VELARIQ 1 mg /Ml Intravesical Solution

Зміст інструкції

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

Velariq 1 mg/mL, intravesical solution

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

1. What is Velariq and what is it used for

What is Velariq
Velariq is a solution containing 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 Velariq solution must be injected directly into the bladder (endovesical use) through
a small tube called a catheter.

What is Velariq used for

• Velariq is used in children from 6 years of age and 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).
• Velariq 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 Velariq must be started and supervised by a doctor specializing in the treatment
of overactive bladder due to neurological disorders.

2. What you need to know before using Velariq

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

Do not use Velariq

• 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 Velariq 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 Velariq;
• you take nitrates sublingually (a medicine that is placed under the tongue to treat chest pain);
• you have an obstruction of the digestive system, as Velariq 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 bodily functions such as heart rate, blood pressure, sweating and digestion;
• you have problems with memory, language or reasoning ability;
• you have excessive thyroid activity which may result in 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.

Velariq may reduce the amount of saliva causing tooth decay, gum disease or mouth infection caused by
fungi (thrush).
Particular attention should be paid when using Velariq in hot weather or in the presence of fever. You should
for example avoid being in the sun and playing sports during the hottest hours. This is because Velariq
reduces the amount of sweat. This can lead to heat exhaustion and heatstroke.

Other medicines and Velariq
Tell your doctor if you are taking or have recently taken or might take any other
medicines.
The use of Velariq 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 Velariq 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).

Velariq with alcohol
Velariq can cause drowsiness or blurred vision. Drowsiness may be worsened 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 Velariq unless it has been prescribed by your doctor.
Breastfeeding
The use of Velariq during breastfeeding is not recommended.

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

3. How to use Velariq

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

Dose
Your doctor will calculate the correct amount of Velariq 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 (from 65 years)
The recommended starting dose is usually 10 mL of Velariq per day.

Children (6 - 12 years)
The recommended starting dose is usually 2 mL of Velariq per day.

If you have liver or kidney problems
If you have liver or kidney problems, tell your doctor.

Method of administration
Your doctor will prescribe Velariq 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 from germs as possible.
• 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 Velariq.

The procedure is as follows:

• 1. Prepare an environment that is as free from germs as possible.
• 2. Insert a sterile, single-use catheter into the bladder as directed by your doctor.
• 3. Completely empty the bladder using the catheter.
• 4. Remove the syringe from the pouch.
• 5. Remove the cap from the syringe.
• 6. Screw the conical luer-lock adapter 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 remaining in the syringe 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 adapter and any
unused medicine must be disposed of.

If you use more Velariq than you should
If you accidentally applied a dose higher than the prescribed one, immediately empty
your bladder with a catheter.
An overdose 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 Velariq
If you forget to use a dose at the usual time, use the usual dose in association with 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 Velariq
If you stop treatment with Velariq, the symptoms and the overactive bladder disorder may
recur or worsen. If you are thinking of 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 Velariq 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 for 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 injection (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 disorders

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

Skin

• facial flushing
• 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 disorder (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 Velariq that has been
prescribed to you.
One patient experienced oxygen deficiency during home oxygen therapy (see
section 2 under “Do not use Velariq”).

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

Reporting of 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 Velariq

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 special storage conditions.
For single use only.
Any unused solution must be disposed of immediately.
Do not dispose of any medicine in waste water 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 Velariq contains

• The active ingredient 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 excipients are: hydrochloric acid, sodium chloride solution (0.9 %).

Description of the appearance of Velariq and contents of the pack
Velariq is a clear and colorless solution. It is presented as a ready-to-use solution in a 10 mL cycloolefin copolymer pre-filled syringe with a plunger and a synthetic bromobutyl rubber cap at the end.
Blisters of 12, 96 and 96 (hospital pack) pre-filled syringes, including sterile adapters, respectively 12 and 96, as an application aid.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
AT: Velariq 1 mg/ml solution for intravesical use
BE: Velariq 1 mg/ml solution for intravesical use / solution intravésicale / Lösung
zur intravesikalen Anwendung
CZ: Tarraconiq 1 mg/ml intravesical solution
DE: Velariq 1 mg/ml Lösung zur intravesikalen Anwendung
LU: Velariq 1 mg/ml Lösung zur intravesikalen Anwendung
NL: Velariq 1 mg/ml solution for intravesical use
PL: Oxybutynin Medice 1 mg/ml solution for bladder use
PT: Velariq 1 mg/ml intravesical solution
SE: Velarmediq 1 mg/ml intravesical solution
SK: Velariq 1 mg/ml intravesical solution