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IMODIUM 2MG SOFT CAPSULES

Active substance: LOPERAMIDE HYDROCHLORIDE

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1 What the medicine is for
Imodium IBS Relief 2 mg Soft Capsules is
used to treat two types of diarrhoea. The
two types have different age limits.

Loperamide hydrochloride

Loperamide hydrochloride

 f your doctor has confirmed that you have
I
Irritable Bowel Syndrome (IBS), this product can
help you treat attacks of IBS diarrhoea associated
with this condition. See also Section 2 Extra
Warnings for IBS patients.
 This medicine can also be used to treat short
term diarrhoea. The age limit and treatment
period for this is different. See Section 1
 Do not take this medicine:
 There are some people who should not use
this medicine. To find out if you are one of
them, see Section 2
 f you have ever had a bad reaction to any of
I
the ingredients. For the list of ingredients,
see Section 6
 Speak to your doctor:
I
 f you suffer from any of the conditions
mentioned in Section 2
 f you are taking any other medicines.
I
See Section 2
 Follow the dosage instructions
carefully. See Section 3

i IBS diarrhoea
!

  adults and young people aged 18 and
For
over who have been diagnosed with IBS
(Irritable Bowel Syndrome).

  o treat attacks that last up to 48 hours.
T
X   ou can use this medicine for up to
Y
2 weeks for repeated attacks, but if any
one attack lasts continuously for longer
than 48 hours, talk to your doctor.

i Short-term diarrhoea
  or adults and children aged 12 and over.
F

!

X

  o treat attacks that last up to 48 hours.
T
 f your attack lasts longer than 48 hours,
I
talk to your doctor.
The capsules contain loperamide hydrochloride,
a substance that helps reduce diarrhoea by
slowing down an overactive bowel. This allows
water and salts that are usually lost in diarrhoea
to be absorbed by the body.

B
2  efore taking this medicine
i
!

Warnings for everyone
This medicine is suitable for most people, but
a few people should not use it:

Do not take this medicine…
X

 f you have ever had a bad reaction to any
I
of the ingredients.
 f you are under 18 years for an IBS patient
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(or under 12 years for short-term diarrhoea).
 I you have severe diarrhoea after taking
f
antibiotics.
 If you are having a flare-up of an

inflammatory bowel condition like
ulcerative colitis.
 f you are constipated, or your stomach
I
appears swollen (especially in children
with severe dehydration).
 f you have acute dysentery, the symptoms
I
of which may include blood in your stools
and a high temperature.
If any of these applies to you, talk to a doctor
or pharmacist and do not take Imodium.

i
i

Warnings for everyone
(continued)

!
! Talk to your doctor first…

X

X

 f you have AIDS and your stomach
I
becomes swollen, stop taking the
capsules immediately and contact your
doctor.
 If you suffer from liver disease.
 If you have diarrhoea that lasts for more

than 48 hours.
 If you have severe diarrhoea as your body

loses more fluid, sugars and salts than
normal.
 If you are taking any other medicines,

including:
 ritonavir (used to treat HIV).

 quinidine (used to treat abnormal heart

rhythms or malaria).
 oral desmopressin (used to treat

excessive urination).
 itraconazole or ketoconazole (used to treat

fungal infections).
 gemfibrozil (used to treat high

cholesterol).
If you are unsure about any of the
medicines you are taking, show the
bottle or pack to your pharmacist.
If any of these applies to you (now or in
the past), talk to a doctor or pharmacist.

Now read this whole leaflet carefully before you
use this medicine. Keep the leaflet: you might need
it again.

Pregnancy or breast-feeding

i

 f you are pregnant, think you are
I
pregnant or planning a pregnancy: ask
your doctor or pharmacist for advice
before taking this medicine.

Extra warnings for IBS
patients

!

Use only if your doctor has previously
diagnosed IBS.
Check the following:

 If you are breast-feeding do not take this

medicine. Small amounts may get into your
milk. Talk to your doctor about a suitable
treatment.

X

Special warnings about this medicine

! Talk to your doctor first…

 This medicine may make you feel dizzy,

tired or sleepy. You may feel less alert, feel
faint or pass out. If you’re affected do not
drive or use machines.
 Your body can lose large amounts of fluids

and salts when you have diarrhoea. You
need to replace the fluid by drinking more
liquid than usual. Ask your pharmacist
about rehydration therapy to replace lost
salts. This is especially important for
children, and frail or older people.

Some of the ingredients can cause
problems
Imodium IBS Relief 2 mg Soft Capsules
contain soya lecithin. If you are allergic to
soya or peanut, do not use this medicinal
product.

i

Do not take this medicine…
 If you are aged under 18.


X

 If you are aged 40 or over and it is some

time since your last IBS attack.
 If you are aged 40 or over and your IBS

symptoms are different this time.
 If you have recently passed blood from

the bowel.
 If you suffer from severe constipation.

 If you are feeling sick or vomiting.
 If you have lost your appetite or lost
weight.
 If you have difficulty or pain passing
urine.
  you have a fever.
If
 If you have recently travelled abroad.
If any of these applies to you, talk to your
doctor before taking Imodium.

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3 How to take this medicine

Check the tables below to see how much
medicine to take.
  wallow the correct number of capsules
S
whole with a drink of water. Do not chew.
For oral use only.
  o not use more than the dose shown in
D
the tables.
 The capsules are not for long-term treatment.


IBS diarrhoea
Age

 If your IBS symptoms get worse.
 f your IBS symptoms have not improved
I
after 2 weeks.

i How long to take Imodium for IBS
diarrhoea

!

X

Short-term diarrhoea

Dose

Age
Adults and
children aged
12 and over

Dose
Take two capsules to start
treatment.
capsule after each
Take one
loose bowel movement.
  o not take for attacks lasting longer than
D
48 hours.
  o not take more than six capsules in a
D
24-hour period.


Adults aged Take two capsules to start
18 and over treatment.
Take one capsule after each
loose bowel movement (or as
advised by your doctor).
  ou can use this medicine for up to
Y
2 weeks for repeated attacks, but do not
take for any one attack lasting longer
than 48 hours.
  o not take more than six capsules in a
D
24-hour period.
  eplace lost fluid by drinking more liquid than usual.
R
 Not for children and young people aged under 18.


R
  eplace lost fluid by drinking more liquid than usual.
 Not for children aged under 12.


i How long to take Imodium for
short-term diarrhoea

Talk to your doctor and stop taking this
medicine:
 f you have been using this medicine
I
continuously for 48 hours.
 f you develop new IBS symptoms.
I

You can use this medicine for up to
2 weeks for repeated attacks of IBS
diarrhoea. But if any one attack lasts for
longer than 48 hours, stop taking Imodium
and talk to your doctor.

!

X

You can use this medicine for up to
48 hours.
If your attack lasts longer than 48 hours, stop
taking Imodium and talk to your doctor.

If anyone takes too much of this
medicine
If anyone takes too many Imodium IBS Relief
2 mg Soft Capsules, contact your doctor or
nearest Accident and Emergency department
taking this leaflet with you.

If you forget to take the medicine
You should only take this medicine as you
need it, following the dosage instructions
above carefully.
If you forget to take a dose, take a dose
after the next loose stool (bowel movement).
Do not take a double dose.

4 Possible side-effects

Imodium IBS Relief 2 mg Soft Capsules can
have side-effects, like all medicines, although
these don’t affect everyone and most are
usually mild.

Get medical help at once
Rare: (affects less than 1 in 1,000 but 1 or
more in 10,000 people)
  llergic reactions including unexplained
A
wheezing, shortness of breath, passing out
or swelling of face and throat.

4
Possible side-effects
(continued)
 Skin rashes, which may be severe and

include blistering or peeling skin.
 Loss of consciousness or reduced level of

consciousness (passing out, feeling faint or
less alert), uncoordinated movements.
If you get any of these, stop using the
medicine and get medical help at once.

Talk to a doctor as soon as possible
Uncommon: (affects less than 1 in 100 but
1 or more in 1,000 people)
 Itchiness or hives.
 Stomach pain or swollen stomach.

Rare: (affects less than 1 in 1,000 but 1 or
more in 10,000 people)
 Difficulties passing water.
 Severe constipation.
 Miosis (narrowing of the pupils of the eye).

If you notice any of the above, stop using the
medicine and talk to a doctor.

Other effects that may occur
Common: (affects less than 1 in 10 but 1 or
more in 100 people)
 Feeling sick, constipation or wind.
 Headache.

Uncommon: (affects less than 1 in 100 but
1 or more in 1,000 people)
 Dizziness or drowsiness.
 Vomiting, indigestion.
 Dry mouth.
Rare: (affects less than 1 in 1,000 but 1 or
more in 10,000 people)
 Tiredness.
Dietary soya-products are known to
cause allergic reactions including severe
anaphylaxis in persons with soya allergy.
Patients with known allergy to peanut protein
carry an enhanced risk for severe reactions
to soya preparations.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.


5 Storing this medicine
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original
package to protect from moisture. Keep
blister in the outer carton to protect from light.

Do not use your medicine after the date shown
as the expiry date on the packaging.
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’s in this medicine
The active ingredient in Imodium
IBS Relief 2 mg Soft Capsules is:
Loperamide hydrochloride 2 mg per capsule.
Other ingredients are: Propylene glycol
monocaprylate, propylene glycol, gelatin,
glycerol, soya lecithin, medium chain triglycerides,
brilliant blue (E133) and purified water.

What the medicine looks like
Imodium IBS Relief 2 mg Soft Capsules are clear
blue liquid filled capsules available in packs of 6 or
12. The pack of 12 is only available in pharmacies.
Product Licence holder: McNeil Products
Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Catalent France, Beinheim SA,
74 rue Principale, F-67930, Beinheim - France.
This leaflet was revised in August 2014.
Imodium is a registered trade mark.

XXXXXX

Reference: 14-0129 v3
Dimensions: 140x500mm
25/07/2014

COLOURS:
Job Bag No.

14-0129

Version

3

Product

PIL

Country

UK

Date

25/07/2014

Manufacturer

Catalent

PMS
320

Imodium IBS Relief 6 and 12

Description

BLACK

SIZE:
140 x 500 mm

Main body text
(PIL’s only)

8.5 pts

A print out of this image should not be used for exact colour matching but to check if the layout,
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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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