VESOLIGO 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Vesoligo 5 mg coated tablets
3. Vesoligo 10 mg coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
4. What is Vesoligo and what is it used for
5. Important information before taking Vesoligo
   1. Warnings and precautions
   2. Children and adolescents
   3. Vesoligo should not be used in children or adolescents under 18 years of age.
   4. Vesoligo and other medicines
   5. Vesoligo with food and drink:
   6. Pregnancy and breastfeeding:
   7. Driving and using machines:
6. How to take Vesoligo
   1. Instructions for proper use:
   2. Taking a higher dose of Vesoligo than recommended
   3. Missing a dose of Vesoligo
   4. Stopping treatment with Vesoligo
7. Possible side effects
   1. Reporting side effects
8. How to store Vesoligo
9. Contents of the pack and other information
   1. What Vesoligo contains
   2. What Vesoligo looks like and contents of the pack
   3. Marketing authorisation holder and manufacturer:

Package Leaflet: Information for the User

Vesoligo 5 mg coated tablets

Vesoligo 10 mg coated tablets

Solifenacin succinate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you specifically. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Table of contents of the leaflet:

• 1. What is Vesoligo and what is it 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 is Vesoligo and what is it used for

The active substance of Vesoligo belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. The action of the medicine increases the amount of urine stored in the bladder, resulting in longer intervals between visits to the toilet.
Vesoligo is used to treat symptoms of an overactive bladder. These symptoms include: urgent urination, i.e. episodes of sudden, urgent need to urinate, frequent urination, and urinary incontinence, related to the fact that the patient did not have time to use the toilet.

2. Important information before taking Vesoligo

When not to take Vesoligo:

• if the patient cannot urinate or cannot empty the bladder (urinary retention),
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis),
• in patients with a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles, p. 1
• if the patient has glaucoma with a narrow angle of filtration (increased pressure of the fluid in the eyeball, progressing with gradual loss of vision),
• in patients with an allergy (hypersensitivity) to solifenacin or any of the other ingredients of this medicine (listed in section 6),
• if the patient is undergoing hemodialysis procedures,
• in patients with severe liver function disorders,
• if the patient has severe kidney disease or moderate liver disease and is taking medicines that may delay the elimination of Vesoligo from the body (e.g. ketoconazole). The doctor or pharmacist will provide information on this.

Before starting treatment with Vesoligo, tell your doctor if any of the above situations apply or have applied in the past.

Warnings and precautions

Before starting to take Vesoligo, discuss it with your doctor or pharmacist:

• if the patient has difficulty emptying the bladder (narrowing of the urine outflow tract from the bladder) or urinating (weak urine stream). In such a case, the risk of urine accumulation in the bladder (urinary retention) is much higher,
• if the patient has gastrointestinal motility disorders (constipation),
• if there is a risk of slowing down the movement of the digestive tract (peristalsis). The doctor will provide information on this,
• if the patient has severe kidney function disorders,
• if the patient has moderate liver function disorders,
• if the patient has a burning stomach pain (hiatal hernia) or heartburn,
• if the patient has autonomic nervous system disorders (autonomic neuropathy).

Children and adolescents

Vesoligo should not be used in children or adolescents under 18 years of age.

Before starting treatment with Vesoligo, tell your doctor if any of the above situations apply or have applied in the past.
Before starting treatment with Vesoligo, the doctor will assess whether there are other causes of frequent urination (e.g. heart failure - insufficient strength of the heart muscle to pump blood - or kidney disease). In case of a urinary tract infection, the doctor will prescribe an antibiotic (an antibacterial medicine, acting on specific bacteria).

Vesoligo and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
It is especially important to inform your doctor if you are taking:

• other anticholinergic medicines, as taking such a medicine with Vesoligo may lead to an increase in both the therapeutic effect and the side effects of both medicines,

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• cholinergic receptor agonist medicines, as they may weaken the effect of Vesoligo,
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Vesoligo may weaken their effect,
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they 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 exacerbate esophagitis.

Vesoligo with food and drink:

Vesoligo can be taken during meals or independently of meals.

Pregnancy and breastfeeding:

Vesoligo should not be used during pregnancy, unless it is absolutely necessary.
Vesoligo should not be used during breastfeeding, as solifenacin passes into breast milk.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines:

Vesoligo may cause blurred vision, and less often drowsiness and fatigue.
If such side effects occur, do not drive or operate any machinery.
Vesoligo contains lactose. The medicine should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or glucose-galactose malabsorption syndrome.

3. How to take Vesoligo

Instructions for proper use:

Vesoligo should always be taken according to the doctor's recommendations.
In case of doubts, consult a doctor or pharmacist.
The tablet should be swallowed whole, with a drink of water.
The medicine can be taken during meals or independently of meals, depending on the patient's preferences.
The tablets should not be crushed.
Usually, a dose of 5 mg per day is used, unless the doctor recommends a dose of 10 mg per day.

Taking a higher dose of Vesoligo than recommended

In case of taking too many Vesoligo tablets or if a child accidentally swallows the medicine, consult a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), urinary retention, and dilated pupils.

Missing a dose of Vesoligo

In case of missing a dose, take the next dose as soon as possible, unless it is close to the time of the next dose. Do not take the medicine more often than once a day. In case of doubts, consult a doctor or pharmacist.

Stopping treatment with Vesoligo

In case of stopping treatment with Vesoligo, the symptoms of an overactive bladder may return or worsen. Stopping treatment should always be consulted with a doctor.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Vesoligo can cause side effects, although not everybody gets them.
If you experience an allergic reaction or a severe skin reaction (e.g. blistering and peeling of the skin), tell your doctor or nurse immediately.
In some patients taking solifenacin succinate (Vesoligo), angioedema (a form of allergic skin reaction that causes swelling of the tissue just below the skin surface) with swelling of the respiratory tract (difficulty breathing) has been reported. If you experience angioedema, stop taking solifenacin succinate (Vesoligo) immediately and start appropriate treatment and/or take appropriate measures.
Vesoligo may cause other side effects, including:

• dry mouth.

Very common (may affect more than 1 in 10 people) side effects include:

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

Common (may affect up to 1 in 10 people) side effects include:

• urinary tract infection, cystitis
• drowsiness, taste disturbances,
• dry eye syndrome,
• dry nose,
• gastroesophageal reflux (heartburn), dry throat,
• dry skin,
• difficulty urinating,
• fatigue, swelling of the lower limbs.

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Uncommon (may affect up to 1 in 100 people) side effects include:

• accumulation of a large amount of hard stool in the colon; obstruction (obstruction) of the colon
• difficulty urinating despite a full bladder (urinary retention)
• dizziness, headaches,
• vomiting,
• itching, rash.

Rare (may affect up to 1 in 1000 people) side effects include:

• hallucinations, confusion,
• hives.

Very rare (may affect up to 1 in 10,000 people) side effects include:

• reduced appetite, increased potassium levels in the blood, which may cause heart rhythm disorders,
• increased pressure in the eyeball,
• changes in ECG, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vesoligo

Store the medicine out of sight and reach of children.
There are no special precautions for storage.
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 month.
Do not use this medicine if the packaging is damaged or visible signs of deterioration are observed.
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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vesoligo contains

The active substance of Vesoligo is solifenacin succinate (Solifenacini succinas) in an amount of 5 mg or 10 mg
The other ingredients are:
tablet core: lactose monohydrate, corn starch, hypromellose 6cPs, magnesium stearate,
tablet coating: hypromellose 6cPs, macrogol 8000, talc, titanium dioxide (E171),
yellow iron oxide (E172) for the 5mg dose,
red iron oxide (E172) for the 10mg dose.

What Vesoligo looks like and contents of the pack

Vesoligo 5 mg coated tablets are round, yellow, and marked with the number "390" on one side of the tablet.
Vesoligo 10 mg coated tablets are round, pink, and marked with the number "391" on one side of the tablet.
The tablets are packaged in PVC/PVDC/Aluminium blisters and 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 Pharmaceutical Company Ltd.
Ostrzykowizna 14 A
05-170 Zakroczym
Poland
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106
Manufacturer:
Zentiva S.A.
Theodor Pallady Boulevard, no. 50, sector 3
032266 Bucharest
Romania
Date of last revision of the leaflet:
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