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TROSPIUM CHLORIDE 20MG FILM-COATED TABLETS

Active substance(s): TROSPIUM CHLORIDE

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Package Leaflet: Information for the user
Trospium chloride 20mg film-coated tablets
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
What is in this leaflet:
1. What Trospium chloride 20mg film-coated tablets are
and what they are used for
2. What you need to know before you take Trospium
chloride 20mg film-coated tablets
3. How to take Trospium chloride 20mg film-coated
tablets
4. Possible side effects
5. How to store Trospium chloride 20mg film-coated
tablets
6. Contents of the pack and other information
1. What Trospium chloride 20mg film-coated tablets
are and what they are used for
Trospium chloride 20mg film-coated tablets is a medicine
used for the relaxation of the urinary 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. What you need to know before you take Trospium
chloride 20mg film-coated tablets
Do not take Trospium chloride 20mg film-coated
tablets
• if you are allergic (hypersensitive) to trospium chloride
or any of the other ingredients of this medicine (listed
in section 6). (An allergic reaction can be a rash,
itchiness or shortness of breath).
• 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.
Warnings and precautions
Talk to your doctor or your pharmacist before taking
Trospium chloride 20mg film-coated tablets if you suffer
from any of the following :
• any type of stomach or bowel obstruction
• an impaired urine flow (e.g. in the case of benign tissue
growth of the male prostate)
• neuropathy i.e. nerve damage
• a 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 (see “Patients with liver disorders”
below)
• any kidney problems (see “Patients with kidney
disorders” below).
Patients with liver disorders
You should not take Trospium chloride 20mg film-coated
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 Trospium chloride 20mg filmcoated tablets – Patients with kidney disorders”).




Children under 12 years of age
Do not give this medicine to children under 12 years of
age.
Other medicines and Trospium chloride 20mg filmcoated tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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 (e.g.
amantadine)
• medicines for the stimulation of motility of the gastrointestinal 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 chloride 20mg filmcoated tablets.
If you are unsure of the types of medicines you are taking,
ask your doctor or pharmacist.
Trospium chloride 20mg film-coated tablets with food
and drink
As high fat diets can affect the action of Trospium
chloride 20mg film-coated tablets, this medicine should
be taken before meals on an empty stomach.
Pregnancy and breast-feeding
Since there is no experience with trospium chloride during
pregnancy and breast-feeding, Trospium chloride 20mg
film-coated tablets should be taken during pregnancy and
breast-feeding only if your doctor considers it absolutely
necessary.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
This medicine can cause blurred vision. Do not drive
motor vehicles, operate machines or perform other
hazardous activities if you suffer from blurred vision after
taking this medicine.
Trospium chloride 20mg film-coated tablets contain
lactose (milk sugar) and sucrose (sugar).
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.
3. How to take Trospium chloride 20mg film-coated
tablets
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Dosage
The recommended dose for adults and children over
12 years of age is one film-coated tablet twice a day
(equivalent to 40 mg of trospium chloride per day), unless
otherwise prescribed by your doctor.
Patients with kidney disorders
If your kidney function is slightly to moderately impaired,
no dose adjustment is required.
In severely impaired kidney function, the dose should
be reduced to one tablet once daily or every second day
(equivalent to 20 mg of trospium chloride daily or every
second day).
You should consult with your doctor about the correct
dose for you.
Use in children
Do not give this medicine to children under 12 years of
age.
Method of administration (How to take the tablets)
Swallow one film-coated tablet whole with a glass of
water. Take the tablet before a meal on an empty stomach.

10.04.2014 1(Black)
Trospium 20mg F-C Tabs Ins-Fr.

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UK
Goa


170 x 39 mm



170 x 310 mm



40 gsm Bible Paper

Font: 9pt. Times New Roman

Revision for Name change as a part of
One Glenmark variation

V:2

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Duration of treatment
Your doctor will want to assess your treatment every 3 to
6 months, to decide whether this medicine is still the best
one for you.
If you take more Trospium chloride 20mg film-coated
tablets than you should
No symptoms and signs of intoxication in humans have
been reported to date.
If you have taken more Trospium chloride 20mg filmcoated tablets than the amount prescribed, you should
contact a doctor or pharmacist immediately.
If you forget to take Trospium chloride 20mg filmcoated tablets
If you miss a dose of Trospium chloride 20mg film-coated
tablets, simply carry on with the next dose as usual. Do
not take a double dose to make up for a forgotten dose.
If you stop taking Trospium chloride 20mg filmcoated tablets
Your symptoms may return if you stop the intake of
Trospium chloride 20mg film-coated tablets before
recommended by your doctor. Therefore, you should take
this medicine 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, this medicine can cause side effects,
although not everybody gets them.
The following side effects below are serious and will
require immediate action if you experience them. Stop
taking Trospium chloride 20mg film-coated 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 (very rare side effect,
affects less than 1 in 10,000 patients)
• a sudden allergic reaction with shortness of breath,
rash, itchiness, wheezing and drop of blood pressure
(frequency of this side effect is unknown)
• life-threatening hypersensitivity reactions with largescale detachment of the skin and/or mucous membranes
(frequency of this side effect is unknown).
The following side effects have also been reported for
Trospium chloride 20mg film-coated 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):
• indigestion (dyspepsia)
• constipation
• abdominal pain
• feeling sick (nausea)
Uncommon side effects (affects 1 to 10 users in 1,000):
• fast heart beat (tachycardia)
• headache
• wind (flatulence)
• diarrhoea
• chest pain
Rare side effects (affects 1 to 10 users in 10,000):
• dizziness
• difficulty seeing objects close-up / blurred vision
• difficulty emptying the bladder, urinary retention
• rash
• joint pain (arthralgia)
• muscle pain (myalgia)
Other possible side effects, for which the frequency
is unknown (cannot be estimated from the available
data)
• accelerated and irregular heart rate (tachyarrhythmia)
• difficulty in breathing (dyspnoea)
• itchiness, nettle rash (hives, urticaria)
• general feeling of weakness (asthenia)
• slight to moderate increase of certain liver values
(serum transaminases)
• sporadic cases of hallucinations, 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 you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.
5. How to store Trospium chloride 20mg film-coated
tablets
Keep this medicine out of the sight and reach of children.
Do not use Trospium chloride 20mg film-coated tablets
after the expiry date which is stated on the blister and on
the carton after EXP. The expiry date refers to the last day
of that month.
This medicine does not require any special storage
conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.
6. Contents of the pack and other information
WhatTrospium chloride 20mg film-coated tablets
contain
• The active substance is trospium chloride. Each filmcoated tablet contains 20 mg trospium chloride.
• The other ingredients are :
Core: Cellulose Microcrystalline, Lactose monohydrate,
Maize starch, Povidone, Croscarmellose sodium, Silica
Colloidal Anhydrous, Magnesium Stearate;
Coating: Sucrose, Copovidone, Titanium Dioxide (E171),
Macrogol 6000, Macrogol 400, Talc, Hypromellose
(E464), Iron Oxide Yellow (E172), Iron Oxide Red
(E172).
What Trospium chloride 20mg film-coated tablets
look like and contents of the pack
Trospium chloride 20mg film-coated tablets are supplied
as:
brownish yellow to light brown, round, biconvex filmcoated tablets, debossed with “L” on one side and “l” on
other side.
Trospium chloride 20mg film-coated tablets are available
in PVC/PVDC-Aluminium blisters of 30, 50, 60, 100
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue
Harrow, MiddlesexHA3 0BU, UK
Manufacturers:
Glenmark Pharmaceuticals s.r.o
Fibichova 143,566 17 Vysoké Mýto,
Czech Republic
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA,
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
France
Trospipharm
20mg
comprimé
pelliculé
Germany:
Trospiumchlorid Glenmark 20mg
Filmtabletten
Ireland
Trospium 20mg film-coated tablets
United Kingdom Trospium chloride 20mg film-coated
tablets
This leaflet was last revised in 04/2014

10.04.2014 1(Black)
Trospium 20mg F-C Tabs Ins-Bk.

xxxxx


xxxx

xxxxxxxx

UK
Goa


170 x 39 mm



170 x 310 mm



40 gsm Bible Paper

Font: 9pt. Times New Roman

Revision for Name change as a part of
One Glenmark variation

V:2

George

1

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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