Vesicare 10mg Film-Coated Tablets

Informations for option: Vesicare 10mg Film-Coated Tablets, show other option

Document: leaflet MAH BRAND_PLPI 21828-0439 change

Vesicare® 10mg film-coated Tablets

(solifenacin succinate)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vesicare film-coated Tablets are available in the following strengths: 5mg and 10mg. Vesicare 10mg film-coated Tablets will be referred to as Vesicare 10mg Tablets throughout the 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 10mg Tablets are and what they are used for

2. What you need to know before you take Vesicare 10mg Tablets

3. How to take Vesicare 10mg Tablets

4. Possible side effects

5. How to store Vesicare 10mg Tablets

6. Contents of the pack and other information

1. What Vesicare 10mg Tablets are and what they are used for

The active substance of Vesicare 10mg Tablets 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 10mg Tablets are 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 10mg Tablets

Do not take Vesicare 10mg Tablets

■ 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 10mg Tablets 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 10mg Tablets starts.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vesicare 10mg Tablets

■ 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 10mg Tablets are 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 10mg Tablets starts.

Before starting Vesicare 10mg Tablets, 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 10mg Tablets

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 10mg Tablets.

■ medicines, like metoclopramide and cisapride, which make the digestive system work faster. Vesicare 10mg Tablets can reduce their effect.

■ medicines, like ketoconazole, ritonavir, nelfinavir, intraconazole, verapamil and diltiazem, which decrease the rate at which Vesicare 10mg Tablets are broken down by the body.

■ medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Vesicare 10mg Tablets are broken down by the body.

■ medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).

Vesicare 10mg Tablets with food and drink

Vesicare 10mg Tablets can be taken with or without food, depending on your preference.

Pregnancy and breast-feeding

You should not use Vesicare 10mg Tablets if you are pregnant unless clearly necessary. Do not use Vesicare 10mg Tablets 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 10mg Tablets 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 10mg Tablets 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 10mg Tablets

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 5mg per day, unless your doctor told you to take 10mg per day.

If you take more Vesicare 10mg Tablets than you should

If you have taken too many Vesicare 10mg Tablets or if a child has accidentally taken Vesicare 10mg Tablets, 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).

POM

If you forget to take Vesicare 10mg Tablets

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 10mg Tablets

If you stop taking Vesicare 10mg Tablets, 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 10mg Tablets). If angioedema occurs, solifenacin succinate (Vesicare 10mg Tablets) should be discontinued immediately and appropriate therapy and/or measures should be taken.

Vesicare 10mg Tablets 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 10mg Tablets

■ There are no special precautions for storage.

■ Keep out of the sight and reach of children.

■ Do not use Vesicare 10mg Tablets after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.

■ If your doctor decides to stop your treatment, take any tablets you have left back to the pharmacy.

■ If your tablets appear to be discoloured or show any other signs of deterioration, take them back to your 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 10mg Tablets contain

The active substance is solifenacin succinate.

Each film-coated tablet contains 10mg solifenacin succinate corresponding to 7.5mg solifenacin.

The other ingredients are maize starch, lactose, hypromellose (E464), magnesium stearate, macrogol, talc, titanium dioxide (E171) and red iron oxide (E172).

What Vesicare 10mg Tablets look like and contents of the pack

Vesicare 10mg Tablets are round, light pink tablets marked with a logo and code 151 on one side and plain on the reverse.

Vesicare 10mg Tablets are supplied in blister packs of 30 tablets.

Manufacturer

Manufactured by: Astellas Pharma Europe BV, Elisabethhof 19, 2353 EW Leiderdorp, The Netherlands. or

Astellas Pharma Europe BV, Hogemaat 2, 7942 JG Meppel,

The Netherlands. or

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

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0439

Leaflet revision & issue date (Ref): 11.07.14

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

FREE CONFIDENTIAL INFORMATION SERVICE

Dear Patient,

Your doctor has prescribed Vesicare 10mg Tablets 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 below).

This service is completely confidential and free of charge.

No personal details will be disclosed to any third party.

To join ring our 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 10mg Tablets pack.

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 our 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.

Page 2 of 2