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TROSEMPT XL 60MG PROLONGED-RELEASE CAPSULE HARD

Active substance(s): TROSPIUM CHLORIDE

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Patient Information Leaflet

Regurin® XL 60mg prolonged-release capsule, hard
(trospium chloride)
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.
• The name of this medicine is Regurin XL 60mg prolonged-release
capsule, hard but will be referred to as Regurin XL throughout the
remainder of this leaflet.
In this leaflet:
1) What Regurin XL is and what it is used for
2) Before you take Regurin XL
3) How to take Regurin XL
4) Possible side effects
5) How to store Regurin XL
6) Further information
1) WHAT REGURIN XL IS AND WHAT IT IS USED FOR
Regurin XL is a medicine used for the relaxation of the muscles 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/ or urgency of urination in patients with an overactive bladder.
2) BEFORE YOU TAKE REGURIN XL
Do not take Regurin XL
− If you have ever had an allergic reaction to trospium chloride or any of
the other ingredients of Regurin XL (An allergic reaction can be a rash,
itchiness or shortness of breath.). For the list of ingredients in Regurin
XL, 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,
• problems with your kidneys,
• severe problems with your liver.
Take special care with Regurin XL
If you suffer from any of the following:
• any type of stomach or bowel obstruction,
• difficulties in passing urine and/or a poor stream of urine (male
prostate disorders),
• neuropathy, i.e. 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.
Talk to your doctor before starting your treatment with Regurin XL if you
think any of these might apply to you.
Patients with liver disorders
You should talk to your doctor if you have a liver disorder. Patients with
severe liver disorders should not take this medicine.
Patients with kidney disorders
You should talk to your doctor if you have a kidney disorder. Patients with
kidney disorders should not take this medicine.
Children under the age of 18 years
Do NOT give Regurin XL to children under 18 years of age.

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 antidepressants e.g. amitryptiline or imipramine
− some 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)
− metoclopramide – medicine used for nausea and vomiting
− medicines containing guar, colestipol or colestyramine.
Please note that this information may also apply to medicines that you
have used recently.
Pregnancy and breast-feeding
Since there is no experience with trospium chloride during pregnancy
and breast feeding, Regurin XL should be taken during pregnancy and
breast-feeding only if your doctor considers it absolutely necessary.
Driving and using machines
Regurin XL 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 XL
This medicine contains sucrose. If you know that you have an intolerance
to certain sugars, please take Regurin XL only after consultation with
your doctor.
3) HOW TO TAKE REGURIN XL
Please always take Regurin XL 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 is one
Regurin XL prolonged-release capsule.
Method of administration
Swallow one prolonged-release capsule whole with a glass of water.
Take the capsule at least one hour before a meal on an empty stomach.
Duration of administration
Your doctor will determine the duration of treatment. The need for
continued treatment should be checked at regular intervals of 3 – 6
months.
Patients with a kidney disorder should consult their doctor and not take
this medicine.
Patients with a liver disorder should consult their doctor before taking this
medicine.
If you take more Regurin XL than you should
If you have taken too much Regurin XL you should contact your doctor or
go to the nearest hospital casualty department immediately.
If you forget to take Regurin XL
If you forget to take a capsule, take your capsule as soon as you
remember, but do not take more than one capsule in one day. Do not
take a double dose to make up for a forgotten capsule.
If you stop taking Regurin XL
Your symptoms may return if you stop taking Regurin XL before
recommended by your doctor. Therefore, you should take Regurin XL 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, Regurin XL can cause side effects, although not
everybody gets them.
The following “very rare” side effects below are important and will require
immediate action if you experience them. You should stop taking Regurin
XL and see your doctor immediately if the following symptoms occur:
• swelling of the face, tongue and windpipe which can cause great
difficulty in breathing
• a sudden allergic reaction with shortness of breath, rash, wheezing
and drop of blood pressure.

What Regurin XL looks like and contents of the pack
Regurin XL 60mg prolonged-release capsules, hard consist of an opaque
orange cap and an opaque white body imprinted with “SAN 60” and
containing white to off-white pellets.
Regurin XL is available in bottle packs containing 30 or 100 capsules.
Manufacturer
Madaus GmbH, 51101 Cologne, Germany
It is procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER. UK
Repackaged by: MPT Pharma Ltd.

The following side effects have been reported for Regurin XL prolongedrelease capsules, hard in clinical trials:

PL: 33532/0437

Very common side effects, affects more than 1 user in 10
• dryness of the mouth.

Leaflet dated 7th May 2016
Leaflet coded XXXXXXXXXX

Common side effects, affects 1 to 10 users in 100
• constipation, nausea, abdominal pain, indigestion,
• dry eyes, dry nose.

Regurin® is a registered trademark of MADAUS GmbH

Uncommon side effects, affects 1 to 10 users in 1,000
• flatulence
Rare side effects, affects 1 to 10 users in 10,000
• difficulty emptying the bladder, urinary retention,
• fast heart rate, palpitations,
• difficulty seeing objects close-up,
• rash,
• general feeling of weakness.
Very rare side effects, affects less than 1 user in 10,000
• urinary tract infection,
• headache.
The following side effects have also been reported for trospium (trospium
is the active ingredient of Regurin XL; it is not known if these side effects
will also occur with the capsules that you have been prescribed):
Difficulty in breathing, diarrhoea, chest pain, slight to moderate increase
of certain liver values (serum transaminases), fast irregular heartbeat,
joint or muscle pains, dizziness.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any 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 REGURIN XL
• Keep out of the sight and reach of children.
• Do not use Regurin XL after the expiry date which is stated on the
container after EXP. The expiry date refers to the last day of that
month.
• This medicinal product does not require any special storage
conditions.
• If your capsules become discoloured or show any sign of deterioration,
return them to your pharmacist.
• 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) FURTHER INFORMATION
What Regurin XL contains
The active substance is: Trospium chloride.
Each prolonged-release capsule contains 60mg trospium chloride.
The other ingredients are: sucrose, maize starch, methyl acrylate-methyl
methacrylate-methacrylic acid-copolymer, sodium dodecyl sulphate,
ammonium hydroxide, medium chain triglycerides, oleic acid,
ethylcellulose, titanium dioxide (E171), hypromellose, macrogol 400,
polysorbate 80, triethyl citrate, talc, gelatin, yellow iron oxide (E172), red
iron oxide (E172), shellac and propylene glycol.

POM

Patient Information Leaflet

Kenporurin XL 60mg prolonged-release capsules, hard
(trospium chloride)
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.
• The name of this medicine is Kenporurin XL 60mg prolonged-release
capsules, hard but will be referred to as Kenporurin XL throughout the
remainder of this leaflet.
In this leaflet:
1) What Kenporurin XL is and what it is used for
2) Before you take Kenporurin XL
3) How to take Kenporurin XL
4) Possible side effects
5) How to store Kenporurin XL
6) Further information
1) WHAT KENPORURIN XL IS AND WHAT IT IS USED FOR
Kenporurin XL is a medicine used for the relaxation of the muscles 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/ or urgency of urination in patients with an overactive bladder.
2) BEFORE YOU TAKE KENPORURIN XL
Do not take Kenporurin XL
− If you have ever had an allergic reaction to trospium chloride or any of
the other ingredients of Kenporurin XL (An allergic reaction can be a
rash, itchiness or shortness of breath.). For the list of ingredients in
Kenporurin XL, 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,
• problems with your kidneys,
• severe problems with your liver.
Take special care with Kenporurin XL
If you suffer from any of the following:
• any type of stomach or bowel obstruction,
• difficulties in passing urine and/or a poor stream of urine (male
prostate disorders),
• neuropathy, i.e. 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.
Talk to your doctor before starting your treatment with Kenporurin XL if
you think any of these might apply to you.
Patients with liver disorders
You should talk to your doctor if you have a liver disorder. Patients with
severe liver disorders should not take this medicine.
Patients with kidney disorders
You should talk to your doctor if you have a kidney disorder. Patients with
kidney disorders should not take this medicine.
Children under the age of 18 years
Do NOT give Kenporurin XL to children under 18 years of age.

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 antidepressants e.g. amitryptiline or imipramine
− some 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)
− metoclopramide – medicine used for nausea and vomiting
− medicines containing guar, colestipol or colestyramine.
Please note that this information may also apply to medicines that you
have used recently.
Pregnancy and breast-feeding
Since there is no experience with trospium chloride during pregnancy
and breast feeding, Kenporurin XL should be taken during pregnancy
and breast-feeding only if your doctor considers it absolutely necessary.
Driving and using machines
Kenporurin XL 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 Kenporurin
XL
This medicine contains sucrose. If you know that you have an intolerance
to certain sugars, please take Kenporurin XL only after consultation with
your doctor.
3) HOW TO TAKE KENPORURIN XL
Please always take Kenporurin XL 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 is one
Kenporurin XL prolonged-release capsule.
Method of administration
Swallow one prolonged-release capsule whole with a glass of water.
Take the capsule at least one hour before a meal on an empty stomach.
Duration of administration
Your doctor will determine the duration of treatment. The need for
continued treatment should be checked at regular intervals of 3 – 6
months.
Patients with a kidney disorder should consult their doctor and not take
this medicine.
Patients with a liver disorder should consult their doctor before taking this
medicine.
If you take more Kenporurin XL than you should
If you have taken too much Kenporurin XL you should contact your
doctor or go to the nearest hospital casualty department immediately.
If you forget to take Kenporurin XL
If you forget to take a capsule, take your capsule as soon as you
remember, but do not take more than one capsule in one day. Do not
take a double dose to make up for a forgotten capsule.
If you stop taking Kenporurin XL
Your symptoms may return if you stop taking Kenporurin XL before
recommended by your doctor. Therefore, you should take Kenporurin XL
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, Kenporurin XL can cause side effects, although not
everybody gets them.

What Kenporurin XL looks like and contents of the pack
Kenporurin XL 60mg prolonged-release capsules, hard consist of an
opaque orange cap and an opaque white body imprinted with “SAN 60”
and containing white to off-white pellets.
Kenporurin XL is available in bottle packs containing 30 or 100 capsules.

The following “very rare” side effects below are important and will require
immediate action if you experience them. You should stop taking
Kenporurin XL and see your doctor immediately if the following
symptoms occur:
• swelling of the face, tongue and windpipe which can cause great
difficulty in breathing
• a sudden allergic reaction with shortness of breath, rash, wheezing
and drop of blood pressure.

Manufacturer
Madaus GmbH, 51101 Cologne, Germany

The following side effects have been reported for Kenporurin XL
prolonged-release capsules, hard in clinical trials:

PL: 33532/0437 Kenporurin XL 60mg prolonged-release capsules, hard

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,
• dry eyes, dry nose.
Uncommon side effects, affects 1 to 10 users in 1,000
• flatulence
Rare side effects, affects 1 to 10 users in 10,000
• difficulty emptying the bladder, urinary retention,
• fast heart rate, palpitations,
• difficulty seeing objects close-up,
• rash,
• general feeling of weakness.
Very rare side effects, affects less than 1 user in 10,000
• urinary tract infection,
• headache.
The following side effects have also been reported for trospium (trospium
is the active ingredient of Kenporurin XL; it is not known if these side
effects will also occur with the capsules that you have been prescribed):
Difficulty in breathing, diarrhoea, chest pain, slight to moderate increase
of certain liver values (serum transaminases), fast irregular heartbeat,
joint or muscle pains, dizziness.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any 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 KENPORURIN XL
• Keep out of the sight and reach of children.
• Do not use Kenporurin XL after the expiry date which is stated on the
container after EXP. The expiry date refers to the last day of that
month.
• This medicinal product does not require any special storage
conditions.
• If your capsules become discoloured or show any sign of deterioration,
return them to your pharmacist.
• 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) FURTHER INFORMATION
What Kenporurin XL contains
The active substance is: Trospium chloride.
Each prolonged-release capsule contains 60mg trospium chloride.
The other ingredients are: sucrose, maize starch, methyl acrylate-methyl
methacrylate-methacrylic acid-copolymer, sodium dodecyl sulphate,
ammonium hydroxide, medium chain triglycerides, oleic acid,
ethylcellulose, titanium dioxide (E171), hypromellose, macrogol 400,
polysorbate 80, triethyl citrate, talc, gelatin, yellow iron oxide (E172), red
iron oxide (E172), shellac and propylene glycol.

It is procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER. UK
Repackaged by: MPT Pharma Ltd.

Leaflet dated 7th May 2016
Leaflet coded XXXXXXXXXX

POM

Patient Information Leaflet

Trosempt XL 60mg prolonged-release capsules, hard
(trospium chloride)
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.
• The name of this medicine is Trosempt XL 60mg prolonged-release
capsules, hard but will be referred to as Trosempt XL throughout the
remainder of this leaflet.
In this leaflet:
1) What Trosempt XL is and what it is used for
2) Before you take Trosempt XL
3) How to take Trosempt XL
4) Possible side effects
5) How to store Trosempt XL
6) Further information
1) WHAT TROSEMPT XL IS AND WHAT IT IS USED FOR
Trosempt XL is a medicine used for the relaxation of the muscles 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/ or urgency of urination in patients with an overactive bladder.
2) BEFORE YOU TAKE TROSEMPT XL
Do not take Trosempt XL
− If you have ever had an allergic reaction to trospium chloride or any of
the other ingredients of Trosempt XL (An allergic reaction can be a
rash, itchiness or shortness of breath.). For the list of ingredients in
Trosempt XL, 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,
• problems with your kidneys,
• severe problems with your liver.
Take special care with Trosempt XL
If you suffer from any of the following:
• any type of stomach or bowel obstruction,
• difficulties in passing urine and/or a poor stream of urine (male
prostate disorders),
• neuropathy, i.e. 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.
Talk to your doctor before starting your treatment with Trosempt XL if you
think any of these might apply to you.
Patients with liver disorders
You should talk to your doctor if you have a liver disorder. Patients with
severe liver disorders should not take this medicine.
Patients with kidney disorders
You should talk to your doctor if you have a kidney disorder. Patients with
kidney disorders should not take this medicine.
Children under the age of 18 years
Do NOT give Trosempt XL to children under 18 years of age.

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 antidepressants e.g. amitryptiline or imipramine
− some 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)
− metoclopramide – medicine used for nausea and vomiting
− medicines containing guar, colestipol or colestyramine.
Please note that this information may also apply to medicines that you
have used recently.
Pregnancy and breast-feeding
Since there is no experience with trospium chloride during pregnancy
and breast feeding, Trosempt XL should be taken during pregnancy and
breast-feeding only if your doctor considers it absolutely necessary.
Driving and using machines
Trosempt XL 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 Trosempt
XL
This medicine contains sucrose. If you know that you have an intolerance
to certain sugars, please take Trosempt XL only after consultation with
your doctor.
3) HOW TO TAKE TROSEMPT XL
Please always take Trosempt XL 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 is one
Trosempt XL prolonged-release capsule.
Method of administration
Swallow one prolonged-release capsule whole with a glass of water.
Take the capsule at least one hour before a meal on an empty stomach.
Duration of administration
Your doctor will determine the duration of treatment. The need for
continued treatment should be checked at regular intervals of 3 – 6
months.
Patients with a kidney disorder should consult their doctor and not take
this medicine.
Patients with a liver disorder should consult their doctor before taking this
medicine.
If you take more Trosempt XL than you should
If you have taken too much Trosempt XL you should contact your doctor
or go to the nearest hospital casualty department immediately.
If you forget to take Trosempt XL
If you forget to take a capsule, take your capsule as soon as you
remember, but do not take more than one capsule in one day. Do not
take a double dose to make up for a forgotten capsule.
If you stop taking Trosempt XL
Your symptoms may return if you stop taking Trosempt XL before
recommended by your doctor. Therefore, you should take Trosempt XL
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, Trosempt XL can cause side effects, although not
everybody gets them.

What Trosempt XL looks like and contents of the pack
Trosempt XL 60mg prolonged-release capsules, hard consist of an
opaque orange cap and an opaque white body imprinted with “SAN 60”
and containing white to off-white pellets.
Trosempt XL is available in bottle packs containing 30 or 100 capsules.

The following “very rare” side effects below are important and will require
immediate action if you experience them. You should stop taking
Trosempt XL and see your doctor immediately if the following symptoms
occur:
• swelling of the face, tongue and windpipe which can cause great
difficulty in breathing
• a sudden allergic reaction with shortness of breath, rash, wheezing
and drop of blood pressure.

Manufacturer
Madaus GmbH, 51101 Cologne, Germany

The following side effects have been reported for Trosempt XL
prolonged-release capsules, hard in clinical trials:

PL: 33532/0437 Trosempt XL 60mg prolonged-release capsules, hard

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,
• dry eyes, dry nose.
Uncommon side effects, affects 1 to 10 users in 1,000
• flatulence
Rare side effects, affects 1 to 10 users in 10,000
• difficulty emptying the bladder, urinary retention,
• fast heart rate, palpitations,
• difficulty seeing objects close-up,
• rash,
• general feeling of weakness.
Very rare side effects, affects less than 1 user in 10,000
• urinary tract infection,
• headache.
The following side effects have also been reported for trospium (trospium
is the active ingredient of Trosempt XL; it is not known if these side
effects will also occur with the capsules that you have been prescribed):
Difficulty in breathing, diarrhoea, chest pain, slight to moderate increase
of certain liver values (serum transaminases), fast irregular heartbeat,
joint or muscle pains, dizziness.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any 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 TROSEMPT XL
• Keep out of the sight and reach of children.
• Do not use Trosempt XL after the expiry date which is stated on the
container after EXP. The expiry date refers to the last day of that
month.
• This medicinal product does not require any special storage
conditions.
• If your capsules become discoloured or show any sign of deterioration,
return them to your pharmacist.
• 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) FURTHER INFORMATION
What Trosempt XL contains
The active substance is: Trospium chloride.
Each prolonged-release capsule contains 60mg trospium chloride.
The other ingredients are: sucrose, maize starch, methyl acrylate-methyl
methacrylate-methacrylic acid-copolymer, sodium dodecyl sulphate,
ammonium hydroxide, medium chain triglycerides, oleic acid,
ethylcellulose, titanium dioxide (E171), hypromellose, macrogol 400,
polysorbate 80, triethyl citrate, talc, gelatin, yellow iron oxide (E172), red
iron oxide (E172), shellac and propylene glycol.

It is procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER. UK
Repackaged by: MPT Pharma Ltd.

Leaflet dated 7th May 2016
Leaflet coded XXXXXXXXXX

POM

Expand view ⇕

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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