PACKAGE LEAFLET: INFORMATION FOR THE USER
Imodium® 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 over 8 years of age
To treat long-lasting (chronic) diarrhoea in adults
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)
You have severe diarrhoea after taking antibiotics
You are having a flare up of ulcerative colitis
You are constipated or your stomach appears swollen (particularly in
children with severe dehydration)
Your child is less than 8 years old
Imodium syrup can be used for children over 4 years old
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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.
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)
oral desmopressin (used to treat excessive urination).
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 breast-feeding 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. 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.
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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).
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 8 years old
Imodium capsules are not recommended for children under 8 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.
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
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
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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.
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.
Very rare (affects less than 1 in 10,000 people)
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
Tell your doctor if you notice any of the following side effects while
using Imodium capsules:
Very rare (affects less than 1 in 10,000 people)
Itchy skin and rash
Difficulty passing water
Other side effects which may occur:
Very rare (affects less than 1 in 10,000 people)
Feeling sick (nausea), being sick (vomiting), indigestion (dyspepsia)
Wind
Feeling drowsy or dizzy
Other side effects that may be due to the medicine or diarrhoea:
Feeling tired
Dry mouth
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.
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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 July 2010.
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