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REGURIN XL 60 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): TROSPIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE
USER



Regurin® XL 60 mg
prolonged-release capsules,
hard

Talk to your doctor before starting your treatment with Regurin
XL if you think any of these might apply to you.

(trospium chloride)

Patients with kidney disorders

This medicine is called Regurin XL 60 mg prolonged-release
capsules, hard but will be referred to as Regurin XL throughout
this leaflet.



any heart conditions, such as coronary artery disease or
congestive heart failure,
any liver problems.

Patients with liver disorders
You should talk to your doctor if you have a liver disorder.
Patients with severe liver disorders should not take this medicine.
You should talk to your doctor if you have a kidney disorder.
Patients with kidney disorders should not take this medicine.

Children under the age of 18 years
Do NOT give Regurin XL to children under 18 years of age.

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 XL is and what it is used for
2)
Before you take Regurin XL
3)
How to take Regurin XL
4)
Possible side effects
5)
How to store Regurin XL
6)
Further information

1) WHAT REGURIN XL IS AND WHAT IT IS USED FOR
Regurin XL is a medicine used for the relaxation of the muscles
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/or urgency of urination in
patients with an overactive bladder.

2) BEFORE YOU TAKE REGURIN XL
Do not take Regurin XL
-









If you have ever had an allergic reaction to trospium
chloride or any of the other ingredients of Regurin XL (An
allergic reaction can be a rash, itchiness or shortness of
breath.). For the list of ingredients in Regurin XL, 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,
problems with your kidneys,
severe problems with your liver.

Take special care with Regurin XL
If you suffer from any of the following:

any type of stomach or bowel obstruction,

difficulties in passing urine and/or a 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,

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 antidepressants e.g. amitryptiline or imipramine
some 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)
metoclopramide – medicine used for nausea and vomiting
medicines containing guar, colestipol or colestyramine.
Please note that this information may also apply to medicines
that you have used recently.

Pregnancy and breast-feeding
Since there is no experience with trospium chloride during
pregnancy and breast feeding, Regurin XL should be taken
during pregnancy and breast-feeding only if your doctor
considers it absolutely necessary.

Driving and using machines
Regurin XL 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 XL
This medicine contains sucrose. If you know that you have an
intolerance to certain sugars, please take Regurin XL only after
consultation with your doctor.

3) HOW TO TAKE REGURIN XL
Please always take Regurin XL 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
is one Regurin XL prolonged-release capsule.

Method of administration
Swallow one prolonged-release capsule whole with a glass of
water. Take the capsule at least one hour before a meal on an
empty stomach.

Duration of administration
Your doctor will determine the duration of treatment.
The need for continued treatment should be checked at regular
intervals of 3 – 6 months.
Patients with a kidney disorder should consult their doctor and
not take this medicine.
Patients with a liver disorder should consult their doctor before
taking this medicine.

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

5) HOW TO STORE REGURIN XL

Keep out of the sight and reach of children.


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



This medicinal product does not require any special storage
conditions.



Do not use Regurin XL if you notice the pack or any of the
capsules are damaged.



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

If you forget to take Regurin XL
If you forget to take a capsule, take your capsule as soon as you
remember, but do not take more than one capsule in one day.
Do not take a double dose to make up for a forgotten capsule.

If you stop taking Regurin XL
Your symptoms may return if you stop taking Regurin XL before
recommended by your doctor. Therefore, you should take
Regurin XL 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 XL can cause side effects, although
not everybody gets them.
The following “very rare” side effects below are important and will
require immediate action if you experience them. You should
stop taking Regurin XL and see your doctor immediately if the
following symptoms occur:

swelling of the face, tongue and windpipe which can cause
great difficulty in breathing,

a sudden allergic reaction with shortness of breath, rash,
wheezing and drop of blood pressure.
The following side effects have been reported for Regurin XL
prolonged-release capsules, hard in clinical trials:
Very common side effects, affects more than 1 user in 10

dryness of the mouth.

6) FURTHER INFORMATION
What Regurin XL contains
The active substance is: Trospium chloride. Each prolongedrelease capsule contains 60 mg trospium chloride.
The other ingredients are:
Capsule contents: sucrose, maize starch, methyl acrylatemethyl methacrylate -methacrylic acid-copolymer, sodium
dodecyl sulphate, ammonium hydroxide, medium chain
triglycerides, oleic acid, ethylcellulose, titanium dioxide (E 171),
hypromellose, macrogol 400, polysorbate 80, triethylcitrate, talc.
Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide
(E 172), red iron oxide (E 172), printing ink (shellac glaze, black
iron oxide (E 172), propylene glycol).

What Regurin XL looks like and contents of the pack

Common side effects, affects 1 to 10 users in 100

constipation, nausea, abdominal pain, indigestion,

dry eyes, dry nose.

Regurin XL prolonged-release capsules, hard, consist of a whitebody and orange cap imprinted with SAN 60 and contain white to
off-white pellets.

Uncommon side effects, affects 1 to 10 users in 1,000

flatulence.

Regurin XL is available in packs containing 30 prolonged-release
capsules.

Rare side effects, affects 1 to 10 users in 10,000

difficulty emptying the bladder, urinary retention,

fast heart rate, palpitations,

difficulty seeing objects close-up,

rash,

general feeling of weakness.

Manufacturer and Product Licence Holder

Very rare side effects, affects less than 1 user in 10,000

urinary tract infection,

headache.
The following side effects have also been reported for trospium
(trospium is the active ingredient of Regurin XL; it is not known if
these side effects will also occur with the capsules that you have
been prescribed): Difficulty in breathing, diarrhoea, chest pain,
slight to moderate increase of certain liver values (serum
transaminases), fast irregular heartbeat, joint or muscle pains,
dizziness.
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.

This product is manufactured by
MADAUS GmbH
51101 Cologne
Germany
Phone: 0221/89 98-0
Fax: 0221/89 98-711
E-mail: info@madaus.de
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.
This medicinal product is authorised in the Member State of
Germany under the name Urivesc 60mg.
POM_

PL: 18980/0838

Regurin® is a registered trade mark of MADAUS GmbH.
Date of leaflet preparation: 17/12/2012

REF: ####
MCP-0838

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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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