Vesicare

Package leaflet: information for the patient

Vesicare, 1 mg/ml, oral suspension
solifenacin succinate
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Vesicare is and what it is 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 pack and other information

1. What Vesicare is and what it is used for

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

• for the treatment of symptoms of overactive bladder in adults. These include urgency, which are sudden, compelling urges to urinate, frequency, and urge incontinence, which is leakage of urine due to being unable to reach the toilet in time.
• for the treatment of neurogenic detrusor overactivity in children aged 2 to 18 years. Neurogenic detrusor overactivity is a condition in which involuntary contractions of the urinary bladder occur, either congenital or resulting from nerve damage affecting bladder control. Untreated neurogenic detrusor overactivity may lead to damage of the urinary bladder and/or kidneys. Vesicare is used to increase the volume of urine the bladder can hold and to reduce urinary leakage.

2. Important information before using Vesicare

When not to use Vesicare

• if the patient cannot pass urine or empty the urinary bladder (urinary retention) and does not perform clean intermittent catheterization;
• if there are severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
• if the patient has a muscle disease called myasthenia gravis, which may cause significant weakening of certain muscles;
• if the patient has narrow-angle glaucoma (increased fluid pressure in the eye leading to gradual loss of vision);
• if the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• if the patient is undergoing haemodialysis;
• if the patient has liver function disorders;
• if the patient has severe kidney disease or moderate liver disease and is also taking medicines that may delay elimination of Vesicare from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

Before starting treatment with Vesicare, inform your doctor if any of the above situations apply or have occurred in the past.

Warnings and precautions

Before starting treatment with Vesicare, discuss with your doctor or pharmacist if:

• the patient has difficulty emptying the bladder (obstruction of urinary outflow) or difficulty passing urine (weak urine stream) and does not perform clean intermittent catheterization. In such cases, the risk of urine accumulation in the bladder (urinary retention) is significantly higher.
• the patient has gastrointestinal motility disorders (constipation);
• there is a risk of slowed gastrointestinal motility (peristalsis). Your doctor will provide further information on this.
• the patient has any condition causing heart rhythm disturbances, especially a disorder known as QT prolongation;
• the patient has severe kidney function impairment;
• the patient has moderate liver function impairment;
• the patient has severe stomach pain (hiatal hernia) or heartburn;
• the patient has disorders of the nervous system (autonomic neuropathy).

Before starting treatment with Vesicare, inform your doctor if any of the above situations apply or have occurred in the past.

Before starting treatment with Vesicare, your doctor will assess whether there are other causes of frequent urination (e.g. heart failure – insufficient pumping capacity of the heart muscle, or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).

Children and adolescents

Vesicare must not be used in children under 2 years of age for the treatment of neurogenic detrusor overactivity.

Vesicare must not be used in children under 18 years of age for the treatment of overactive bladder syndrome.

Vesicare with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

It is especially important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as using such medicines together with Vesicare may increase both the therapeutic effects and the adverse effects of both medicines;
• cholinergic receptor agonists, as they may reduce the effectiveness of Vesicare;
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Vesicare may reduce their effectiveness;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they may slow down the metabolism of Vesicare;
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Vesicare;
• bisphosphonates, as they may cause or worsen oesophagitis.

Vesicare with food and drink

Vesicare oral suspension must not be taken with food or any drink other than water. After taking a dose, drink a glass of water. See section 3.

Accidental ingestion with food or drink may cause a bitter taste and numbness in the mouth.

Pregnancy and breastfeeding

If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should consult her doctor or pharmacist before using this medicine.

Vesicare must not be used during pregnancy unless absolutely necessary.

Vesicare must not be used during breastfeeding, as solifenacin passes into breast milk.

Driving and operating machinery

Vesicare may cause blurred vision, and less frequently, drowsiness and fatigue. If these adverse effects occur, do not drive or operate any machinery.

Vesicare oral suspension contains benzoic acid:
This medicine contains 0.015 mg of benzoic acid per ml, equivalent to 0.15 mg/10 ml.

Vesicare oral suspension contains ethanol:
Ethanol originates from natural orange flavouring.
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% w/v) or less than 1 ml of wine (10% w/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 allergic reactions (possibly delayed). Symptoms of allergic reaction include: rash, difficulty swallowing or breathing, swelling of lips, face, throat, and tongue.

Vesicare oral suspension contains propylene glycol:
This medicine contains 20 mg of propylene glycol per ml, equivalent to 200 mg/10 ml.

Vesicare oral suspension contains sodium hydroxide:
This medicine contains less than 1 mmol of sodium (23 mg) per ml, meaning the medicine is considered "sodium-free".

If Vesicare oral suspension gets into the eyes: rinse thoroughly with water.

3. How to use Vesicare

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
This medicine should be taken orally, once daily. Vesicare can be taken before or after food. After taking a dose of Vesicare, drink a glass of water. Do not take this medicine with food and (or) other beverages. Accidental intake with food and (or) other beverages may cause a bitter taste and numbness in the mouth.

Adults with overactive bladder syndrome
Your doctor will determine the appropriate dose to take. To measure and administer the dose, use the oral syringe and bottle adapter supplied with Vesicare oral suspension. If a daily dose of 10 mg (10 ml) is required, use the oral syringe twice to administer the total amount of each dose. Before reusing, rinse the tip of the oral syringe with warm water.

Children and adolescents (aged 2 to 18 years) with neurogenic detrusor overactivity
Your doctor will inform you of the dose to take and will determine the appropriate dose based on body weight. You must strictly follow these instructions.
To measure and administer the dose, use the oral syringe and bottle adapter supplied with Vesicare oral suspension. If the prescribed dose is greater than 5 mg (5 ml) per day, use the oral syringe twice to administer the total amount of each dose. Before reusing, rinse the tip of the oral syringe with warm water.

How to draw the correct dose of Vesicare using the oral syringe
Use the oral syringe and bottle adapter supplied with Vesicare oral suspension to measure the correct dose of medicine.

Preparing the Vesicare oral suspension bottle for first use

1. Wash your hands thoroughly.
2. Open the carton and remove the bottle, syringe, and adapter.
3. Place the bottle on a flat surface and remove the cap.
4. Firmly press the adapter into the neck of the bottle.
5. Ensure the top of the adapter is aligned with the top of the bottle neck.
6. The adapter should remain in the bottle neck for the entire 28-day shelf life period.
7. Close the bottle with 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 ensure the adapter is in place in the neck. Insert the tip of the oral syringe into the central opening of the adapter until it is securely in place.
4. Carefully invert the bottle and syringe, ensuring the adapter remains securely in place.
5. Slowly pull back the plunger of the syringe to draw the prescribed amount of suspension from the inverted bottle.
6. If too much medicine has been drawn by mistake, remove the excess.
7. Ensure there are no air bubbles in the syringe. If an air bubble appears, press the plunger upward to expel it.
8. Keep the syringe in place and return the bottle to an upright position so that the syringe plunger does not move. Gently remove the syringe from the adapter. The adapter should remain in place.
9. Confirm the correct dose has been measured. Place the syringe into the mouth and gently press down the plunger to administer the medicine to the patient.
10. After administering the dose, close the bottle with the cap.
11. Wash the syringe with warm water. Leave it to dry.

Note: If the patient requires a dose > 5 ml, rinse the tip of the oral syringe with warm water before reusing.

Cleaning the oral syringe
After use, clean the oral syringe with warm water only.
The oral syringe may be used throughout the 28-day shelf life period after first opening (see section 5).

Taking more Vesicare than prescribed
If you take too much Vesicare or if a child accidentally swallows it, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and visual disturbances, hallucinations, excessive excitation, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), urine retention (urinary retention), and dilated pupils.

Missing a dose of Vesicare
If you miss a dose, take the next dose as soon as possible, unless it is almost time for the next scheduled dose. Do not take the medicine more than once a day. If in doubt, consult your doctor or pharmacist.

Stopping Vesicare treatment
If you stop taking Vesicare, your underlying bladder condition may return or worsen. Stopping treatment should always be discussed with your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment with Vesicare should be discontinued and medical advice should be sought immediately if the patient experiences any of the following adverse reactions:

• If an allergic attack occurs (a reaction that starts suddenly and progresses rapidly, including generalized itching, urticaria, swelling, breathing difficulties and/or other allergic reactions known as anaphylaxis) or a severe skin reaction (e.g. blistering and peeling of the outer layer of skin).
• If angioedema (a type of allergic skin reaction causing swelling of tissue just beneath the skin surface) occurs, particularly involving swelling of the airways (causing breathing difficulties).
  Angioedema has been reported in some patients taking Vesicare.

Vesicare may cause other adverse reactions listed below.

Very common (may affect more than 1 in 10 people):

• dry mouth

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

• urinary tract infection, cystitis (inflammation of the bladder),
• somnolence, taste disturbances,
• dry eye syndrome,
• nasal dryness,
• gastroesophageal reflux (heartburn), throat dryness,
• dry skin,
• difficulty in urination,
• fatigue, peripheral edema (swelling of the lower limbs).

Rare (may affect up to 1 in 1000 people):

• accumulation of hard stool in the colon; colon obstruction,
• difficulty passing urine despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

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

• hallucinations, confusion,
• urticaria (hives).

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

• decreased appetite, increased blood potassium levels which may lead to cardiac arrhythmias,
• increased intraocular pressure,
• ECG changes, irregular heartbeat, palpitations, tachycardia (rapid heartbeat),
• voice disorders,
• liver function abnormalities,
• muscle weakness,
• kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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. Adverse reactions may also be reported to the Marketing Authorisation Holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Vesicare

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

6. Contents of the pack and other information

What Vesicare contains

• The active substance is solifenacin succinate, 1 mg per 1 ml of suspension.
• Other ingredients: potassium polacrilin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), simethicone (30% emulsion consisting of simethicone, polyethylene glycol sorbitan tristearate (E436), methylcellulose (E461), polyethylene glycol stearate, glycerides, xanthan gum (E415), benzoic acid (E210), sorbic acid (E200), sulfuric acid (E513), and water), carbomer, xylitol (E967), potassium acesulfame (E950), natural orange flavour (composed of orange essential oils, natural flavouring 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 watery, homogeneous suspension, white or almost white, with an orange flavour. Vesicare oral suspension is available in a 150 ml amber-coloured bottle made of polyethylene terephthalate (PET), closed with a child-resistant cap made of high-density polyethylene/polypropylene (HDPE/PP). The cardboard box contains an oral syringe with a capacity of 5 ml and a connector designed to be placed in the neck of the bottle, used for dosing and administration.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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,
The Netherlands

For further information, please contact the local representative of the Marketing Authorisation Holder.
Astellas Pharma Sp. z o.o.
ul. Żwirki i Wigury 16C
02-092 Warsaw
Tel.: (22) 545 11 11

This medicinal product is authorised in the European Economic Area and 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, The Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Spain and the United Kingdom (Northern Ireland): Vesicare
Italy: Vesiker
Germany: Vesicur
Ireland: Vesitrim