VESICARE 5MG FILM-COATED TABLETS

Active substance: SOLIFENACIN SUCCINATE

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1317, 1318
Assessed against
Vesicare® 5mg Film-Coated Tablets 07.10.13[7]
the UK PIL dated
Vesicare® 10mg Film-Coated Tablets
June 2013succinate)
(solifenacin

PATIENT INFORMATION LEAFLET

MOCK UP

Your medicine is available using one of the above name but will be referred
to as Vesicare throughout the following 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
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.
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).

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).

By mcdermottc at 12:08 pm, Oct 22, 13

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
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.

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.

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

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).

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
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
If you get any side effects, talk to your doctor or pharmacist. This includes
any side effects not listed in this leaflet.
5. HOW TO STORE VESICARE
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.
If the tablets become discoloured or shows any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required.
These measures will help to protect the environment
6. FURTHER INFORMATION
What Vesicare contains
Each Vesicare tablet contains either 5mg or 10mg solifenacin succinate
which is the active ingredient in these tablets. The tablets also contain
maize starch, lactose monohydrate, hypromellose, magnesium stearate,
macrogol 8000, talc, hypromellose and titanium dioxide (E171).
Vesicare 5mg Film Coated Tablets also contains yellow ferric oxide (E172).
Vesicare 10mg Film Coated Tablets also contains red ferric oxide (E172).
What Vesicare looks like and contents of the pack
Vesicare 5mg Film-Coated Tablets are available as round light yellow film
coated tablet marked with Yamanouchi symbol and ‘150’ on one side and
plain on the other side.
Vesicare 10mg Film-Coated Tablets are available as round light pink film
coated tablet marked with Yamanouchi symbol and ‘151’ on one side and
plain on the other side.
Vesicare is available in blister strip packs of 30 tablets.

Product Licence Holder and Manufacturer
Manufacturer Astellas Pharma Europe BV., Elisabethhof 19, 2353 EW
Leiderdorp, The Netherlands and Procured from the EU by Product Licence
Holder: Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.

POM

Vesicare 5mg Film-Coated Tablets - PL 20636/1317
Vesicare 10mg Film-Coated Tablets - PL 20636/1318

Leaflet revision and issue date (Ref) 07.10.13[7]
Vesicare is a trademark of Astellas Pharma Europe BV.

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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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