IMODIUM PLUS CAPLET

Active substance: SIMETICONE

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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…

loperamide hydrochloride, simeticone

In children less than 12 years old.
If you are allergic (hypersensitive) to loperamide hydrochloride,
simeticone or any of the other ingredients of the caplets (see
section 6).
■ If you have a high temperature (e.g. above 38° C) or blood in your
stools.
■ If you are having a flare up of an inflammatory bowel condition like
ulcerative colitis.
■ If you have severe diarrhoea after taking antibiotics.
■ If you are constipated or your stomach appears swollen.



Please read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still need to
take Imodium Plus Caplets carefully to get the best results.
■ Keep this leaflet. You may need to read it again.
■ Ask your pharmacist if you need more information or advice.
■ You must contact a doctor if your symptoms worsen or do not improve
after two days.
■ If any of the side-effects get serious, or if you notice any side-effects not
listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What the medicine is for.
2. Before taking this medicine.
3. How to take this medicine.
4. Possible side-effects.
5. Storing this medicine.
6. Further information.

1 What the medicine is for

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The caplets are used to treat a short-lived attack of diarrhoea when it
occurs with stomach cramps, bloating and wind.
The caplets contain loperamide hydrochloride, which helps reduce diarrhoea
by slowing down an overactive bowel. It also helps the body to absorb more
water and salts from the bowel. The caplets also contain simeticone, which
breaks up the trapped wind in the bowel that causes cramps and bloating.
This medicine is for use in adults and children aged 12 years and over.

If any of these apply to you, get advice from a doctor or pharmacist
without taking Imodium Plus Caplets.

Talk to your doctor or pharmacist…

Imodium Plus Caplets 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.
■ If you have severe diarrhoea as your body loses more fluid, sugars and
salts than normal. You will need to replace the fluid by drinking more
liquid than usual. Ask your pharmacist about special powders which
replace the sugars and salts.
■ If you have AIDS and your stomach becomes swollen, stop taking the
caplets immediately and contact your doctor.
■ If you have liver disease. Check with your doctor before using the caplets.
Some of the side-effects might be more troublesome.


Taking other medicines

Talk to your doctor or pharmacist 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)
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription, because Imodium Plus Caplets may interact with them.
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 of the medicine 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.

3 How to take this medicine

Check the table overleaf to see how much medicine to take.
■ Swallow the correct number of caplets 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

Do not give the caplets to children less than 12 years old.

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2 Before taking this medicine

Unless your doctor has told you otherwise, follow these instructions:
Age

Dose

Adults over 18 years old

Swallow two caplets initially, followed
by one caplet after every loose stool
(bowel movement).

Children and young adults
(12 to 18 years)

Swallow one caplet initially, followed
by one caplet after every loose stool
(bowel movement).




Do not take more than 4 caplets in a day.
If you are no better after two days, stop taking the caplets and contact
your doctor.

If anyone takes too much of this medicine

Too many caplets may make you feel drowsy, or make it difficult to think
clearly or carry out normal activities. Your muscles may feel stiff or you may
experience breathing difficulties. You may have a dry mouth or the pupils
of your eyes may become small. You may have stomach pain, feel sick or
vomit, be constipated or have difficulty passing water.
If you have taken too many Imodium Plus Caplets, contact a doctor or
nearest Accident and Emergency (casualty) taking this leaflet with you.

If you forget to take the medicine

Take one caplet after the next loose stool (bowel movement). Do not
take a double dose to make up for a forgotten dose.
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 Plus Caplets can cause side-effects, although
not everybody gets them.

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 any of these side-effects becomes serious, contact a doctor or
hospital immediately.
If you notice any side-effects not listed in this leaflet, tell your doctor or
pharmacist as soon as possible.

5 Storing this medicine

Keep out of the reach and sight of children. Do not use the caplets after
the expiry date on the blister and box. The expiry date refers to the last
day of that month. 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.

6 Further information
What’s in this medicine?

The active ingredients are: Loperamide hydrochloride (2 mg per caplet)
and Simeticone (measured as 125 mg dimeticone per caplet).
The other ingredients are: Calcium hydrogen phosphate anhydrous,
microcrystalline cellulose, acesulfame potassium, artificial vanilla flavour
(includes propylene glycol, maltodextrin and benzyl alcohol), sodium starch
glycolate (type A) and stearic acid.

What the medicine looks like

The caplets are white capsule shaped tablets marked with a line between “2”
and “125” on one side and “IMO” on the other side.
Each pack contains 6, 8, 10, 12, 15, 16, 18 or 20 caplets in blister strips.
Not all pack sizes may be marketed.
Marketing Authorisation 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 2012.
Imodium is a registered trade mark.

11-0165
GB - 985210

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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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