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IMODIUM CLASSIC 2MG CAPSULES

Active substance(s): LOPERAMIDE HYDROCHLORIDE

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Transcript
loperamide hydrochloride

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

Imodium Classic is used to treat two types of
diarrhoea. The two types have different age
limits.

Short-term diarrhoea
„ For adults and children aged 12 and over.

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…

„ To treat attacks that last up to 48 hours.

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

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

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

IBS diarrhoea

„ If you have severe diarrhoea after taking
antibiotics.

„ 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.

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

„ 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
–1–

FACE 1

AW_112568.pdf - Page 1 of 5 - March 16, 2016 - 12:34:43

1 What the medicine is for

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.

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.

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.

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.

–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_112568.pdf - Page 2 of 5 - March 16, 2016 - 12:34:43

Warnings for everyone
(continued)

How long to take Imodium for
short-term diarrhoea

How long to take Imodium for IBS
diarrhoea

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.

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.

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.

IBS diarrhoea

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.

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.

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.

If anyone takes too much of this
medicine
If anyone takes too many Imodium 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 can have side-effects, like all
medicines, although these don’t affect
everyone and most are usually mild.
This section is continued over the page.

Turn over c
–3–

FACE 3

AW_112568.pdf - Page 3 of 5 - March 16, 2016 - 12:34:44

3 How to take this medicine

(continued)
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 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 Capsules are green / grey capsules
marked ‘Imodium’ and ‘JANSSEN’. They are
available in packs of 8, 12 or 18 capsules.
Not all pack sizes may be marketed.

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 March 2016.
Imodium is a registered trade mark.
GB - AW_112568
16-0056

–4–

FACE 4

AW_112568.pdf - Page 4 of 5 - March 16, 2016 - 12:34:44

4 Possible side-effects

Imodium Classic is used to treat two types of diarrhoea.
The two types have different age limits.

loperamide hydrochloride

i

Warnings for everyone

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

Short-term diarrhoea
 For adults and children aged 12 and over.

Do not take this medicine…

 To treat attacks that last up to 48 hours.
T
 his 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

!

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

i

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

X
!

X

 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.

2 Before taking this medicine

1 What the medicine is for

 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).
 quinidine (used to treat abnormal heart rhythms or
malaria).

Imodium Classic 2 mg Capsules
Job bag: 16-0057
Version: 1
Size:
150No.
x 52016-0057
mm
Job Bag
main body text: 8.5 pts
Version

1

Product

Imodium Classic

Description

PIL

Country

UK

Date

08/03/2015

Manufacturer VDR
Software

InDesign CS6

 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.

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

! Talk to your doctor first…

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.
 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.

 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

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.

Profile

SIZE:

Main body text

150 x 520 mm

8.5 pts

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.

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

Special warnings about this medicine

PMS
320

(PILs only)

i

Pregnancy or breast-feeding

COLOURS:

Black

Extra warnings for IBS patients

Turn Over

3 How to take this medicine
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.

X

i
!

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.

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

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

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

Get medical help at once

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.

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

Talk to a doctor as soon as possible

If you forget to take the medicine

Talk to your doctor and stop taking this medicine:

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

!

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

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

Age Dose
Take two capsules to start treatment.
Adults and children
aged 12 and over
Take one capsule after each loose
bowel movement.

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.

Age Dose

 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.

Short-term diarrhoea

How long to take Imodium for short-term diarrhoea

If anyone takes too much of this medicine
If anyone takes too many Imodium capsules, contact your doctor or
nearest Accident and Emergency department taking this leaflet
with you.


Adults
aged 18
and over

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

i

IBS diarrhoea

How long to take Imodium for IBS diarrhoea

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.

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.
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)
 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.

X

Imodium Classic 2 mg Capsules
Job bag: 16-0057
Version: 1
Size:
150No.
x 52016-0057
mm
Job Bag
Main
body text: 18.5 pts
Version
Product

Imodium Classic

Description

PIL

Country

UK

Date

08/03/2015

Manufacturer VDR
Software

InDesign CS6

COLOURS:
PMS
320
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.

5 Storing this medicine

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.

6 Further information
What’s in this medicine
The active ingredient in Imodium 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 Capsules are green / grey capsules marked ‘Imodium’
and ‘JANSSEN’, available in packs of 8, 12 or 18 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 March 2016.
16-0057
Imodium is a registered trade mark.

Expand view ⇕

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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