Vesoxx

Package leaflet: Information for the user

Vesoxx 1 mg/ml, intravesical solution

oxybutynin chloride
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Vesoxx is and what it is used for

What Vesoxx is
Vesoxx is a solution containing a medicine called oxybutynin chloride. It works by relaxing the bladder muscles and stopping sudden muscle contractions (spasms). This helps control the release of water (urine).
Vesoxx solution must be injected directly into the bladder (intravesical use) 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 for the treatment of neurogenic overactive bladder due to a neurological disease, such as:
  • spinal cord injury;
  • spina bifida (a birth defect of the spinal cord).
• Vesoxx is used only if your bladder is not well controlled by taking this type of medicine orally, and if you currently empty your bladder using a catheter.

Treatment with Vesoxx should be initiated and supervised by a doctor specialized in the treatment of neurogenic overactive bladder.

2. What you need to know before using Vesoxx

The following section contains information that is important to know before using this
medicinal product.
Do not use Vesoxx

• if you are allergic to oxybutynin chloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have a rare autoimmune disease called myasthenia gravis, which weakens the muscles and makes them easily fatigued;
• if you have a severe stomach or intestinal disorder such as severe ulcerative colitis or toxic megacolon (an acute dilation of the intestine);
• if you have glaucoma (increased pressure in the eyes, sometimes sudden and painful, with blurred vision or loss of sight). If there is a family history of glaucoma, inform your doctor;
• if you are receiving oxygen therapy.

Warnings and precautions
Talk to your doctor before using Vesoxx if:

• you have a urinary tract infection. Your doctor may need to prescribe antibiotics;
• you are over 65 years old and may be more sensitive to Vesoxx;
• you are taking sublingual nitrates (a medicine placed under the tongue to treat chest pain);
• you have an obstruction of the digestive system, as Vesoxx may slow down movements of the stomach and intestines;
• you have a stomach hernia (hiatal hernia) or heartburn;
• you have a nerve disorder called autonomic neuropathy affecting involuntary body functions such as heart rate, blood pressure, sweating, and digestion;
• you have problems with memory, language, or reasoning ability;
• you have an overactive thyroid gland, which may cause increased appetite, weight loss, or excessive sweating;
• you have narrowing of the blood vessels supplying blood and oxygen to the heart;
• you have heart problems that may cause shortness of breath or swelling of the ankles;
• you have an irregular and/or rapid heartbeat;
• you have high blood pressure;
• you have an enlarged prostate. Vesoxx may reduce saliva production, leading to tooth decay, gum disease, or fungal infection of the mouth (thrush).

Particular care should be taken when using Vesoxx in hot weather or if you have a fever. For example, you should avoid sun exposure and physical exercise during the hottest hours. This is because Vesoxx reduces sweating. This may lead to heat exhaustion or heat stroke.
Other medicines and Vesoxx
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Using Vesoxx together with 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 substance in Vesoxx is oxybutynin chloride, which may slow down the gastrointestinal tract and thus affect the absorption of other oral medicines. Alternatively, using this medicine together with others may increase the effect of oxybutynin chloride.
In particular, inform your doctor if you are taking any of the following medicines:

• Bisphosphonates (used to treat osteoporosis) and other medicines that may cause or worsen inflammation of the oesophagus.
• 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 mental illness).
• Tricyclic antidepressants (used to treat depression).
• Dipyridamole (used to treat blood clotting disorders).
• Quinidine (used to treat heart rhythm abnormalities).
• Atropine and other anticholinergic medicines (used to treat gastrointestinal disorders such as irritable bowel syndrome).

Vesoxx and alcohol
Vesoxx may cause drowsiness or blurred vision. Drowsiness may be worsened by alcohol consumption.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
Pregnancy
Do not use Vesoxx during pregnancy unless specifically prescribed by your doctor.
Breastfeeding
The use of Vesoxx during breastfeeding is not recommended.
Driving and using machines
Vesoxx may cause drowsiness or blurred vision. Be especially careful when driving or operating machinery.

3. How to use Vesoxx

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Dose
Your doctor will determine the correct amount of Vesoxx needed for the treatment of your overactive bladder. Do not change the dose on your own initiative.
During the initial phase of treatment, your doctor will periodically monitor your bladder function and, if necessary, adjust the dose.
Adolescents (from 12 years of age), adults and elderly (aged 65 and over)
The recommended starting dose is usually 10 ml of Vesoxx per day.
Children (6 - 12 years)
The recommended starting dose is usually 2 ml of Vesoxx per day.
If you have liver or kidney problems
If you have liver or kidney problems, inform your doctor.
Method of administration
Your doctor will prescribe Vesoxx only if you, your family members or your caregiver are familiar with the procedure known as "intermittent catheterisation (CIC)". This is a technique performed at least six times a day to help empty the bladder using a catheter.
The acronym CIC stands for Intermittent Catheterisation (Clean Intermittent Catheterisation) :

• Clean: as germ-free as possible.
• Intermittent: performed at regular intervals, several times a day.
• Catheterisation: using a catheter, a thin tube, to drain urine from the bladder.

Your doctor will teach you and/or your family members or caregiver the CIC procedure and the administration of Vesoxx.
The procedure is as follows:

1. Prepare a germ-free environment.
2. Insert a sterile, single-use catheter into the bladder as instructed by your doctor.
3. Completely empty the bladder through the cathetere.
4. Remove the syringe from the blister.
5. Remove the cap from the syringe.
6. Screw a conical step luer-lock connector onto the end of the syringe.
7. Using this connector, attach the catheter to the syringe.
8. Inject the specified amount of solution into the bladder by applying constant pressure on the plunger of the syringe.
9. If the dose is less than one syringe (10 ml), the unused solution remains in the syringe, which must be taken to a pharmacy for disposal.
10. Remove the catheter. The injected solution remains in the bladder until the next catheterisation.

Each syringe is for single use only. The urethral catheter, the conical step luer-lock connector and any unused medicine must be discarded.
If you use more Vesoxx than you should
If you accidentally apply a higher dose than prescribed, immediately empty your bladder using a catheter.
An overdose may cause symptoms such as restlessness, dizziness, speech and vision disturbances, muscle weakness or rapid heartbeat.
If you experience one or more of these symptoms, contact your doctor or the nearest hospital immediately.
If you forget to use Vesoxx
If you forget to take a dose at the usual time, take the usual dose at the next scheduled catheterisation. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you have any doubts, always consult your doctor.
If you stop using Vesoxx
If you stop treatment with Vesoxx, symptoms and overactive bladder problems may return or worsen. If you are considering stopping treatment, always consult your doctor.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects that occur most frequently are typical of this type of medicine and include dry mouth, drowsiness and constipation.
The following side effects have been reported with the use of oxybutynin chloride, although not all have been reported with intravesical use. The frequency of these side effects is unknown (the frequency cannot be estimated from the available data).
Stop taking Vesoxx and/or contact a doctor immediately if:

• you have a severe allergic reaction causing swelling of the face or throat (angioedema)*;
• you experience reduced sweating, leading to overheating in hot environments (heat stroke)*;
• you experience sudden eye pain with blurred vision or loss of vision (glaucoma)*.

Inform your doctor or pharmacist if any of the following side effects become severe or last for more than a few days:
Kidneys

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

Mental disorders

• seeing or hearing things that are not there (hallucinations)
• cognitive disorders
• restlessness and excessive movements (hyperactivity)
• agitation*
• mental clouding or confusion
• difficulty sleeping
• agoraphobia (e.g. fear of leaving home, entering shops, being in crowds or public places)
• inability to concentrate
• anxiety*
• nightmares*
• feeling excessively suspicious and distrustful of others (paranoia)*
• symptoms of depression*
• becoming dependent on oxybutynin (in patients with a history of drug or substance abuse)*

Consciousness

• disorientation
• loss of consciousness
• lethargy
• feeling of tiredness
• drowsiness
• feeling dizzy or vertigo

Eyes

• dry eyes
• abnormal sensation in the eyes
• inability of the eye to automatically adjust focus between near and distant objects, possibly resulting in blurred or double vision and eye strain
• blurred vision*
• increased pressure in the eyes*

Heart and blood vessel disorders

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

Skin

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

Digestive problems

• constipation
• dry mouth
• abdominal discomfort
• pain in the lower or upper abdomen
• feeling unwell
• indigestion
• diarrhoea
• vomiting*
• loss of appetite (anorexia)*
• reduced appetite*
• difficulty swallowing (dysphagia)*
• heartburn*
• abnormal bloating accompanied by pain and nausea or vomiting (pseudo-obstruction)*
• altered sense of taste
• thirst

General disorders

• chest discomfort
• feeling cold
• headache
• nervous system disorder (anticholinergic syndrome)
• convulsive seizures
• increased level of a hormone called prolactin in the blood. In women, changes in the normal menstrual cycle or spontaneous milk discharge from the breast may occur. Men may experience disturbances in libido or erection, as well as breast tissue enlargement.

* These side effects have also been reported with this type of medicine. However, it is not known whether these side effects will also occur with the Vesoxx medicine prescribed to you.
One patient experienced oxygen deficiency during home oxygen therapy (see section 2, “Do not use Vesoxx”).
Additional side effects in children and adolescents
Children may be more sensitive to the effects of this product, particularly side effects affecting the central nervous system and psychiatric side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vesoxx

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the syringe label and on the
carton after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Keep the syringes
in the outer packaging to protect the medicine from light.
For single-dose use only.
Any unused solution must be immediately discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Vesoxx contains

• The active substance is oxybutynin chloride: 1 ml of solution contains 1 mg of oxybutynin chloride. A pre-filled graduated syringe containing 10 ml of sterile solution contains 10 mg of oxybutynin chloride.
• The other excipients are: hydrochloric acid, sodium chloride, water for injections.

Description of the appearance of Vesoxx and contents of the pack
Vesoxx 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, with a plunger and a cap made of synthetic bromobutyl rubber.
Pack: Box containing 100 syringes.

Marketing Authorization Holder
FARCO-PHARMA GmbH
Gereonsmühlengasse 1-11
50670 Cologne
Germany

Manufacturer
Almed GmbH
Motzener Strasse 41
12277 Berlin
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: VESOXX 1 mg/ml Lösung zur intravesikalen Anwendung
Austria: Vesoxx 1 mg/ml Lösung zur intravesikalen Anwendung
Belgium: VESOXX 1 mg/ml
Slovakia: VESOXX 1 mg/ml
Spain: Vesoxx 1 mg/ml solución intravesical
Italy: Vesoxx
Luxembourg: VESOXX
Netherlands: VESOLOX 1 mg/ml oplossing voor intravesicaal gebruik
Poland: Vesoxx
Portugal: Vesoxx
Czech Republic: VESOXX
Sweden: Vesoxx