Vesicare

Leaflet accompanying the packaging: patient information

Vesicare, 1 mg/ml, oral suspension

solifenacin succinate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

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

1. What is Vesicare and what is it used for

The active substance of Vesicare belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This action allows for longer intervals between visits to the toilet and increases the amount of urine held in the bladder.
Vesicare is used:

• to treat symptoms of an overactive bladder in adults. These symptoms include: urgent urination, which are unexpected, urgent needs to urinate, frequent urination, and incontinence related to not being able to get to the toilet in time.
• to treat a condition called neurogenic detrusor overactivity in children aged 2 to 18 years. Neurogenic detrusor overactivity is a condition where there are involuntary contractions of the bladder muscle, which are congenital or result from nerve damage controlling the bladder. Untreated neurogenic detrusor overactivity can lead to bladder and/or kidney damage. Vesicare is used to increase the amount of urine in the bladder and reduce urine leakage.

2. Important information before taking Vesicare

When not to take Vesicare

• if the patient is unable to urinate or empty their bladder (urinary retention) and does not perform clean intermittent catheterization;
• if there are severe gastrointestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
• if there is a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles;
• if there is glaucoma with a narrow angle of filtration (increased pressure in the eyeball progressing with gradual vision loss);
• if there is an allergy to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• if hemodialysis is being performed;
• if there are liver function disorders;
• if there are severe kidney diseases or moderate liver diseases and other medicines are being taken that may delay the elimination of Vesicare from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

Before starting treatment with Vesicare, the patient should inform their doctor if any of the above situations occur or have occurred in the past.

Warnings and precautions

Before starting treatment with Vesicare, the patient should discuss it with their doctor or pharmacist

• if there are difficulties in emptying the bladder (narrowing of the urethra) or urinating (weak urine stream) and clean intermittent catheterization is not being performed. In such cases, the risk of urine accumulation in the bladder (urinary retention) is much higher.
• if there are gastrointestinal motility disorders (constipation);
• if there is a risk of slowed gastrointestinal motility (peristalsis). The doctor will provide information on this.
• if there is any condition that affects heart rhythm, especially a condition called QT interval prolongation;
• if there are severe kidney function disorders;
• if there are moderate liver function disorders;
• if there is a burning stomach pain (hiatal hernia) or heartburn;
• if there are autonomic nervous system disorders (autonomic neuropathy).

Before starting treatment with Vesicare, the patient should inform their doctor if any of the above situations occur or have occurred in the past.
Before starting treatment with Vesicare, the doctor will assess whether there are other causes of frequent urination (e.g., heart failure - insufficient heart muscle strength to pump blood or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial medicine, acting on specific bacteria).

Children and adolescents

Vesicare should not be used in children under 2 years of age for the treatment of neurogenic detrusor overactivity.
Vesicare should not be used in children under 18 years of age for the treatment of overactive bladder syndrome.

Vesicare and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
It is especially important to inform the doctor if the patient is taking:

• other anticholinergic medicines, as taking such a medicine with Vesicare may lead to increased therapeutic and adverse effects of both medicines
• cholinergic receptor agonist medicines, as they may weaken the effect of Vesicare
• gastrointestinal motility enhancers, such as metoclopramide and cisapride, as Vesicare may weaken their effect
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Vesicare
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Vesicare
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Vesicare with food and drink

Vesicare oral suspension should not be taken with food or drink other than water. After taking a dose of Vesicare, the patient should drink a glass of water. See section 3.
Accidental consumption with food or drink may cause a bitter taste and numbness in the mouth.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Vesicare should not be used during pregnancy, unless it is absolutely necessary.
Vesicare should not be used during breastfeeding, as solifenacin passes into breast milk.

Driving and using machines

Vesicare may cause blurred vision, and less often, drowsiness and fatigue. If such side effects occur, the patient should not drive or operate any machinery.
Vesicare oral suspension contains benzyl alcohol:this medicine contains 0.015 mg of benzyl alcohol per ml, which corresponds to 0.15 mg/10 ml.

Vesicare oral suspension contains ethanol:

Etanol comes from natural orange flavor.
This medicine contains 48.4 mg of alcohol (ethanol) in the maximum dose of 10 ml of Vesicare oral suspension. The ethanol content in 10 ml of Vesicare oral suspension corresponds to 1 ml of beer (4% v/v) or less than 1 ml of wine (10% v/v). The small amount of alcohol in this medicine will not cause any noticeable effects.

Vesicare oral suspension contains methyl parahydroxybenzoate and

propyl parahydroxybenzoate:these substances may cause an allergic reaction (likely to be delayed). Symptoms of an allergic reaction include: rash, swallowing difficulties, breathing difficulties, swelling of the mouth, face, throat, and tongue.
Vesicare oral suspension contains propylene glycol:this medicine contains 20 mg of propylene glycol per ml, which corresponds to 200 mg/10 ml.
Vesicare oral suspension contains sodium hydroxide:this medicine contains less than 1 mmol of sodium (23 mg) per 1 ml, which means the medicine is considered "sodium-free".
If Vesicare oral suspension gets into the eyes: they should be rinsed with plenty of water.

3. How to take Vesicare

This medicine should always be taken as directed by the doctor. If there are any doubts, the patient should consult their doctor or pharmacist.
The medicine should be taken orally, once a day. The medicine can be taken before or after a meal. After taking a dose of Vesicare, the patient should drink a glass of water. The medicine should not be taken with food or other drinks. Accidental consumption with food or drink may cause a bitter taste and numbness in the mouth.
Adults with overactive bladder syndrome
The doctor will determine the appropriate dose to be taken. To measure and administer the dose, the oral syringe and adapter provided with Vesicare oral suspension should be used. If a dose of 10 mg (10 ml) per day is required, the syringe should be used twice to administer the total amount of each dose. Before reusing, the oral syringe tip should be rinsed with warm water.
Children and adolescents (aged 2 to 18 years) with neurogenic detrusor overactivity
The doctor will inform the patient about the dose to be taken and will determine the appropriate dose based on body weight. These instructions should be followed carefully.
To measure and administer the dose, the oral syringe and adapter provided with Vesicare oral suspension should be used. If the prescribed dose is greater than 5 mg (5 ml) per day, the syringe should be used twice to administer the total amount of each dose. Before reusing, the oral syringe tip should be rinsed with warm water.

How to take the correct dose of Vesicare using the oral syringe

The oral syringe and adapter provided with Vesicare oral suspension should be used to measure the correct dose of the medicine.
Preparing the Vesicare oral suspension bottle for first use

• 1. Wash your hands thoroughly.
• 2. Open the box and remove the bottle, syringe, and adapter.
• 3. Place the bottle on a flat surface and remove the cap.
• 4. Press the adapter firmly into the neck of the bottle.
• 5. Make sure the top of the adapter is in line with the top of the bottle neck.
• 6. The adapter should remain in the bottle neck until the end of the 28-day validity period.
• 7. Close the bottle using the cap.

Before each oral administration

• 1. Wash your hands thoroughly.
• 2. Shake the Vesicare oral suspension bottle at least 20 times.
• 3. Remove the cap from the bottle and make sure the adapter is in the bottle neck. Insert the tip of the oral syringe into the hole in the center of the adapter until it is in place.
• 4. Carefully turn the bottle and syringe upside down, making sure the adapter remains in place.
• 5. Slowly pull the syringe plunger to draw the prescribed amount of suspension from the inverted bottle.
• 6. Remove any excess if too much medicine is accidentally drawn.
• 7. Make sure there are no air bubbles in the syringe. If an air bubble appears, press the plunger upwards to remove it.
• 8. Leave the syringe in place and turn the bottle upright so that the syringe plunger does not move. Gently remove the syringe from the adapter. The adapter should remain in place.
• 9. Make sure the correct dose has been measured. Place the syringe in the mouth and gently press the plunger down to administer the medicine to the patient.
• 10. After administering the dose, close the bottle using the cap.
• 11. Wash the syringe with warm water. Leave it to dry.

Note: If the patient requires a dose > 5 ml, rinse the syringe tip with warm water before reusing.
Cleaning the oral syringe
After use, wash the oral syringe with warm water only.
The oral syringe can be used for the entire 28-day validity period after first opening (see section 5).

Taking a higher dose of Vesicare than recommended

If too much Vesicare is taken or if Vesicare is accidentally swallowed by a child, the patient should immediately contact their doctor or pharmacist.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), urine accumulation in the bladder (urinary retention), and dilated pupils.

Missing a dose of Vesicare

If a dose of Vesicare is missed, the patient should take the next dose as soon as possible, unless it is almost time for the next dose. The medicine should not be taken more than once a day. If there are any doubts, the patient should consult their doctor or pharmacist.

Stopping treatment with Vesicare

If treatment with Vesicare is stopped, the underlying bladder condition may return or worsen. Stopping treatment with Vesicare should always be discussed with the doctor.
If there are any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Vesicare can cause side effects, although not everybody gets them.
The patient should stop taking Vesicare and immediately consult their doctor if they experience any of the following side effects:
If an allergic reaction occurs (a side effect that occurs suddenly and quickly, including generalized itching, hives, swelling, breathing difficulties, and/or other allergic reactions, called anaphylaxis) or a severe skin reaction (e.g., blistering and peeling of the skin).
If angioedema occurs (a form of allergy that causes swelling of the tissue just beneath the skin's surface, resulting in swelling of the airways).
Some patients taking Vesicare have reported angioedema.
Vesicare may cause other side effects, listed below.

• Very common(may affect more than 1 in 10 people) side effects include:

dry mouth.

• Common(may affect up to 1 in 10 people) side effects include:

blurred vision, constipation, nausea, indigestion with symptoms such as: feeling of fullness in the stomach, abdominal pain, belching, heartburn, discomfort in the abdominal cavity.

• Uncommon(may affect up to 1 in 100 people) side effects include:

urinary tract infection, cystitis

• drowsiness, taste disturbances,
• dry eye syndrome,
• dryness in the nose,
• gastroesophageal reflux (heartburn), dry throat,
• dry skin,
• urination difficulties,
• fatigue, swelling of the lower limbs.

Rare(may affect up to 1 in 1,000 people) side effects include:

• accumulation of a large amount of hard stool in the colon; bowel obstruction (intestinal obstruction)
• difficulty urinating despite a full bladder (urinary retention)
• dizziness, headaches,
• vomiting,
• itching, rash.

Very rare(may affect up to 1 in 10,000 people) side effects include:

• hallucinations, confusion,
• hives.

Frequency not known(frequency cannot be estimated from the available data)

• decreased appetite, increased potassium levels in the blood, which can cause heart rhythm disturbances,
• increased pressure in the eyeball,
• changes in ECG, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor. 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
PL-02 222 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 this medicine.

5. How to store Vesicare

The medicine should be stored out of sight and reach of children.
The oral syringe should be stored in a clean and dry place, away from sunlight and heat sources.
Do not use this medicine after the expiry date stated on the label, carton, or bottle after: Expiry Date (EXP). The expiry date refers to the last day of the month stated.
Store in the original packaging to protect from light. There are no special storage instructions for the medicinal product. After first opening the bottle, the oral suspension can be stored for 28 days.
Any remaining medicine should be discarded after 28 days from opening the bottle.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment. The bottle, syringe, adapter, and unused remnants of the medicinal product should be disposed of in accordance with local regulations.

6. Contents of the packaging and other information

What Vesicare contains

• The active substance of Vesicare is solifenacin succinate, 1 mg per 1 ml of suspension.
• Other ingredients: potassium polacrilin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), simethicone (emulsion 30% consisting of simethicone, polyethylene glycol stearate, methylcellulose (E461), polyethylene glycol stearate, glycerides, xanthan gum (E415), benzyl alcohol (E210), sorbic acid (E200), sulfuric acid (E513), and water), carbomer, xylitol (E967), acesulfame potassium (E950), natural orange flavor (consisting of orange essential oils, natural flavoring substances, ethanol, propylene glycol (E1520), butylhydroxyanisole (E320), and water), sodium hydroxide, purified water.

What Vesicare looks like and contents of the pack

Vesicare oral suspension is a white or almost white, uniform suspension with an orange flavor.
Vesicare oral suspension is available in an orange polyethylene terephthalate (PET) bottle with a child-resistant closure made of high-density polyethylene-polypropylene (HDPE/PP).
The carton contains an oral syringe with a capacity of 5 ml and an adapter for insertion into the neck of the bottle, which are used for dosing and administration.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Astellas Pharma Sp. z o.o.
ul. Żwirki i Wigury 16C
02-092 Warsaw
Tel.: (22) 545 11 11
Manufacturer/Importer:
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel,
Netherlands
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder.
Astellas Pharma Sp. z o.o.
ul. Żwirki i Wigury 16C
02-092 Warsaw
Tel.: (22) 545 11 11

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

under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Spain, and the United Kingdom (Northern Ireland): Vesicare
Italy: Vesiker
Germany: Vesicur
Ireland: Vesitrim

Date of last revision of the leaflet: 04/2024