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IMODIUM INSTANT MELTS

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

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1 What the medicine is for

Instant
Melts
Loperamide hydrochloride










This medicine is used for two different types of diarrhoea.
They have different age limits. See Section 1 ▶
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 ▶
If you have Irritable Bowel Syndrome (IBS) see also Section 2
Extra warnings for IBS patients ▶
Follow the dosage instructions carefully. See Section 3 ▶

Now read this whole leaflet carefully before you use this
medicine. Keep the leaflet: you might need it again.

2 Before taking this medicine

IMODIUM® Instant Melts are used to treat two types of
diarrhoea.
The two types have different age limits.

Warnings for everyone

Short-term diarrhoea

Do not take this medicine…



For adults and children aged 12 and over.



To treat attacks that last up to 48 hours.



If your attack lasts longer than 48 hours, talk to your doctor.

IBS diarrhoea


For adults and young people aged 18 and over who have
been diagnosed with IBS (Irritable Bowel Syndrome).



To treat attacks that last up to 48 hours.



You can use this medicine for up to 2 weeks for repeated
attacks, but if any one attack lasts continuously for longer
than 48 hours, talk to your doctor.

The tablets contain loperamide hydrochloride, a substance that
helps reduce diarrhoea by slowing down an overactive bowel.
This allows water and salts that are usually lost in diarrhoea to
be absorbed by the body.

oral desmopressin (used to treat excessive urination).
itraconazole or ketoconazole (used to treat fungal
infections).
■ gemfibrozil (used to treat high cholesterol).
If you are unsure about any of the medicines you are taking,
show the bottle or pack to your pharmacist.
If any of these applies to you (now or in the past), talk to
a doctor or pharmacist.



This medicine is suitable for most people, but a few people
should not use it:
If you have ever had a bad reaction to any of the ingredients.
■ If it is for a child aged under 12 (or under 18 for an IBS
patient).
■ 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
(especially in children with severe dehydration).
■ If you have acute dysentery, the symptoms of which may
include blood in your stools and a high temperature.
If any of these applies to you, talk to a doctor or pharmacist
and do not take IMODIUM®.


Talk to your doctor first…

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 you have diarrhoea that 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:
■ ritonavir (used to treat HIV).
■ quinidine (used to treat abnormal heart rhythms or
malaria).


Pregnancy or breast-feeding

If you are pregnant, think you are pregnant or planning
a pregnancy: ask your doctor or pharmacist for advice before
taking this medicine.
■ If you are breast-feeding do not take this medicine. 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.
You may feel less alert, feel faint or pass out. If you’re affected
do not drive or use machines.
■ Your body can lose large amounts of fluids and salts when you
have diarrhoea. You need to replace the fluid by drinking more
liquid than usual. Ask your pharmacist about rehydration
therapy to replace lost salts. This is especially important
for children, and frail or older people.
■ 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® Instant Melts.


Some of the ingredients can cause problems

Aspartame (E951) contains a source of phenylalanine.
This may be harmful for people with phenylketonuria.
Mint flavour contains traces of sulphites. This may rarely
cause severe hypersensitivity reactions and bronchospasm.

Extra warnings for IBS patients

Use only if your doctor has previously diagnosed IBS.
Check the following:

Do not take this medicine…


If you are aged under 18.

Talk to your doctor first…

If you are aged 40 or over and it is some time since your
last IBS attack.
■ If you are aged 40 or over and your IBS symptoms are
different this time.
■ If you have recently passed blood from the bowel.
■ If you suffer from severe constipation.
■ If you are feeling sick or vomiting.
■ If you have lost your appetite or lost weight.
■ If you have difficulty or pain passing urine.
■ If you have a fever.
■ If you have recently travelled abroad.
If any of these applies to you, talk to your doctor before
taking IMODIUM®.


Turn Over ▶

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Check the tables below to see how much medicine to take.
■ Peel back the lid and tip the tablet out. Do not push the tablets
through the lid.
■ Place the correct number of tablets on the tongue. The tablets
dissolve quickly in your mouth, so you don’t need water to
swallow them. Do not chew. For oral use only.
■ Do not use more than the dose shown in the tables.
■ The tablets are not for long-term treatment.

Short-term diarrhoea
Age

Dose

Adults and children
aged 12 and over

Take two tablets to start treatment.
Take one tablet after each loose
bowel movement.




Do not take for attacks lasting longer than 48 hours.
Do not take more than six tablets in a 24-hour period.

Replace lost fluid by drinking more liquid than usual.
■ Not for children aged under 12.


IBS diarrhoea
Age

Dose

Adults aged 18 and
over

Take two tablets to start treatment.
Take one tablet after each loose
bowel movement (or as advised by
your doctor).

You can use this medicine for up to 2 weeks for repeated
attacks, but do not take for any one attack lasting longer
than 48 hours.
■ Do not take more than six tablets in a 24-hour period.





Replace lost fluid by drinking more liquid than usual.
Not for children and young people aged under 18.

Talk to your doctor and stop taking this medicine:
■ If you have been using this medicine continuously for
48 hours.
■ If you develop new IBS symptoms.
■ If your IBS symptoms get worse.
■ If your IBS symptoms have not improved after 2 weeks.

How long to take IMODIUM® for IBS diarrhoea
How long to take IMODIUM® for short-term
diarrhoea

TOP

You can use this medicine for up to 48 hours.
If your attack lasts longer than 48 hours, stop taking IMODIUM®
and talk to your doctor.

You can use this medicine for up to 2 weeks for repeated
attacks of IBS diarrhoea. But if any one attack lasts for longer
than 48 hours, stop taking IMODIUM® and talk to your
doctor.

If anyone takes too much of this medicine

If you have taken too many Imodium® Instant Melts, 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, lifethreatening consequences), muscle stiffness, uncoordinated
movements, drowsiness, difficulty urinating, or weak breathing.
Children react more strongly to large amounts of Imodium®
Instant Melts than adults. If a child takes too much or shows any
of the above symptoms, call a doctor immediately.

If you forget to take the medicine

You should only take this medicine as you need it, 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® can have side-effects, like all medicines, although
these don’t affect everyone and most are usually mild.

Get medical help at once

Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 people)
■ Allergic reactions including unexplained wheezing, shortness
of breath, passing out or swelling of face and throat.
■ Skin rashes, which may be severe and include blistering or
peeling skin.
■ Loss of consciousness or reduced level of consciousness
(passing out, feeling faint or less alert), uncoordinated movements.
If you get any of these, stop using the medicine and get
medical help at once.

Talk to a doctor as soon as possible

Uncommon: (affects less than 1 in 100 but 1 or more in
1,000 people)
■ Itchiness or hives.
■ Stomach pain or swollen stomach.
Rare: (affects less than 1 in 1,000 but 1 or more in
10,000 people)
■ Difficulties passing water.
■ Severe constipation.
■ Burning or prickling sensation of the tongue.
■ Miosis (narrowing of the pupils of the eye).
If you notice any of the above, stop using the medicine and
talk to a doctor.

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 Storing this medicine
Keep the product out of the sight and reach of children.
Store in the original package.
Do not use your medicine after the date shown as the expiry
date on the packaging.

6 Further information
What’s in this medicine

Other effects that may occur

The active ingredient in IMODIUM® Instant Melts is:
Loperamide hydrochloride 2 mg per tablet.
Other ingredients are: Gelatin, mannitol, aspartame,
mint flavour and sodium hydrogen carbonate.

Uncommon: (affects less than 1 in 100 but 1 or more in
1,000 people)
■ Dizziness or drowsiness.
■ Vomiting, indigestion.
■ Dry mouth.

What the medicine looks like

Common: (affects less than 1 in 10 but 1 or more in 100 people)
■ Feeling sick, constipation or wind.
■ Headache.

Rare: (affects less than 1 in 1,000 but 1 or more in
10,000 people)
■ Tiredness.

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.

IMODIUM® Instant Melts come in the form of white,
orodispersible (dissolve in the mouth) tablets available in packs
of 12 and 18 (not all pack sizes may be marketed).
Product Licence holder: McNeil Products Ltd, Maidenhead,
Berkshire, SL6 3UG, UK.
Manufacturer:
Janssen-Cilag, Domaine de Maigremont,
27100 Val-de-Reuil, France.
This leaflet was revised April 2017.
IMODIUM® is a registered trade mark.
16-0318

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3 How to take this medicine

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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