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IMODIUM 1 MG/5 ML ORAL SOLUTION

Active substance(s): LOPERAMIDE HYDROCHLORIDE

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Package leaflet: Information for the user

© J-C 2014

Imodium® 1 mg/5 ml oral solution
Loperamide hydrochloride
Imodium is a registered trademark

Read all of this leaflet carefully
before you start using this
medicine because it contains
important information for you.

• 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 signs of illness are the
same as yours
• If you get any side effects talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. See
section 4.

What is in this leaflet
1 What Imodium oral solution is and
what it is used for
2 What you need to know before you use
Imodium oral solution
3 How to use Imodium oral solution
4 Possible side effects
5 How to store Imodium oral solution
6 Contents of the pack and other
information

1 What Imodium oral solution is and what it is used for
The name of your medicine is Imodium
1mg/5ml oral solution. It is called Imodium oral
solution in this leaflet.

What Imodium oral solution is used
for
Imodium oral solution is used:
• To treat sudden short-lived (acute) attacks
of diarrhoea in adults and children over
4 years of age
• To treat long-lasting (chronic) diarrhoea
in adults
If your child is using Imodium oral solution,
the ‘you’ stated everywhere below should
be read as ‘your child’.

How Imodium oral solution works

Imodium oral solution contains 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 What you need to know before you use Imodium oral
solution
Do not use Imodium oral solution:

• If you are allergic to anything in Imodium
oral solution (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 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
oral solution.

Warnings and precautions

Check with your doctor before using Imodium
oral solution 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 oral solution
immediately and contact your doctor
You may still be able to use Imodium oral
solution, but you should discuss this with your
doctor first.

Replacing fluid and salts

Imodium oral solution only treats 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.

Other medicines and Imodium oral
solution

Please tell your doctor or pharmacist if you
are taking, have recently taken or might take
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 oral
solution 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 breast 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 and 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.

Imodium oral solution contains

• sodium saccharin (4.85 mg of sodium in
5 ml): To be taken into consideration by
patients on a controlled sodium diet
• methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216). These
may cause an allergic reaction. This reaction
may happen some time after you have taken
Imodium oral solution
• cochineal red A (E124) which may cause
allergic reactions
• small amounts of ethanol (alcohol), less than
100 mg per dose

3 How to use Imodium oral solution
Always use Imodium oral solution 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 5 ml doses
of the oral solution

How to use the measuring cup

The measuring cup provided is marked with
a 5 ml graduation line.
Keep the measuring cup the same way up as
it sits on the bottle cap. To be certain that you
fill the correct side, make sure that the side
with the graduations (the side that holds less)
is uppermost. This is the side you have to fill.
The arrow on the side should also be
pointing up.

How much to take

The dose of Imodium oral solution 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 four 5 ml doses (20 ml) of the oral
solution straight away
• From then on take two 5 ml doses (10 ml)
after each episode of diarrhoea
• Never take more than sixteen 5 ml doses
(80 ml) of the oral solution in any 24 hour
period
• You can take this medicine for up to 5 days
Children aged 9 and above
• Take two 5 ml doses (10 ml) of the oral
solution 4 times a day until diarrhoea is
controlled
• You can take this medicine for no more than
5 days

© J-C 2014

3 How to use Imodium oral solution (continued)
Children aged 4-8 years old
• Take one 5 ml dose of the oral solution 3 to
4 times a day until the diarrhoea is
controlled
• You can take this medicine for no more than
3 days
If you are not getting better within 2 days
of taking your first dose of Imodium oral
solution, stop
go back
to your
doctor. He
orgo
she
taking
this medicine
and
may
to doctor.
examine
to check
on why
back want
to your
Heyou
or she
may want
to you
have
diarrhoea.
examine
you to check on why you have diarrhoea.

Long-lasting (chronic) diarrhoea

Adults
• Your doctor will tell you how much Imodium
oral solution to take. This will depend on
how serious your condition is
• You will probably start with a dose
of between four to eight 5 ml doses (20 ml to
40 ml) spread out over a day
• Your doctor will find the dose that suits you
best. He or she may then suggest you take
the oral solution twice a day
• Never take more than sixteen 5 ml doses
(80 ml) of the oral solution in any 24 hour
period

If you forget to take Imodium oral
solution

• 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 oral
solution than you should

If you take more Imodium oral solution 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.

Children
• Imodium oral solution is not recommended
for long-lasting (chronic) diarrhoea in
children

4 Possible side effects
Like all medicines, this medicine can
cause side effects, although not everybody
gets them.
Stop using Imodium oral solution 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)
Tell your doctor if you notice any of the
following side effects while using
Imodium oral solution:
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.

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

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.

6 Contents of the pack and other information
What Imodium oral solution
contains

• The active substance is loperamide
hydrochloride.
Each 5 ml dose of oral solution contains 1 mg
loperamide hydrochloride. (The oral solution
contains 0.2 mg of loperamide hydrochloride
in each millilitre.)
• The other ingredients are glycerol,
sodium saccharin, methyl
parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), cochineal red
A (E124), raspberry flavour, redcurrant
flavour, ethanol, citric acid and water.

What Imodium oral solution looks
like and contents of the pack

Imodium oral solution is a red, fruit-flavoured,
sugar-free oral solution.
It is available in 100 ml amber glass bottles
with a plastic measuring cup.

Marketing Authorisation Holder:
Janssen-Cilag Ltd, 50-100 Holmers Farm
Way, High Wycombe, Buckinghamshire
HP12 4EG, UK

Manufacturer:

Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium
OR
McGregor Cory Ltd, Middleton Close,
Banbury, Oxfordshire OX16 4RS, UK

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in June
April 2014.
2015

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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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