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SOLIFENACIN SUCCINATE 5MG TABLETS

Active substance(s): SOLIFENACIN SUCCINATE

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Warnings and precautions

S1757 LEAFLET Vesicare 201500306

PACKAGE LEAFLET: INFORMATION FOR USER

Talk to your doctor or pharmacist before taking Vesicare


Your medicine is known as Vesicare 5mg Tablets and will be
referred to as Vesicare throughout the following leaflet.

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.



Information about other strength i.e. Vesicare 10mg Tablets also
may be present in this leaflet.

if you have some obstruction of the digestive system
(constipation).



Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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.



Keep this leaflet. You may need to read it again.



if you have moderate liver disease.



If you have any further questions, ask your doctor or
pharmacist.



if you have a stomach tear (hiatus hernia) or heartburn.





if you have a nervous disorder (autonomic neuropathy).

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.

®

Vesicare 5mg Tablets
(solifenacin succinate)



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

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).

4. Possible side effects
5. How to store Vesicare

Other medicines and Vesicare

6. Contents of the pack and other information

Please tell your doctor or pharmacist if you are taking or have
recently taken or might take other medicines.

1. WHAT VESICARE IS AND WHAT IT IS USED FOR

It is especially important to inform your doctor if you are taking:

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.



other anticholinergic medicines, effects and side effects of both
medications can be enhanced.



cholinergics as they can reduce the effect of Vesicare.



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.

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



2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
VESICARE

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).

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.

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

Very rare (may affect up to 1 in 10,000 people)

Instructions for proper use



hallucinations, confusion



allergic rash

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.

Not known (frequency cannot be estimated from the available data)


decreased appetite, high levels of blood potassium which can
cause abnormal heart rhythm

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



increased pressure in the eyes



If you have taken too much Vesicare or if a child has accidentally
taken Vesicare, contact your doctor or pharmacist immediately.

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

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

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.

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.

5. HOW TO STORE VESICARE

If you have any further questions on the use of this product, ask
your doctor or pharmacist.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



There are no special precautions for storage.



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.

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.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. This will help to protect
the environment

4. POSSIBLE SIDE EFFECTS

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:

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Vesicare contains


The active ingredient is solifenacin succinate. Each tablet
contains 5mg solifenacin succinate.



Vesicare also contains the following inactive ingredients: maize
starch, lactose monohydrate, hypromellose, magnesium
stearate, macrogol 8000, talc, titanium dioxide (E171) and
yellow iron oxide (E172).

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)

What Vesicare looks like and contents of the pack


Vesicare is round, light-yellow, film-coated tablet marked with
the Yamanouchi logo and ‘150’ on the same side and plain on
the other.



Vesicare comes in blister packs containing 30 tablets.



urinary tract infection, bladder infection



sleepiness, impaired sense of taste (dysgeusia)



Manufacturer

dry (irritated) eyes



dry nasal passages

These products are manufactured by Astellas Pharma Europe BV,
Elisabethhof 19, 2353 EW Leiderdorp, The Netherlands.



reflux disease (gastro-oesophageal reflux), dry throat



dry skin

Product Licence holder



difficulty in passing urine



tiredness, accumulation of fluid in the lower legs (oedema)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

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

POM

PL No: 19488/1757

Leaflet revision date: 06 March 2015
Vesicare is registered trademarks of Astellas Pharma
S1757 LEAFLET Vesicare 201500306

S1757 LEAFLET Solifenacin 20150306

PACKAGE LEAFLET: INFORMATION FOR USER

Solifenacin Succinate 5mg Tablets
The name of your medicine is Solifenacin Succinate 5mg Tablets
but will be referred to as Solifenacin Tablets throughout the
following leaflet.
Information about other strength i.e. Solifenacin Succinate 10mg
Tablets also may be present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Tablets


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.



Keep this leaflet. You may need to read it again.





if you suffer from severe kidney disease.

If you have any further questions, ask your doctor or
pharmacist.



if you have moderate liver disease.



if you have a stomach tear (hiatus hernia) or heartburn.



if you have a nervous disorder (autonomic neuropathy).





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 Tablets are and what they are used for
2. What you need to know before you take Solifenacin Tablets
3. How to take Solifenacin Tablets
4. Possible side effects
5. How to store Solifenacin Tablets
6. Contents of the pack and other information
1. WHAT SOLIFENACIN TABLETS ARE AND WHAT THEY
ARE USED FOR

Children and adolescents
Solifenacin Tablets are 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 Tablets
starts.
Before starting Solifenacin Tablets, 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 Tablets
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:

The active substance of Solifenacin Tablets 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.



other anticholinergic medicines, effects and side effects of both
medications can be enhanced.



cholinergics as they can reduce the effect of Solifenacin
Tablets.

Solifenacin Tablets are 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.



medicines, like metoclopramide and cisapride, which make the
digestive system work faster. Solifenacin Tablets can reduce
their effect.



medicines, like ketoconazole, ritonavir, nelfinavir, intraconazole,
verapamil and diltiazem, which decrease the rate at which
Solifenacin Tablets are broken down by the body



medicines like rifampicin, phenytoin and carbamazepine, as
they may increase the rate at which Solifenacin Tablets are
broken down by the body.



medicines such as bisphosphonates, that can cause or
exacerbate inflammation of the gullet (oesophagitis).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SOLIFENACIN TABLETS
Do not take Solifenacin Tablets


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)

Pregnancy and breast-feeding



if you are allergic to solifenacin or any of the other ingredients
of this medicine (listed in section 6)

You should not use Solifenacin Tablets if you are pregnant unless
clearly necessary.



if you are undergoing kidney dialysis



if you have severe liver disease

Do not use Solifenacin Tablets if you are breast-feeding as
solifenacin may get into your breast milk.



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 Tablets 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 Tablets
starts.

Solifenacin Tablets with food and drink
Solifenacin Tablets can be taken with or without food, depending on
your preference.

Ask your doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Solifenacin Tablets 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 Tablets contain 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 SOLIFENACIN TABLETS



vomiting

Instructions for proper use



itching, rash

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Very rare (may affect up to 1 in 10,000 people)

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.



hallucinations, confusion



allergic rash

The usual dose is 5 mg per day, unless your doctor told you to take
10 mg per day.
If you take more Solifenacin Tablets than you should

Not known (frequency cannot be estimated from the available data)


If you have taken too much Solifenacin Tablets or if a child has
accidentally taken Solifenacin Tablets, contact your doctor or
pharmacist immediately.

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

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 Tablets
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 Tablets
If you stop taking Solifenacin Tablets , 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.

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 SOLIFENACIN TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

4. POSSIBLE SIDE EFFECTS



There are no special precautions for storage.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



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



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. This will help to protect
the environment

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 Tablets). If angioedema occurs,
solifenacin succinate (Solifenacin Tablets) should be discontinued
immediately and appropriate therapy and/or measures should be
taken.
Solifenacin Tablets may cause the following other side effects:

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Very common (may affect more than 1 in 10 people)

What Solifenacin Tablets contain





The active ingredient is solifenacin succinate. Each tablet
contains 5mg solifenacin succinate.



Solifenacin Tablets also contain the following inactive
ingredients: maize starch, lactose monohydrate, hypromellose,
magnesium stearate, macrogol 8000, talc, titanium dioxide
(E171) and yellow iron oxide (E172).

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

What Solifenacin Tablets look like and contents of the pack


Solifenacin Tablets are round, light-yellow, film-coated tablets
marked with the Yamanouchi logo and ‘150’ on the same side
and plain on the other.



Solifenacin Tablets come in blister packs containing 30 tablets.

Uncommon (may affect up to 1 in 100 people)


urinary tract infection, bladder infection



sleepiness, impaired sense of taste (dysgeusia)



dry (irritated) eyes

Manufacturer



dry nasal passages



reflux disease (gastro-oesophageal reflux), dry throat

These products are manufactured by Astellas Pharma Europe BV,
Elisabethhof 19, 2353 EW Leiderdorp, The Netherlands.



dry skin



difficulty in passing urine



tiredness, accumulation of fluid in the lower legs (oedema)

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

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

POM

PL No: 19488/1757

Leaflet revision date: 06 March 2015
S1757 LEAFLET Solifenacin 20150306

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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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