VESICARE 5 MG FILM-COATED TABLETS

Active substance: SOLIFENACIN SUCCINATE

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

T04879

(solifenacin succinate)

Patient Information Leaflet
Your medicine is available in either of the
above names but will be referred to as
Vesicare throughout the following.
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.
• This 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. What you need to know before you take
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 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. What you need to know before you
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. How to take vesicare
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.

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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.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
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.
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 a 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
disease
(gastro-oesophageal
• reflux
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.

5. How to store Vesicare
There are no special precautions for storage.
Keep out of the sight and reach of children.
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.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
If the medicine becomes discoloured or
shows any other signs of deterioration, you
should seek the advice of your doctor or
pharmacist who will tell you what to do.

6. Contents of the pack and other
information
What Vesicare 5 mg tablets contains
• Each tablet contains 5mg solifenacin
succinate corresponding to 3.8 mg
solifenacin.
• The other ingredients are
maize starch, lactose, hypromellose
(E464), magnesium stearate, macrogol,
talc, titanium dioxide (E171), iron oxide
(E172).
What Vesicare 10 mg tablets contain
• Each tablet contains 10mg solifenacin
succinate corresponding to 7.5 mg
solifenacin.
• The other ingredients are
maize starch, lactose, hypromellose
(E464), magnesium stearate, macrogol,
talc, titanium dioxide (E171), 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 30 tablets.
Manufacturer and Product Licence Holder
This product is manufactured by Astellas
Pharma Europe B.V., P.O. Box 108, 2350 AC
Leiderdorp, The Netherlands. It is procured
from within the EU by the Product Licence
Holder: Swinghope Limited, Brandon House,
Marlowe Way, Croydon CR0 4XS and
repackaged by Interport Limited, Brandon
House, Marlowe Way, Croydon CR0 4XS.
POM
PL No: 10380/1456
Vesicare 5 mg film-coated tablets
PL No: 10380/1457
Vesicare 10 mg film-coated tablets
Leaflet revision date: 11/02/2014
Vesicare® is registered trademark of Astellas
Pharma
Europe
B.V.
Leiderdorp,
Netherlands.

T04879

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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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