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TROSPIUM CHLORIDE 20MG FILM-COATED TABLETS

Active substance(s): TROSPIUM CHLORIDE / TROSPIUM CHLORIDE / TROSPIUM CHLORIDE

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Trospium chloride 20mg Film-coated Tablets
Patient Information Leaflet
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 Filmcoated 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 Film-coated 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 gastro-intestinal tract which
are used to treat impaired gastric emptying or complaints due to reflux of
gastric acid (reflux disease), e.g. metoclopramide
• medicines containing the substances guar, colestipol or cholestyramine
which should not be taken simultaneously with Trospium chloride 20mg
Film-coated 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.
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 Film-coated tablets than the
amount prescribed, you should contact a doctor or pharmacist immediately.
If you forget to take Trospium chloride 20mg Film-coated 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 Film-coated 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 Filmcoated 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 large-scale 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.
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 Trospium chloride 20mg Film-coated tablets
• Keep out of the sight and reach of children.
• Do not use after the expiry date printed on the carton and blister label after
‘EXP’. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
• 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) Contents of the pack and other information
What Trospium chloride 20mg Film-coated tablets contain:
The active substance is trospium chloride. Each film-coated tablet contains
20mg 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, talc,
Opadry yellow 03B82720 (hypromellose, macrogol 400, titanium dioxide
(E171), yellow iron oxide (E172), red iron oxide (E172)).
What Trospium chloride 20mg Film-coated tablets look like and
contents of the pack
Trospium chloride 20mg Film-coated tablets are brownish yellow to light
brown, round, biconvex film-coated tablets, debossed with “L” on one side
and “1” on other side.
They are available in blister packs containing 30 and 60 tablets.
PL 10383/2225

Trospium chloride 20mg Film-coated tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Glenmark Pharmaceuticals Europe
Limited, Building 2, Croxley Green Business Park, Croxley Green,
Hertfordshire, WD18 8YA, United Kingdom
or
Glenmark Pharmaceuticals s.r.o., Hvězdova 1716/2B, 140 78, Prague 4,
Czech Republic.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 21.03.2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

Expand Transcript

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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