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IMODIUM PLUS COMFORT TABLETS

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

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Plus Comfort Tablets
Loperamide hydrochloride & 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.

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 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…
■ 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.
® Plus Comfort tablets only treat the symptoms of diarrhoea. In some cases, the cause of your
■ IMODIUM
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.
■ 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 Comfort tablets.

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.



Dose



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

Age

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

Adults and children 12 years and over

Adults over 18 years old

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.

Children and young adults
(12 to 18 years)





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

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

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.

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

4 Possible side-effects

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.

If you have taken too many IMODIUM® Plus Comfort tablets, 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 Comfort tablets 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

Keep the product out of sight and reach 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.

5 Storing this medicine

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:

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

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 April 2017.
IMODIUM® is a registered trade mark.

What the medicine looks like

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.

6 Further information

Expand Transcript

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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