Document: leaflet MAH BRAND_PLPI 18067-0403 change

• leaflet MAH BRAND_PLPI 18067-0403
• leaflet MAH BRAND_PLPI 19065-0459
• leaflet MAH BRAND_PLPI 19065-0521
• leaflet MAH BRAND_PLPI 30984-0252
• leaflet MAH BRAND_PLPI 39352-0200
• leaflet MAH BRAND_PLPI 39352-0323
• leaflet MAH BRAND_PLPI 46245-0002
• leaflet MAH GENERIC_PL 00289-1909
• leaflet MAH GENERIC_PL 04569-1503
• leaflet MAH GENERIC_PL 17907-0543

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503912/PL1d

®

Vesicare 10 mg Film-Coated Tablets (solifenacin succinate)

Patient Information Leaflet

The name of your medicine is Vesicare® 10 mg Film-Coated Tablets. Throughout this leaflet it will be referred to as Vesicare®. This product is available in other strengths.

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 YOL	1 NEED TO KNOW BEFORE YOU TAKEl
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, 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).

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.

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.

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 heartbeat

•    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.

What Vesicare® looks like and contents of the pack

Vesicare® 10 mg tablets are round, light pink tablets, marked with a company logo and '151' on the same side and plain on the other.

Vesicare® 10 mg tablets are supplied in blister packs of 30 tablets. There are 10 tablets in each blister strip and 3 blister strips in each pack.

Product Licence Holder and Manufacturer Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.

Manufactured by Astellas Pharma Europe BV, Sylviusweg 62, 2333 BE Leiden, The Netherlands.

Vesicare® 10 mg Film-Coated Tablets _

PL No: 18067/0403    |POM|

Vesicare® is a registered trademark of Astella Pharma Europe BV.

This leaflet was last revised on 30^th September 2014.

To request a copy of this leaflet in Braille, large print or audio please call 01622 690172

Solifenacin Succinate 10 mg Film-Coated Tablets

Patient Information Leaflet

The name of your medicine is Solifenacin Succinate 10 mg Film-Coated Tablets. Throughout this leaflet it will be referred to as Solifenacin Succinate. This product is available in other strengths.

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 Solifenacin Succinate is and what it is used for

2)    What you need to know before you take Solifenacin Succinate

3)    How to take Solifenacin Succinate

4)    Possible side effects

5)    How to store Solifenacin Succinate

6)    Contents of the pack and other information

The active substance of Solifenacin Succinate 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.

Solifenacin Succinate 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| SOLIFENACIN SUCCINATE^^^^^^^^H

Do not take Solifenacin Succinate

•    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 Solifenacin Succinate 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 Solifenacin Succinate starts.

Warnings and precautions

Talk to your doctor or pharmacist before taking Solifenacin Succinate.

•    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

Solifenacin Succinate 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 Solifenacin Succinate starts.

Before starting Solifenacin Succinate, 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 Solifenacin Succinate

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 Solifenacin Succinate.

•    medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin Succinate can reduce their effect.

•    medicines, like ketoconazole, ritonavir, nelfinavir, intraconazole, verapamil and diltiazem, which decrease the rate at which Solifenacin Succinate is broken down by the body

•    medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Solifenacin Succinate is broken down by the body.

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

Solifenacin Succinate with food and drink

Solifenacin Succinate can be taken with or without food, depending on your preference.

Pregnancy and breast-feeding

You should not use Solifenacin Succinate if you are pregnant unless clearly necessary.

Do not use Solifenacin Succinate 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

Solifenacin Succinate may cause blurred vision and sometimes sleepiness or tiredness. If you suffer from any of these side effects, do not drive or operate machinery.

Solifenacin Succinate 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.

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 Solifenacin Succinate than you should

If you have taken too much Solifenacin Succinate or if a child has accidentally taken Solifenacin Succinate, 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 Solifenacin Succinate

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 Solifenacin Succinate

If you stop taking Solifenacin Succinate, 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.

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. If angioedema occurs, solifenacin succinate should be discontinued immediately and appropriate therapy and/or measures should be taken.

Solifenacin Succinate 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 heartbeat

•    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 of the safety of this medicine.

What Solifenacin Succinate looks like and contents of the pack

Solifenacin Succinate 10 mg tablets are round, light pink tablets, marked with a company logo and '151' on the same side and plain on the other.

Solifenacin Succinate 10 mg tablets are supplied in blister packs of 30 tablets. There are 10 tablets in each blister strip and 3 blister strips in each pack.

Product Licence Holder and Manufacturer

Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.

Manufactured by Astellas Pharma Europe BV, Sylviusweg 62, 2333 BE Leiden, The Netherlands.

Solifenacin Succinate 10 mg Film-Coated Tablets

PL No: 18067/0403    |POM|

This leaflet was last revised on 30^th September 2014.

To request a copy of this leaflet in Braille, large print or audio please call 01622 690172

|5) HOW TO STORE SOLIFENACIN SUCCINATE|

•    There are no special precautions for storage.

•    Keep out of the sight and reach of children.

•    Do not use Solifenacin Succinate 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 you notice any sign of deterioration or discolouration of your medicine, please tell your pharmacist immediately.

6) CONTENTS OF	: THE PACK AND OTHER|
INFORMATION

What Solifenacin Succinate contains

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

•    The other ingredients are maize starch, lactose monohydrate, hypromellose (E464), magnesium stearate, macrogol 8000, talc, titanium dioxide (E171) and red iron oxide (E172).

503913/PL1d