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VESICARE 5MG FILM-COATED TABLET

Active substance: SOLIFENACIN SUCCINATE

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141889

United Kingdom

Package leaflet: Information for the user

181x596mm
LFT_205 FD

5 mg film-coated tablets

23.10.13/09:33

VTB 4641

10 mg film-coated tablets

Eq. to: N/A

solifenacin succinate

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
T
•  his medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
If
•  you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Vesicare is and what it is used for
2.   hat you need to know before you take
W
Vesicare
3. How to take Vesicare
4. Possible side effects
5. How to store Vesicare
6. Contents of the pack and other information

1.  hat Vesicare is and what it is
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used for
The active substance of Vesicare belongs to
the group of anticholinergics. These medicines
are used to reduce the activity of an overactive
bladder. This enables you to wait longer before
having to go to the bathroom and increases the
amount of urine that can be held by your bladder.
Vesicare is used to treat the symptoms of a
condition called overactive bladder. These
symptoms include: having a strong, sudden urge
to urinate without prior warning, having to urinate
frequently or wetting yourself because you could
not get to the bathroom in time.

2.  hat you need to know before you
W
take Vesicare
Do not take Vesicare
• if you have an inability to pass water or to empty
your bladder completely (urinary retention)
• if you have a severe stomach or bowel condition
(including toxic megacolon, a complication
associated with ulcerative colitis)
• if you suffer from the muscle disease called
myasthenia gravis, which can cause an extreme
weakness of certain muscles
• if you suffer from increased pressure in the
eyes, with gradual loss of eye sight (glaucoma)
• if you are allergic to solifenacin or any of the
other ingredients of this medicine (listed in
section 6)
• if you are undergoing kidney dialysis
• if you have severe liver disease
• if you suffer from severe kidney disease or
moderate liver disease AND at the same time
are being treated with medicines that may
decrease the removal of Vesicare from the body
(for example, ketoconazole). Your doctor or
pharmacist will have informed you if this is the
case.
Inform your doctor if you have or ever had any of
the above mentioned conditions before treatment
with Vesicare starts.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Vesicare
• if you have trouble emptying your bladder
(= bladder obstruction) or have difficulty in
passing urine (e.g. a thin urine flow). Risk of
accumulation of urine in the bladder (urinary
retention) is much higher.
• if you have some obstruction of the digestive
system (constipation).
• if you are at risk of your digestive system
slowing down (stomach and bowel movements).
Your doctor will have informed you if this is the
case.
• if you suffer from severe kidney disease.
• if you have moderate liver disease.
• if you have a stomach tear (hiatus hernia) or
heartburn.
• if you have a nervous disorder (autonomic
neuropathy).
Children and adolescents
Vesicare is not to be used in children or
adolescents under 18 years.
Inform your doctor if you have or ever had any of
the above mentioned conditions before treatment
with Vesicare starts.
Before starting Vesicare, your doctor will assess
whether there are other causes for your need
to pass urine frequently (for example heart
failure (insufficient pumping power of the heart)
or kidney disease). If you have a urinary tract
infection, your doctor will prescribe you an
antibiotic (a treatment against particular bacterial
infections).

Other medicines and Vesicare
Please tell your doctor or pharmacist if you are
taking or have recently taken or might take other
medicines.
It is especially important to inform your doctor if
you are taking:
• other anticholinergic medicines, effects and side
effects of both medications can be enhanced.
• cholinergics as they can reduce the effect of
Vesicare.
• medicines, like metoclopramide and cisapride,
which make the digestive system work faster.
Vesicare can reduce their effect.
• medicines, like ketoconazole, ritonavir,
nelfinavir, intraconazole, verapamil and
diltiazem, which decrease the rate at which
Vesicare is broken down by the body
• medicines like rifampicin, phenytoin and
carbamazepine, as they may increase the rate
at which Vesicare is broken down by the body.
• medicines such as bisphosphonates, that can
cause or exacerbate inflammation of the gullet
(oesophagitis).
Vesicare with food and drink
Vesicare can be taken with or without food,
depending on your preference.
Pregnancy and breast-feeding
You should not use Vesicare if you are pregnant
unless clearly necessary.
Do not use Vesicare if you are breast-feeding as
solifenacin may get into your breast milk.
Ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Vesicare may cause blurred vision and
sometimes sleepiness or tiredness. If you suffer
from any of these side effects, do not drive or
operate machinery.
Vesicare contains lactose. If you have
been told by your doctor that you have a rare
hereditary problem of galactose intolerance,
Lapp lactase deficiency or glucose-galactose
malabsorption you should not use this medicine.

3.  ow to take Vesicare
H
Instructions for proper use
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
You should swallow the whole tablet with some
liquid. It can be taken with or without food,
according to your preference. Do not crush the
tablets.
The usual dose is 5 mg per day, unless your
doctor told 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 accidentally taken Vesicare, contact your
doctor or pharmacist immediately.
Symptoms of overdose may include: headache,
dry mouth, dizziness, drowsiness and blurred
vision, perceiving things that are not there
(hallucinations), over- excitability, seizures
(convulsions), difficulty breathing, elevated heart
rate (tachycardia), accumulation of urine in the
bladder (urinary retention) and dilated 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 your next dose. Never take more than one
dose per day. If you are in doubt, always consult
your doctor or pharmacist.
If you stop taking Vesicare
If you stop taking Vesicare, your symptoms of
overactive bladder may return or worsen. Always
consult your doctor, if you are considering
stopping the treatment.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

FREE CONFIDENTIAL INFORMATION SERVICE
Dear Patient,
Your doctor has prescribed Vesicare to help treat your bladder symptoms.
To help ensure you have the best possible information about your condition, you can join the
Vesicare Information Programme (VIP). By joining the programme you will be entitled to receive
any of a number of items from our Information Service (see examples overleaf).
This service is completely confidential and free of charge.
No personal details will be disclosed to any third party.
To join ring our
FREEPHONE NUMBER - 0800 072 7740.
Or visit the VIP website at www.astellas-vip.co.uk
To gain entry to the site or to join by calling the freephone number, you will need the batch
number found on the end of your Vesicare pack.

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Vesicare 5+10mg

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4.  ossible side effects
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5.  ow to store Vesicare
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Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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

If you experience an allergic attack, or a severe
skin reaction (e.g. blistering and peeling of the
skin), you must inform your doctor or pharmacist
immediately.

Do not use Vesicare after the expiry date which
is stated on the carton after EXP. The expiry date
refers to the last day of that month.

Angioedema (skin allergy that results in the
swelling that occurs in the tissue just below
the surface of the skin) with airway obstruction
(difficulty in breathing) has been reported
in some patients on solifenacin succinate
(Vesicare). If angioedema occurs, solifenacin
succinate (Vesicare) should be discontinued
immediately and appropriate therapy and/or
measures should be taken.
Vesicare may cause the following other 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 abdominal fullness,
abdominal pain, burping, nausea, and heartburn
(dyspepsia), stomach discomfort
Uncommon (may affect up to 1 in 100 people)
• urinary tract infection, bladder infection
• sleepiness, impaired sense of taste (dysgeusia)
• dry (irritated) eyes
• dry nasal passages
• reflux disease (gastro-oesophageal reflux), dry
throat
dry skin

• difficulty in passing urine
• tiredness, accumulation of fluid in the lower
legs (oedema)
Rare (may affect up to 1 in 1,000 people)
• lodging of a large amount of hardened stool in
the large intestine (faecal impaction)
build up of urine in the bladder due to inability to

empty the bladder (urinary retention)
dizziness, headache

• vomiting
• itching, rash
Very rare (may affect up to 1 in 10,000 people)
• hallucinations, confusion
• allergic rash
Not known (frequency cannot be estimated from
the available data)
• decreased appetite, high levels of blood
potassium which can cause abnormal heart
rhythm
increased pressure in the eyes

• changes in the electrical activity of the heart
(ECG), irregular heartbeat, feeling your
heartbeat, faster heart beat
voice disorder

• liver disorder
• muscle weakness
• renal disorder
Reporting of side effects
If you get 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 via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

There are no special precautions for storage.

6.  ontents of the pack and other
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information
What Vesicare contains
• The active substance is solifenacin succinate
5 mg or 10 mg
The other ingredients are maize starch, lactose,

hypromellose (E464), magnesium stearate,
macrogol, talc, titanium dioxide (E171) and iron
oxide (E172)
What Vesicare looks like 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 blister packs
of 3, 5, 10, 20, 30, 50, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Astellas Pharma Ltd.
2000 Hillswood Drive
Chertsey
Surrey
KT16 0RS
UK.
Tel +44 (0) 203 379 8700
Manufacturer:
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands.
Tel +31 71 5455745
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Greece,
Hungary, Iceland, Latvia, Lithuania, Luxemburg,
Malta, Netherlands, Norway, Poland, Portugal,
Sweden, Slovenia, Slovakia, Spain and United
Kingdom: Vesicare
Italy: Vesiker
Germany: Vesikur
Ireland: Vesitirim
This leaflet was last revised in 10/2013.

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Some of the support items available free to Vesicare-treated patients when they join the Vesicare
Information Programme include:
VIP Helpful Hints Leaflet - Provides background information and support on your condition.
VIP DVD Programme - Includes tips from a Continence Advisor and a General Practitioner, on bladder
retraining and pelvic floor exercises.
VIP Symptom Progress Monitor - Helps you to record the impact of your treatment, over time.
VIP Website - As a Vesicare-treated patient you can gain access to information and support on your
condition via the VIP website at www.astellas-vip.co.uk.
VIP Help Line - Allows you to telephone our free phone helpline on 0800 072 7740 with any questions
you may have.
VIP Care Team – Telephone contact from a nurse to provide help and support.
VIP Reminder Emails, Letters or Texts - A reminder for you to contact your doctor when your tablets
are about to run out.
May we take this opportunity of wishing you the very best of health.
Astellas Pharma Ltd.

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25-10-13 13:32

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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