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SOLIFENACIN SUCCINATE 10 MG TABLETS

Active substance(s): SOLIFENACIN SUCCINATE / SOLIFENACIN SUCCINATE / SOLIFENACIN SUCCINATE

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Vesicare® 5 mg Tablets / Solifenacin succinate 5 mg Tablets
Vesicare® 10 mg Tablets / Solifenacin succinate 10 mg Tablets
(solifenacin succinate)
important information for you.
• 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

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
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
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,
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
(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,
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.
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
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

5. How to store Vesicare

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 and blister label 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

There are no special precautions for storage.

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

throat
• dry skin


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
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.

If the tablets become discoloured or show any
other signs of deterioration, seek the advice of
your pharmacist.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other
information
What Vesicare contains
• The active substance is solifenacin succinate.
Each tablet contains 5 mg solifenacin succinate
corresponding to 3.8 mg solifenacin or 10 mg
solifenacin succinate corresponding to 7.5 mg
solifenacin.
• The other ingredients are maize starch, lactose
monohydrate, hypromellose, magnesium
stearate, macrogol 8000, talc, titanium dioxide
E 171, yellow ferric oxide E 172 (Vesicare 5
mg) and red ferric oxide E 172 (Vesicare 10
mg).
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 one side and plain on the other
side.
Vesicare 10 mg tablets are round, light pink
tablets marked with the company logo and the
code ‘151’ on one side and plain on the other
side.
Vesicare tablets are supplied in blister packs of
30 tablets.
Manufacturer
Astellas Pharma Europe
B.V. Sylviusweg 62
2333 BE Leiden
The Netherlands.
Procured from within the EU and repackaged
by the Product Licence holder:
Shakespeare Pharma Ltd.
1B Harrison Court
Hilton Business Park
Hilton
DE65 5UR
United Kingdom.
Vesicare® 5 mg Tablets / Solifenacin succinate
5 mg Tablets
PL: 40593/0051
Vesicare® 10 mg Tablets / Solifenacin succinate
10 mg Tablets
PL: 40593/0052

POM

September 2016.
Vesicare® is a registered trademark of Astellas
Pharma Europe B.V.

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Nazwa wyrobu:

ulotka
Vesicare 5
Vesicare 10

23-200 Kraśnik, ul. Kolejowa 14
tel.: 81 884 05 00, fax: 81 884 05 05
www.ajg.com.pl

Klient:

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Farmakod:

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Korekta nr:
2

06 10 2016

Zatwierdził/data:
Arial/Arial Bold min 10 pkt

Unit 1B, Harrison Court,
Hilton Business Park, Hilton,
Derbyshire, DE65 5UR

Opracował/data:

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181 x 516 mm / 181 x 33 mm
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Kod wyrobu:

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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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