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VESICARE 10MG TABLETS

Active substance(s): SOLIFENACIN SUCCINATE

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Vesicare® 10mg Tablets /
Solifenacin Succinate 10mg Tablets
(solifenacin succinate)
This medicine is known by any of the above names but will be referred
to as Vesicare throughout this leaflet. Please note that the leaflet also
contains information about other strength (Vesicare 5mg Tablets).
Package Leaflet: Information for the user
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.

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, itraconazole,
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.

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.

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
VESICARE

Ask your doctor or pharmacist for advice before taking this
medicine.

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.

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.

Inform your doctor if you have or ever had any of the above
mentioned conditions before treatment with Vesicare starts.

The usual dose is 5 mg per day, unless your doctor told you to take
10 mg per day.

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).

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
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, pharmacist or nurse.
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
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the carton and blister.
The expiry date refers to the last day of that month.
If the tablets show any signs of deterioration, seek the advice of
your pharmacist.
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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What is in your medicine?
The name of your medicine is Vesicare 10mg Tablets. Each filmcoated tablet contains 10mg of solifenacin succinate equivalent to
7.5mg of solifenacin. Your medicine also contains the following
inactive ingredients: maize starch, lactose monohydrate,
hypromellose, magnesium stearate, macrogol 8000, talc, titanium
dioxide (E171) and red ferric oxide (E172).
Vesicare are round, light pink tablets with the manufacturer’s logo
and ‘151’ on one side and plain on the other side.
Your medicine is available in blister strips of 30 tablets.
Who has made your medicine?
Vesicare are manufactured by Yamanouchi Europe B.V., Hogemaat
2, 7942JG Meppel, The Netherlands and are procured within the
EU by the Product Licence holder: Caseview (PL) Ltd., 20 Alliance
Court, Alliance Road, London W3 0RB and repackaged by OPD
Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR.
PL 13826/1292

POM

Vesicare 10mg Tablets / Solifenacin Succinate 10mg Tablets
Leaflet revision date (ref): 22/09/2015
Vesicare is a registered Trade Mark of Astellas Pharma Europe BV,
The Netherlands.
To request a copy of this in Braille, large print or audio please call
01923 332 796.

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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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