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IMODIUM PLUS CAPLET

Active substance(s): LOPERAMIDE HYDROCHLORIDE / SIMETICONE / LOPERAMIDE HYDROCHLORIDE / SIMETICONE

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GB - AW_117851

Job bag No: 16-0323, v5
Component number: AW_117851
Dimension: 160 x 536 mm

Plus Caplets
Loperamide hydrochloride & Simeticone

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

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.

2 Before taking this medicine

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…

■ 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.
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…

® Plus Caplets only treat the symptoms of diarrhoea. In some cases, the cause of your diarrhoea
■ IMODIUM
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.
■ Do not take this product for anything other than its intended use (see section 1) and never take more than
the recommended amount (see section 3). Serious heart problems (symptoms of which include fast or
irregular heartbeat) have been reported in patients who have taken too much loperamide, the active
ingredient in IMODIUM® Plus Caplets.

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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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.

4 Possible side-effects

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.

If you forget to take the medicine

If you have taken too many IMODIUM® Plus Caplets, immediately contact a doctor or hospital for advice.
Symptoms may include: increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms
can have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements,
drowsiness, difficulty urinating, weak breathing, dry mouth or the pupils of your eyes may become small,
stomach pains, feel sick or vomit or be constipated.
Children react more strongly to large amounts of IMODIUM® Plus Caplets than adults. If a child takes too
much or shows any of the above symptoms, call a doctor immediately.

If anyone takes too much of this medicine

Dose
Swallow two caplets initially, followed by one caplet after every loose stool
(bowel movement).
Children and young adults
Swallow one caplet initially, followed by one caplet after every loose stool
(12 to 18 years)
(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.

Age
Adults over 18 years old

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

Adults and children 12 years and over

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.

Reporting of side effects

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



This leaflet was revised April 2017.
IMODIUM® is a registered trade mark.

16-0323
GB - AW_117851

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.

What the medicine looks like

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’s in this medicine?

6 Further information

Keep this medicine out of the sight and reach 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.

5 Storing this medicine

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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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