REGURIN 20MG TABLETS

Active substance: TROSPIUM CHLORIDE

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Trospium Chloride 20mg Tablets
Regurin 20mg Tablets
Ceris 20mg Tablets
(trospium chloride)
Your medicine is available as the above names, but will be referred to as
Regurin throughout this:
Patient Information 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 is and what it is used for
2) Before you take Regurin
3) How to take Regurin
4) Possible side effects
5) How to store Regurin
6) Further information

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).
Children under the age of 12 years
Do not give Regurin to children under the age of 12 years.
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.

Regurin 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).

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 Regurin.

2) Before you take Regurin

Please note that this information may also apply to medicines that you have
used recently.

1) What Regurin is and what it is used for

Do not take Regurin:
- If you have ever had an allergic reaction to trospium chloride or any of the
other ingredients of Regurin (An allergic reaction can be a rash, itchiness
or shortness of breath). For the list of ingredients in Regurin, 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 Regurin
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 ie. 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 Regurin and they will decide what to do.
Patients with liver disorders
You should not take Regurin if have a serious liver disorder. If you have a
slight to moderate liver impairment you should talk to your doctor before
taking this medicine.

Taking Regurin with food and drink
As high fat diets can affect the action of Regurin, 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.
Driving and using machines
Regurin 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 Regurln
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. Regurin is
suitable for patients with coeliac disease.

3) How to take Regurin
Always take Regurin 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 Regurin 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 Regurin 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 Regurin than you should
If you have taken too much Regurin you should contact your doctor or go to
the nearest hospital casualty department immediately.
If you forget to take Regurin
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 Regurin
Your symptoms may return if you stop the intake of Regurin before
recommended by your doctor. Therefore, you should take Regurin 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 can cause side effects, although not everybody
gets them.
The following side effects are important and will require immediate action if
you experience them. You should stop taking Regurin 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).
The following side-effects have been reported for Regurin:
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 (dyspepsia).
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 users 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 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.

5) How to store Regurin
 Do not use after the expiry date printed on the carton, label or blister strip.
 Keep all medicines out of the reach and sight of children.
 If your doctor tells you to stop taking the tablets, please take them back to
the pharmacist for safe disposal. Only keep them if your doctor tells you
to.
 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) Further information
What Regurin contains:
The active substance is: trospium chloride 20 mg
Each round, yellow, film-coated tablet with no markings contains 20mg of
the active ingredient trospium chloride.
Regurin also contain the following inactive ingredients; microcrystalline
cellulose, wheat starch, lactose monohydrate, povidone, croscarmellose
sodium, stearic acid, palmitic acid, carmellose sodium, colloidal anhydrous
silica, talc, sucrose, calcium carbonate (E170) macrogol 8000, titanium
dioxide (E171), yellow iron oxide (E172), carnauba wax and white bees
wax.
What Regurin looks like and the contents of the pack:
Regurin tablets are round, yellow, film-coated tablet with no markings.
Regurin tablets are available as blister packs of 30 tablets.
PL10383/1277

POM

Who makes and repackages your medicine:
Your medicine is manufactured by Madaus GmbH, 51101 Cologne,
Germany. Procured from within the EU and repackaged by the Product
Licence holder: Primecrown Ltd. 4/5 Northolt Trading Estate, Belvue Road,
Northolt, Middlesex, UB5 5QS.
Leaflet date: 26.09.2012
Ceris® and Regurin® are trademarks of Madaus GmbH, Cologne, Germany.

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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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