Skip to Content

REGURIN 20MG COATED TABLETS

Active substance(s): TROSPIUM CHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Regurin® 20mg coated tablets
(trospium chloride)
This medicine is called Regurin 20mg coated tablets but will be
referred to as Regurin 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 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

1)

WHAT REGURIN IS AND WHAT IT IS USED FOR

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).

2) BEFORE YOU TAKE REGURIN
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 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 Regurin and they will
decide what to do.

Patients with liver disorders
You should not take Regurin 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).
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.
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 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 Regurin.
Please note that this information may also apply to medicines
that you have used recently.

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
Regurin
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).

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.

5)

HOW TO STORE REGURIN



Keep out of the reach and sight of children.



Do not use Regurin after the expiry date which is stated on
the carton and the blister foil after EXP. The expiry date
refers to the last day of that month.

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.

Storage conditions

This medicinal product does not require any special storage
conditions.


Do not use Regurin if you notice that the pack or any of the
tablets are damaged.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.



If the medicine becomes discoloured or shows any other
signs of deterioration, you should seek the advice of your
pharmacist who will advice you what to do.

Like all medicines, Regurin 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.



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

The following side effects below are serious 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).

6)

FURTHER INFORMATION

4)

POSSIBLE SIDE EFFECTS

What Regurin contains
The active substance is trospium chloride,
Each coated tablet contains 20mg trospium chloride.
The other ingredients are:
Tablet core: Wheat starch, microcrystalline cellulose, lactose
monohydrate, povidone, croscarmellose sodium, stearic acid,
silica colloidal anhydrous, talc.
Tablet coating: Sucrose, carmellose sodium, talc, silica colloidal
anhydrous, calcium carbonate (E 170), macrogol 8000, titanium
dioxide (E 171), yellow iron oxide (E l72), white beeswax,
carnauba wax.
Note for diabetics: one coated tablet corresponds to 0.06 g
carbohydrate (equivalent to 0.005 bread units).

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 user in 10,000

dizziness,

difficulty emptying of the bladder, urinary retention,

difficulty seeing objects close-up,

rash,

joint and muscle pains.

Whet Regurin looks like and contents of the pack
Regurin tablets are brownish-yellow, glossy coated tablets with a
diameter of approximately 7mm.
Regurin is available in packs containing 60 tablets.
Manufacturer
This product is manufactured by MADAUS GmbH, 51101
Cologne, Germany. It is procured within the EU and repackaged
by Mediwin Limited Product Licence Holder Mediport Limited
13 Martello Enterprise Centre, Courtwick Lane, Littlehampton,
West Sussex, BN17 7PA, United Kingdom.
POM_

PL: 18980/0822

Regurin® is a registered trade mark of MADAUS GmbH.
Date of leaflet preparation: 29/11/2016
PIL-0822-S0006

+ 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.

Hide