VESICARE 5 mg FILM-COATED TABLETS

2. What you need to know before you take 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 hemodialysis
• 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 Vesicare

• if you have problems emptying your bladder (obstruction of the bladder) 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 activity of the digestive system (movements of the stomach and intestines). 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 a nervous disorder (autonomic neuropathy).

Children and adolescents

Vesicare should not be used in children and 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 taking, have recently taken, or might take any other medicines.

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

• other anticholinergic medicines, as the activity and side effects of both medicines may increase.
• cholinergic medicines, 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 elimination of Vesicare from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the 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, breastfeeding, and fertility

Do not use Vesicare if you are pregnant unless it is 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 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, contact them 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 unsure, 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).

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 are unsure, consult your doctor or pharmacist.

If you stop taking Vesicare

If you stop taking Vesicare, your overactive bladder symptoms may return 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 experience an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), tell your doctor or nurse immediately.

Angioedema (allergic reaction in the skin that results in inflammation of 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 stopped 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 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 (dysgeusia)
• dry eyes (irritated)

• dryness of the nasal passages
• gastroesophageal reflux disease
• 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 heartbeat, 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 leaflet. You can also report side effects directly to the Spanish Medicines Agency: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 after EXP. The expiry date is the last day of the month shown.

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. Return any unused medicine to your pharmacist. This will help protect the environment.

6. Package contents 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), and iron oxide (E172).

Appearance of the product and package contents

The 5 mg Vesicare tablets are light yellow, round tablets marked with a company logo and the code "150" on the same face.

The 10 mg Vesicare tablets are pink, round 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 caps of 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized 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 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/