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TROSEPHARMA XL 60MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): TROSPIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
REGURIN® XL 60mg PROLONGED-RELEASE CAPSULES, HARD
(trospium chloride)
This product is available as the above name but will be referred to as Regurin XL throughout
remainder of this 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 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.
0B

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.
1B

Children under the age of 18 years
Do NOT give Regurin XL to children under 18 years of age.
2B

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. amitriptyline 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 prolongedrelease capsule.
3B

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.
4B

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.
5B

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.
The following side effects have been reported for Regurin XL prolonged-release capsules, hard
in clinical trials:
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.
6B

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.
7B

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.
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.
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 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 blister and 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.
• Do not use Regurin XL if you notice that the package has been damaged or shows signs of
tampering.
• If this medicine becomes discoloured or show signs of any deterioration, you should seek the
advice of 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 60 mg trospium chloride.
The other ingredients are:
Capsule contents: Sucrose, Maize starch, Methyl acrylate-methyl methacrylate-methacrylic acidcopolymer, sodium dodecyl sulfate, Ammonium hydroxide, Medium chain triglycerides, Oleic
acid, Ethylcellulose, Titanium dioxide (E 171), Hypromellose, Macrogol 400, Polysorbate 80,
Triethyl citrate, Talc
Capsule shell: Gelatin, Titanium dioxide (E 171), Yellow iron oxide (E 172), Red iron oxide (E
172)
Printing ink: (Shellac glaze, Black iron oxide (E 172), Propylene glycol)
What Regurin XL looks like and contents of the pack
The capsules are hard, consist of a white body and an orange cap imprinted with SAN 60 and
contain white to off-white pellets.
Regurin XL is available in packs containing 28 prolonged-release capsules.
PL: 15814/1251

Regurin® XL 60mg Prolonged-Release Capsules, Hard

POM

Manufactured by MADAUS GmbH, 51101 Cologne, Germany and procured from within the EU
and repackaged by the Product Licence holder: OPD Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Leaflet update and revision date (ref): 14.01.2016.
Regurin is a registered trademark of MADAUS GmbH, Germany.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER
SIGPORURIN XL 60mg PROLONGED-RELEASE CAPSULES, HARD
(trospium chloride)
This product is available as the above name but will be referred to as Sigporurin XL throughout
remainder of this 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 Sigporurin XL is and what it is used for
2. Before you take Sigporurin XL
3. How to take Sigporurin XL
4. Possible side effects
5. How to store Sigporurin XL
6. Further information
1. WHAT SIGPORURIN XL IS AND WHAT IT IS USED FOR
Sigporurin 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 SIGPORURIN XL
Do not take Sigporurin XL
• If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of
Sigporurin XL (An allergic reaction can be a rash, itchiness or shortness of breath.). For the
list of ingredients in Sigporurin 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 Sigporurin 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 Sigporurin 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.
0B

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.
1B

Children under the age of 18 years
Do NOT give Sigporurin XL to children under 18 years of age.
2B

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. amitriptyline 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,
Sigporurin XL should be taken during pregnancy and breast-feeding only if your doctor considers
it absolutely necessary.
Driving and using machines
Sigporurin 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 Sigporurin XL
This medicine contains sucrose. If you know that you have an intolerance to certain sugars,
please take Sigporurin XL only after consultation with your doctor.
3. HOW TO TAKE SIGPORURIN XL
Please always take Sigporurin 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 Sigporurin XL
prolonged-release capsule.
3B

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.
4B

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.
5B

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 Sigporurin XL than you should
If you have taken too much Sigporurin XL you should contact your doctor or go to the nearest
hospital casualty department immediately.
If you forget to take Sigporurin 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 Sigporurin XL
Your symptoms may return if you stop taking Sigporurin XL before recommended by your doctor.
Therefore, you should take Sigporurin 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, Sigporurin 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 Sigporurin 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.
The following side effects have been reported for Sigporurin XL prolonged-release capsules,
hard in clinical trials:
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.
6B

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.
7B

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 Sigporurin 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.
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.
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 SIGPORURIN XL
• Keep out of the sight and reach of children.
• Do not use Sigporurin XL after the expiry date which is stated on the blister and 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.
• Do not use Sigporurin XL if you notice that the package has been damaged or shows signs of
tampering.
• If this medicine becomes discoloured or show signs of any deterioration, you should seek the
advice of 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 Sigporurin XL contains
The active substance is: Trospium chloride.
Each prolonged-release capsule contains 60 mg trospium chloride.
The other ingredients are:
Capsule contents: Sucrose, Maize starch, Methyl acrylate-methyl methacrylate-methacrylic acidcopolymer, sodium dodecyl sulfate, Ammonium hydroxide, Medium chain triglycerides, Oleic
acid, Ethylcellulose, Titanium dioxide (E 171), Hypromellose, Macrogol 400, Polysorbate 80,
Triethyl citrate, Talc
Capsule shell: Gelatin, Titanium dioxide (E 171), Yellow iron oxide (E 172), Red iron oxide (E
172)
Printing ink: (Shellac glaze, Black iron oxide (E 172), Propylene glycol)
What Sigporurin XL looks like and contents of the pack
The capsules are hard, consist of a white body and an orange cap imprinted with SAN 60 and
contain white to off-white pellets.
Sigporurin XL is available in packs containing 28 prolonged-release capsules.
PL: 15814/1251

Sigporurin XL 60mg Prolonged-Release Capsules, Hard

POM

Manufactured by MADAUS GmbH, 51101 Cologne, Germany and procured from within the EU
and repackaged by the Product Licence holder: OPD Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Leaflet update and revision date (ref): 14.01.2016.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER
TROSEPHARMA XL 60mg PROLONGED-RELEASE CAPSULES, HARD
(trospium chloride)
This product is available as the above name but will be referred to as Trosepharma XL
throughout remainder of this 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 Trosepharma XL is and what it is used for
2. Before you take Trosepharma XL
3. How to take Trosepharma XL
4. Possible side effects
5. How to store Trosepharma XL
6. Further information
1. WHAT TROSEPHARMA XL IS AND WHAT IT IS USED FOR
Trosepharma 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 TROSEPHARMA XL
Do not take Trosepharma XL
• If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of
Trosepharma XL (An allergic reaction can be a rash, itchiness or shortness of breath.). For the
list of ingredients in Trosepharma 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 Trosepharma 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 Trosepharma 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.
0B

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.
1B

Children under the age of 18 years
Do NOT give Trosepharma XL to children under 18 years of age.
2B

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. amitriptyline 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,
Trosepharma XL should be taken during pregnancy and breast-feeding only if your doctor
considers it absolutely necessary.
Driving and using machines
Trosepharma 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 Trosepharma XL
This medicine contains sucrose. If you know that you have an intolerance to certain sugars,
please take Trosepharma XL only after consultation with your doctor.
3. HOW TO TAKE TROSEPHARMA XL
Please always take Trosepharma 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 Trosepharma XL
prolonged-release capsule.
3B

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.
4B

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.
5B

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 Trosepharma XL than you should
If you have taken too much Trosepharma XL you should contact your doctor or go to the nearest
hospital casualty department immediately.
If you forget to take Trosepharma 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 Trosepharma XL
Your symptoms may return if you stop taking Trosepharma XL before recommended by your
doctor. Therefore, you should take Trosepharma 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, Trosepharma 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 Trosepharma 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.
The following side effects have been reported for Trosepharma XL prolonged-release capsules,
hard in clinical trials:
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.
6B

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.
7B

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 Trosepharma 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.
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.
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 TROSEPHARMA XL
• Keep out of the sight and reach of children.
• Do not use Trosepharma XL after the expiry date which is stated on the blister and 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.
• Do not use Trosepharma XL if you notice that the package has been damaged or shows signs
of tampering.
• If this medicine becomes discoloured or show signs of any deterioration, you should seek the
advice of 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 Trosepharma XL contains
The active substance is: Trospium chloride.
Each prolonged-release capsule contains 60 mg trospium chloride.
The other ingredients are:
Capsule contents: Sucrose, Maize starch, Methyl acrylate-methyl methacrylate-methacrylic acidcopolymer, sodium dodecyl sulfate, Ammonium hydroxide, Medium chain triglycerides, Oleic
acid, Ethylcellulose, Titanium dioxide (E 171), Hypromellose, Macrogol 400, Polysorbate 80,
Triethyl citrate, Talc
Capsule shell: Gelatin, Titanium dioxide (E 171), Yellow iron oxide (E 172), Red iron oxide (E
172)
Printing ink: (Shellac glaze, Black iron oxide (E 172), Propylene glycol)
What Trosepharma XL looks like and contents of the pack
The capsules are hard, consist of a white body and an orange cap imprinted with SAN 60 and
contain white to off-white pellets.
Trosepharma XL is available in packs containing 28 prolonged-release capsules.
PL: 15814/1251

Trosepharma XL 60mg Prolonged-Release Capsules, Hard

POM

Manufactured by MADAUS GmbH, 51101 Cologne, Germany and procured from within the EU
and repackaged by the Product Licence holder: OPD Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Leaflet update and revision date (ref): 14.01.2016.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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