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REGURIN XL 60 MG PROLONGED-RELEASE CAPSULE HARD

Active substance(s): TROSPIUM CHLORIDE

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Regurin® XL
PACKAGE LEAFLET:
INFORMATION FOR THE USER

60 mg prolonged-release capsules, hard
Trospium chloride

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,
• any heart conditions, such as coronary artery
disease or congestive heart failure,
• any liver problems.
Talk to your doctor before starting your treatment with
Regurin XL if you think any of these might apply to
you.
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.
Patients with kidney disorders
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.
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.

- 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.
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.

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)

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SPECIFICATION BOX: Beipackzettel
PRODUCT:

Regurin XL 60 mg
Black

MEDA-NO.:

56UK2248164-00

MFS-NO.:

704134

LAETUS-CODE: 145
EAN-CODE:

---

COUNTRY:

UK

SIGHTMARKS:

---

LANGUAGE:

Englisch

PACK-SIZE:

138 x 420 mm

CORRECTION: 3. Corr.

FONT-SIZE:

Helvetica Cond. 8 pt

DATE:

20.06.2016

Regurin® XL
PACKAGE LEAFLET:
INFORMATION FOR THE USER

60 mg prolonged-release capsules, hard
Trospium chloride

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.
Common side effects, affects 1 to 10 users in 100
• constipation, nausea, abdominal pain, indigestion,
• dry eyes, dry nose.
Uncommon side effects, affects 1 to 10 users in
1,000
• flatulence
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.
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.

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
Regurin XL prolonged-release capsules, hard consist of a
white-coloured and an orange-coloured part imprinted
with SAN 60 and contain white to off-white pellets.
Regurin XL is available in packs containing 4 (sample),
7, 10, 14, 28, 30, 56, 60, 84, 90, 100 and 10x28
prolonged-release capsules. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop's Stortford
CM22 6PU, UK
Distributor
Speciality European Pharma Limited
14 Took‘s Court
London
EC4A 1LB
UK
Tel: +44 (0)20 7421 7400
Fax: +44 (0)20 7421 7401
Email: info@SpePharma.com
This medicinal product is authorised in the Member
States of the EEA under the following names:
Denmark
Spasmo-lyt Depot
Germany
Urivesc 60mg
Retardkapseln
Finland
Spasmo-lyt Depot 60mg
United Kingdom
Regurin XL 60mg

prolonged-release capsule,
hard
Italy
Urivesc 60mg capsule

rigide a rilascio prolungato
Luxemburg
Urivesc 60mg Retard-
kapseln
Austria
Urivesc 60mg Retard-
kapseln
Portugal
Urivesc SR
Spain
Urivesc 60mg cápsulas

duras de liberación
prolongada
This leaflet was last approved in June 2016.

5. HOW TO STORE REGURIN XL
Keep out of the reach and sight 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 that the package
has been damaged or shows signs of tampering.
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 XL contains
The active substance is: Trospium chloride.
Each prolonged-release capsule contains 60 mg
trospium chloride.
The other ingredients are:
Capsule contents: Sucrose, Maize starch, Methyl
acrylate-methyl methacrylate-methacrylic acid-copolymer, Ammonium hydroxide, Medium chain
triglycerides, Oleic acid, Ethylcellulose, Titanium
dioxide (E 171), Hypromellose, Macrogol 400,
Polysorbate 80, Triethyl citrate, Talc
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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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