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SOLIFENACIN SUCCINATE 5 MG FILM COATED TABLETS

Active substance(s): SOLIFENACIN SUCCINATE / SOLIFENACIN SUCCINATE

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5000000/PL1a
®

Vesicare 5 mg Film-Coated Tablets
®
Vesicare 10 mg Film-Coated Tablets
(solifenacin succinate)
Patient Information Leaflet
®

The name of your medicine is Vesicare 5 mg Film-Coated
®
Tablets or Vesicare 10 mg Film-Coated Tablets. Throughout
®
this leaflet it will be referred to as Vesicare .
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

®

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.

®

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.

Driving and using machines
®
may cause blurred vision and sometimes
Vesicare
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.
®

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.

®

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).

®

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
Continued overleaf

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.

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.
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.
Ginova Ltd and Ginova UK Ltd are not associated with
Astellas Pharma Europe B.V.

®

5) HOW TO STORE VESICARE
• 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.
• There are no special precautions for storage.
• 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 you notice any sign of deterioration or discolouration
of your medicine, please tell your pharmacist
immediately.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
®
What Vesicare contains
• Each 5 mg film-coated tablet contains 5 mg solifenacin
succinate.
• Each 10 mg film-coated tablet contains 10 mg
solifenacin succinate.
• The other ingredients are maize starch, lactose
monohydrate, 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 a triangular logo and ‘150’ on the same side and plain on
the other.
®

Vesicare 10 mg tablets are round, light pink tablets marked
with a triangular logo and ‘151’ on the same side and plain on
the other.
®

Vesicare tablets are supplied in blister packs of 30 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Astellas Pharma Europe BV, Sylviusweg 62, 2333 BE Leiden,
The Netherlands.
®

Vesicare 5 mg Film-Coated Tablets
PL No: 18067/0495
®
Vesicare 10 mg Film-Coated Tablets
PL No: 18067/0496

POM

®

Vesicare is a registered trademark of Astellas Pharma
Europe BV.
st

This leaflet was last revised on 21 February 2017.

To request a copy of this leaflet in
Braille, large print or audio please
call 01622 690172.
500000/PL1a

5000000/PL1a

Solifenacin Succinate 5 mg Film-Coated Tablets
Solifenacin Succinate 10 mg Film-Coated Tablets
Patient Information Leaflet
The name of your medicine is Solifenacin Succinate 5 mg
Film-Coated Tablets or Solifenacin Succinate 10 mg FilmCoated Tablets. Throughout this leaflet it will be referred to as
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.
• 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 Solifenacin Succinate is and what it is used for
2) What you need to know before you take
Solifenacin Succinate
3) How to take Solifenacin Succinate
4) Possible side effects
5) How to store Solifenacin Succinate
6) Contents of the pack and other information
1) WHAT SOLIFENACIN SUCCINATE IS AND WHAT IT IS
USED FOR
The active substance of Solifenacin Succinate 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.
Solifenacin Succinate 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
SOLIFENACIN SUCCINATE
Do not take Solifenacin Succinate
• 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
Solifenacin Succinate 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 Solifenacin
Succinate starts.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin
Succinate
• 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
Solifenacin Succinate 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 Solifenacin
Succinate starts.
Before starting Solifenacin Succinate, 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 Solifenacin Succinate
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
Solifenacin Succinate.
• medicines, like metoclopramide and cisapride, which
make the digestive system work faster. Solifenacin
Succinate can reduce their effect.
• medicines, like ketoconazole, ritonavir, nelfinavir,
intraconazole, verapamil and diltiazem, which
decrease the rate at which Solifenacin Succinate is
broken down by the body.
• medicines
like
rifampicin,
phenytoin
and
carbamazepine, as they may increase the rate at
which Solifenacin Succinate is broken down by the
body.
• medicines such as bisphosphonates, that can cause or
exacerbate inflammation of the gullet (oesophagitis).
Solifenacin Succinate with food and drink
Solifenacin Succinate can be taken with or without food,
depending on your preference.
Pregnancy and breast-feeding
You should not use Solifenacin Succinate if you are pregnant
unless clearly necessary.
Do not use Solifenacin Succinate 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
Solifenacin Succinate may cause blurred vision and
sometimes sleepiness or tiredness. If you suffer from any of
these side effects, do not drive or operate machinery.
Solifenacin Succinate contains lactose. If you have been
told by your doctor that you have a rare hereditary problem of
galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption you should not use this medicine.
3) HOW TO TAKE SOLIFENACIN SUCCINATE
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 Solifenacin Succinate than you should
If you have taken too much Solifenacin Succinate or if a child
has accidentally taken Solifenacin Succinate, 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 Solifenacin Succinate
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 Solifenacin Succinate
If you stop taking Solifenacin Succinate, 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 (Solifenacin
Succinate). If angioedema occurs, solifenacin succinate
(Solifenacin Succinate) should be discontinued immediately
and appropriate therapy and/or measures should be taken.
Solifenacin Succinate 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
Continued overleaf

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.
5) HOW TO STORE SOLIFENACIN SUCCINATE
• Keep out of the sight and reach of children.
• Do not use Solifenacin Succinate after the expiry date
which is stated on the carton after EXP. The expiry
date refers to the last day of that month.
• There are no special precautions for storage.
• 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 you notice any sign of deterioration or discolouration
of your medicine, please tell your pharmacist
immediately.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Solifenacin Succinate contains
• Each 5 mg film-coated tablet contains 5 mg solifenacin
succinate.
• Each 10 mg film-coated tablet contains 10 mg
solifenacin succinate.
• The other ingredients are maize starch, lactose
monohydrate, hypromellose (E464), magnesium
stearate, macrogol, talc, titanium dioxide (E171) and
iron oxide (E172).
What Solifenacin Succinate looks like and contents of the
pack
Solifenacin Succinate 5 mg tablets are round, light yellow
tablets marked with a triangular logo and ‘150’ on the same
side and plain on the other.
Solifenacin Succinate 10 mg tablets are round, light pink
tablets marked with a triangular logo and ‘151’ on the same
side and plain on the other.
Solifenacin Succinate tablets are supplied in blister packs of
30 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Astellas Pharma Europe BV, Sylviusweg 62, 2333 BE Leiden,
The Netherlands.
Solifenacin Succinate 5 mg Film-Coated Tablets
PL No: 18067/0495
Solifenacin Succinate 10 mg Film-Coated Tablets
PL No: 18067/0496
POM
st

This leaflet was last revised on 21 February 2017.

To request a copy of this leaflet in
Braille, large print or audio please
call 01622 690172.

500000/PL1a

Expand view ⇕

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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