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TROSPIUM CHLORIDE 20 MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Regurin® 20mg Tablets / Trospium Chloride® 20mg Tablets
(trospium chloride)
This product is available in the above names but will be referred to
as Trospium Chloride throughout 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 Trospium Chloride is and what it is used for
2. Before you take Trospium Chloride
3. How to take Trospium Chloride
4. Possible side effects
5. How to store Trospium Chloride
6. Further information
1.

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 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 (such as those used
to treat Parkinson's disease, asthma and stomach cramps)
 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.
Please note that this information may also apply to medicines that
you have used recently.

What Trospium Chloride is and what it is used for

Trospium Chloride is a medicine used for the relaxation 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 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.

Children under the age of 12 years
Do not give Trospium Chloride to children under the age of 12
years.

Taking Trospium Chloride with food and drink
As high fat diets can affect the action of Trospium Chloride, the
medicine should be taken before meals on an empty stomach.
Pregnancy and breast-feeding
Please tell your doctor if you are pregnant, think you might be
pregnant, or are breastfeeding. Your doctor will decide if this
medicine is suitable for you.

Before you take Trospium Chloride

Do not take Trospium Chloride
 If you have ever had an allergic reaction to trospium chloride or
any of the other ingredients of Trospium Chloride (An allergic
reaction can be a rash, itchiness or shortness of breath). For
the list of ingredients in Trospium Chloride, 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.
Take special care with Trospium Chloride
If you suffer from any of the following:
 any type of stomach or bowel obstruction,
 difficulties in passing urine and/or 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,
 any kidney problems.
If any of the above apply to you, it is important that you speak to
your doctor or pharmacist before taking Trospium Chloride and they
will decide what to do.
Patients with liver disorders
You should not take Trospium Chloride 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 'For
patients with kidney disorders).

Driving and using machines
Trospium Chloride 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
Trospium Chloride
This product contains lactose (milk sugar) and sucrose (sugar). 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.
This product also contains wheat starch. If you suffer from wheat
allergy (different from coeliac disease) you should not take this
product. Trospium Chloride is suitable for patients with coeliac
disease.
3.

How to take Trospium Chloride

Always take Trospium Chloride exactly 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
for adults and children over the age of 12 years is one Trospium
Chloride tablet taken twice daily (equivalent to 40 mg of trospium
chloride daily).
Method of administration
Swallow one tablet whole with a glass of water. Take the tablet
before a meal on an empty stomach.
Duration of treatment
Your doctor will determine the duration of treatment.
The need for continued treatment should be checked by your
doctor at regular intervals of 3-6 months.
For patients with kidney disorders
If your kidney function is slightly to moderately impaired, no dose
adjustment of Trospium Chloride 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.

If you take more Trospium Chloride than you should
If you have taken too much Trospium Chloride you should contact
your doctor or go to the nearest hospital casualty department
immediately.

5.

How to store Trospium Chloride

Do not store above 25°C.
Keep out of the sight and reach of children.

If you forget to take Trospium Chloride
If you forget to take a tablet, take your tablet as soon as you
remember, but do not take more than two tablets in one day
(unless prescribed otherwise).
If you stop taking Trospium Chloride
Your symptoms may return if you stop the intake of Trospium
Chloride before recommended by your doctor. Therefore, you
should take Trospium Chloride 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.

Do not use after the expiry date shown on the carton label and
blister strip.
If your doctor tells you to stop using this medicine, take any unused
tablets to your pharmacist for safe disposal. Only keep them if told
to do so by your doctor.
If you notice signs of your medicine deteriorating, consult 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.

Possible side effects
6.

Like all medicines, Trospium Chloride can cause side effects,
although not everybody gets them.
The side effects occurring most frequently are typical for this kind
of medicine and comprise dry mouth, dyspepsia and constipation.

Further information

What Trospium Chloride contains
The active substance is trospium chloride. Each tablet contains
20mg of trospium chloride.

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 which can cause
great difficulty in breathing (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).

Each tablet also contains the following ingredients: lactose,
sucrose, macrogol 8000, microcrystalline cellulose, wheat starch,
povidone, calcium carbonate (E170), croscarmellose sodium, silica
colloidal anhydrous, stearic acid, carmellose sodium, talc,
beeswax, carnauba wax, yellow iron oxide (E172), titanium dioxide
(E171).

The following side effects have been reported for Trospium
Chloride
Very common side effects, affects more than 1 user in 10
 dryness of the mouth.

Manufacturer
Trospium Cholride is manufactured by MADAUS GmbH, Cologne,
Germany.
Procured from within the EU. Repackaged by the Product Licence
holder: G Pharma Ltd, Dakota Avenue, Salford M50 2PU.

Common side effects, affects 1 to 10 users in 100
 constipation, nausea, abdominal pain, indigestion (dyspepsia).

PL No: 16369/0852
Trospium Chloride® 20mg Tablets

Uncommon side effects, affects 1 to 10 users in 1,000
 fast heart rate (tachycardia),
 headache,
 flatulence, diarrhoea,
 chest pain.
Rare side effects, affects 1 to 10 user in 10,000
 dizziness,
 difficulty emptying of the bladder, urinary retention,
 difficulty seeing objects close-up,
 rash,
 joint and muscle pains.
Other possible side effects, for which the frequency is not
known
 accelerated and irregular heart rate (tachyarrhythmia),
 difficulty in breathing,
 itchiness, nettle-rash (hives),
 general feeling of weakness (asthenia),
 slight to moderate increase of certain liver values (serum
transaminases),
 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.
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.

What Trospium Chloride looks like and contents of the pack
Trospium Chloride 20mg Tablets are circular, biconvex, yellow
sugar-coated, unprinted tablets with a white core.
Trospium Chloride 20mg Tablets are available as blister packs of
60 tablets.

POM

Leaflet Revision: 19th December 2012

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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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