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IMODIUM ORIGINAL 2MG CAPSULES

Active substance(s): LOPERAMIDE HYDROCHLORIDE / LOPERAMIDE HYDROCHLORIDE / LOPERAMIDE HYDROCHLORIDE

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Original

2mg Capsules

Loperamide hydrochloride
„ This medicine is used for two different types
of diarrhoea. They have different age limits.
See Section 1 c

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

Short-term diarrhoea

„ 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 c
„ If you have ever had a bad reaction to any
of the ingredients. For the list of ingredients,
see Section 6 c

„ For adults and children aged 12 and over.

„ Speak to your doctor:
„ If you suffer from any of the conditions
mentioned in Section 2 c
„ If you are taking any other medicines.
See Section 2 c

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

„ If you have Irritable Bowel Syndrome (IBS)
see also Section 2 Extra warnings for IBS patients c
„ Follow the dosage instructions carefully.
See Section 3 c
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist has
told you.

„ To treat attacks that last up to 48 hours.
„ If your attack lasts longer than 48 hours,
talk to your doctor.

IBS diarrhoea

„ To treat attacks that last up to 48 hours.
„ You can use this medicine for up to
2 weeks for repeated attacks, but if any
one attack lasts continuously for longer than
48 hours, 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.

–1–

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

Do not take this medicine…
„ If you have ever had a bad reaction to any
of the ingredients.
„ If it is for a child aged under 12 (or under
18 for an IBS patient).
„ If you have severe diarrhoea after taking
antibiotics.
„ If you are having a flare-up of an
inflammatory bowel condition like
ulcerative colitis.
„ If you are constipated, or your stomach
appears swollen (especially in children with
severe dehydration).
„ If you have acute dysentery, the symptoms 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®.
This section is continued over the page.

Turn over c

FACE 1

AW_117801.pdf - Page 1 of 5 - April 24, 2017 - 14:12:29

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

Talk to your doctor first…
„ If you have AIDS and your stomach 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 been told by your doctor that you
have an intolerance to some sugars.
„ 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.

Pregnancy or breast-feeding
„ If you are pregnant, think you are pregnant
or planning a pregnancy: ask your doctor
or pharmacist for advice before taking this
medicine.
„ 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.

Driving and using machines
„ 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, cycle
or use machines.

Some of the ingredients can cause
problems
This medicine contains lactose. If you have been
told by your doctor that you have an intolerance
to some sugars contact your doctor before
taking this medicine.

Extra warnings for IBS patients
Use only if your doctor has previously diagnosed
IBS.
Check the following:

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

Special warnings about this medicine
„ 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.
„ Do not take this product for anything other
than its intended use (see section 1) and never
take more than the recommended amount (see
section 3). Serious heart problems (symptoms
of which include fast or irregular heartbeat)
have been reported in patients who have taken
too much loperamide, the active ingredient in
IMODIUM® Original 2mg Capsules.

–2–

Talk to your doctor first…
„ 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.
„ If you have a fever.
„ If you have recently travelled abroad.
If any of these applies to you, talk to your
doctor before taking IMODIUM®.

FACE 2

AW_117801.pdf - Page 2 of 5 - April 24, 2017 - 14:12:29

Warnings for everyone
(continued)

Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if
you are not sure.
Check the tables below to see how much
medicine to take.
„ Swallow the correct number of capsules whole
with a drink of water. For oral use only.
„ Do not use more than the dose shown in the
tables.
„ The capsules are not for long-term
treatment.

Short-term diarrhoea
Age

Dose

Adults and
children aged
12 and over

Take two capsules to start
treatment.
Take one capsule after each
loose bowel movement.

„ Do not take for attacks lasting longer than
48 hours.
„ Do not take more than six capsules in a 24- hour
period.
„ Replace lost fluid by drinking more liquid than
usual.
„ Not for children aged under 12.

How long to take IMODIUM® for
short-term diarrhoea

How long to take IMODIUM® for IBS
diarrhoea

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.

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.

IBS diarrhoea

If anyone takes too much of this
medicine

Age

Dose

Adults aged
18 and over

Take two capsules to start
treatment.
Take one capsule after each
loose bowel movement (or as
advised by your doctor).

„ You can use this medicine for up to
2 weeks for repeated attacks, but do not
take for any one attack lasting longer than
48 hours.
„ Do not take more than six capsules in a 24-hour
period.
„ Replace lost fluid by drinking more liquid than
usual.
„ Not for children and young people aged under 18.
Talk to your doctor and stop taking this
medicine:
„ If you have been using this medicine
continuously for 48 hours.
„ If you develop new IBS symptoms.
„ If your IBS symptoms get worse.
„ If your IBS symptoms have not improved
after 2 weeks.
–3–

If you have taken too many Imodium® Original
2mg Capsules, immediately contact a doctor
or hospital for advice. Symptoms may include:
increased heart rate, irregular heartbeat, changes
to your heartbeat (these symptoms can have
potentially serious, life-threatening consequences),
muscle stiffness, uncoordinated movements,
drowsiness, difficulty urinating, or weak breathing.
Children react more strongly to large amounts of
Imodium® Original 2mg Capsules than adults.
If a child takes too much or shows any of the
above symptoms, call a doctor immediately.

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.

Turn over c

FACE 3

AW_117801.pdf - Page 3 of 5 - April 24, 2017 - 14:12:29

3 How to take this medicine

IMODIUM® can have side-effects, like all
medicines, although these don’t affect everyone
and most are usually mild.

Get medical help at once
Rare: (may affect up to 1 in 1,000 people)
„ Allergic reactions including unexplained
wheezing, shortness of breath, passing out or
swelling of face and throat.
„ 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: (may affect up to 1 in 100 people)
„ Itchiness or hives.
„ Stomach pain or swollen stomach.
Rare: (may affect up to 1 in 1,000 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: (may affect up to 1 in 10 people)
„ Feeling sick, constipation or wind.
„ Headache.
Uncommon: (may affect up to 1 in 100 people)
„ Dizziness or drowsiness.
„ Vomiting, indigestion.
„ Dry mouth.
Rare: (may affect up to 1 in 1,000 people)
„ Tiredness.

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

Do not throw away any medicines 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® Original 2mg
Capsules is: Loperamide hydrochloride 2 mg per
capsule.
Other ingredients are: Lactose, maize starch,
talc and magnesium stearate (E572). The capsule
itself is made up of titanium dioxide (E171), black
ferrous oxide (E172), yellow ferric oxide (E172),
indigo carmine (E132), erythrosine (E127) and
gelatin.

What the medicine looks like
Imodium® Original 2mg Capsules are green / grey
capsules marked ‘Imodium’ and ‘JANSSEN’. They
are available in packs of 6 capsules.

Keep this medicine out of the sight
and reach of children.

Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.

Store in the original package.

Manufacturer: Janssen-Cilag, Domaine de
Maigremont, 27100 Val de Reuil, France.

Do not use your medicine after the date shown
as the expiry date on the packaging.

This leaflet was revised April 2017.
IMODIUM® is a registered trade mark.
GB - AW_117801
16-0314

–4–

FACE 4

AW_117801.pdf - Page 4 of 5 - April 24, 2017 - 14:12:29

4 Possible side-effects

2 Before taking this medicine

1 What the medicine is for
IMODIUM Original 2mg Capsules is used to treat two types of
diarrhoea. The two types have different age limits.
®

Original

2mg Capsules

i

Loperamide hydrochloride
 This medicine is used for two different types of diarrhoea.
They have different age limits. 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
 If you have ever had a bad reaction to any of the ingredients.
For the list of ingredients, see Section 6
 Speak to your doctor:
 If you suffer from any of the conditions mentioned in Section 2
 If you are taking any other medicines. See Section 2
 
If you have Irritable Bowel Syndrome (IBS) see also Section 2
Extra warnings for IBS patients

!

i
X
!

X

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

Short-term diarrhoea

Do not take this medicine…

 For adults and children aged 12 and over.
 To treat attacks that last up to 48 hours.
 If your attack lasts longer than 48 hours, talk to your doctor.
IBS diarrhoea
 For adults and young people aged 18 and over who have
been diagnosed with IBS (Irritable Bowel Syndrome).
 To treat attacks that last up to 48 hours.
 You can use this medicine for up to 2 weeks for repeated
attacks, but if any one attack lasts continuously for longer
than 48 hours, 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.

i

 If you have ever had a bad reaction to any of the ingredients.
 If it is for a child aged under 12 (or under 18 for an IBS patient).
 If you have severe diarrhoea after taking antibiotics.
 If you are having a flare-up of an inflammatory bowel
condition like ulcerative colitis.
 If you are constipated, or your stomach appears swollen
(especially in children with severe dehydration).
 If you have acute dysentery, the symptoms 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®.

! Talk to your doctor first…

X

 Follow the dosage instructions carefully. See Section 3
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
Now read this whole leaflet carefully before you use this
medicine. Keep the leaflet: you might need it again.

 If you have AIDS and your stomach 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 been told by your doctor that you have an
intolerance to some sugars.
 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).

Imodium Original 2mg capsules
16-0315, v2
Dimension: 150 x 520 mm
16-0315
Job Bag
No. 8.5
Main body
text:
pts
Version

2

Product

Imodium Original 48hr

Description

PIL

Country

UK

Date

21/04/2017

Manufacturer VDR
Software

 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).

InDesign CS6

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.

Pregnancy or breast-feeding
 If you are pregnant, think you are pregnant or planning a
pregnancy: ask your doctor or pharmacist for advice before
taking this medicine.
 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.

Driving and using machines
 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, cycle or use machines.

Special warnings about this medicine
 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.
 Do not take this product for anything other than its intended
use (see section 1) and never take more than the recommended
amount (see section 3). Serious heart problems (symptoms of
which include fast or irregular heartbeat) have been reported

COLOURS:
PMS
7468

PMS
661

Black

Profile

SIZE:

Main body text

150 x 520 mm

8.5 pts

(PILs only)

A print out of this image should not be used for exact colour matching but to check if the layout,
spelling, text and colour references are correct. Please check thoroughly.

in patients who have taken too much loperamide, the active
ingredient in IMODIUM® Original 2mg Capsules.

Some of the ingredients can cause problems
This medicine contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars contact your
doctor before taking this medicine.

Extra warnings for IBS patients

i

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

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

! Talk to your doctor first…
 If you are aged 40 or over and it is some time since your
last IBS attack.

X 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.
 If you have a fever.
 If you have recently travelled abroad.
If any of these applies to you, talk to your doctor before
taking IMODIUM®.

Turn Over

3 How to take this medicine

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

Always take this medicine exactly as described in this leaflet
or as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Check the tables below to see how much medicine to take.
 Swallow the correct number of capsules whole with a drink of
water. For oral use only.
 Do not use more than the dose shown in the tables
 The capsules are not for long-term treatment.

Short-term diarrhoea
Age
Dose
Adults and children
Take two capsules to start treatment.
aged 12 and over Take one capsule after each loose
bowel movement.
 Do not take for attacks lasting longer than 48 hours.
 Do not take more than six capsules in a 24-hour period.
 Replace lost fluid by drinking more liquid than usual.
 Not for children aged under 12.

i

How long to take IMODIUM® for short-term diarrhoea

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.

!

X

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.

If anyone takes too much of this medicine

If you have taken too many Imodium® Original 2mg Capsules,
immediately contact a doctor or hospital for advice. Symptoms
X may include: increased heart rate, irregular heartbeat, changes
to your heartbeat (these symptoms can have potentially

2

Product

Imodium Original 48hr

Description

PIL

Country

UK

Date

21/04/2017

Manufacturer VDR
Software

InDesign CS6

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

6 Further information

Rare: (may affect up to 1 in 1,000 people)
 Tiredness.

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.

If you get any of these, stop using the medicine and get medical
help at once.

Version

Rare: (may affect up to 1 in 1,000 people)
 Difficulties passing water.
 Severe constipation.
 Miosis (narrowing of the pupils of the eye).

Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not use your medicine after the date shown as the expiry
date on the packaging.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to dispose of medicines
no longer required. These measures will help to protect the
environment.

Uncommon: (may affect up to 1 in 100 people)
 Dizziness or drowsiness.
 Vomiting, indigestion.
 Dry mouth.

Rare: (may affect up to 1 in 1,000 people)
 Allergic reactions including unexplained wheezing, shortness of
breath, passing out or swelling of face and throat.
 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.

Imodium Original 2mg capsules
16-0315, v2
Dimension: 150 x 520 mm
16-0315
Bag No.
Main bodyJobtext:
8.5 pts

5 Storing this medicine

Uncommon: (may affect up to 1 in 100 people)
 Itchiness or hives.
 Stomach pain or swollen stomach.

Common: (may affect up to 1 in 10 people)
 Feeling sick, constipation or wind.
 Headache.

Get medical help at once

How long to take IMODIUM® for IBS diarrhoea

Talk to a doctor as soon as possible

Other effects that may occur

IMODIUM® can have side-effects, like all medicines, although
these don’t affect everyone and most are usually mild.

If you have been using this medicine continuously for
48 hours.
 If you develop new IBS symptoms.
 If your IBS symptoms get worse.
 If your IBS symptoms have not improved after 2 weeks.

!

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

Talk to your doctor and stop taking this medicine:

i

serious, life-threatening consequences), muscle stiffness,
uncoordinated movements, drowsiness, difficulty urinating,
or weak breathing.
Children react more strongly to large amounts of Imodium®
Original 2mg Capsules than adults. If a child takes too much or
shows any of the above symptoms, call a doctor immediately.

COLOURS:
PMS
7468

PMS
661

Black

Profile

SIZE:

Main body text

150 x 520 mm

8.5 pts

(PILs only)

A print out of this image should not be used for exact colour matching but to check if the layout,
spelling, text and colour references are correct. Please check thoroughly.

What’s in this medicine
The active ingredient in IMODIUM® Original 2mg Capsules is:
Loperamide hydrochloride 2 mg per capsule.
Other ingredients are: Lactose, maize starch, talc and
magnesium stearate (E572). The capsule itself is made up of
titanium dioxide (E171), black ferrous oxide (E172), yellow ferric
oxide (E172), indigo carmine (E132), erythrosine (E127) and gelatin.

What the medicine looks like
IMODIUM® Original 2mg Capsules are green / grey capsules
marked ‘Imodium’ and ‘JANSSEN’, available in packs of
6 capsules.
Product Licence holder: McNeil Products Ltd, Maidenhead,
Berkshire, SL6 3UG, UK.
Manufacturer: Janssen-Cilag, Domaine de Maigremont,
27100 Val de Reuil, France.
This leaflet was revised April 2017.
IMODIUM® is a registered trade mark.

16-0315

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.

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