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TROSPIUM CHLORIDE 20 MG FILM-COATED TABLETS

Active substance(s): TROSPIUM CHLORIDE

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PACKAGE LEAFLET

PATIENT INFORMATION LEAFLET

TROSPIUM CHLORIDE 20 MG FILM-COATED TABLETS

• 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 become s
please tell your doctor or pharmacist.

1. What is Trospium Chloride and what is it used for?
2. Before you take Trospium Chloride
3. How to take Trospium Chloride
4. Possible side effects
5. Storing Trospium Chloride
6. Further information

1. What is Trospium Chloride and
what is it used for?
The name of this medicine is Trospium Chloride
20 mg Film-Coated Tablets. Trospium Chloride
20 mg Film-Coated Tablets are used to treat the
symptoms of overactive bladder conditions.
For example, needing to go to the toilet
frequently, needing to suddenly rush to the toilet
wetting yourself.

2. Before you take Trospium Chloride
Do not take Trospium Chloride if your doctor
has told you that you have:
• An allergic reaction to Trospium Chloride or
any of the ingredients listed in section 6.
(An allergic reaction can be a rash, itchiness
or shortness of breath).
• Urinary retention i.e. urination occurs less
frequently than normal.
• The eye condition glaucoma.
• Abnormal/faster than normal heart beats.
• Myasthenia gravis (a disorder which causes
muscle fatigue).
• A severe gastro-intestinal condition, such as
toxic megacolon.
Do NOT give this product to children under 12
years of age.
Special Precautions
Check with your doctor or pharmacist before
taking your medicine if you suffer from any of the
following:
• Any type of stomach or bowel obstruction.
• Blockage of the urinary tract.
• Neuropathy i.e. nerve damage.

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 you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
taking this medicine.
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. Taking some medicines together
can be harmful.

In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
• Amantadine (used in the treatment of
Parkinson’s disease or as protection against
• Tricyclic antidepressants.
• A ‘sympathomimetic’ (one of a class of drugs
which can increase the heart rate).
• Metoclopramide (a drug which increases the
rate of movement of digested food through
your gastro-intestinal system).
• Guar gum (sometimes used in a type of
diabetes).
• Cholestyramine or colestipol (drugs used to
reduce the levels of certain fats in your
bloodstream).
If you are unsure of the types of medicines you
are taking, ask your doctor or pharmacist.
Pregnancy and breast feeding
If you are pregnant or breast feeding talk to your
doctor before taking Trospium Chloride.
Driving and using machines
Trospium Chloride does not affect your ability to
drive or use machines.
Important information about some of the
ingredients of Trospium Chloride
This product contains lactose. 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.

3. How to take Trospium Chloride
Always take this medicine exactly as your doctor
or pharmacist has told you. You should check
with them if you are not sure. Trospium Chloride
should be taken orally.
Adults and children 12 years or over:
The usual dose for adults is one tablet twice a
day. Doctors may prescribe different doses to
this. For example, patients with kidney problems
may take a reduced dose of one tablet per day or
one tablet every second day.
Read the pharmacist’s label it will tell you exactly
how many you should take.
The tablets should be swallowed whole with a
glass of water, before meals on an empty
stomach.
If symptoms persist, contact your doctor or
pharmacist. Your doctor will want to assess your
treatment every 3 to 6 months, to decide
whether this medicine is the best one for you.
continued... please turn over

Trospium Chloride 20 mg Tablet PIL - UK & Ireland
item no:

approved for print/date

AAAI5742

dimensions: 148 x 300

print proof no: 3

pharmacode:

origination date: 08.12.15

min pt size: 8pt

originated by:

R.Paul

revision date:

29.01.16

Technical Approval

revised by:

R.Paul

date sent: 08.12.15

supplier:

IL/Tiofarma BV

technically app. date: 11.01.16

Children under 12 years of age:
This product should not be taken by children
under 12 years of age.
If you take more Trospium Chloride than you
should:
It is always important to follow the recommended
dose on the label. If too many tablets are taken by
accident, contact your doctor or hospital
immediately.
If you forget to take Trospium Chloride:
Take the dose as soon as you remember to take
it and then continue on as before. Do not take a
double dose to make up for a forgotten dose.
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 Chloride can have
side effects, although not everybody gets them.
The side effects occurring most frequently are
typical for this kind of medicine and comprise of
dry mouth, dyspepsia and constipation.
To give you an idea of how many patients might
get side effects, they have been listed as very
common, common, uncommon, rare, very rare
and other side effects. These mean the following:
Very common More than 1 in 10 people.
Common

Up to 1 in 10 people.

Uncommon

Up to 1 in 100 people.

Rare

Up to 1 in 1,000 people.

Very rare

Fewer than 1 in 10,000 people.

Other side
effects

The frequency is not known.

colours/plates
1. black
2.
3.
4.
5.
6.
Non Printing Colours
1. Profile (Non Print)

2.

Other Side Effects:
• Accelerated and irregular heart rate
(tachyarrhythmia)

• Itchiness
• Nettle rash (hives)
• General feeling of weakness (asthenia)
• Slight to moderate increase of certain liver
enzyme levels
• 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
Reporting of side effects:
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
report side effects directly via the national
reporting system (see below). By reporting side
effects you can help provide more information on
the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL – Dublin 2
Tel: +353 1 6764971 Fax: +353 1 6762517
Website: www.hpra.ie E-mail: medsafety@hpra.ie

5. Storing Trospium Chloride
Keep all medicines out of the reach and sight of
children.

The following side effects below are serious and
will require immediate action if you experience
them. You should stop taking Trospium
Chloride and see your doctor immediately if
the following symptoms occur:
• Swelling of the face, tongue and windpipe
(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).
Less serious side effects:

Do not use Trospium Chloride after the expiry
date on the carton and blister. 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.

6. Further Information
What Trospium Chloride contains:
Each coated tablet contains 20 mg of trospium
chloride as the active ingredient.
The tablets also contain maize starch, lactose
monohydrate, microcrystalline cellulose,
povidone K30, sodium starch glycolate,
magnesium stearate, macrogol 400,
hypromellose and iron oxide yellow (E172).
What Trospium Chloride looks like and
contents of the pack:
Trospium Chloride tablets are round yellow
tablets.

Very Common:
• Dry mouth

Trospium Chloride tablets are available in boxes
of 20 or 60 tablets. Not all pack sizes may be
marketed.

Common:
• Constipation
• Nausea
• Abdominal pain
• Indigestion (dyspepsia)

Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.
Whiddon Valley, Barnstaple,
North Devon, EX32 8NS, UK
Manufacturer:
Tiofarma
Benjamin Franklinstraat 9, 3261 LW
Oud-Beijerland, Netherlands

Uncommon:
• Fast heart rate (tachycardia)
• Headache
• Flatulence
• Diarrhoea
• Chest pain

This leaflet was last revised in January 2016.

For information in large print, on
tape, on CD or in Braille, phone
+44 (0)1271 385 257.

Rare:
• Dizziness

• Urinary retention

• Rash
• Joint and muscle pains

AAAI5742

Trospium Chloride 20 mg Tablet PIL - UK & Ireland
item no:

approved for print/date

AAAI5742

dimensions: 148 x 300

print proof no: 3

pharmacode:

origination date: 08.12.15

min pt size: 8pt

originated by:

R.Paul

revision date:

29.01.16

Technical Approval

revised by:

R.Paul

date sent: 08.12.15

supplier:

IL/Tiofarma BV

technically app. date: 11.01.16

colours/plates
1. black
2.
3.
4.
5.
6.
Non Printing Colours
1. Profile (Non Print)

2.

PACKAGE LEAFLET

PATIENT INFORMATION LEAFLET

TROSPIUM CHLORIDE 20 MG FILM-COATED TABLETS

• 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 become s
please tell your doctor or pharmacist.

1. What is Trospium Chloride and what is it used for?
2. Before you take Trospium Chloride
3. How to take Trospium Chloride
4. Possible side effects
5. Storing Trospium Chloride
6. Further information

1. What is Trospium Chloride and
what is it used for?
The name of this medicine is Trospium Chloride
20 mg Film-Coated Tablets. Trospium Chloride
20 mg Film-Coated Tablets are used to treat the
symptoms of overactive bladder conditions.
For example, needing to go to the toilet
frequently, needing to suddenly rush to the toilet
wetting yourself.

2. Before you take Trospium Chloride
Do not take Trospium Chloride if your doctor
has told you that you have:
• An allergic reaction to Trospium Chloride or
any of the ingredients listed in section 6.
(An allergic reaction can be a rash, itchiness
or shortness of breath).
• Urinary retention i.e. urination occurs less
frequently than normal.
• The eye condition glaucoma.
• Abnormal/faster than normal heart beats.
• Myasthenia gravis (a disorder which causes
muscle fatigue).
• A severe gastro-intestinal condition, such as
toxic megacolon.
Do NOT give this product to children under 12
years of age.
Special Precautions
Check with your doctor or pharmacist before
taking your medicine if you suffer from any of the
following:
• Any type of stomach or bowel obstruction.
• Blockage of the urinary tract.
• Neuropathy i.e. nerve damage.

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 you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
taking this medicine.
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. Taking some medicines together
can be harmful.

In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
• Amantadine (used in the treatment of
Parkinson’s disease or as protection against
• Tricyclic antidepressants.
• A ‘sympathomimetic’ (one of a class of drugs
which can increase the heart rate).
• Metoclopramide (a drug which increases the
rate of movement of digested food through
your gastro-intestinal system).
• Guar gum (sometimes used in a type of
diabetes).
• Cholestyramine or colestipol (drugs used to
reduce the levels of certain fats in your
bloodstream).
If you are unsure of the types of medicines you
are taking, ask your doctor or pharmacist.
Pregnancy and breast feeding
If you are pregnant or breast feeding talk to your
doctor before taking Trospium Chloride.
Driving and using machines
Trospium Chloride does not affect your ability to
drive or use machines.
Important information about some of the
ingredients of Trospium Chloride
This product contains lactose. 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.

3. How to take Trospium Chloride
Always take this medicine exactly as your doctor
or pharmacist has told you. You should check
with them if you are not sure. Trospium Chloride
should be taken orally.
Adults and children 12 years or over:
The usual dose for adults is one tablet twice a
day. Doctors may prescribe different doses to
this. For example, patients with kidney problems
may take a reduced dose of one tablet per day or
one tablet every second day.
Read the pharmacist’s label it will tell you exactly
how many you should take.
The tablets should be swallowed whole with a
glass of water, before meals on an empty
stomach.
If symptoms persist, contact your doctor or
pharmacist. Your doctor will want to assess your
treatment every 3 to 6 months, to decide
whether this medicine is the best one for you.
continued... please turn over

Trospium Chloride 20 mg Tablet PIL - UK & Ireland
item no:

approved for print/date

AAAI5742

dimensions: 148 x 300

print proof no: 3

pharmacode:

origination date: 08.12.15

min pt size: 8pt

originated by:

R.Paul

revision date:

29.01.16

Technical Approval

revised by:

R.Paul

date sent: 08.12.15

supplier:

IL/Tiofarma BV

technically app. date: 11.01.16

Children under 12 years of age:
This product should not be taken by children
under 12 years of age.
If you take more Trospium Chloride than you
should:
It is always important to follow the recommended
dose on the label. If too many tablets are taken by
accident, contact your doctor or hospital
immediately.
If you forget to take Trospium Chloride:
Take the dose as soon as you remember to take
it and then continue on as before. Do not take a
double dose to make up for a forgotten dose.
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 Chloride can have
side effects, although not everybody gets them.
The side effects occurring most frequently are
typical for this kind of medicine and comprise of
dry mouth, dyspepsia and constipation.
To give you an idea of how many patients might
get side effects, they have been listed as very
common, common, uncommon, rare, very rare
and other side effects. These mean the following:
Very common More than 1 in 10 people.
Common

Up to 1 in 10 people.

Uncommon

Up to 1 in 100 people.

Rare

Up to 1 in 1,000 people.

Very rare

Fewer than 1 in 10,000 people.

Other side
effects

The frequency is not known.

colours/plates
1. black
2.
3.
4.
5.
6.
Non Printing Colours
1. Profile (Non Print)

2.

Other Side Effects:
• Accelerated and irregular heart rate
(tachyarrhythmia)

• Itchiness
• Nettle rash (hives)
• General feeling of weakness (asthenia)
• Slight to moderate increase of certain liver
enzyme levels
• 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
Reporting of side effects:
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
report side effects directly via the national
reporting system (see below). By reporting side
effects you can help provide more information on
the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL – Dublin 2
Tel: +353 1 6764971 Fax: +353 1 6762517
Website: www.hpra.ie E-mail: medsafety@hpra.ie

5. Storing Trospium Chloride
Keep all medicines out of the reach and sight of
children.

The following side effects below are serious and
will require immediate action if you experience
them. You should stop taking Trospium
Chloride and see your doctor immediately if
the following symptoms occur:
• Swelling of the face, tongue and windpipe
(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).
Less serious side effects:

Do not use Trospium Chloride after the expiry
date on the carton and blister. 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.

6. Further Information
What Trospium Chloride contains:
Each coated tablet contains 20 mg of trospium
chloride as the active ingredient.
The tablets also contain maize starch, lactose
monohydrate, microcrystalline cellulose,
povidone K30, sodium starch glycolate,
magnesium stearate, macrogol 400,
hypromellose and iron oxide yellow (E172).
What Trospium Chloride looks like and
contents of the pack:
Trospium Chloride tablets are round yellow
tablets.

Very Common:
• Dry mouth

Trospium Chloride tablets are available in boxes
of 20 or 60 tablets. Not all pack sizes may be
marketed.

Common:
• Constipation
• Nausea
• Abdominal pain
• Indigestion (dyspepsia)

Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.
Whiddon Valley, Barnstaple,
North Devon, EX32 8NS, UK
Manufacturer:
Tiofarma
Benjamin Franklinstraat 9, 3261 LW
Oud-Beijerland, Netherlands

Uncommon:
• Fast heart rate (tachycardia)
• Headache
• Flatulence
• Diarrhoea
• Chest pain

This leaflet was last revised in January 2016.

For information in large print, on
tape, on CD or in Braille, phone
+44 (0)1271 385 257.

Rare:
• Dizziness

• Urinary retention

• Rash
• Joint and muscle pains

AAAI5742

Trospium Chloride 20 mg Tablet PIL - UK & Ireland
item no:

approved for print/date

AAAI5742

dimensions: 148 x 300

print proof no: 3

pharmacode:

origination date: 08.12.15

min pt size: 8pt

originated by:

R.Paul

revision date:

29.01.16

Technical Approval

revised by:

R.Paul

date sent: 08.12.15

supplier:

IL/Tiofarma BV

technically app. date: 11.01.16

colours/plates
1. black
2.
3.
4.
5.
6.
Non Printing Colours
1. Profile (Non Print)

2.

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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