VESICARE 1 mg/mL ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Vesicare 1 mg/ml Oral Suspension

solifenacin, succinate

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Vesicare and what is it used for
2. What you need to know before taking Vesicare
3. How to take Vesicare
4. Possible side effects
5. Storing Vesicare
6. Contents of the pack and further information

1. What is Vesicare and what is it used for

The active substance of Vesicare belongs to the group of anticholinergics. These medicines are used to reduce the activity of the overactive bladder. This allows you to have more time before you need to urinate and increases the amount of urine your bladder can hold.

Vesicare is used to:

• treat the symptoms of overactive bladder syndrome in adults.

These symptoms include: having a strong and sudden need to urinate without prior warning, having to urinate frequently or having urine leaks because you cannot get to the toilet in time.

• treat a disease called "neurogenic detrusor overactivity" in children aged 2 to 18 years. Neurogenic detrusor overactivity is a disease in which there are involuntary bladder contractions due to a birth condition or nerve damage that controls the bladder. If left untreated, neurogenic detrusor overactivity can cause damage to the bladder and/or kidneys.

Vesicare is used to increase the amount of urine that the bladder can hold and reduce urine leaks.

2. What you need to know before taking Vesicare

Do not take Vesicare

• if you have difficulty urinating or emptying your bladder completely (urinary retention) and do not have clean intermittent catheterization (CIC);
• if you have a severe stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis);
• if you have a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles;
• if you have high pressure in the eyes, with gradual loss of vision (glaucoma);
• if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• if you are undergoing renal dialysis;
• if you have severe liver disease;
• if you have severe kidney disease or moderate liver disease and are being treated with medicines that may decrease the elimination of Vesicare from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with Vesicare, tell your doctor if you have or have had any of the diseases mentioned above.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vesicare

• if you have problems emptying your bladder (= bladder obstruction) or urinating (e.g. a weak urine flow) and do not have clean intermittent catheterization (CIC). In this case, the risk of urine accumulation in the bladder (urinary retention) is much higher;
• if you have any obstruction of the digestive tract (constipation);
• if you have a risk of decreased activity of the digestive tract (movements of the stomach and intestine). Your doctor will inform you if this is the case;
• if you have any disorder that leads to alterations in your heart rhythm, especially an anomaly known as QT interval prolongation;
• if you have severe kidney disease;
• if you have moderate liver disease;
• if you have a hernia (hiatal hernia) or heartburn;
• if you have a nervous disorder (autonomic neuropathy).

Before starting treatment with Vesicare, tell your doctor if you have or have had any of the diseases mentioned above.

Before starting treatment with Vesicare, your doctor will assess if there are other causes for your frequent need to urinate (e.g. heart failure (insufficient pumping capacity of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (treatment against certain bacterial infections).

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 or adolescents under 18 years of age for the treatment of overactive bladder.

Other medicines and Vesicare

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is especially important that you tell your doctor if you are taking:

• other anticholinergic medicines, the activity and side effects of both medicines may increase.
• cholinergic medicines, as they may reduce the effect of Vesicare.
• medicines such as metoclopramide or cisapride, which may speed up the functioning of the digestive tract. Vesicare may reduce their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of Vesicare from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of Vesicare from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Vesicare with food and drinks

Vesicare oral suspension should not be taken with food and/or other drinks except water. Take a glass of water after taking your dose. See section 3. If you accidentally take the suspension with food and/or drinks, you may notice a bitter taste and a sensation of numbness in your mouth.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not use Vesicare if you are pregnant, unless it is absolutely necessary.

Do not use Vesicare during breastfeeding, as solifenacin may pass into breast milk.

Driving and using machines

Vesicare may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or use machines.

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

Vesicare oral suspension contains ethanol:the ethanol comes from the natural orange flavor.

This medicine contains 48.4 mg of alcohol (ethanol) per maximum dose of 10 ml of Vesicare oral suspension. The amount of ethanol contained in 10 ml of Vesicare oral suspension is equivalent to 1 ml of beer (4% p/v) or less than 1 ml of wine (10% p/v). The small amount of alcohol in this medicine does not produce any noticeable effect.

Vesicare oral suspension contains methyl hydroxybenzoate and propyl hydroxybenzoate:this may cause an allergic reaction (which may be delayed). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

Vesicare oral suspension contains propylene glycol:this medicine contains 20 mg of propylene glycol per ml, which is 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; this is, essentially "sodium-free".

If Vesicare oral suspension comes into contact with your eyes, rinse and wash your eyes with plenty of water.

3. How to take Vesicare

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Take this medicine orally once a day. You can take this medicine before or after a meal. Drink a glass of water after taking your dose of Vesicare. Do not take this medicine with food and/or other drinks except water. If you accidentally take the suspension with food and/or drinks, you may notice a bitter taste and a sensation of numbness in your mouth.

Adults with overactive bladder

Your doctor will determine the appropriate dose for you. Use the oral syringe and adapter provided with Vesicare oral suspension to measure and administer the dose. If you need to take a dose of 10 mg (10 ml) per day, you will need to use the syringe twice to administer the total amount of each dose. Rinse the end of the oral syringe with hot water before reusing it.

Children and adolescents (aged 2 to 18 years) with neurogenic detrusor overactivity

Your doctor will tell you what dose you/your child should take. Your doctor will calculate the correct dose for each patient based on their body weight. Follow their instructions carefully.

Use the oral syringe and adapter provided with Vesicare oral suspension to measure and administer the dose. If you need a dose greater than 5 mg (5 ml) per day, you will need to use the syringe twice to administer the total amount of each dose. Rinse the end of the oral syringe with hot water before reusing it.

How to take the dose of Vesicare using an oral syringe

Use the oral syringe and adapter provided with Vesicare oral suspension to measure the correct dose.

Preparation for first use of a bottle of Vesicare oral suspension

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. Firmly insert the adapter into the neck of the bottle.
5. Make sure the top of the adapter is level 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. Replace the cap on the bottle.

Before each oral administration

1. Wash your hands thoroughly.
2. Shake the bottle of Vesicare oral suspension at least 20 times.
3. Remove the cap and ensure the adapter is in place. Insert the end of the oral syringe into the central opening of the bottle adapter until it is firmly seated.
4. Carefully turn the bottle and syringe upside down, making sure the adapter remains in place.
5. While keeping the bottle upside down, slowly pull the syringe plunger to withdraw the prescribed amount of medicine.
6. If you accidentally withdraw too much medicine, discard the excess.
7. Make sure there are no air bubbles in the syringe. If a bubble appears, push the plunger up to remove it.
8. Leave the syringe in place, turn the bottle upright, and ensure the plunger does not move. Then, gently remove the syringe from the adapter. The adapter should remain in place.
9. Check that you have measured the correct dose. Place the syringe in the mouth and gently push the plunger to administer the medicine to the patient.
10. After completing administration, close the bottle with the cap.
11. Wash the syringe with hot water and let it dry.

Note: If the patient requires a dose > 5 ml, rinse the end of the syringe with hot water before reusing it.

Cleaning the oral syringe

After use, clean the oral syringe only with hot water.

The oral syringe can be used throughout the 28-day validity period after first opening (see section 5).

If you take more Vesicare than you should

If you have taken too much Vesicare or if a child has accidentally taken Vesicare, contact your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms in case of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perception of things that are not there (hallucinations), over-excitability, convulsions, difficulty breathing, increased heart rate (tachycardia), accumulation of urine in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Vesicare

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take the next dose. Never take more than one dose per day. If you are unsure, consult your doctor or pharmacist.

If you stop taking Vesicare

If you stop taking Vesicare, the symptoms of your underlying bladder disease may return or worsen. Always consult your doctor if you are thinking of stopping treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Vesicare and seek medical attention immediately if you notice any of the following side effects:

If you suffer an allergic reaction (a rapid and sudden effect called "anaphylaxis" that manifests as generalized itching, hives, swelling, difficulty breathing, and/or other allergic reactions) or a severe skin reaction (e.g. blistering and peeling of the skin).

If you suffer angioedema (allergy in the skin that results in inflammation that occurs in the tissue under the skin surface) with airway obstruction (difficulty breathing). Angioedema has been reported in some patients treated with Vesicare.

Vesicare may cause the following side effects:

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, indigestion with symptoms such as feeling of stomach heaviness, abdominal pain, belching, heartburn (dyspepsia), stomach discomfort

Uncommon(may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness, taste disorder (dysgeusia)
• dry eyes (irritated)

• dryness of the nasal passages
• gastroesophageal reflux disease (GERD), dry throat
• dry skin
• difficulty urinating
• fatigue, fluid accumulation in legs (edema)

Rare(may affect up to 1 in 1,000 people)

• accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• accumulation of urine in the bladder due to inability to empty the bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, skin rash

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

• hallucinations, confusion

• allergic skin reaction

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

• decreased appetite, high levels of potassium in the blood that can cause abnormal heart rhythm
• increased pressure in the eyes
• changes in the electrical activity of the heart (ECG), irregular heartbeats, palpitations, rapid heart rate
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Vesicare

Keep this medicine out of the sight and reach of children.

Store the oral syringe clean and dry in a place protected from sunlight and heat.

Do not use this medicine after the expiry date which is stated on the label, carton, or bottle after EXP. The expiry date is the last day of the month indicated.

Store this medicine in its original container to protect it from light. This medicine does not require any special storage temperature. After the first opening of the bottle, the suspension can be stored for 28 days.

Discard any remaining medicine after 28 days after opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment. The disposal of unused medicine, bottle, syringe, and adapter will be carried out in accordance with local regulations.

6. Container Content and Additional Information

Vesicare Composition

• The active ingredient is solifenacin, succinate 1 mg per ml of suspension.
• The other components are potassium polacrylate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), propylene glycol (E-1520), 30% simethicone emulsion (composed of simethicone, polyoxyethylene sorbitan trioleate (E-436), methylcellulose (E-461), polyethylene glycol stearate, glycerides, xanthan gum (E-415), benzoic acid (E-210), sorbic acid (E-200), sulfuric acid (E-513), and water), carbomer, xylitol (E-967), potassium acesulfame (E-950), natural orange flavor (composed of orange essential oils, natural flavoring substances, ethanol, propylene glycol (E-1520), butylhydroxyanisole (E-320), and water), sodium hydroxide, and purified water.

Product Appearance and Container Content

Vesicare oral suspension is a homogeneous, aqueous suspension, white to off-white in color, with an orange flavor.

Vesicare oral suspension is provided in a 150 ml amber polyethylene terephthalate (PET) bottle with a high-density polyethylene-polypropylene child-resistant cap.

The box contains dosing and administration devices: a 5 ml oral syringe and a pressure adapter for the bottle neck.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - 31st floor

28046 Madrid (Spain)

Tel. +31 91 4952700

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

This medicinal product 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, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania, and Sweden: Vesicare

Italy: Vesiker

Germany: Vesikur

Ireland: Vesitirim

Date of the Last Revision of this Leaflet:September 2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/