Vesicare 5 mg

Package Leaflet: Information for the User

Vesicare 5 mg coated tablets

Vesicare 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents:

• 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 in Vesicare belongs to a group of medicines called antimuscarinics. These medicines reduce the activity of an overactive bladder. This allows for longer intervals between visits to the toilet and increases the amount of urine that can be held in the bladder. Vesicare is used to treat the symptoms of an overactive bladder. These symptoms include: sudden urges to urinate, frequent urination, and involuntary loss of urine, because the patient cannot get to the toilet in time.

2. Important information before taking Vesicare

When not to take Vesicare:

• if you have difficulty emptying your bladder or cannot empty your bladder (urinary retention)
• if you have severe gastrointestinal disorders (toxic megacolon, a complication associated with ulcerative colitis)
• if you have a muscle disorder called myasthenia gravis, which can cause significant weakness of certain muscles
• if you have narrow-angle glaucoma (increased pressure in the eye, which can lead to gradual loss of vision)
• if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
• if you are undergoing hemodialysis
• if you have severe liver function disorders
• if you have severe kidney disease or moderate liver disease and are taking medicines that may delay the elimination of Vesicare from the body (e.g., ketoconazole). Your doctor or pharmacist will provide information on this.

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

Warnings and precautions

Before taking Vesicare, discuss with your doctor or pharmacist:

• if you have difficulty emptying your bladder or urinating (narrowing of the urethra). In this case, the risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have gastrointestinal disorders (constipation)
• if there is a risk of slowing down the movement of the digestive tract (peristalsis). Your doctor will provide information on this.
• if you have severe kidney function disorders
• if you have moderate liver function disorders
• if you have a burning sensation in the stomach (hiatus hernia) or heartburn
• if you have autonomic nervous system disorders (autonomic neuropathy)

Children and adolescents

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

Before starting treatment with Vesicare, tell your doctor if any of the above situations apply or have applied in the past. Before starting treatment with Vesicare, your 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, your doctor will prescribe an antibiotic (an antibacterial medicine).

Vesicare and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. It is especially important to inform your doctor if you are taking: other antimuscarinic medicines, as taking such a medicine with Vesicare may lead to increased therapeutic and adverse effects of both medicines; 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 with or without food.

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 taking any medicine, consult your doctor or pharmacist.

Driving and using machines:

Vesicare may cause blurred vision, and less often, drowsiness and fatigue. If such side effects occur, do 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:

Always take Vesicare exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Swallow the tablet whole with a drink of water. You can take Vesicare with or without food, as you prefer. Do not crush the tablets. The usual dose is 5 mg once daily, unless your doctor advises you to take a dose of 10 mg once daily.

Taking more than the recommended dose of Vesicare

If you have taken too many Vesicare tablets or if a child has accidentally taken Vesicare, contact your doctor or pharmacist immediately. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive excitement, seizures, breathing difficulties, rapid heartbeat, and urinary retention.

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 dose. Do not take more than one dose in 24 hours. If you are unsure, consult your doctor or pharmacist.

Stopping treatment with Vesicare

If you stop taking Vesicare, the symptoms of an overactive bladder may return or worsen. Stopping treatment with Vesicare should always be discussed with your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vesicare can cause side effects, although not everybody gets them. If you experience an allergic reaction or severe skin reaction (e.g., blistering and peeling of the skin), tell your doctor or nurse immediately. Some patients taking solifenacin succinate (Vesicare) have reported angioedema (a type of allergic skin reaction that causes swelling of the tissue just beneath the skin). If you experience angioedema, stop taking solifenacin succinate (Vesicare) and seek medical attention. 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, indigestion with symptoms such as: feeling of fullness, abdominal pain, belching, nausea, heartburn, discomfort in the abdomen.

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 (blockage) 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 disturbances,
• increased eye pressure,
• 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. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vesicare

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton/blisters after EXP. The expiry date refers to the last day of that month. There are no special storage precautions. After first opening the bottle, the tablets can be stored for 6 months. Keep the bottle tightly closed.

6. Contents of the pack and other information

What Vesicare contains

• The active substance is solifenacin succinate in a dose of 5 mg or 10 mg
• The other ingredients are maize 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 yellow, round, and marked with a logo and the number "150" on the same side. Vesicare 10 mg coated tablets are pink, round, and marked with a logo and the number "151" on the same side. 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., ul. Żwirki i Wigury 16C, 02-092 Warsaw, Poland. Manufacturer: Delpharm Meppel B.V., Hogemaat 2, 7942 JG Meppel, Netherlands. For further information, contact the representative of the marketing authorisation holder. Astellas Pharma Sp. z o.o., ul. Żwirki i Wigury 16C, 02-092 Warsaw, phone: (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