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SOLIFENACIN SUCCINATE 5 MG FILM COATED TABLETS

Active substance(s): SOLIFENACIN SUCCINATE

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Patient Information Leaflet



®

Vesicare 5 mg Film-coated Tablets
(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.
Your tablets are called Vesicare® 5 mg Film-coated Tablets but
throughout this leaflet will be referred to as Vesicare.
Your medicine is available in other strengths.
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.






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

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).

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.

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

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

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.
If your doctor tells you to stop taking the tablets, return any unused
tablets to your pharmacist to be destroyed. Do not throw them
away with your normal household waste. This will help to protect
the environment.
If your tablets become discoloured or show any signs of
deterioration, consult your pharmacist for advice.

6. Contents of the pack and other information
What Vesicare contains
The active substance is solifenacin succinate.
Each tablet contains 5 mg solifenacin succinate.
Other ingredients are maize starch, lactose monohydrate,
hypromellose, magnesium stearate, macrogol 8000, talc, titanium
dioxide (E171) and yellow 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 and plain on the
reverse.
Vesicare tablets are supplied in blister packs of 30 and 90 tablets.

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)

Manufacturer:
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands.

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

Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD

Very rare (may affect up to 1 in 10,000 people)
• hallucinations, confusion
• allergic rash

Procured from within the EU.
Product licence holder: Ecosse Pharmaceuticals Ltd,
3 Young Place, East Kilbride G75 0TD

PL 19065/0458

POM

This leaflet was revised: 08/05/2015
E0458/1
Vesicare® is a registered trade mark of Astellas Pharma Europe BV

Patient Information Leaflet

Solifenacin succinate 5 mg Film-coated Tablets
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.
Your tablets are called Solifenacin succinate 5 mg Film-coated Tablets
but throughout this leaflet will be referred to as Solifenacin succinate.
Your medicine is available in other strengths.
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 glucose-galactose
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.

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 Solifenacin succinate




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
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





There are no special precautions for storage.
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.
If your doctor tells you to stop taking the tablets, return any unused
tablets to your pharmacist to be destroyed. Do not throw them
away with your normal household waste. This will help to protect
the environment.
If your tablets become discoloured or show any signs of
deterioration, consult your pharmacist for advice.

6. Contents of the pack and other information
What Solifenacin succinate contains
The active substance is solifenacin succinate 5 mg.
Each tablet contains 5 mg solifenacin succinate.
The other ingredients are maize starch, lactose monohydrate,
hypromellose, magnesium stearate, macrogol 8000, talc, titanium
dioxide (E171) and yellow 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 the company logo and the code “150” on the same side
and plain on the reverse.
Solifenacin succinate tablets are supplied in blister packs of 30 and 90
tablets.
Manufacturer:
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands.
Procured from within the EU.
Product licence holder: Ecosse Pharmaceuticals Ltd,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD
PL 19065/0458
This leaflet was revised: 08/05/2015
E0458/1(S)

POM

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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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