Vesoligo

Package leaflet: Information for the user

Vesoligo 5 mg film-coated tablets
Vesoligo 10 mg film-coated tablets
Solifenacin succinate

Read the entire leaflet carefully before use, as it contains important information for the patient.
Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents:

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

1. What Vesoligo is and what it is used for

The active substance in Vesoligo belongs to a group of medicines called anticholinergics. These medicines reduce overactivity of the bladder. The effect of the medicine increases the amount of urine the bladder can hold, thereby extending the time between trips to the toilet.
Vesoligo is used to treat symptoms of overactive bladder. These symptoms include urgency, which are sudden, compelling urges to pass urine, urinary frequency, and urinary incontinence, occurring when the patient cannot reach the toilet in time.

2. Important information before using Vesoligo

When not to use Vesoligo:

• if the patient is unable to pass urine or empty the urinary bladder (urinary retention),
• if the patient has severe gastrointestinal disorders (toxic megacolon, a complication associated with ulcerative colitis),
• in patients suffering from a muscle disease called myasthenia, which may cause significant weakness of certain muscles, p. 1
• if the patient has narrow-angle glaucoma (increased fluid pressure in the eye leading to gradual loss of vision),
• in patients allergic (hypersensitive) to solifenacin or any of the other ingredients of this medicine (listed in section 6),
• if the patient is undergoing hemodialysis,
• in patients with severe liver function impairment,
• if the patient has severe kidney disease or moderate liver disease and is simultaneously taking medicines that may delay elimination of Vesoligo from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

Before starting treatment with Vesoligo, inform your doctor if any of the above situations apply or have occurred in the past.
Warnings and precautions
Before starting treatment with Vesoligo, discuss with your doctor or pharmacist:

• if the patient has difficulty emptying the bladder (obstruction of urinary outflow from the bladder) or difficulty passing urine (weak urinary stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is significantly higher,
• if the patient has gastrointestinal motility disorders (constipation),
• if there is a risk of slowed gastrointestinal motility (peristalsis). Your doctor will provide further information,
• if the patient has severe kidney function impairment,
• if the patient has moderate liver function impairment,
• if the patient suffers from severe stomach pain (hiatal hernia) or heartburn,
• if the patient has nervous system disorders (autonomic neuropathy).

Children and adolescents
Vesoligo must not be used in children or adolescents under 18 years of age.
Before starting treatment with Vesoligo, inform your doctor if any of the above situations apply or have occurred in the past.
Before initiating treatment with Vesoligo, the doctor will assess whether there are other possible causes of frequent urination (e.g. heart failure – insufficient cardiac muscle strength to pump blood effectively – or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).
Vesoligo with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
It is particularly important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as concomitant use with Vesoligo may enhance both the therapeutic effects and adverse reactions of both medicines,

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• cholinergic receptor agonists, as they may reduce the effectiveness of Vesoligo,
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Vesoligo may reduce their effectiveness,
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they may slow down the metabolism of Vesoligo,
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Vesoligo,
• medicines such as bisphosphonates, as they may cause or worsen esophagitis.

Vesoligo with food and drink:
Vesoligo can be taken with or without food.
Pregnancy and breastfeeding:
Vesoligo must not be used during pregnancy unless absolutely necessary.
Vesoligo must not be used during breastfeeding, as solifenacin passes into breast milk.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery:
Vesoligo may cause blurred vision, and less commonly drowsiness and fatigue.
If these adverse effects occur, do not drive or operate any machinery.
Vesoligo contains lactose. This medicine should not be used in patients with rare hereditary galactose intolerance, Lapp-type lactase deficiency, or glucose-galactose malabsorption syndrome.

3. How to use Vesoligo

Instructions for proper use:
Vesoligo should always be used as directed by the physician.
If in doubt, consult your doctor or pharmacist.
The tablet should be swallowed whole with liquid.
The medicine may be taken with or without food, depending on patient preference.
Do not crush the tablets.
The usual dose is 5 mg once daily, unless the physician prescribes a dose of 10 mg
once daily.

Taking more Vesoligo than prescribed
If too many Vesoligo tablets have been taken or if a child accidentally swallows the
medicine, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and
visual disturbances, hallucinations, excessive excitation, seizures (convulsions),
difficulty breathing, rapid heartbeat (tachycardia), urinary retention, and dilated pupils.

Missing a dose of Vesoligo
If a dose is missed, take the next dose as soon as possible, unless it is almost time for
the next scheduled dose. Do not take the medicine more often than once daily.
If in doubt, consult your doctor or pharmacist.

Stopping Vesoligo treatment
If Vesoligo treatment is stopped, symptoms of overactive bladder may return or worsen.
Discontinuation of the medicine should always be discussed with the physician.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If the patient experiences an allergic attack or a severe skin reaction (e.g. blistering and peeling of the outer layer of skin), a doctor or nurse should be informed immediately.
Angioedema (a type of allergic skin reaction causing swelling of the tissue just beneath the skin surface), including swelling of the airways (difficulty breathing), has been reported in some patients taking solifenacin succinate (Vesoligo). If angioedema occurs, treatment with solifenacin succinate (Vesoligo) should be stopped immediately and appropriate treatment and/or emergency measures should be initiated.

Vesoligo may cause other adverse reactions listed below:

Very common (may occur in more than 1 in 10 people):

• dry mouth

Common (may occur in less than 1 in 10 people):

• blurred vision,
• constipation, nausea, dyspepsia with symptoms such as: feeling of fullness in the stomach, abdominal pain, belching, nausea, heartburn, feeling of discomfort in the abdominal cavity.

Uncommon (may occur in less than 1 in 100 people):

• urinary tract infection, cystitis,
• somnolence, taste disturbances,
• dry eye syndrome,
• nasal dryness,
• gastroesophageal reflux (heartburn), dry throat,
• dry skin,
• difficulty in urination,
• fatigue, peripheral oedema.

Rare (may occur in less than 1 in 1,000 people):

• faecal impaction; colonic obstruction,
• difficulty passing urine despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

Very rare (may occur in less than 1 in 10,000 people):

• hallucinations, confusion,
• urticaria.

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

• decreased appetite, increased blood potassium levels which may cause cardiac rhythm disturbances,
• increased intraocular pressure,
• changes in ECG, irregular heartbeat, palpitations, tachycardia,
• voice disorders,
• liver function abnormalities,
• muscle weakness,
• kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Vesoligo

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date (EXP) stated on the
carton/blister. The expiry date refers to the last day of the stated month.
Do not use this medicine if the packaging is damaged or if there are visible signs of deterioration.
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Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Vesoligo contains
The active substance in Vesoligo is solifenacin succinate (Solifenacini succinas) in an amount of 5 mg or 10 mg.
The other ingredients are:
Tablet core: Monohydrate lactose, Corn starch, Hypromellose 6cPs, Magnesium stearate,
Tablet coating: Hypromellose 6cPs, Macrogol 8000, Talc, Titanium dioxide (E171),
Iron oxide yellow (E172) for the 5 mg dose,
Iron oxide red (E172) for the 10 mg dose.

What Vesoligo looks like and contents of the pack
Vesoligo 5 mg coated tablets are round, light yellow in colour, marked on one side with the number "390".
Vesoligo 10 mg coated tablets are round, light pink in colour, marked on one side with the number "391".
The tablets are packed in PVC/PVDC/Aluminium blisters and placed in cardboard boxes containing: 10, 20, 30 or 90 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
LEK-AM Sp. z o.o.
Ostrzykowizna 14 A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Manufacturer:
S.C. Zentiva S.A.
B-dul Theodor Pallady nr. 50, sector 3
032266 Bucharest
Romania
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