Vesicare 10 mg

Leaflet attached to the packaging: Information for the user

Vesicare 5 mg coated tablets

Vesicare 10 mg coated tablets

Solifenacin succinate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Vesicare and what is it used for
• 2. Important information 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 is Vesicare and what is it used for

The active substance of Vesicare belongs to a group of cholinolytic medicines. These medicines reduce the activity of an overactive bladder. This action allows for longer intervals between using the toilet and increases the amount of urine held in the bladder. Vesicare is used to treat the symptoms of an overactive bladder. These 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 Vesicare

When not to take Vesicare:

• if the patient cannot urinate or cannot empty their 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, which can cause significant weakness of some muscles
• if the patient has glaucoma with a narrow angle of filtration (increased pressure of the fluid in the eyeball, which can lead to gradual vision loss)
• if the patient is allergic 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 disorders
• if the patient has severe kidney disease or moderate liver disease and is taking medicines that may delay the elimination of Vesicare from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

Before starting treatment with Vesicare, the doctor should be informed if any of the above situations occur or have occurred in the past.

Warnings and precautions

Before starting to take Vesicare, the doctor or pharmacist should be consulted:

• if the patient has difficulty emptying their bladder (narrowing of the urethra) 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 nervous system disorders (autonomic nervous system neuropathy)

Children and adolescents

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

Before starting treatment with Vesicare, the doctor should be informed if any of the above situations occur or have occurred in the past. Before starting treatment with Vesicare, 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). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial medicine).

Vesicare and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. It is especially important to inform the doctor if the patient is taking: other cholinolytic medicines, as taking such a medicine with Vesicare may lead to an increase in both the therapeutic effect and the side effects of both medicines, medicines from the group of cholinergic receptor agonists, as they may weaken the effect of Vesicare, medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Vesicare may weaken their effect, medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they 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 exacerbate esophagitis.

Vesicare with food and drink:

Vesicare can be taken during meals or independently of meals.

Pregnancy and breastfeeding:

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

Driving and using machines:

Vesicare may cause blurred vision, and less often, drowsiness and fatigue. If such side effects occur, the patient should not drive or operate any machinery. Vesicare 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 Vesicare

Instructions for proper use:

Vesicare should always be used in accordance with the doctor's recommendations. In case of doubts, the doctor or pharmacist should be consulted. The tablet should be swallowed whole, with a drink. The medicine can be taken during meals or independently of meals, depending on the patient's preferences. The tablets should not be crushed. The usual dose is 5 mg once a day, unless the doctor recommends a dose of 10 mg once a day.

Taking a higher dose of Vesicare than recommended

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

Missing a dose of Vesicare

In case of missing a dose, the next dose should be taken as soon as possible, unless it is almost time for the next dose. The medicine should not be taken more than once a day. In case of doubts, the doctor or pharmacist should be consulted.

Stopping treatment with Vesicare

If treatment with Vesicare is stopped, the symptoms of an overactive bladder may return or worsen. Stopping treatment with Vesicare should always be consulted with a doctor. If there are any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Vesicare can cause side effects, although not everybody gets them. If the patient experiences an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), they should immediately inform their doctor or nurse. Some patients taking solifenacin succinate (Vesicare) have reported angioedema (a form of allergic skin reaction that causes swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing). If the patient experiences angioedema, they should immediately stop taking solifenacin succinate (Vesicare) and initiate appropriate treatment and/or take appropriate measures. Vesicare may cause other side effects, including:

• dry mouth.

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

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

Uncommon (may affect up to 1 in 100 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.

Rare (may affect up to 1 in 1,000 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.

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

• hallucinations, confusion,
• hives.

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

• decreased appetite, increased potassium levels in the blood, which can 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 any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Vesicare

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the carton/blisters after: Expiry date (EXP)/EXP. The expiry date refers to the last day of that month. There are no special precautions for storage. After the first opening of 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 of Vesicare is solifenacin succinate in a dose of 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 coated tablets are round, light yellow, and marked with a logo and the number "150" on the same side. Vesicare 10 mg coated tablets are round, light pink, and marked with a logo and the number "151" on the same side. The tablets are packaged 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 authorization holder and manufacturer:

Marketing authorization holder: Astellas Pharma Sp. z o.o., ul. Żwirki i Wigury 16C, 02-092 Warsaw, Poland. Manufacturer: Delpharm Meppel B.V., Hogemaat 2, 7942 JG Meppel, Netherlands. For more detailed information, please contact the representative of the marketing authorization holder. Astellas Pharma Sp. z o.o., ul. Żwirki i Wigury 16C, 02-092 Warsaw, phone number: (22) 545 11 11. The medicinal product is available in other countries of the European Economic Area under the following names: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovakia, Spain, United Kingdom: Vesicare, Italy: Vesiker, Germany: Vesicur, Ireland: Vesitrim.

Date of last revision of the leaflet:

04/2024.