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IMODIUM ORIGINAL 2MG CAPSULES

Active substance(s): LOPERAMIDE HYDROCHLORIDE

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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

 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).

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).

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:
17-0344, Version 1,
Dated 01/08/2017

Job Bag No.

17-0344

Version

1

Product

Imodium Original 48hr

Description

PIL

Country

UK

Date

01/08/2017

Manufacturer VDR
Software

InDesign CS6

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

5 Storing this medicine

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).

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.

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

6 Further information

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.

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.

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.

COLOURS:
Job Bag No.

17-0344

Version

1

Product

Imodium Original 48hr

Description

PIL

Country

UK

Date

01/08/2017

Manufacturer VDR
Software

InDesign CS6

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 or 12 capsules. Not all pack sizes may be marketed.
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 July 2017.
IMODIUM® is a registered trade mark.

17-0344

AW_129813.pdf - Page 1 of 5 - August 7, 2017 - 09:03:24
–1–

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.

Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist has
told you.

„ Follow the dosage instructions carefully.
See Section 3 c

„ 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.

„ To treat attacks that last up to 48 hours.

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

IBS diarrhoea

„ If your attack lasts longer than 48 hours,
talk to your doctor.

„ To treat attacks that last up to 48 hours.

„ For adults and children aged 12 and over.

Short-term diarrhoea

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

1 What the medicine is for

„ If you have Irritable Bowel Syndrome (IBS)
see also Section 2 Extra warnings for IBS patients c

„ 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

„ 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

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

2mg Capsules

Loperamide hydrochloride

Original

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

Turn over c

This section is continued over the page.

If any of these applies to you, talk to a doctor or
pharmacist and do not take IMODIUM®.

„ If you have acute dysentery, the symptoms of
which may include blood in your stools and
a high temperature.

„ If you are constipated, or your stomach
appears swollen (especially in children with
severe dehydration).

„ If you are having a flare-up of an
inflammatory bowel condition like
ulcerative colitis.

„ If you have severe diarrhoea after taking
antibiotics.

„ If it is for a child aged under 12 (or under
18 for an IBS patient).

„ If you have ever had a bad reaction to any
of the ingredients.

Do not take this medicine…

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

Warnings for everyone

2 Before taking this medicine

FACE 1

17-0343, AW_129813,
Version 1,
Dated 07/08/2017

AW_129813.pdf - Page 2 of 5 - August 7, 2017 - 09:03:24

If any of these applies to you (now or in
the past), talk to a doctor or pharmacist.

If you are unsure about any of the medicines
you are taking, show the bottle or pack to your
pharmacist.

„ 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).

Talk to your doctor first…

Warnings for everyone
(continued)

–2–

„ 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.

„ 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.

Special warnings about this medicine

„ 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.

Driving and using machines

„ 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.

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

Pregnancy or breast-feeding

If any of these applies to you, talk to your
doctor before taking IMODIUM®.

„ 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.

Talk to your doctor first…

„ If you are aged under 18.

Do not take this medicine…

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

Extra warnings for IBS patients

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.

Some of the ingredients can cause
problems

FACE 2

AW_129813.pdf - Page 3 of 5 - August 7, 2017 - 09:03:24

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

Adults and
children aged
12 and over

„ Replace lost fluid by drinking more liquid than
usual.
„ Not for children aged under 12.

„ Do not take for attacks lasting longer than
48 hours.
„ Do not take more than six capsules in a 24- hour
period.

Dose

Age

Short-term diarrhoea

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.

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.

3 How to take this medicine

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

Adults aged
18 and over

–3–

„ 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.

Talk to your doctor and stop taking this
medicine:

„ Replace lost fluid by drinking more liquid than
usual.
„ Not for children and young people aged under 18.

„ 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.

Dose

Age

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.

How long to take IMODIUM® for
short-term diarrhoea

Turn over c

If you forget to take a dose, take a dose
after the next loose stool (bowel movement).
Do not take a double dose.

You should only take this medicine as you need it,
following the dosage instructions above carefully.

If you forget to take the medicine

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 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.

If anyone takes too much of this
medicine

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.

How long to take IMODIUM® for IBS
diarrhoea

FACE 3

AW_129813.pdf - Page 4 of 5 - August 7, 2017 - 09:03:24

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

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

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

Talk to a doctor as soon as possible

If you get any of these, stop using the medicine
and 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.

Get medical help at once

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

4 Possible side-effects

–4–

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

Store in the original package.

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

5 Storing this medicine

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.

Reporting of side effects

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

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

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

Other effects that may occur

GB - AW_129813
17-0343

IMODIUM® is a registered trade mark.

This leaflet was revised July 2017.

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

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

Imodium® Original 2mg Capsules are green / grey
capsules marked ‘Imodium’ and ‘JANSSEN’.
They are available in packs of 6 or 12 capsules.
Not all pack sizes may be marketed.

What the medicine looks like

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.

The active ingredient in Imodium® Original 2mg
Capsules is: Loperamide hydrochloride 2 mg per
capsule.

What’s in this medicine

6 Further information

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.

FACE 4

AW_129813.pdf - Page 5 of 5 - August 7, 2017 - 09:03:24

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