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SOLIFENACIN SUCCINATE 10MG FILM COATED TABLETS

Active substance(s): SOLIFENACIN SUCCINATE

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Previously assessed against UK PIL dated October 2013

PACKAGE LEAFLET: INFORMATION FOR THE USER

By BeeharryN at 2:38 pm, Jul 21, 2014

®

VESICARE 5mg FILM-COATED TABLETS /
SOLIFENACIN SUCCINATE 5mg FILM-COATED TABLETS
VESICARE® 10mg FILM-COATED TABLETS /
SOLIFENACIN SUCCINATE 10mg FILM-COATED TABLETS
Variation 0008: Add/Amend: 1. To add a manufacturer `Astellas Pharma Europe
BV, Sylviusweg
62, 2333 Be Leiden, The Netherlands' to the licence with the consequential changes to
(solifenacin
succinate)
the labels and leaflet.
This medicine is available as any of the above names but will be referred to as Vesicare throughout the following
2. The leaflet has been corrected to incorporate the changes from variation 5 and 6.
leaflet.
No other changes
approved

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.
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).
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, itraconazole, 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
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.
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
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
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
• 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.
• If your tablets show visible signs of deterioration, show it to a pharmacist who will advise you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Vesicare contains
• The active substance is solifenacin succinate.
• Vesicare 5mg film-coated Tablets / Solifenacin Succinate 5mg film-coated Tablets:
Each film-coated tablet contains 5mg of solifenacin succinate equivalent to 3.8mg solifenacin.
• Vesicare 10mg film-coated Tablets / Solifenacin Succinate 10mg film-coated Tablets:
Each film-coated tablet contains 10mg of solifenacin succinate equivalent to 7.5mg solifenacin.
• The other ingredients are maize starch, lactose, hypromellose (E464), magnesium stearate, macrogol, talc and
titanium dioxide (E171).
Vesicare 5mg tablets also contain yellow iron oxide (E172).
Vesicare 10mg tablets also contain red iron oxide (E172).
What Vesicare looks like and contents of the pack
Vesicare 5 mg tablets are round pale yellow film-coated tablets debossed with a logo and 150 on one side and
plain on the reverse.
Vesicare 10 mg tablets are round pale pink film-coated tablets debossed with a logo and 151 on one side and plain
on the reverse.
Vesicare tablets are available in blister packs of 30 tablets.
PL No: 15814/1012 Vesicare 5mg film-coated Tablets
PL No: 15814/1013 Vesicare 10mg film-coated Tablets

POM

Manufactured by Astellas Pharma Europe BV, Elisabethhof 19, 2353 EW Leiderdorp, The Netherlands OR Astellas
Pharma Europe BV, Sylviusweg 62, 2333 BE Leiden, The Netherlands OR Astellas Pharma Europe BV, Hogemaat
2, 7942 JG Meppel, The Netherlands. Procured from within the EU and repackaged by the Product Licence holder:
OPD Laboratories Ltd, Unit-6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 21.07.2014.
Vesicare is a registered Trade Mark of Astellas Pharma Europe BV, The Netherlands.
To request a copy of this in Braille, large print or audio please call 01923 332 796.

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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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