Package Insert: Information for the User

Vesicare 1 mg/ml Oral Suspension

solifenacin succinate

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section4.

1. What Vesicare is and for what it is used

2. What you need to know before starting to take Vesicare

3. How to take Vesicare

4. Possible adverse effects

5. Storage of Vesicare

6. Contents of the package and additional information

The active ingredient of Vesicare belongs to the group of anticholinergics. These medications are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to go to the bathroom and increases the amount of urine that your bladder can hold.

Vesicare is used for:

• 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 leakage due to not making it to the bathroom on time.

• To treat a condition called«neurogenic detrusor overactivity»in children aged 2to 18years old. Neurogenic detrusor overactivity is a condition in which involuntary bladder contractions occur due to a birth defect or damage to the nerves that control the bladder. If left untreated, neurogenic detrusor overactivity can cause damage to the bladder and/or kidneys.

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

Do not take Vesicare

• if you have difficulty urinating or emptying your bladder completely (urinary retention) and do not have intermittent clean catheterization (ICC);
• 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 in certain muscles;
• if you have high eye pressure, with gradual loss of vision (glaucoma);
• if you are allergic to solifenacin or any of the other components of this medication (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 medications that can decrease the elimination of Vesicare from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Inform your doctor if you have or have had any of the above-mentioned diseases before starting treatment with Vesicare.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vesicare

• if you have difficulty emptying your bladder or urinating (e.g., weak urine flow) and do not have intermittent clean catheterization (ICC). 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 (gastrointestinal motility). Your doctor will inform you if this is the case;
• if you have any disorder that causes alterations in your heart rhythm, especially a condition known as prolonged QT interval;
• if you have severe kidney disease;
• if you have moderate liver disease;
• if you have a hiatal hernia or heartburn;
• if you have an autonomic neuropathy.

Inform your doctor if you have or have had any of the above-mentioned diseases before starting treatment with Vesicare.

Before starting treatment with Vesicare, your doctor will evaluate if there are other causes for your need to urinate frequently (e.g., heart failure 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 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 medications and Vesicare

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• other anticholinergic medications, the activity and adverse effects of both medications may increase.
• anticholinergic medications, as they may reduce the effect of Vesicare.
• medications such as metoclopramide or cisapride, which can accelerate the functioning of the digestive tract. Vesicare may reduce their effect.
• medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of Vesicare from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, which may increase the rate of elimination of Vesicare from the body.
• medications such as bisphosphonates, which may cause or worsen esophagitis.

Taking Vesicare with food and drinks

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

Pregnancy and lactation

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

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 operating machinery

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 medication 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 natural orange flavor.

This medication 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 medication has no perceptible effect.

Vesicare oral suspension contains methyl and propyl parahydroxybenzoate:this may cause an allergic reaction (possibly delayed). Among the signs of an allergic reaction are: skin rash, difficulty swallowing or breathing, inflammation of the lips, face, throat, or tongue.

Vesicare oral suspension contains propylene glycol:this medication contains 20 mg of propylene glycol per ml, which is equivalent to 200 mg/10 ml.

Vesicare oral suspension contains sodium hydroxide:this medication 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 flush your eyes with plenty of water.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt,consult your doctor or pharmacist again.

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

Adults with overactive bladder

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

Children and adolescents (between 2years and 18years) 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 the adapter provided with Vesicare oral suspension to measure and administer the dose. If you need a dose greater than 5mg (5ml) per day, you will have to use the syringe twice to administer the total amount of each dose. Clear 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 the adapter provided with Vesicare oral suspension to measure the correct dose.

Preparation for first-time use of a Vesicare oral suspension bottle

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. Insert the adapter firmly 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 must remain in the bottle neck until the end of the 28day 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 20times.
3. Remove the cap and make sure the adapter is in place. Insert the tip of the oral syringe into the central opening of the adapter on the bottle until it is firmly seated.
4. Carefully place the bottle and syringe upside down, making sure the adapter remains in place.
5. While keeping the bottle upside down, slowly pull the plunger of the syringe to extract the prescribed amount of medication.
6. If you accidentally extract too much medication, 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, place the bottle upright, and make sure 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 completing administration, close the bottle with the cap.
11. Clean the syringe with warm water and let it dry.

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

Cleaning the oral syringel

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

The oral syringe can be used throughout the 28day validity period after the first opening (see section5).

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, phone 91 562 04 20 indicating the medication and the amount ingested.

The symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perception of things that are not there (hallucinations), over-excitement, convulsions, 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 to take the next dose. Never take more than one dose per day. If you have any doubts, consult your doctor or pharmacist.

If you interrupt treatment with Vesicare

If you stop taking Vesicare, your underlying bladder symptoms may return or worsen. Consult your doctor if you are thinking of interrupting treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

If you experience an allergic attack (a rapid and sudden side effect called "anaphylaxis" that manifests as generalized itching, hives, inflammation, difficulty breathing, and/or other allergic reactions) or a severe skin reaction (for example, the formation of blisters and skin peeling).

If you experience angioedema (allergy on the skin that results in inflammation that occurs in the tissue beneath the skin surface) with respiratory tract 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 10people)

• dry mouth

Common(may affect up to 1 in 10people)

• 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 100people)

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

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

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

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

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

• hallucinations, confusion

• allergic skin rash

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

• decreased appetite, elevated potassium levels in the blood that may cause abnormal heart rhythm
• increased eye pressure
• changes in heart electrical activity (ECG), irregular heartbeats, palpitations, rapid heart rate
• voice disorder
• liver disorder
• muscle weakness
• renal disorder

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the reach and sight of children.

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

Do not use this medication after the expiration date that appears on the label, the box, or the bottle after CAD. The expiration date is the last day of the month indicated.

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

Dispose of any remaining medication after 28days after opening the bottle.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at thePharmaceutical Waste Collection Pointof the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment. The disposal of unused medication, the bottle, syringe, and adapter will be carried out in accordance with local regulations.

Composition of Vesicare

• The active ingredient issolifenacin, succinate 1mg per ml of suspension.
• The other components are potassium polacrilin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), propylene glycol (E-1520), emulsion of simethicone at 30% (composed of simethicone, polyoxethylene sorbitan triesterate (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 flavorings, ethanol, propylene glycol (E-1520), butylhydroxyanisole (E-320) and water), sodium hydroxide, purified water.

Appearance of the product and contents of the package

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

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - Floor 31

28046 Madrid (Spain)

Tel. +31 91 4952700

Responsible for manufacturing

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with 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

Revision date of this leaflet:September 2023.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/