IMODIUM PLUS COMFORT TABLETS

Active substance: SIMETICONE

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2 Before taking this medicine
loperamide, simeticone
This medicine is used to treat sudden short-lived (acute) attacks
of diarrhoea and calm additional abdominal discomfort such
as cramps, wind and bloating.
■ This medicine is for use by adults and children aged 12 years and
over.
■ 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 ▶
■ Follow the dosage instructions carefully. Children and adults
need different amounts. These are shown in the dosage table.
See Section 3 ▶
Now read this whole leaflet carefully before you use this
medicine. Keep the leaflet: you might need it again.


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1 What the medicine is for
Imodium Plus Comfort tablets is a medicine which is used to treat
sudden short-lived (acute) attacks of diarrhoea and calm additional
abdominal discomfort such as cramps, wind and bloating.
The tablets contain loperamide hydrochloride, which helps reduce
diarrhoea by slowing down an overactive bowel, which helps the
body to absorb water and salts from the bowel. The tablets also
contain simeticone, which is an anti-foaming agent that breaks
up trapped wind in the bowel that causes cramps and bloating.

This medicine is suitable for most adults and children aged
12 years and over, but a few people should not use it. If you are
in any doubt, talk to your doctor or pharmacist.

Do not take this medicine…
If you have ever had a bad reaction to any of the
ingredients.
■ If it is for a child under 12 years old.
■ 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.
■ If you have acute dysentery, the symptoms of which may
include blood in your stools and a high temperature.
If any of these apply to you, get advice from a doctor or
pharmacist without taking Imodium Plus Comfort tablets.


Talk to your doctor or pharmacist…
If you have AIDS and your stomach becomes swollen,
stop taking the tablets immediately and contact your
doctor.
■ If you suffer from liver disease.
■ If your diarrhoea lasts for more than 48 hours.
■ If you have severe diarrhoea as your body loses more
fluid, sugars and salts than normal.
■ If you are taking any other medicines, including:
■ quinidine (used to treat abnormal heart rhythms or malaria)
■ itraconazole or ketoconazole (antifungal medicines)
■ gemfibrozil (used to treat high cholesterol)
■ ritonavir (used to treat HIV infection and AIDS)
■ desmopressin (used to control thirst and urine production
in patients with diabetes insipidus)


If you are unsure about any of the medicines you are taking,
show the bottle or pack to your pharmacist.
If any of these bullet points apply to you now or in the past,
talk to a doctor or pharmacist.

If you are pregnant or breast-feeding
Ask your doctor or pharmacist for advice before taking
this medicine if you are pregnant, think you are pregnant
or planning to 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.


Special warnings about this medicine
This medicine may make you feel dizzy, tired or sleepy.
If affected do not drive or operate machinery.
■ Imodium Plus Comfort tablets only treat the symptoms
of diarrhoea. In some cases, the cause of your diarrhoea
may require treatment. If symptoms persist or worsen,
please contact your doctor. When you have diarrhoea,
your body can lose large amounts of fluids and salts.
You will need to replace the fluid by drinking more liquid
than usual. Ask your pharmacist about special powders
(known as oral rehydration therapy) which replace fluids
and salts lost during diarrhoea.


3 How to take this medicine
Check the table overleaf to see how much medicine to take.
■ Swallow the correct number of tablets whole with a drink of water.
■ For oral use only.
■ Do not use more than the stated dose shown in the table.

Children under 12 years old
This medicine is not recommended for children under
12 years old.

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AW_88003.pdf - Page 1 of 3 - August 28, 2013 - 12:07:48

This medicine is for use in adults and children aged 12 years
and over.

Age

Dose

Adults over 18 years old

Swallow two tablets initially,
followed by one tablet after each
loose bowel movement.

Children and young adults
(12 to 18 years)

Swallow one tablet initially,
followed by one tablet after each
loose bowel movement.




Do not take more than 4 tablets in any 24 hour period.
Do not take for more than 48 hours. If symptoms persist for
more than 48 hours talk to your doctor.

If anyone takes too much of this medicine
If anyone takes too many Imodium Plus Comfort tablets,
contact your doctor or nearest Accident and Emergency
department (Casualty) taking this leaflet with you.

If you forget to take the medicine
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.

4 Possible side-effects
Imodium Plus Comfort tablets can have side-effects, like all medicines,
although these don’t affect everyone and are usually mild.

If you experience any of the following, stop using the
medicine and seek immediate medical help:
Allergic reactions including swelling of the face, tongue or throat,
difficulty swallowing, unexplained wheezing, shortness of breath
which may be accompanied by skin rash or hives.

If you experience any of the following, stop using the
medicine and talk to your doctor:
Difficulties passing water
Severe abdominal pain, abdominal bulging or swelling or fever
which may be due to a blocked or enlarged bowel
■ Severe constipation



Other effects which may occur include:
Common side effects:
(less than 1 in 10 but more than 1 in 100 people get these):
■ Headache
■ Feeling sick
■ A change in the way some things taste
Uncommon side effects:
(less than 1 in 100 but more than 1 in 1000 people get these):
■ Drowsiness
■ Dizziness
■ Weakness
■ Constipation
■ Vomiting
■ Indigestion
■ Wind
■ Dry mouth
■ Rash
Rare side effects:
(less than 1 in 1000 but more than 1 in 10 000 people get these):
■ Loss of consciousness or decreased consciousness
■ Excessive contraction of the pupil of the eye
■ Skin rash, which may lead to severe blistering and peeling of
the skin
■ Hives
■ Itching
■ Tiredness
If you experience any side-effects not included in this leaflet or are
not sure about anything, talk to your doctor or pharmacist.

5 Storing this medicine
Keep the product out of the reach and sight of children.
This medicinal product does not require any special storage
conditions.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help protect the environment.
Do not use your medicine after the date shown as the expiry
date on the packaging.

6 Further information
What’s in this medicine?
The active ingredients in Imodium Plus Comfort tablets
are: Loperamide hydrochloride 2 mg and simeticone
(equivalent to 125 mg dimeticone) per tablet.
Other ingredients are: Calcium hydrogen phosphate anhydrous,
microcrystalline cellulose, acesulfame K, artificial vanilla flavour
(includes propylene glycol, maltodextrin and benzyl alcohol),
sodium starch glycolate (type A) and stearic acid.

What the medicine looks like
Imodium Plus Comfort tablets are white capsule shaped tablets
marked with a line between “2” and “125” on one side and
“IMO” on the other side available in packs of 6.
Product Licence holder:
McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer:
Janssen-Cilag SpA Via C.Janssen, Borgo San Michele, Latina, Italy.
This leaflet was revised August 2013
Imodium is a registered trade mark.

GB - AW_88003

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AW_88003.pdf - Page 2 of 3 - August 28, 2013 - 12:07:48

Adults and children 12 years and over

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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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