VESOXX 1 mg /Ml Roztwór Do Pęcherza Moczowego

Treść ulotki

1. Vesoxx 1 mg/ml, intravesical solution
   1. What is Vesoxx and what is it 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

Vesoxx 1 mg/ml, intravesical solution

oxybutynin hydrochloride

Read this leaflet carefully before you start using this medicine as 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Vesoxx and what is it used for

What is Vesoxx
Vesoxx is a solution that contains a medicine called oxybutynin hydrochloride. It works
by relaxing the muscles of the bladder and stopping sudden muscle contractions (spasms). This
helps to control the release of water (urine).
The Vesoxx solution must be injected directly into the bladder (endovesical use) through
a small tube called a catheter.

What is Vesoxx used for

• Vesoxx is used in children from 6 years of age and in adults for the treatment of overactive bladder due to a neurological condition, 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 by mouth and if you are currently emptying your bladder with a catheter.

Treatment with Vesoxx must be started and monitored by a doctor specializing in the treatment
of overactive bladder due to neurological disorders.

2. What you need to know before using Vesoxx

The following paragraph contains information that is important to know beforeusing this
medicine.

Do not use Vesoxx

• if you are allergic to oxybutynin hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a rare autoimmune disease called myasthenia gravis which weakens the muscles making them weak and easily fatigued;
• if you have a severe disease of the stomach or intestine such as severe ulcerative colitis or toxic megacolon (an acute dilation of the intestine);
• if you suffer from glaucoma (increased pressure in the eyes, sometimes sudden and painful, with blurred vision or loss of vision). If there are cases of glaucoma in your family, report this to 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 for you;
• you are over 65 years old and may be more sensitive to Vesoxx;
• you are taking nitrates sublingually (a medicine that is placed under the tongue to treat chest pain);
• you have an obstruction of the digestive system, as Vesoxx may slow down stomach and intestinal movements;
• you have a stomach laceration (hiatal hernia) or heartburn;
• you have a nervous system disorder called autonomic neuropathy affecting involuntary functions of the body, such as heart rate, blood pressure, sweating and digestion;
• you have problems with memory, speech or reasoning ability;
• you have excessive activity of the thyroid gland which may involve 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 ankles;
• you have an irregular and/or rapid heartbeat;
• you have high blood pressure;
• you have an enlarged prostate. Vesoxx may reduce the amount of saliva causing tooth decay, gum disease or fungal infection of the mouth (thrush).

Particular attention should be paid to using Vesoxx when it is hot or in the presence of fever. For
example, you should avoid being in the sun and playing sports during the hottest hours. This is because Vesoxx reduces the
amount of sweat. This can lead to heat exhaustion and heat stroke.

Other medicines and Vesoxx
Tell your doctor if you are taking or have recently taken or might take any other
medicines.
The use of 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 intensity of these
side effects.
The active ingredient of Vesoxx is oxybutynin hydrochloride which may slow down the digestive tract and
therefore affect the absorption of other medicines taken by mouth or, the use of this
medicine together with others may increase the effect of oxybutynin hydrochloride.
In particular, tell your doctor if you are taking any of the following medicines:

• Bisphosphonates (used for the treatment of osteoporosis) and other medicines that can cause or worsen inflammation of the esophagus.
• Ketoconazole, itraconazole or fluconazole (used in the treatment of fungal infections).
• Erythromycin, a macrolide antibiotic (used in the treatment of bacterial infections).
• Biperiden, levodopa or amantadine (used in the treatment of Parkinson's disease).
• Antihistamines (used in the treatment of allergies, such as hay fever).
• Phenothiazine, butyrophenones or clozapine (used in the treatment of mental illness).
• Tricyclic antidepressants (used in the treatment of depression).
• Dipyridamole (used in the treatment of blood clotting problems).
• Quinidine (used in the treatment of heart rhythm abnormalities).
• Atropine and other anticholinergic medicines (used in the treatment of gastrointestinal disorders such as irritable bowel syndrome).

Vesoxx with alcohol
Vesoxx can cause drowsiness or blurred vision. Drowsiness may be aggravated by the consumption
of alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.
Pregnancy
If you are pregnant, you should not use Vesoxx unless it has been prescribed by your doctor.
Breastfeeding
The use of Vesoxx during breastfeeding is not recommended.

Driving and using machines
Vesoxx can cause drowsiness or blurred vision. Take particular care when driving
vehicles or using machinery.

3. How to use Vesoxx

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor.

Dosage
Your doctor will calculate the correct amount of Vesoxx needed for the treatment of your overactive bladder. Do not change the dose on your own initiative.
During the start of treatment, your doctor will periodically check the function of your bladder and, if necessary, will modify the dose.

Adolescents (from 12 years of age), adults and the elderly (65 years and over)
The recommended initial dose is usually 10 ml of Vesoxx per day.

Children (6 - 12 years)
The recommended initial 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 or your family members or the person assisting you are familiar with the procedure called “intermittent bladder catheterization (CIC)”. This is a technique used at least six times a day to help empty the bladder with a catheter.
The acronym CIC stands for Intermittent bladder catheterization (Clean Intermittent Catheterisation):

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

Your doctor will teach you and/or your family members or the person assisting you the procedure for CIC and the administration of Vesoxx.

The procedure is as follows:

• 1. Prepare an environment that is as free as possible from germs.
• 2. Insert a sterile, single-use catheter into the bladder as indicated by your doctor.
• 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 conical luer-lock connector with steps onto the end of the syringe.
• 7. Using the latter, connect the catheter to the syringe.
• 8. Inject the specific amount of solution into the bladder, applying constant pressure to the syringe plunger.
• 9. If the dose is less than 1 syringe (10 ml), the unused solution remains in the syringe, which must be taken to a pharmacy and then disposed of.
• 10. Remove the catheter. The injected solution remains in the bladder until the next catheterization.

Each syringe is for single use only. The urethral catheter, the conical luer-lock connector with steps, and any unused medicine must be disposed of.

If you use more Vesoxx than you should
If you accidentally applied a dose higher than the prescribed one, immediately empty your bladder with a catheter.
An excessive dosage may cause symptoms such as restlessness, dizziness, speech and vision disturbances, muscle weakness, or a rapid heartbeat.
If you experience one or more of these symptoms, contact your doctor or the nearest hospital as soon as possible.

If you forget to use Vesoxx
If you forget to use a dose at the usual time, use the usual dose at the next catheterization. However, if it is almost time for the next dose, skip the missed one.
Do not use a double dose to make up for the missed dose.
If you have any doubts, always consult your doctor.

If you stop using Vesoxx
If you stop treatment with Vesoxx, the symptoms and the overactive bladder disorder may reappear 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 more frequently are typical of this type of medicine and include
dry mouth, drowsiness and constipation.
With the use of oxybutynin hydrochloride, the following side effects have been reported, although not all
have been reported with intravesical use. The frequency of these side effects is not known (the
frequency cannot be defined based on available data).

Stop taking Vesoxx and/or contact your doctor immediately if:

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

Inform your doctor or pharmacist if any of the following side effects becomes serious or lasts more than
a few days:

Kidneys

• urinary tract infection
• presence of bacteria in the urine that does not cause symptoms
• urgent need to urinate (urinary urgency)
• protein in the urine
• blood in the urine
• pain during the (instillation) of the solution into the bladder
• difficulty urinating 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 and public spaces)
• inability to concentrate
• anxiety*
• nightmares*
• feeling of excessive suspicion and distrust 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 tired
• drowsiness
• feeling dizzy or lightheaded

Eyes

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

Heart and blood vessel diseases

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

Skin

• hot flashes
• skin rash
• decreased sweating
• night sweats
• itchy rash with blisters (urticaria)*
• dry skin*
• skin more sensitive to the sun (photosensitivity)*

Digestive problems

• constipation
• dry mouth
• abdominal discomfort
• pain in the lower or upper abdomen
• feeling unwell
• indigestion
• diarrhea
• vomiting*
• loss of appetite (anorexia)*
• decreased 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 disease (anticholinergic syndrome)
• seizures
• higher level in the blood of a hormone called prolactin. In women, changes in the normal menstrual cycle or spontaneous leakage of milk from the breasts may occur. Men may experience libido or erectile dysfunction as well as an increase in breast tissue.

* These side effects have also been reported for this type of medicine. However, it is not
known whether these side effects will also occur with the medicine Vesoxx that has been
prescribed to you.
One patient experienced oxygen deficiency during home oxygen therapy (see
paragraph 2 under “Do not use Vesoxx”).

Additional side effects in children and adolescents
Children may be more sensitive to the effects of this product, especially to side effects
affecting the central nervous system and psychiatric disorders.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the syringe label and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Keep the syringes
in the outer packaging to protect the medicine from light.
For single use only.
Any unused solution must be disposed of immediately.
Do not dispose of any medicine in 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 pack and other information

What Vesoxx contains

• The active substance is oxybutynin hydrochloride 1 ml of solution contains 1 mg of oxybutynin hydrochloride. One pre-filled graduated syringe with 10 ml of sterile solution contains 10 mg of oxybutynin hydrochloride.
• 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 and colourless solution. It is presented as a ready-to-use solution in a
pre-filled 10 ml cycloolefin copolymer syringe with a plunger and a rubber bromobutyl synthetic cap at the end.
Pack of 100 syringes.

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

Manufacturer
Almed GmbH
Motzener Strasse 41
12277 Berlin
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany: VESOXX 1 mg/ml solution for intravesical use
Austria: Vesoxx 1 mg/ml solution for intravesical use
Belgium: VESOXX 1 mg/ml
Slovakia: VESOXX 1 mg/ml
Spain Vesoxx 1 mg/ml intravesical solution
Italy Vesoxx
Luxembourg: VESOXX
Netherlands: VESOLOX 1 mg/ml solution for intravesical use
Poland: Vesoxx
Portugal: Vesoxx
Czech Republic: VESOXX
Sweden: Vesoxx