Vesicare 10 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Vesicare 5 mg, film-coated tablets
Vesicare 10 mg, film-coated tablets

solifenacin succinate

Read the entire leaflet carefully before you start taking this medicine, as 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 prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Vesicare is and what it is used for
2. What you need to know 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 Vesicare is and what it is used for

The active substance in Vesicare belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to go to the toilet 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 a sudden and strong urge to urinate without prior warning, needing to urinate frequently, or leaking urine because you cannot reach the toilet in time.

2. What you need to know before taking Vesicare

Do not take Vesicare

• if you have difficulty passing urine 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 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 also being treated with medicines that may reduce the elimination of Vesicare from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this applies.

Before starting treatment with Vesicare, inform your doctor if you have or have had any of the conditions mentioned above.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vesicare

• if you have difficulty emptying your bladder (= bladder obstruction) or passing urine (e.g. weak urine stream). The risk of urine build-up in the bladder (urinary retention) is much higher.
• if you have an obstruction in the digestive system (constipation).
• if you are at increased risk of reduced activity of the digestive system (stomach and intestinal movements). Your doctor will inform you if this applies.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have a hiatal hernia or heartburn.
• if you have a nerve disorder (autonomic neuropathy).

Children and adolescents

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

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

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

Taking Vesicare with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• other anticholinergic medicines, as the activity and adverse effects of both medicines may increase.
• cholinergic agents, as they may reduce the effect of Vesicare.
• medicines such as metoclopramide or cisapride, which speed up the digestive system. Vesicare may reduce their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which slow down the elimination of Vesicare from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate at which Vesicare is eliminated from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Vesicare with food and drink

Vesicare can be taken with or without food, according to your preference.

Pregnancy, breast-feeding and fertility

Do not use Vesicare during pregnancy unless absolutely necessary.

Do not use Vesicare while 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 become pregnant, consult your doctor or pharmacist before using 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 operate machinery.

Vesicare contains lactose.

If your doctor has informed you that you have a hereditary intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Vesicare

Instructions for correct use

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

You should swallow the tablet whole with liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.

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

If you take more Vesicare than you should

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

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not there (hallucinations), marked excitement, seizures, 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 almost time for your 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 return or worsen. Always consult your doctor if you are considering stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Angioedema (a skin allergy resulting in swelling of the tissue beneath the skin's surface), with airway obstruction (difficulty breathing), has been reported in some patients treated with solifenacin succinate (Vesicare). If angioedema occurs, treatment with solifenacin succinate (Vesicare) must be immediately discontinued and appropriate treatment and/or measures must be taken.

Vesicare may cause the following adverse 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 stomach heaviness, abdominal pain, belching, nausea, and heartburn (dyspepsia), stomach discomfort

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

• urinary tract infection, bladder infection
• somnolence
• abnormal taste perception (dysgeusia)
• dry (irritated) eyes
• dry nasal passages
• gastroesophageal reflux disease (acid reflux)
• dry throat
• dry skin
• difficulty urinating
• fatigue
• fluid accumulation in the lower limbs (edema)

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

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

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

• hallucinations, confusion
• allergic skin rash

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

• decreased appetite, high levels of potassium in the blood which may cause an abnormal heart rhythm
• increased pressure in the eyes
• changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vesicare

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of any containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vesicare

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

Appearance of the product and contents of the pack

Vesicare 5 mg tablets are round, light yellow tablets marked with the company logo and the code “150” on the same side.

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Astellas Pharma, S.A.
Paseo de la Castellana, 259 D - 31st Floor
28046 Madrid (Spain)
Tel. +31 91 4952700

Manufacturer

Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
The Netherlands

This medicinal product 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 the most recent review of this leaflet: August 2013.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/