Skip to Content

VESICARE 10 MG FILM-COATED TABLET

Active substance(s): SOLIFENACIN SUCCINATE / SOLIFENACIN SUCCINATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

PIL45233/0023_003

10 mg film-coated tablet
(solifenacin succinate)
Your medicine is called Vesicare® 10 mg Film-coated tablet but will be referred to as Vesicare throughout the following leaflet.
Information for other strengths of Vesicare 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.
• 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.
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.

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.

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).

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.

Children and adolescents
Vesicare is not to be used in children or adolescents
under 18 years.

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

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.

PIL45233/0023_003
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).

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 Vesicare
Keep out of the sight and reach of childern.

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.

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.

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.

6. Contents of the pack and other information
What Vesicare contains
• Each tablet contains 10 mg solifenacin succinate.
• The other ingredients are maize starch, lactose
monohydrate, hypromellose (E464), magnesium
stearate, macrogol 8000, talc, titanium dioxide (E171)
and iron oxide (E172)
What Vesicare looks like and contents of the pack
Vesicare 10 mg tablets are round, light pink tablets marked
with the company logo and the code “151” on the same
side.
Vesicare tablets are supplied in blister packs of 30 tablets.
Not all pack sizes may be marketed.

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.

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

Vesicare may cause the following other side effects:
Very common (may affect more than 1 in 10 people)
• dry mouth

Procured from within the EU & repackaged by Product
Licence holder:
Originalis B.V., Joop Geesinkenweg 901 1114 AB
Amsterdam-Duivendrecht
The Netherlands

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

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

POM

PL 45233/0023 Vesicare® 10 mg film-coated tablet

This leaflet was last revised in 03/2017.

Blind or partially
sighted?
Is this leaflet hard to see
or read?
Call 2036301310 or write
to info@originalis.eu to
obtain the leaflet in a
format suitable for you.

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

O0173210x297-MHRA-01

Expand Transcript

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.

Hide