmbH

Motzener Strasse 41

12277 Berlin

Germany

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

Date of the last revision of this leaflet:March 2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Dosage

A neuro-urologist will perform an initial dose adjustment with close urodynamic monitoring.

There is no established dosage regimen, as significant interindividual differences in bladder pressure and required doses to improve neurogenic detrusor overactivity have been observed. Therefore, dosage regimens (dose and timing) should be determined individually according to the patient's needs.

Individual doses will be administered to sufficiently control urodynamic parameters (maximum detrusor pressure <40 cm h2o) in order to achieve complete inhibition of neurogenic detrusor overactivity.< p>

During intravesical treatment with oxybutynin, urodynamic parameters will be monitored at regular intervals as indicated by the urologist.

Pediatric Population

The safety and efficacy of oxybutynin hydrochloride have not yet been established in children from 0 to 5 years of age.

Dosage Recommendations for the Following Age Groups

Dosage recommendations have been calculated according to the percentiles of body weight of the different age groups (see Table 1).

Table 1:Dosage Recommendations for the Following Age Groups

If it is considered necessary to administer higher doses than the initial dose, the dose should be gradually increased until the neurogenic detrusor overactivity is sufficiently controlled to allow for close monitoring of efficacy and safety. The required daily maintenance doses can be divided into several applications (Tables 2 and 3). If six clean intermittent catheterizations (CIC) are used per day, the following dosage regimen is recommended:

Table 2:Recommended Dosage Regimen (children from 6 to 12 years)

Table 3:Recommended Dosage Regimen for Initial Doses of 10 mg (adolescents from 12 years, adults, and elderly)

Children (from 6 to 12 years)

Dosing is individual with an initial dose of 0.1 mg/kg intravesically in the morning. The dose may be adjusted after one week of treatment. The lowest effective dose should be chosen. The daily dose may be increased up to 30 mg per day to achieve an adequate effect, provided that side effects are tolerated. No more than 10 mg should be administered per single dose.

The safety and efficacy of oxybutynin hydrochloride have not yet been established in children under 6 years of age.

Elderly (over 65 years)

As with other anticholinergics, caution should be exercised in elderly and frail patients, especially if doses above 30 mg per day are considered necessary.

Renal or Hepatic Impairment

Vesoxx should be used with caution in patients with renal or hepatic impairment. The use of Vesoxx in these patients should be carefully monitored, and dose reduction may be necessary.