VESICARE 10MG TABLETS

Active substance: SOLIFENACIN SUCCINATE

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PROOF HISTORY:
v.1 - waymade - 19/03/13

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

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).

DATE:

CUSTOMER
APPROVED:

Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with
Vesicare starts.

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

DATE:
DATE OF PROOF: 19/03/13
6464/2403B

DT

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).

CODE:

JANUARY 2013

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

Vesicare 10mg tabs

ARTWORKER:

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).

PRODUCT:

CUSTOMER: Waymade

REF:

Q.A.
APPROVED:

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.

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 the Astellas 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.

WARNING!

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is known as the above names but will be referred to as Vesicare throughout this leaflet. Another
strength (5mg) is also available.

WARNING!

27mm

VESICARE® 10mg FILM-COATED TABLETS/
SOLIFENACIN SUCCINATE 10mg FILM-COATED TABLETS
(solifenacin succinate)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000B

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.

PROOF HISTORY:
v.1 - waymade - 19/03/13

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.
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

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

DATE:

CUSTOMER
APPROVED:

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)

DATE:
DATE OF PROOF: 19/03/13







5. How to store Vesicare
There are no special storage instructions for Vesicare 10mg tablets/Solifenacin succinate 10mg
tablets.
Keep all medicines out of the sight and reach of children.
Do not use after the expiry date printed on the carton, carton label or blister strip. The expiry date
refers to the last day of that month.
If your doctor tells you to stop taking the medicine or when you need to dispose of it, please take it
back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
If the medicine becomes discoloured or show signs of deterioration, you should seek the advice of
your pharmacist.

6. Contents of the pack and other information
Your medicine is called Vesicare 10mg tablets/Solifenacin succinate 10mg tablets.
Each tablet contains 10mg of the active ingredient solifenacin succinate corresponding to 7.5mg solifenacin.
6464/2403B

DT

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 (Torsade de Pointes)
• voice disorder
• liver disorder
• muscle weakness
• renal disorder
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet.

CODE:

JANUARY 2013

ARTWORKER:
Vesicare 10mg tabs
PRODUCT:

CUSTOMER: Waymade

REF:

Q.A.
APPROVED:

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

Vesicare 10mg tablets/Solifenacin succinate 10mg tablets also contain the following ingredients: maize
starch, lactose, hypromellose, magnesium stearate, macrogol, talc, titanium dioxide (E171), and yellow iron
oxide (E172).
Vesicare 10mg tablets/Solifenacin succinate 10mg tablets are available as blister packs of 30 tablets.
Each white round tablet is marked with a Yamanouchi logo and '151' on one side and plain on the other.
POM

PL No: 6464/2403

This product is manufactured by Yamanouchi Europe BV, Meppel, Holland and procured from within the EU
and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 13.3.2013
Vesicare is a registered trademark of Astellas Pharma B.V.
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 the Astellas 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.
May we take this opportunity of wishing you the very best of health.
Astellas Pharma Ltd.
This service is provided by Astellas and is not associated with Waymade PLC.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

WARNING!

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

WARNING!

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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.

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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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