VESICARE 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vesicare 5 mg, film-coated tablets

Vesicare 10 mg, film-coated tablets

solifenacin succinate

Read the package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Vesicare and what is it used for

The active substance in Vesicare belongs to the group of anticholinergics. These medicines are used to reduce the activity of the overactive bladder. This allows you to have more time before you need to urinate and increases the amount of urine your bladder can hold.

Vesicare is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a sudden and urgent need to urinate, having to urinate frequently, or having involuntary leakage of urine.

2. What you need to know before taking Vesicare

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 disorder called myasthenia gravis, which can cause extreme weakness of certain muscles
• if you have high pressure in the eyes, with gradual loss of vision (glaucoma)
• if you are allergic to solifenacin or any of the other ingredients of this medicine (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 medicines that may decrease the elimination of Vesicare from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with Vesicare, tell your doctor if you have or have had any of the above-mentioned diseases.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Vesicare

• if you have a problem emptying your bladder (= bladder obstruction) or urinating (e.g. a 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 (stomach and intestinal movements). 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 a hiatal hernia or heartburn.
• if you have an autonomic nervous disorder (autonomic neuropathy).

Children and adolescents

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

Tell your doctor before starting treatment with Vesicare if any of the above circumstances have ever occurred to you.

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

Using Vesicare with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important that you tell your doctor if you are taking:

• other anticholinergic medicines, as the activity and side effects of both medicines may increase.
• cholinergics, as they may reduce the effect of Vesicare.
• medicines such as metoclopramide or cisapride, which make the digestive system work faster. Vesicare may reduce their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of Vesicare from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of Vesicare from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Vesicare with food and drinks

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

Pregnancy, breast-feeding, and fertility

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

Do not use Vesicare during breast-feeding, as solifenacin may pass into breast milk.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Vesicare contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to take Vesicare

Instructions for correct use

Follow exactly the instructions for administration of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Swallow the tablet whole with some liquid. It can be taken with or without food, as you prefer. Do not crush the tablets.

The normal 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 mistake, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (Tel. 91 562 04 20).

The symptoms in case of 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), accumulation of urine 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, always consult your doctor or pharmacist.

If you stop taking Vesicare

If you stop taking Vesicare, your overactive bladder symptoms may come back or worsen. Always consult your doctor if you are thinking of stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you suffer from an allergic attack or a severe skin reaction (e.g. blistering and peeling of the skin), you should inform your doctor or nurse immediately.

Angioedema (allergic reaction in the skin resulting in inflammation that occurs in the tissue under the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate (Vesicare). If angioedema occurs, treatment with solifenacin succinate (Vesicare) should be discontinued immediately and appropriate treatment and/or measures should 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 heaviness in the stomach, abdominal pain, belching, nausea, and heartburn (dyspepsia), stomach discomfort

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

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

• dryness of the nasal passages
• reflux disease (gastroesophageal reflux)
• dry throat
• dry skin
• difficulty urinating
• fatigue
• accumulation of fluid in the lower limbs (edema)

Rare side effects (may affect up to 1 in 1,000 people)

• accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• accumulation of urine 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

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

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

• changes in the electrical activity of the heart (ECG), irregular heartbeats, palpitations, rapid heartbeat
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vesicare

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month stated.

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.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Vesicare

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

Appearance of the product and pack contents

The 5 mg Vesicare tablets are light yellow, round, film-coated tablets marked with a company logo and the code “150” on the same face.

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

Vesicare tablets are available in blister packs of 3, 5, 10, 20, 30, 50, 60, 90, 100, or 200 tablets. Vesicare tablets are also available in PEAD bottles with a PP cap of 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - Planta 31

28046 Madrid (Spain)

Tel. +31 91 4952700

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

This medicine is authorised in the Member States of the European Economic Area under 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

Date of last revision of this package leaflet:August 2013.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/