Vesiker

Package leaflet: Information for the user

Vesiker 1 mg/ml oral suspension

solifenacin succinate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Vesiker is and what it is used for

The active substance of Vesiker belongs to the group of anticholinergics. These medicines are used to
reduce the activity of the overactive bladder. This helps to delay the need to go to the bathroom and
increases the amount of urine that can be held in your bladder.
Vesiker is used for:

• treating the symptoms of a condition called overactive bladder in adult patients. These symptoms include: a strong and sudden urge to urinate without prior warning, frequent need to urinate, or urinary leakage because you cannot reach the toilet in time.
• treating a condition called neurogenic detrusor overactivity in children aged 2 to 18 years. Neurogenic detrusor overactivity is a condition in which involuntary bladder contractions occur due to a congenital (present from birth) condition or nerve damage affecting bladder control. If left untreated, neurogenic detrusor overactivity may lead to damage of the bladder and/or kidneys. Vesiker is used to increase the amount of urine the bladder can hold and to reduce urinary leakage.

2. What you should know before taking Vesiker

Do not take Vesiker:

• if you have an obstruction to urination (passage of urine) or to complete bladder emptying (urinary retention) and you are not following a clean intermittent catheterization (CIC) program;
• if you have a serious stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis);
• if you suffer from the muscle disease called myasthenia gravis, which causes extreme weakness of certain muscles;
• if you have increased intraocular pressure with gradual loss of vision (glaucoma);
• if you are allergic to solifenacin or to 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 simultaneously being treated with medicines that may reduce the elimination of Vesiker from the body (e.g., ketoconazole). Your doctor or pharmacist will advise you about this.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Vesiker:

• if you have difficulty emptying your bladder (= bladder obstruction) or if you experience problems with urine passage (e.g., reduced urine flow) and you are not performing clean intermittent catheterization (CIC). In such cases, the risk of urine accumulation in the bladder (urinary retention) is significantly higher;
• if you have gastrointestinal obstructions (constipation);
• if you are at risk of reduced gastrointestinal motility (stomach and intestinal movements). Your doctor will inform you about this possibility;
• if you suffer from any condition affecting heart rhythm, particularly a known abnormality called QT interval prolongation;
• if you have severe kidney disease;
• if you have moderate liver disease;
• if you have a stomach hernia (hiatal hernia) or heartburn;
• if you have nervous system disorders (autonomic neuropathy).

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

Before starting treatment with Vesiker, your doctor must ensure that there are no other underlying causes for frequent urination (e.g., heart failure (inadequate ability of the heart to pump blood) or kidney disease). If you have a urinary tract infection, your doctor may prescribe an antibiotic (treatment for specific bacterial infections).

Children and adolescents

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

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

Other medicines and Vesiker

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

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

• other anticholinergic medicines, as the effectiveness and side effects of both medicines may increase;
• cholinergic agents, which may reduce the effectiveness of Vesiker;
• medicines such as metoclopramide and cisapride, which stimulate gastrointestinal motility, as Vesiker may reduce their effectiveness;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of Vesiker from the body;
• medicines such as rifampicin, phenytoin, and carbamazepine, which may increase the rate of elimination of Vesiker from the body;
• medicines such as bisphosphonates, which may cause or worsen inflammation of the throat (esophagitis).

Vesiker with food and drinks

Vesiker oral suspension must not be taken together with food and/or drinks, except water. After taking a dose, drink a glass of water. See section 3. If you have accidentally taken the suspension together with food and/or drinks, you may experience a bitter taste and a sensation of numbness in the mouth.

Pregnancy and breastfeeding

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

You must not take Vesiker during pregnancy unless strictly necessary.

Do not use Vesiker while breastfeeding, as solifenacin may be excreted in breast milk.

Driving and using machines

Vesiker may cause blurred vision and, occasionally, drowsiness or fatigue. Therefore, avoid driving or operating machinery if you experience these side effects.

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

Vesiker 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 Vesiker oral suspension. The amount of ethanol in 10 ml of Vesiker oral suspension is equivalent 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 produce any significant effect.

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

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

Vesiker oral suspension contains sodium hydroxide: This medicine contains less than 1 mmol (23 mg) of sodium per ml and is therefore essentially 'sodium-free'.

In case of accidental contact of Vesiker oral suspension with the eyes: rinse and clean the eyes thoroughly with plenty of water.

3. How to take Vesiker

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Take this medicine by mouth once daily. You may take this medicine before or after meals. After taking a dose of Vesiker, drink a glass of water. Do not take this medicine together with food and/or other beverages. If you accidentally take the suspension together with food and/or other beverages, you may experience a bitter taste and a numb sensation in the mouth.

Adults with overactive bladder
Your doctor will determine the appropriate dose for you. To measure and administer the dose, use the oral dosing syringe and the bottle adapter supplied with Vesiker oral suspension. 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 tip of the oral dosing syringe with lukewarm water before reusing it.

Children and adolescents (aged 2 to 18 years) with neurogenic detrusor overactivity
Your doctor will tell you what dose you or your child should take. The doctor will calculate the correct dose based on body weight. You must follow their instructions carefully.
To measure and administer the dose, use the oral dosing syringe and the bottle adapter supplied with Vesiker oral suspension. If you need to take 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 tip of the oral dosing syringe with lukewarm water before reusing it.

How to administer a dose of Vesiker using an oral dosing syringe
To measure the correct dose, use the oral dosing syringe and the adapter supplied with Vesiker oral suspension.

Preparation for first use of the Vesiker oral suspension bottle

1. Wash your hands thoroughly.
2. Open the cardboard box 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 level with the top of the bottle neck.
6. The adapter must remain in the bottle neck for the entire 28-day shelf life period.
7. Replace the cap on the bottle.

Before each oral administration

1. Wash your hands thoroughly.
2. Shake the Vesiker oral suspension bottle at least 20 times.
3. Remove the bottle cap and ensure the adapter is in place in the bottle neck. Insert the tip of the oral dosing syringe into the central opening of the bottle adapter until it is securely in place.
4. Carefully turn the bottle and syringe upside down, ensuring the adapter remains in position.
5. From the inverted bottle, slowly pull back the plunger of the syringe to draw up the amount prescribed by your doctor.
6. If too much medicine has been drawn up by mistake, discard the excess amount.
7. Ensure there are no air bubbles in the syringe. If an air bubble appears, push the plunger upward to remove it.
8. Keep the syringe in place and rotate the bottle back to an upright position, ensuring the syringe plunger does not move. Gently remove the syringe from the adapter. The adapter must remain in place.
9. Confirm that the correct dose has been measured. Place the syringe in the mouth and gently push the plunger to administer the medicine to the patient.
10. After administration is complete: close the bottle with the cap.
11. Wash the syringe with lukewarm water. Allow it to dry.

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

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

If you take more Vesiker than you should
If you have taken too much Vesiker or if a child has accidentally taken Vesiker, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of non-existent objects (hallucinations), overexcitement, epileptic seizures, breathing difficulties, increased heart rate (tachycardia), urine retention in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Vesiker
If you forget to take a dose at your usual time, take it as soon as you remember, unless it is time for your next dose. Never take a double dose to make up for a forgotten dose.
If you have any doubts, always consult your doctor or pharmacist.

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

If you have any 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 everyone will experience them.
Stop treatment with Vesiker and seek immediate medical help if you experience any of the following side effects:

• If you have an allergic reaction (a sudden and rapid adverse reaction consisting of generalized itching, hives, swelling, breathing difficulties and/or other allergic reactions, known as anaphylaxis) or a severe skin reaction (e.g. blistering and peeling of the skin).
• If you develop angioedema (a skin allergic reaction characterized by swelling of the tissue just beneath the skin surface) with airway obstruction (difficulty breathing).
  Angioedema has been reported in some patients treated with Vesiker.

Vesiker may cause the following additional 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 bloating, abdominal pain, belching, heartburn (dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

• Urinary tract infections, bladder infections
• Drowsiness, altered taste perception (dysgeusia)
• Dry (irritated) eyes
• Dry nose
• Reflux disease (gastroesophageal reflux), dry throat
• Dry skin
• Difficulty urinating
• Fatigue, fluid accumulation in the lower legs (edema)

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

• Accumulation of large amounts of hardened feces in the colon (fecal impaction)
• Increased urine volume in the bladder due to inability to empty the bladder (urinary retention)
• Dizziness, headache
• Vomiting
• Itching, rash

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

• Hallucinations, confusion
• Allergic rash

Not known (frequency cannot be estimated from the available data)

• Decreased appetite, high levels of potassium in the blood which may cause abnormal heart rhythm
• Increased intraocular pressure
• Changes in heart electrical activity (ECG), irregular heartbeat, sensation of palpitations, rapid heartbeat
• Voice disorders
• Liver disorders
• Muscle weakness
• Kidney disorders

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vesiker

Keep this medicine out of the sight and reach of children.
Store the oral syringe in clean and dry conditions, protecting it from sunlight and heat.
Do not use this medicine after the expiry date stated on the label, box or bottle after EXP. The expiry date refers to the last day of that month.
Keep this medicine in its original packaging to protect it from light. This medicine does not require any special storage temperature. After first opening the bottle, the suspension can be stored for 28 days.
Dispose of any unused medicine after 28 days from opening the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment. The bottle, syringe, adapter and any unused medicine must be disposed of in accordance with local regulations.

6. Package contents and other information

What Vesiker contains

• The active substance is solifenacin succinate 1 mg per ml of suspension.
• The other ingredients are: polacrilin potassium, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), simeticone emulsion 30% (containing simeticone, polyoxyethylene stearate sorbitan (E436), methylcellulose (E461), polyethylene glycol stearate, glycerides, xanthan gum (E415), benzoic acid (E210), sorbic acid (E200), sulfuric acid (E513) and water), carbomer, xylitol (E967), acesulfame potassium (E950), natural orange flavour (containing orange essential oils, natural flavouring substances, ethanol, propylene glycol (E1520), butylated hydroxyanisole (E320) and water), sodium hydroxide, purified water.

Description of the appearance of Vesiker and contents of the pack
Vesiker oral suspension is a homogeneous aqueous suspension, white to off-white in colour, with an orange flavour.
Vesiker oral suspension is available in a 150 ml amber-coloured polyethylene terephthalate (PET) bottle,
closed with a high-density polyethylene-polypropylene child-resistant cap.
The dosing and administration devices are included in the cardboard box: a 5 ml oral dosing syringe and a press-in adapter for the bottle neck.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Astellas Pharma S.p.A.
Viale Don Luigi Sturzo, 43
20154 Milano (MI)
Italy

Manufacturer
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
The Netherlands

This medicinal product is authorised 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, The Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Spain, and the United Kingdom (Northern Ireland): Vesicare
Italy: Vesiker
Germany: Vesikur
Ireland: Vesitirim