VESIKER 5 mg Film-Coated Tablets

Зміст інструкції

1. Vesiker 1 mg/ml oral suspension
   1. What is Vesiker and what is it 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. Package Contents and Other Information

Vesiker 1 mg/ml oral suspension

solifenacina succinato

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Vesiker and what is it used for

The active substance of Vesiker belongs to the group of anticholinergics. These medicines are used to
reduce the activity of an overactive bladder. This allows delaying the need to go to the bathroom and
increases the amount of urine that can be contained within your bladder.
Vesiker is used for:

• treating the symptoms of a condition defined as overactive bladder in adult patients. These symptoms include: a strong and sudden urge to urinate without preceding signals, the need to urinate frequently, or wetting oneself because one cannot reach the bathroom in time.
• treating a condition defined as neurogenic detrusor overactivity in children from 2 to 18 years of age. Neurogenic detrusor overactivity is a condition in which involuntary bladder contractions occur caused by a congenital condition (present from birth) or damage to the nerves that control the bladder. If left untreated, neurogenic detrusor overactivity can lead to bladder and/or kidney damage. Vesiker is used to increase the amount of urine that can be retained in the bladder and reduce urinary leakage.

2. What you need to know before taking Vesiker

Do not take Vesiker if:

• you have an inability to urinate (emission of urine) or complete emptying of the bladder (urinary retention) and if you are not following a program of clean intermittent catheterization (CIC);
• you have a serious problem with your stomach or intestines (including toxic megacolon, a complication associated with ulcerative colitis);
• you suffer from a muscle disease defined as myasthenia gravis, which causes extreme weakness of some muscles;
• you suffer from increased eye pressure, with gradual loss of vision (glaucoma);
• you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• you are undergoing renal dialysis;
• you suffer from severe liver disease;
• you suffer from severe kidney disease or mild liver disease and are simultaneously treated with medicines that can reduce the elimination of Vesiker from the body (for example, ketoconazole). Your doctor or pharmacist will inform you about this.

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

Warnings and precautions
Consult your doctor or pharmacist before taking Vesiker if:

• you have difficulty emptying your bladder (= bladder obstruction) or if you have difficulty passing urine (for example, reduced urine flow) and do not follow a clean intermittent catheterization. In these cases, the risk of urine accumulation inside the bladder (urinary retention) is much higher;
• you have obstructions of the digestive system (constipation);
• you have a risk of reduced gastrointestinal motility (movements of the stomach and intestines). Your doctor will inform you about this possibility;
• you suffer from any disorder that causes an alteration of the heart rhythm, especially an abnormality known as prolongation of the QT interval;
• you suffer from severe kidney disease;
• you suffer from moderate liver disease;
• you have a tear in the stomach (hiatal hernia) or heartburn;
• you have disorders of the nervous system (autonomic neuropathy).

Before starting treatment with Vesiker, tell your doctor if you have or have ever had any of the conditions listed above.
Before starting treatment with Vesiker, the doctor must ascertain that there are no other causes that lead to the need to urinate frequently (for example, heart failure (insufficient ability of the heart to pump blood) or kidney disease). If you have a urinary tract infection, your doctor may prescribe you an antibiotic (treatment for specific bacterial infections).

Children and adolescents
Vesiker should not be used in children under 2 years of age for the treatment of neurogenic detrusor overactivity.
Vesiker should not be used in children under 18 years of age for the treatment of overactive bladder.

Other medicines and Vesiker
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
It is particularly important to inform your doctor if you are taking:

• other anticholinergic medicines, as the effectiveness and side effects of both medicines may increase.
• cholinergics that may reduce the effectiveness of Vesiker.
• medicines, such as metoclopramide and cisapride, that stimulate the motility of the gastrointestinal tract, 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 esophagus (esophagitis).

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Vesiker if you are pregnant unless it is strictly necessary.
Do not use Vesiker if you are breastfeeding, as solifenacin may be excreted in breast milk.

Driving and using machines
Vesiker can cause blurred vision and, sometimes, drowsiness or fatigue. Therefore, avoid driving or using machines 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:This medicine contains small amounts of ethanol (alcohol), less than 100 mg per maximum daily dose (10 ml of Vesiker oral suspension). The ethanol comes from the natural orange flavour.

Vesiker oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions). The 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 glycolthis medicine contains 20 mg of propylene glycol per ml, equivalent to 200 mg/10 ml.

Vesiker oral suspension contains sodium hydroxidethis medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. is essentially ‘sodium-free’.

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

3. How to take Vesiker

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
Take this medicine by mouth, once a day. You can take this medicine before or after meals. After taking a dose of Vesiker, drink a glass of water. Do not take this medicine in
conjunction with food and/or other beverages. If you have accidentally taken the suspension in
conjunction with food and/or other beverages, you may experience a bitter taste and a feeling of numbness
in your mouth.
Adults with overactive bladder
The usual dose is 5 mg (5 ml) per day, unless your doctor has told you to take 10 mg (10 ml)
per day. If you need to take a dose of 5 mg, you must use a 5 ml oral administration syringe. If you need to take a dose of 10 mg, you must use a 10 ml oral administration syringe.
Children and adolescents (aged 2 to 18 years) with neurogenic detrusor overactivity
Your doctor will tell you which dose you or your child should take. The doctor will calculate the correct dose for the
patient based on their body weight. Your pharmacist and doctor will tell you what type of syringe to use.
You must follow their instructions carefully.

How to administer a dose of Vesiker with an oral administration syringe
To be sure to measure the correct amount, use the oral use syringe and adapter provided by
your pharmacist or healthcare professional.

• 1. Shake the bottle at least 20 times before each administration.
• 2. Before using a bottle, remove the cap and attach the adapter to the neck of the bottle, according to the instructions of your pharmacist or healthcare professional.
• 3. Insert the tip of the oral administration syringe into the adapter until it is firmly in place.
• 4. Carefully turn the bottle and syringe upside down.
• 5. Holding the bottle upside down, move the syringe plunger to draw up the amount of medicine prescribed by your doctor.
• 6. Leave the syringe on the bottle and rotate the bottle, making sure the plunger does not move. Gently remove the syringe from the adapter and check the correctness of the measured dose.
• 7. Slowly dispense the oral suspension directly into the patient's mouth until all the medicine has been administered.
• 8. If a pressure adapter is used, leave the adapter in the neck of the bottle or follow the instructions of your pharmacist or healthcare professional.
• 9. Close the bottle with the cap.
• 10. Remove the plunger from the syringe body by gently pulling. Wash the syringe and plunger with water and let them dry before storing the oral syringe. If you take more Vesiker than you shouldIf you have taken too much Vesiker or if a child has accidentally taken Vesiker, consult your doctor or pharmacist immediately.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and
blurred vision, perception of non-existent objects (hallucinations), overexcitation, epileptic seizures,
breathing problems, increased heart rate (tachycardia), urine accumulation
in the bladder (urinary retention) and pupil dilation (mydriasis).

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

If you stop taking Vesiker
If you stop taking Vesiker, the symptoms of your
bladder condition may reappear 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 everybody gets them.
Stop treatment with Vesiker and seek immediate medical help if you experience any of the
following side effects:
If an allergic reaction occurs (a sudden and rapid side effect consisting of generalised itching, hives, swelling, difficulty breathing and/or other allergic reactions, known as anaphylaxis) or
a severe skin reaction (e.g. blistering and peeling of the skin).
If angioedema occurs (an allergic skin manifestation consisting of swelling of the
tissue just below the skin surface) with airway obstruction (difficulty breathing).
Angioedema has been reported in some patients treated with Vesiker.
Vesiker may cause the following other 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 abdominal bloating, abdominal pain, belching, nausea and heartburn (dyspepsia), discomfort in the stomach

Uncommon(may affect up to 1 in 100 people)

• urinary tract infections, bladder infections
• drowsiness, abnormal taste perception (dysgeusia)
• dryness (irritation) of the eyes
• dry nose
• reflux disease (gastroesophageal reflux), dry throat
• dry skin
• difficulty urinating
• fatigue, fluid retention in the lower leg (edema)

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

• accumulation of large amounts of stool in the colon (fecal impaction)
• increased amount of urine in the bladder caused by the 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 available data)

• decreased appetite, high levels of potassium in the blood which can cause abnormal heart rhythm
• increased eye pressure
• changes in heart electrical activity (ECG), irregular heartbeat, sensation of palpitations, fast heartbeat
• voice disorders
• liver disorders
• muscle weakness
• kidney disorders

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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.
Do not use Vesiker after the expiry date which is stated on the label, the carton or the 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 particular storage temperature. After the first opening of the bottle, the suspension
can be stored for 28 days.
Dispose of any unused medicine after 28 days of opening the bottle.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help to protect the environment.

6. Package Contents and Other Information

What Vesiker contains

• The active ingredient is solifenacin succinate 1 mg per ml of suspension.
• The other components are: potassium polyacrilin, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), simeticone emulsion 30% (containing simeticone, polyethylene 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), acesulfame potassium (E950), natural orange flavour (components: 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 package contents
Vesiker suspension is a homogeneous aqueous suspension from white to off-white in colour, with an aroma of
orange.
Vesiker suspension is available in 150 ml amber-coloured polyethylene terephthalate (PET) bottles, closed
with a polyethylene (PE) screw cap.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Astellas Pharma S.p.A.
Via del Bosco Rinnovato, 6 – U7
20090 Assago (Milan)

Manufacturer
Astellas Pharma Europe B.V.Hogemaat 2, 7942 JG Meppel, Netherlands

Astellas Pharma Europe B.V.Sylviusweg 62, 2333 BE Leiden, Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece,
Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Sweden, Slovenia, Slovakia, Spain and United Kingdom: Vesicare
Italy: Vesiker
Germany: Vesikur
Ireland: Vesitirim
If you forget to take a tablet at the usual time, take it as soon as you remember, unless it is time to take the next dose. Do not take more than one dose a day. If in
doubt, always consult your doctor or pharmacist.