Vesicare 5 mg

Patient Information Leaflet

Vesicare 5 mg film-coated tablets
Vesicare 10 mg film-coated tablets
Solifenacin succinate
Please read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What Vesicare is and what it is used for

The active substance in Vesicare belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between visits to the toilet and increases the amount of urine the bladder can hold.
Vesicare is used to treat the symptoms of an overactive bladder. These symptoms include urgency, which is a sudden, compelling need to pass urine, urinary frequency, and urinary incontinence due to not being able to reach the toilet in time.

2. Important information before using Vesicare

When not to use Vesicare:

• if the patient is unable to pass urine or empty the urinary bladder (urinary retention)
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis)
• in patients suffering from a muscle disease called myasthenia gravis, which may cause significant weakness of certain muscles
• 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 haemodialysis
• in patients with severe liver function disorders
• if the patient has severe kidney disease or moderate liver disease and is simultaneously taking medicines that may delay elimination of Vesicare from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

Before starting treatment with Vesicare, inform your doctor if any of the above conditions apply or have occurred in the past.

Warnings and precautions

Before starting treatment with Vesicare, 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 urine 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 disorders
• if the patient has moderate liver function disorders
• if the patient suffers from severe stomach pain (hiatal hernia) or heartburn
• if the patient has nervous system disorders (autonomic neuropathy)

Children and adolescents

Vesicare must not be used in children or adolescents under 18 years of age.

Before starting treatment with Vesicare, inform your doctor if any of the above conditions apply or have occurred in the past.

Before initiating treatment with Vesicare, your doctor will assess whether there are other possible causes of frequent urination (e.g. heart failure – insufficient pumping strength of the heart muscle, or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).

Vesicare with other medicines

Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines you plan to take.

It is particularly important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as concomitant use with Vesicare may enhance both the therapeutic effects and adverse reactions of both drugs
• medicines belonging to cholinergic receptor agonists, as they may reduce the effectiveness of Vesicare
• medicines enhancing gastrointestinal motility, such as metoclopramide and cisapride, as Vesicare may reduce their effectiveness
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they may slow down the metabolism of Vesicare
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Vesicare
• medicines such as bisphosphonates, as they may cause or worsen oesophagitis.

Vesicare with food and drink:

Vesicare may be taken during meals or independently of meals.

Pregnancy and breastfeeding:

Vesicare should not be used during pregnancy unless absolutely necessary.

Vesicare should not be used during breastfeeding, as solifenacin passes into breast milk.

Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery:

Vesicare may cause blurred vision, and less frequently, drowsiness and fatigue. If these adverse effects occur, do not drive or operate any machinery.

Vesicare 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 take Vesicare

Instructions for proper use:
Vesicare should always be taken exactly as prescribed by your doctor.
If you have any doubts, contact your doctor or pharmacist.
The tablet should be swallowed whole with liquid.
The medicine can be taken during meals or independently of meals, depending on patient preference.
Do not crush the tablets.
The usual dose is 5 mg once daily, unless your doctor prescribes a dose of 10 mg once daily.

Taking more Vesicare than prescribed
If you have taken too many Vesicare tablets, or if a child accidentally swallows Vesicare, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and visual disturbances, hallucinations, excessive excitement, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils.

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

Stopping Vesicare treatment
If you stop taking Vesicare, symptoms of overactive bladder may return or worsen. Always consult your doctor before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences an allergic attack or a severe skin reaction (e.g. blistering and peeling of the 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 (Vesicare). If angioedema occurs, treatment with solifenacin succinate (Vesicare) must be stopped immediately and appropriate treatment and/or corrective measures should be initiated.
Vesicare 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), throat dryness,
• dry skin,
• difficulty passing urine,
• fatigue, peripheral edema.

Rare (may occur in less than 1 in 1000 people):

• accumulation of hard stool in the colon; colon 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 arrhythmia,
• increased intraocular pressure,
• ECG changes, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function abnormalities,
• muscle weakness,
• kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. 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
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vesicare 5 mg

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blister: Expiry date (EXP)/EXP. The expiry date refers to the last day of the stated month.
No special storage conditions required.
After first opening the bottle, the tablets can be stored for 6 months. The bottle should be tightly closed.

6. Contents of the pack and other information

What Vesicare contains

• The active substance in Vesicare is solifenacin succinate, 5 mg or 10 mg.
• The other ingredients are corn starch, lactose monohydrate, hypromellose (E464), magnesium stearate, macrogol, talc, titanium dioxide (E171), iron oxide (E172).

What Vesicare looks like and contents of the pack

Vesicare 5 mg film-coated tablets are round, light yellow in colour, marked on one side with the logo and the number "150".

Vesicare 10 mg film-coated tablets are round, light pink in colour, marked on one side with the logo and the number "151".

The tablets are packed in blisters containing: 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Vesicare tablets are also available in HDPE bottles with a polypropylene (PP) cap, containing 100 tablets per bottle.
Not all pack sizes may be marketed.
In Poland, packs containing 30 tablets are available.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Astellas Pharma Sp. z o.o.
Żwirki i Wigury 16C
02-092 Warsaw
Poland

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

For further information, contact the Marketing Authorisation Holder:
Astellas Pharma Sp. z o.o.
Żwirki i Wigury 16C
02-092 Warsaw
Telephone number: (22) 545 11 11

The medicinal product is available in other European Economic Area countries under the following names:
Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovakia, Spain, United Kingdom: Vesicare
Italy: Vesiker
Germany: Vesicur
Ireland: Vesitrim
04/2024