Leaflet: information for the user

Vesicare 5 mg, film-coated tablets

Vesicare 10 mg, film-coated tablets

solifenacin succinate

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribedonlyfor you. Do not give it to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceany side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

1.What Vesicare is and what it is used for

2.What you need to know before you start taking Vesicare

3.How to take Vesicare

4.Possible side effects

5.Storage of Vesicare

6.Contents of the pack and additional information

The active ingredient of Vesicare belongs to the group of anticholinergics.These medications are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to go to the bathroom and increases the amount of urine that your bladder can hold.

Vesicare is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without prior warning, having to urinate frequently or experiencing urine leakage due to not making it to the bathroom on time.

Do not take Vesicare

• if you have difficulty urinating or emptying your bladder completely (urinary retention)
• if you have a severe stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis)
• if you have a muscle disease called myasthenia gravis, which can cause extreme weakness in certain muscles
• if you have high eye pressure with gradual loss of vision (glaucoma)
• if you are allergic to solifenacin or any of the other components of this medication (listed in section 6)
• if you are undergoing renal dialysis
• if you have severe liver disease
• if you have severe kidney disease or moderate liver disease and are being treated with medications that can reduce the elimination of Vesicare from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Inform your doctor before starting treatment with Vesicare if you have or have had any of the conditions mentioned above.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vesicare

• if you have difficulty emptying your bladder (= bladder obstruction) or urinating (e.g. weak urine flow). The risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have any obstruction of the digestive system (constipation).
• if you have an increased risk of decreased digestive system activity (gastrointestinal motility). Your doctor will inform you if this is the case.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have hiatal hernia or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

Children and adolescents

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

Inform your doctor before starting treatment with Vesicare, if any of the circumstances mentioned above have occurred at any time.

Before starting treatment with Vesicare, your doctor will evaluate whether there are other causes for your need to urinate frequently (e.g. heart failure or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Use of Vesicare with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is especially important to inform your doctor if you are taking:

• other anticholinergic medications, the activity and adverse effects of both medications may increase.
• cholinergic medications, which may reduce the effect of Vesicare.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Vesicare may reduce their effect.
• medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce the rate of elimination of Vesicare from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, which may increase the rate of elimination of Vesicare from the body.
• medications such as bisphosphonates, which may cause or worsen esophagitis.

Taking Vesicare with food and drinks

Vesicare can be taken with or without food, as you prefer.

Pregnancy, breastfeeding, and fertility

Do not use Vesicare if you are pregnant unless absolutely necessary.

Do not use Vesicare during breastfeeding as solifenacin may pass into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Vesicare may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or operate machinery.

Vesicare contains lactose.

If your doctor has indicated that you have a hereditary intolerance to certain sugars, consult with them before taking this medication.

Instructions for Correct Use

Follow exactly the administration instructions for this medication as indicated by your doctor.If in doubt,consult your doctor or pharmacist again.

Swallow the entire tablet with some liquid. You can take it with or without food, as you prefer. Do not crush the tablets.

The usual dose is 5 mg per day, unless your doctor tells you to take 10 mg per day.

If You Take More Vesicare Than You Should

If you have taken too much Vesicare or if a child has taken Vesicare by accident, contact your doctor or pharmacist immediately, or call the Toxicological Information Service (Tel. 91 562 04 20).

The symptoms of an overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perception of things that are not there (hallucinations), pronounced excitement, convulsions, difficulty breathing, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If You Forget to Take Vesicare

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take the next dose. Never take more than one dose per day. If you have any doubts, consult your doctor or pharmacist.

If You Interrupt Treatment with Vesicare

If you stop taking Vesicare, your overactive bladder symptoms may return or worsen. Consult your doctor at all times if you are thinking of interrupting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience an allergic attack or a severe skin reaction (for example, the formation of blisters and peeling of the skin), you must inform your doctor or nurse immediately.

Angioedema (allergy on the skin resulting in inflammation that occurs in the tissue beneath the surface of the skin) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate (Vesicare). If angioedema appears, treatment with solifenacin succinate (Vesicare) must be stopped immediately and appropriate treatment and/or measures must be taken.

Vesicare may cause the following side effects:

Very common (may affect more than 1 in 10 people)

• dry mouth

Common (may affect up to 1 in 10 people)

• blurred vision
• constipation, nausea, indigestion with symptoms such as a feeling of stomach heaviness, abdominal pain, belching, nausea, and stomach burning (dyspepsia), stomach discomfort

Rare side effects (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness
• abnormal taste perception (dysgeusia)
• dry, irritated eyes

• nasal dryness
• gastroesophageal reflux disease (GERD)
• dry throat
• dry skin
• difficulty urinating
• fatigue
• swelling of the lower extremities (edema)

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

• large amounts of hardened feces in the large intestine (fecal impaction)
• urine accumulation in the bladder due to inability to empty the bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, skin rash

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

• hallucinations, confusion

• allergic skin rash

Unknown frequency (frequency cannot be estimated from available data)

• decreased appetite, high levels of potassium in the blood that may cause an abnormal heart rhythm
• increased eye pressure

• changes in heart electrical activity (ECG), irregular heartbeats, palpitations, rapid heart rate
• voice disorder
• liver disorder
• muscle weakness
• renal disorder

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required. After the first opening of the bottle, the tablets can be stored for 6 months. Keep the bottle tightly closed.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vesicare

• The active ingredient is solifenacin succinate 5 mg or 10 mg.
• The other components are cornstarch, lactose, hypromellose (E464), magnesium stearate, macrogol, talc, titanium dioxide (E171), and iron oxide (E172).

Appearance of the product and contents of the packaging

Vesicare 5 mg tablets are round, yellowish-colored tablets marked with a company logo and the code “150” on the same face.

Vesicare 10 mg tablets are round, pale pink tablets marked with a company logo and the code “151” on the same face.

Vesicare tablets are supplied in blisters of 3, 5, 10, 20, 30, 50, 60, 90, 100, or 200 tablets. Vesicare tablets are also supplied in PEAD bottles with PP stoppers containing 100 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - 31st Floor

28046 Madrid (Spain)

Tel. +31 91 4952700

Responsible for manufacturing

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria, Belgium, Cyprus, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Netherlands, Hungary, Iceland, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, United Kingdom, Czech Republic, and Sweden: Vesicare

Italy: Vesiker

Germany: Vesikur

Ireland: Vesitirim

Last review date of this leaflet:August 2013.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/