IMODIUM CAPSULES 2MG

Active substance: LOPERAMIDE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

capsules
Loperamide hydrochloride
Imodium is a registered trademark

Read all of this leaflet carefully
before you start using 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 you get side effects and they become
serious or if you notice any side effects
not listed in this leaflet, please tell your
doctor or pharmacist

In this leaflet
1 What Imodium capsules are and what
they are used for
2 Before you use Imodium capsules
3 How to use Imodium capsules
4 Possible side effects
5 How to store Imodium capsules
6 Further information

1 What Imodium capsules are and what they are
used for
The name of your medicine is Imodium capsules.

What Imodium capsules are used for
Imodium capsules are used:
• To treat sudden short-lived (acute) attacks
of diarrhoea in adults and children aged
9 years and above
• To treat long-lasting (chronic) diarrhoea
in adults
If your child is aged 9 years and above the
‘you’ stated everywhere below should be read
as ‘your child’.

How Imodium capsules work

Imodium capsules contain a medicine
called loperamide hydrochloride. It belongs
to a group of medicines which helps reduce
diarrhoea by slowing down an overactive
bowel. It also helps the body to absorb more
water and salts from the bowel.

2 Before you use Imodium capsules
Do not use Imodium capsules :

• If you are allergic to anything in Imodium
capsules (listed in section 6 below)
• If you have severe diarrhoea after taking
antibiotics
• If you are having a flare up of ulcerative colitis
• If you are constipated or your stomach
appears swollen
• For a child less than 9 years old
Imodium syrup can be used for children
over 4 years old

Do not use this medicine if any of the above
applies to you. If you are not sure, talk to your
doctor or pharmacist before using Imodium
capsules.

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2 Before you use Imodium capsules (continued)
Take special care with Imodium
capsules

Check with your doctor before using Imodium
capsules if:
• You have acute dysentery, the symptoms
of which may include blood in your stools
and a high temperature. You will also need
to be given other medicines to treat this
• You suffer from liver problems
• You have AIDS and your stomach becomes
swollen. Stop taking the capsules
immediately and contact your doctor
You may still be able to use Imodium capsules,
but you should discuss this with your doctor first.

Replacing fluid and salts

Imodium capsules only treat the symptoms
of diarrhoea. When you have diarrhoea,
your body loses large amounts of fluid
and salts. You should therefore replace
this lost fluid by drinking more than normal.
This is especially important for children.
Your doctor may also give you a special powder
containing sugar and salts (known as oral
rehydration therapy) to help your body replace
the fluid and salts lost during diarrhoea.

Taking other medicines

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines that you
buy without a prescription or herbal medicines.
In particular, tell your doctor or pharmacist
if you are taking any of the following:
• ritonavir (used to treat HIV)
• quinidine (used to treat abnormal heart
rhythms or malaria)
• itraconazole, ketoconazole (used to treat
fungal infections)
• gemfibrozil (used to reduce levels of cholesterol)
• oral desmopressin (used to treat excessive
urination)
• other drugs that slow down or speed
up movement in the gut

Pregnancy and breast-feeding

Tell your doctor before taking Imodium capsules
if you are pregnant, think you may be pregnant
or might become pregnant.
Do not take this medicine if you are breastfeeding as small amounts may get into your milk.
Talk to your doctor about a suitable treatment.
Ask your doctor or pharmacist for advice
before taking any medicine if you are pregnant
or breast-feeding.

Driving or using machines

This medicine may make you feel dizzy, tired
or sleepy. You may also lose consciousness,
feel faint or less alert. If affected do not drive
or operate machinery.

Important information about some of
the ingredients of Imodium capsules
Imodium capsules contain lactose. If your
doctor has told you that you are intolerant
of some sugars, discuss it with them before
taking this medicine.

3 How to use Imodium capsules
Always use Imodium capsules exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth
• Swallow the correct number of capsules
whole with a drink of water

How much to take

The dose of Imodium capsules that you will
need will depend on whether your diarrhoea
is a sudden attack (acute) or a long-lasting
condition (chronic).

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3 How to use Imodium capsules (continued)
Short-lived (acute) diarrhoea
Adults
• Take 2 capsules straight away
• From then on take 1 capsule after each
episode of diarrhoea
• You can take this medicine for up to 5 days
• Never take more than 8 capsules in any
24 hour period
Children aged 9-12 years old
• Take 1 capsule 4 times a day until diarrhoea
is controlled
• You can take this medicine for up to 5 days
Children under 9 years old
• Imodium capsules are not recommended
for children under 9 years old
• Imodium syrup can be used for children
over 4 years old
If you are not getting better within 2 days
of taking your first dose of Imodium capsules,
go back to your doctor. He or she may want
to examine you to check on why you have
diarrhoea.

Children
• Imodium capsules are not recommended
for long-lasting (chronic) diarrhoea.

If you forget to take Imodium
capsules

• You should only take this medicine as required
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 to make up for
a forgotten dose

If you use more Imodium capsules
than you should

If you take more Imodium capsules than you
were told to or if someone else has taken any,
talk to a doctor or go to the nearest hospital
casualty department straight away.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

Long-lasting (chronic) diarrhoea
Adults
• Your doctor will tell you how many Imodium
capsules to take. This will depend on how
serious your condition is
• You will probably start with a dose of between
2 and 4 capsules spread out over a day
• Your doctor will find the dose that suits you
best. He or she may then suggest you take
the capsules twice a day
• Never take more than 8 capsules in any
24 hour period

4 Possible side effects
Like all medicines, Imodium capsules can
cause side effects, although not everybody
gets them.
Stop using Imodium capsules and tell
your doctor straight away if you notice
or suspect any of the following. You may
need urgent medical treatment.
• Sudden swelling of the face, lips or throat.
Hives (also known as nettle rash or urticaria),
severe irritation, reddening or blistering
of your skin. These may be signs of a severe
allergic reaction

• Blistering of your skin, mouth, eyes and
genitals
• Stomach pain or severe swollen stomach
• Severe constipation
• Loss of consciousness or reduced level
of consciousness (feeling faint or less alert)

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4 Possible side effects (continued)
Tell your doctor if you notice any of the
following side effects while using Imodium
capsules:
Common side effects (affects more than
1 in 100 patients)
• Headache
• Feeling dizzy
• Feeling sick (nausea)
• Constipation
• Wind
Uncommon side effects (affects fewer than
1 in 100 patients)
• Feeling sleepy or drowsy
• Dry mouth
• Being sick (vomiting), indigestion (dyspepsia)
• Rash

Rare side effects (affects fewer than
1 in 1000 patients)
• Tiny pupils
• Itchy skin
• Difficulty passing water
• Feeling tired
• Problems with co-ordination
• Unusually stiff muscles causing poor control
of movement
Some of the listed side effects may be due
to the diarrhoea, such as discomfort around
the middle, feeling sick or being sick, dry mouth,
feeling tired, drowsy or dizzy and wind.
If any of the side effects gets serious, or if you
notice any other side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5 How to store Imodium capsules
Keep out of the reach and sight of children.
Do not use Imodium capsules after the expiry
date which is stated on the label. The expiry
date refers to the last day of that month.

Medicines should not be disposed of via
wastewater or household waste. These measures
will help protect the environment. Return any
leftover Imodium capsules to your pharmacist.

6 Further information
The active substance in Imodium capsules
is loperamide hydrochloride.
Each Imodium capsule contains 2 mg
of loperamide hydrochloride.
The other ingredients are lactose, maize
starch, talc and magnesium stearate. The capsule
itself is made up of titanium dioxide (E171),
iron oxides (E172), indigo carmine (E132),
erythrosine (E127) and gelatin.

What Imodium capsules look like
and contents of the pack

Imodium capsules are green/grey capsules
marked 'Imodium' and 'JANSSEN'.
They are available in blister packs of 30 capsules
or tubs of 250 capsules (for the pharmacist).

The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers
Farm Way, High Wycombe,
Buckinghamshire HP12 4EG, UK
Imodium capsules are made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium
OR
Janssen-Cilag SA, Campus de Maigremont,
27100 Val de Reuil, France
OR
McGregor Cory Ltd, Middleton Close,
Banbury, Oxfordshire OX 16 4RS, UK

For information in large
print, tape, CD or
Braille, telephone
0800 7318450.
This leaflet was last approved in 01/2012.

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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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