Vesicare 5 Mg Film-Coated Tablets
Out of date information, search anotherAssessed against UKP IL dated April 2011
Vesicare® 5 mg film-coated tablets Vesicare® 10 mg film-coated tablets
(solifenacin succinate)
APPROVED r
By Pratyush Bhartiya at 5:55 pm, Jan 05, 201
Your medicine is available in either of the above name and strengths but will be referred to as Vesicare throughout the following.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Id this leaflet
1. What Vesicare is and what it is used for
2. Before you take Vesicare
3. How to take Vesicare
4. Possible side effects
5. How to store Vesicare
6. Further 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. 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 (hypersensitive) to solifenacin or any of the other ingredients of Vesicare
• 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.
Take special care with 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 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.
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.
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).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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).
Taking 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.
Important information about some of the ingredients of Vesicare
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 Vesicare exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
POM
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, Vesicare can cause side effects, although not everybody gets them. Vesicare may cause the following:
Very common side effects (likely to affect more than 1 in 10 patients)
• dry mouth
Common side effects (likely to affect more than 1 in 100 and less than 1 in 10 patients)
• blurred vision
• constipation, nausea, indigestion with symptoms such as abdominal fullness, abdominal pain, burping, nausea, and heartburn (dyspepsia), stomach discomfort
Uncommon side effects (likely to affect more than 1 in 1000 and less than 1 in 100 patients)
• 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 side effects (likely to affect more than 1 in 10,000 and less than 1 in 1000 patients)
• 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 side effects (likely to affect less than 1 in 10,000 patients)
• hallucinations, confusion
• changes in the electrical activity of the heart (ECG), irregular heartbeat (Torsade de Pointes)
• allergic rash
• skin allergy that results in the swelling that occurs in the tissue just below the surface of the skin (angioedema).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Vesicare
There are no special precautions for storage. Keep out of the reach and sight 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.
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.
If the medicine become discoloured or show any other signs of deterioration, you should seek the advice of your doctor or pharmacist who will tell you what to do.
6. Further information
What Vesicare 5mg tablets contain
• Each tablet contains 5mg solifenacin succinate corresponding to 3.8 mg solifenacin.
• The other ingredients are
maize starch, lactose monohydrate, hypromellose, magnesium stearate, macrogol 8000, talc, titanium dioxide (E171), yellow iron oxide (E172).
What Vesicare 10mg tablets contain
• Each tablet contains 10mg solifenacin succinate corresponding to 7.5 mg solifenacin.
• The other ingredients are
maize starch, lactose monohydrate, hypromellose, magnesium stearate, macrogol 8000, talc, titanium dioxide (E171), red 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.
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.
Manufacturer and Product Licence Holder
This product is manufactured by Astellas Pharma Europe B.V., PO. Box 108, 2350 AC Leiderdorp, The Netherlands. It is procured from within the EU by the Product Licence holder: Swinghope Limited, Brandon House, Marlowe Way, Croydon CR0 4XS and repackaged by Interport Limited, Brandon House, Marlowe Way, Croydon CR0 4XS.
PL No: 10380/1454
Vesicare 5 mg film-coated tablets
PL No: 10380/1455
Vesicare 10 mg film-coated tablets
Leaflet revision date: 20/12/11
Vesicare® is registered trademark of Astellas Pharma Europe B.V., Leiderdorp,
Netherlands.
T03201