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Patients with liver disorders

S218 LEAFLET Regurin 20150305

PACKAGE LEAFLET: INFORMATION FOR THE USER REGURIN® 20mg TABLETS (trospium chloride)

Your medicine is known as Regurin 20mg Tablets but will be referred to as Regurin throughout the following patient information leaflet.

In this leaflet:

1.    What Regurin is and what it is used for

2.    Before you take Regurin

3.    How to take Regurin

4.    Possible side effects

5.    How to store Regurin

6.    Further information

1. WHAT REGURIN IS AND WHAT IT IS USED FOR

Regurin is a medicine used for the relaxation of the bladder. It is used for the treatment of symptoms associated with involuntary loss of urine (wetting) and/or increased frequency of urination and imperative urge of urination in patients with hyperactive bladder (involuntary urge of urination and voiding problems of unknown origin or due to nervous system disorders).

2. BEFORE YOU TAKE REGURIN

Do not take Regurin

-    If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of Regurin (An allergic reaction can be a rash, itchiness or shorbless of breath). For the list of ingredients in Regurin, please see section 6.

-    If you suffer from any of the following:

•    urinary retention, i.e. blockage of the urinary tract.

•    the eye condition narrow-angle glaucoma,

•    abnormal/ faster than normal heart beats,

•    myasthenia gravis (a disorder that causes muscle fatigue),

•    a severe gastro-intestinal condition, such as toxic megacolon.

Take special care with Regurin

If you suffer from any of the following:

-    any type of stomach or bowel obstruction,

-    difficulties in passing urine and/or poor stream of urine (male prostate disorders),

-    neuropathy ie. nerve damage.

-    a hernia of the diaphragm with inflammation of the oesophagus due to reflux of gastric acid (hiatus hernia associated with reflux oesophagitis). This is usually associated with heartburn which worsens on bending or lying down,

-    an overactive thyroid,

-    any heart conditions, such as coronary artery disease or congestive heart failure,

-    any liver problems,

-    any kidney problems.

If any of the above apply to you, it is important that you speak to your doctor or pharmacist before taking Regurin and they will decide what to do.

You should not take Regurin if you have a serious liver disorder. If you have a slight to moderate liver impairment you should talk to your doctor before taking this medicine.

Patients with kidney disorders

If you have a kidney disorder you should talk to your doctor before taking this medicine. Your doctor will, if necessary, give you a lower dose (see dosage instructions in Section 3- How to take 'For patients with kidney disorders).

Children under the age of 12 years

Do not give Regurin to children under the age of 12 years.

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.

Inform your doctor in particular if you are taking any of the following medicines:

-    certain medicines for the treatment of abnormal sadness (depression), e.g. amitriptyline or imipramine

-    medicines for the treatment of asthma that may accelerate the heart rate (e.g. salbutamol)

-    other medicines with anticholinergic action (such as those used to treat Parkinson's disease, asthma and stomach cramps)

-    medicines for the stimulation of motility of the gastro-intestinal tract which are used to treat impaired gastric emptying or complaints due to reflux of gastric acid (reflux disease), e.g. metoclopramide

-    medicines containing the substances guar, colestipol or cholestyramine which should not be taken simultaneously with Regurin.

Please note that this information may also apply to medicines that you have used recently.

Taking Regurin with food and drink

As high fat diets can affect the action of Regurin, the medicine should be taken before meals on an empty stomach.

Pregnancy and breast-feeding

Please tell your doctor if you are pregnant, think you might be pregnant, or are breastfeeding. Your doctor will decide if this medicine is suitable for you.

Driving and using machines

Regurin can cause blurred vision. If you experience this, do not drive or use any tools or machines.

Important Information about some of the Ingredients of Regurin

This product contains lactose (milk sugar) and sucrose (sugar). If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product

This product also contains wheat starch. If you suffer from wheat allergy (different from coeliac disease) you should not take this product. Regurin is suitable for patients with coeliac disease.

3. HOW TO TAKE REGURIN

Always take Regurin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Usual dose unless otherwise prescribed by your doctor

Unless otherwise prescribed by your doctor, the usual daily dose for adults and children over the age of 12 years is one Regurin tablet taken twice daily (equivalent to 40 mg of trospium chloride daily).

Method of administration

Swallow one tablet whole with a glass of water. Take the tablet before a meal on an empty stomach.

Duration of treatment

Your doctor will determine the duration of treatment.

The need for continued treatment should be checked by your doctor at regular intervals of 3-6 months.

For patients with kidney disorder

If your kidney function is slightly to moderately impaired, no dose adjustment of Regurin is required. In severely impaired kidney function, the dose should be reduced to one tablet once daily or every second day (equivalent to 20mg of trospium chloride daily or every second day).

You should consult with your doctor about the correct dose for you.

If you take more Regurin than you should

If you have taken too much Regurin you should contact your doctor or go to the nearest hospital casualty department immediately.

If you forget to take Regurin

If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than two tablets in one day (unless prescribed otherwise).

If you stop taking Regurin

Your symptoms may return if you stop the intake of Regurin before recommended by your doctor. Therefore, you should take Regurin for as long as prescribed by your doctor. Please consult your doctor if you wish to stop treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Other possible side effects, for which the frequency is not

known

•    accelerated and irregular heart rate (tachyarrhythmia),

•    difficulty in breathing,

•    itchiness, nettle-rash (hives),

•    general feeling of weakness (asthenia),

•    slight to moderate increase of certain liver values (serum transaminases),

•    sporadic cases of hallucination, confusion and agitation have occurred mostly in elderly patients and can be facilitated by neurological diseases and/or other drugs with a similar mechanism of action taken at the same time.

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 REGURIN

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Keep container tightly closed.

•    Keep in cool & dry place.

•    Do not use after the expiry date printed on the carton label or blister strip.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, Regurin can cause side effects, although not everybody gets them.

The side effects occurring most frequently are typical for this kind of medicine and comprise dry mouth, dyspepsia and constipation.

The following side effects below are serious and will require immediate action if you experience them. You should stop taking Regurin and see your doctor immediately if the following symptoms occur:

•    swelling of the face, tongue and windpipe which can cause great difficulty in breathing (affects less than 1 user in 10,000)

•    a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure (frequency unknown)

•    serious reactions with severe blistering and peeling of the skin and/or mucous membranes like for example in the lips, eyes, mouth, nose, and genitals. This may be accompanied by a fever and chills, aching muscles and generally feeling unwell (frequency unknown).

The following side effects have been reported for Regurin:

Very common side effects, affects more than 1 user in 10

•    dryness of the mouth.

Common side effects, affects 1 to 10 users in 100

•    constipation, nausea, abdominal pain, indigestion (dyspepsia).

What Regurin contains

•    Each tablet contains 20mg of the active ingredient, trospium chloride.

•    Regurin Tablets also contain the following inactive ingredients: sucrose, wheat starch, microcrystalline cellulose, talc, lactose monohydrate, calcium carbonate, titanium dioxide (E 171), stearic / palmitic acid, croscarmellose sodium, povidone, macrogol 8000, colloidal silicon dioxide, yellow iron oxide (E 172), carmellose sodium, white bees wax, carnauba wax.

What Regurin looks like and contents of the pack

Regurin Tablets are unmarked brownish-yellow coated tablets.

Regurin Tablets are available as blister packs of 30, 60 or 120

tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Madaus GmbH, 51101 Cologne,

Germany.

I POM I PL No: 19488/0218

S218 LEAFLET Trospium 20150305

PACKAGE LEAFLET: INFORMATION FOR THE USER TROSPIUM CHLORIDE 20mg TABLETS (trospium chloride)

Your medicine is known as Trospium Chloride 20mg Tablets but will be referred to as Trospium Tablets throughout the following patient information leaflet.

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.

In this leaflet:

1.    What Trospium Tablets are and what they are used for

2.    Before you take Trospium Tablets

3.    How to take Trospium Tablets

4.    Possible side effects

5.    How to store Trospium Tablets

6.    Further information

1. WHAT TROSPIUM TABLETS ARE AND WHAT THEY ARE USED FOR

Trospium Tablets are medicine used for the relaxation of the bladder. It is used for the treatment of symptoms associated with involuntary loss of urine (wetting) and/or increased frequency of urination and imperative urge of urination in patients with hyperactive bladder (involuntary urge of urination and voiding problems of unknown origin or due to nervous system disorders).

You should not take Trospium Tablets if you have a serious liver disorder. If you have a slight to moderate liver impairment you should talk to your doctor before taking this medicine.

Patients with kidney disorders

If you have a kidney disorder you should talk to your doctor before taking this medicine. Your doctor will, if necessary, give you a lower dose (see dosage instructions in Section 3- How to take 'For patients with kidney disorders).

Children under the age of 12 years

Do not give Trospium Tablets to children under the age of 12 years. 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.

Inform your doctor in particular if you are taking any of the following medicines:

-    certain medicines for the treatment of abnormal sadness (depression), e.g. amitriptyline or imipramine

-    medicines for the treatment of asthma that may accelerate the heart rate (e.g. salbutamol)

-    other medicines with anticholinergic action (such as those used to treat Parkinson's disease, asthma and stomach cramps)

-    medicines for the stimulation of motility of the gastro-intestinal tract which are used to treat impaired gastric emptying or complaints due to reflux of gastric acid (reflux disease), e.g. metoclopramide

-    medicines containing the substances guar, colestipol or cholestyramine which should not be taken simultaneously with Trospium Tablets.

Please note that this information may also apply to medicines that you have used recently.

Taking Trospium Tablets with food and drink

As high fat diets can affect the action of Trospium Tablets, the medicine should be taken before meals on an empty stomach.

2. BEFORE YOU TAKE TROSPIUM TABLETS

Do not take Trospium Tablets

-    If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of Trospium Tablets (An allergic reaction can be a rash, itchiness or shorbless of breath). For the list of ingredients in Trospium Tablets, please see section 6.

-    If you suffer from any of the following:

•    urinary retention, i.e. blockage of the urinary tract.

•    the eye condition narrow-angle glaucoma,

•    abnormal/ faster than normal heart beats,

•    myasthenia gravis (a disorder that causes muscle fatigue),

•    a severe gastro-intestinal condition, such as toxic megacolon.

Take special care with Trospium Tablets

If you suffer from any of the following:

-    any type of stomach or bowel obstruction,

-    difficulties in passing urine and/or poor stream of urine (male prostate disorders),

-    neuropathy ie. nerve damage.

-    a hernia of the diaphragm with inflammation of the oesophagus due to reflux of gastric acid (hiatus hernia associated with reflux oesophagitis). This is usually associated with heartburn which worsens on bending or lying down,

-    an overactive thyroid,

-    any heart conditions, such as coronary artery disease or congestive heart failure,

-    any liver problems,

-    any kidney problems.

If any of the above apply to you, it is important that you speak to your doctor or pharmacist before taking Trospium Tablets and they will decide what to do.

Pregnancy and breast-feeding

Please tell your doctor if you are pregnant, think you might be pregnant, or are breastfeeding. Your doctor will decide if this medicine is suitable for you.

Driving and using machines

Trospium Tablets can cause blurred vision. If you experience this, do not drive or use any tools or machines.

Important Information about some of the Ingredients of Trospium Tablets

This product contains lactose (milk sugar) and sucrose (sugar). If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product

This product also contains wheat starch. If you suffer from wheat allergy (different from coeliac disease) you should not take this product. Trospium Tablets are suitable for patients with coeliac disease.

3. HOW TO TAKE TROSPIUM TABLETS

Always take Trospium Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Usual dose unless otherwise prescribed by your doctor

Unless otherwise prescribed by your doctor, the usual daily dose for adults and children over the age of 12 years is one Trospium tablet taken twice daily (equivalent to 40mg of trospium chloride daily).

Method of administration

Swallow one tablet whole with a glass of water. Take the tablet before a meal on an empty stomach.

Duration of treatment

Your doctor will determine the duration of treatment.

The need for continued treatment should be checked by your doctor at regular intervals of 3-6 months.

For patients with kidney disorder

If your kidney function is slightly to moderately impaired, no dose adjustment of Trospium Tablets is required. In severely impaired kidney function, the dose should be reduced to one tablet once daily or every second day (equivalent to 20mg of trospium chloride daily or every second day).

You should consult with your doctor about the correct dose for you.

If you take more Trospium Tablets than you should

If you have taken too much Trospium Tablets you should contact your doctor or go to the nearest hospital casualty department immediately.

If you forget to take Trospium Tablets

If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than two tablets in one day (unless prescribed otherwise).

If you stop taking Trospium Tablets

Your symptoms may return if you stop the intake of Trospium Tablets before recommended by your doctor. Therefore, you should take Trospium Tablets for as long as prescribed by your doctor. Please consult your doctor if you wish to stop 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, Trospium Tablets can cause side effects, although not everybody gets them.

The side effects occurring most frequently are typical for this kind of medicine and comprise dry mouth, dyspepsia and constipation.

The following side effects below are serious and will require immediate action if you experience them. You should stop taking Trospium Tablets and see your doctor immediately if the following symptoms occur:

•    swelling of the face, tongue and windpipe which can cause great difficulty in breathing (affects less than 1 user in 10,000)

•    a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure (frequency unknown)

•    serious reactions with severe blistering and peeling of the skin and/or mucous membranes like for example in the lips, eyes, mouth, nose, and genitals. This may be accompanied by a fever and chills, aching muscles and generally feeling unwell (frequency unknown).

The following side effects have been reported for Trospium Tablets: Very common side effects, affects more than 1 user in 10

•    dryness of the mouth.

Common side effects, affects 1 to 10 users in 100

•    constipation, nausea, abdominal pain, indigestion (dyspepsia).

Uncommon side effects, affects 1 to 10 users in 1,000

•    fast heart rate (tachycardia),

•    headache,

•    flatulence, diarrhoea,

•    chest pain.

Other possible side effects, for which the frequency is not

known

•    accelerated and irregular heart rate (tachyarrhythmia),

•    difficulty in breathing,

•    itchiness, nettle-rash (hives),

•    general feeling of weakness (asthenia),

•    slight to moderate increase of certain liver values (serum transaminases),

•    sporadic cases of hallucination, confusion and agitation have occurred mostly in elderly patients and can be facilitated by neurological diseases and/or other drugs with a similar mechanism of action taken at the same time.

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 TROSPIUM TABLETS

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Keep container tightly closed.

•    Keep in cool & dry place.

•    Do not use after the expiry date printed on the carton label or blister strip.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

What Trospium Tablets contain

•    Each tablet contains 20mg of the active ingredient, trospium chloride.

•    Trospium Tablets also contain the following inactive ingredients: sucrose, wheat starch, microcrystalline cellulose, talc, lactose monohydrate, calcium carbonate, titanium dioxide (E 171), stearic / palmitic acid, croscarmellose sodium, povidone, macrogol 8000, colloidal silicon dioxide, yellow iron oxide (E172), carmellose sodium, white bees wax, carnauba wax.

What Trospium Tablets look like and contents of the pack

Trospium Tablets are unmarked brownish-yellow coated tablets.

Trospium Tablets are available as blister packs of 30, 60 or 120

tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Madaus GmbH, 51101 Cologne,

Germany.

I POM I PL No: 19488/0218

Leaflet revision date: 5 March 2015

S218 LEAFLET Trospium 20150305

Rare side effects, affects 1 to 10 user In 10,000

•    dizziness,

•    difficulty emptying of the bladder, urinary retention,

•    difficulty seeing objects dose-up,

•    rash,

•    joint and muscle pains.