Vesicare 1 mg/ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vesicare 1 mg/ml oral suspension

solifenacin, succinate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Vesicare is and what it is used for
2. What you need to know 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 the group of anticholinergics. These medicines are used to reduce the activity of the overactive bladder. This allows you to have more time before needing to go to the toilet and increases the amount of urine that your bladder can hold.

Vesicare is used to:

• treat symptoms of overactive bladder syndrome in adults.

These symptoms include a sudden, strong urge to urinate without prior warning, frequent urination, or leaking urine before reaching the toilet.

• treat a condition called "neurogenic detrusor overactivity" in children aged between 2 and 18 years. Neurogenic detrusor overactivity is a condition in which involuntary bladder contractions occur due to a birth condition or nerve damage affecting bladder control. If left untreated, neurogenic detrusor overactivity may cause damage to the bladder and/or kidneys.

Vesicare is used to increase the volume of urine the bladder can hold and to reduce urinary leakage.

2. What you need to know before taking Vesicare

Do not take Vesicare

• if you have difficulty passing urine or emptying your bladder completely (urinary retention) and you do not perform clean intermittent catheterisation (CIC);
• if you have a severe stomach or bowel condition (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 renal disease or moderate liver disease AND are also being treated with medicines that may reduce the elimination of Vesicare from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this applies.

Before starting treatment with Vesicare, inform your doctor if you have or have had any of the conditions listed above.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vesicare

• if you have problems emptying your bladder (= bladder obstruction) or difficulty passing urine (e.g., weak urine stream) and you do not perform clean intermittent catheterisation (CIC). In such cases, 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 are at risk of reduced digestive system activity (stomach and intestinal movements). Your doctor will inform you if this applies;
• if you have a condition that causes disturbances in your heart rhythm, especially a condition known as QT prolongation;
• if you have severe kidney disease;
• if you have moderate liver disease;
• if you have a diaphragm tear (hiatal hernia) or heartburn;
• if you have a nervous system disorder (autonomic neuropathy).

Before starting treatment with Vesicare, inform your doctor if you have or have had any of the conditions listed above.

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

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 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 need to take any other medicines.

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

• other anticholinergic medicines, as the activity and adverse effects of both medicines may increase;
• cholinergic agents, as they may reduce the effect of Vesicare;
• medicines such as metoclopramide or cisapride, which can speed up digestive system function. Vesicare may reduce their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate at which Vesicare is eliminated from the body;
• medicines such as rifampicin, phenytoin, and carbamazepine, which may increase the rate at which Vesicare is eliminated from the body;
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Vesicare with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not use Vesicare during pregnancy unless 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 operate 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: the ethanol comes from natural orange flavouring.

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% v/v) or less than 1 ml of wine (10% v/v). The small amount of alcohol in this medicine does not produce any noticeable effect.

Vesicare oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: these may cause an allergic reaction (possibly 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, 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; thus, it is essentially “sodium-free”.

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

3. How to take Vesicare

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Adults with overactive bladder

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

Children and adolescents (aged between 2 and 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 body weight. Follow the instructions carefully.

Use the oral syringe and bottle adapter supplied with Vesicare oral suspension to measure and administer the dose. If you need a dose greater than 5 mg (5 ml) daily, you will need to use the syringe twice to administer the total amount of each dose. Rinse the tip of the oral syringe with warm water before reusing it.

How to take the dose of Vesicare using an oral syringe

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

Preparation for first use of a Vesicare oral suspension bottle

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 insert the adapter into the neck of the bottle.
5. Ensure the top of the adapter is flush with the top of the bottle neck.
6. The adapter must remain in the bottle neck for the entire 28-day validity period.
7. Replace the cap on the bottle.

Before each oral administration

1. Wash your hands thoroughly.
2. Shake the Vesicare oral suspension bottle at least 20 times.
3. Remove the cap and ensure the adapter is in place in the bottle neck. Insert the tip of the oral syringe into the central opening of the bottle adapter until it is securely fitted.
4. Carefully turn the bottle and syringe upside down, ensuring the adapter remains in place.
5. While holding the bottle upside down, slowly pull back the plunger of the syringe to draw up the amount of medicine prescribed by your doctor.
6. If you accidentally draw up too much medicine, discard the excess.
7. Ensure there are no air bubbles in the syringe. If an air bubble appears, push the plunger upward to remove it.
8. Keeping 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 must 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 medication to the patient.
10. After administration is complete, close the bottle with the cap.
11. Wash the syringe with warm water and allow it to dry.

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

Cleaning of the oral syringe

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

The oral syringe may be used throughout the 28-day validity period following 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 at 91 562 04 20, stating the medicine and the amount ingested.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not there (hallucinations), over-excitability, seizures, difficulty breathing, increased heart rate (tachycardia), urine retention 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 for your next dose. Never take more than one dose per day. If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Vesicare

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• If you suffer an allergic attack (a sudden and rapid adverse reaction called "anaphylaxis" presenting as generalized itching, hives, swelling, difficulty breathing, and/or other allergic reactions) or a severe skin reaction (for example, blistering and peeling of the skin).
• If you experience angioedema (a skin allergy causing swelling in the tissue beneath the skin's surface) with airway obstruction (difficulty breathing). Angioedema has been reported in some patients treated with Vesicare.

Vesicare may cause the following adverse 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 stomach heaviness, abdominal pain, burping, heartburn (dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

• Urinary tract infection, bladder infection
• Drowsiness, disturbance in taste sensation (dysgeusia)
• Dry, irritated eyes
• Dryness of the nasal passages
• Gastroesophageal reflux disease (acid reflux), dry throat
• Dry skin
• Difficulty urinating
• Fatigue, fluid accumulation in legs (edema)

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

• Accumulation of hardened stool in the large intestine (fecal impaction)
• Urinary retention (urine accumulation in the bladder due to inability to empty it)
• Dizziness, headache
• Vomiting
• Itching, skin rash

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

• Hallucinations, confusion
• Allergic skin rash

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

• Decreased appetite, elevated blood potassium levels that may cause abnormal heart rhythm
• Increased pressure in the eyes
• Changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heart rate
• Voice disorder
• Liver disorder
• Muscle weakness
• Kidney disorder

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vesicare

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

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

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 month indicated.

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

Discard any remaining medicine 28 days after opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment. Disposal of unused medicine, bottle, syringe, and adapter must comply with local regulations.

6. Contents of the pack and other information

Composition of Vesicare

• The active substance is solifenacin succinate 1 mg per ml of suspension.
• The other components are polacriline potassium, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), propylene glycol (E-1520), 30% simethicone emulsion (comprising simethicone, polyoxyethylene sorbitan tristearate (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), acesulfame potassium (E-950), natural orange flavour (comprising orange essential oils, natural flavouring substances, ethanol, propylene glycol (E-1520), butylhydroxyanisole (E-320) and water), sodium hydroxide, purified water.

Nature of the product and contents of the container

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

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

The package contains dosing and administration devices: a 5 ml oral syringe and a press-in 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
The Netherlands

This medicinal product is authorized in the European Economic Area member states 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, the Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania and Sweden: Vesicare
Italy: Vesiker
Germany: Vesikur
Ireland: Vesitirim

Date of the most recent revision of this leaflet: September 2023.

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