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IMODIUM CLASSIC 2MG CAPSULES

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

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Classic

1 What the medicine is for
2mg Capsules

Loperamide hydrochloride
„ This medicine is used for two different types
of diarrhoea. They have different age limits.
See Section 1 c
„ 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 c
„ If you have ever had a bad reaction to any
of the ingredients. For the list of ingredients,
see Section 6 c
„ Speak to your doctor:
„ If you suffer from any of the conditions mentioned
in Section 2 c
„ If you are taking any other medicines.
See Section 2 c
„ If you have Irritable Bowel Syndrome (IBS)
see also Section 2 Extra warnings for IBS patients c
„ Follow the dosage instructions carefully.
See Section 3 c
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist has
told you.

IMODIUM® Classic 2mg Capsules is used to treat
two types of diarrhoea. The two types have
different age limits.

Short-term diarrhoea
„ 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.

2 Before taking this medicine
Warnings for everyone
This medicine is suitable for most people,
but a few people should not use it:

Do not take this medicine…
„ 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®.
This section is continued over the page.

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

Talk to your doctor first…
„ If you have AIDS and your stomach becomes
swollen, stop taking the capsules 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 been told by your doctor that you
have an intolerance to some sugars.
„ 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).
„ 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.

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.

Driving and using machines

Some of the ingredients can cause
problems
This medicine contains lactose. If you have been
told by your doctor that you have an intolerance to
some sugars contact your doctor before taking this
medicine.

Extra warnings for IBS
patients

„ 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, cycle or use
machines.

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

Special warnings about this medicine

„ If you are aged under 18.

Do not take this medicine…
„ 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® Classic 2mg Capsules.

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®.

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Warnings for everyone
(continued)

How long to take IMODIUM® for
short-term diarrhoea

How long to take IMODIUM® for IBS
diarrhoea

Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you
are not sure.

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.

Check the tables below to see how much
medicine to take.
„ Swallow the correct number of capsules whole
with a drink of water. For oral use only.
„ Do not use more than the dose shown in the
tables.
„ The capsules are not for long-term treatment.

IBS diarrhoea

If anyone takes too much of this
medicine

Short-term diarrhoea

„ 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 capsules in a 24-hour
period.

Age

Dose

Adults and
children aged
12 and over

Take two capsules to start
treatment.
Take one capsule after each
loose bowel movement.

Age

Dose

Adults aged
18 and over

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

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

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

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

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.

If you have taken too many Imodium® Classic 2mg
Capsules, 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, or weak breathing.
Children react more strongly to large amounts
of Imodium® Classic 2mg Capsules 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.

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3 How to take this medicine

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: (may affect up to 1 in 1,000 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: (may affect up to 1 in 100 people)
„ Itchiness or hives.
„ Stomach pain or swollen stomach.
Rare: (may affect up to 1 in 1,000 people)
„ Difficulties passing water.
„ Severe constipation.
„ Miosis (narrowing of the pupils of the eye).
If you notice any of the above, stop using the
medicine and talk to a doctor.

Other effects that may occur
Common: (may affect up to 1 in 10 people)
„ Feeling sick, constipation or wind.
„ Headache.
Uncommon: (may affect up to 1 in 100 people)
„ Dizziness or drowsiness.
„ Vomiting, indigestion.
„ Dry mouth.

Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6 Further information
What’s in this medicine

Rare: (may affect up to 1 in 1,000 people)
„ Tiredness.

The active ingredient in IMODIUM® Classic 2mg
Capsules is: Loperamide hydrochloride 2 mg per
capsule.

Reporting of side effects

Other ingredients are: Lactose, maize starch, talc
and magnesium stearate (E572). The capsule itself is
made up of titanium dioxide (E171), black ferrous oxide
(E172), yellow ferric oxide (E172), indigo carmine
(E132), erythrosine (E127) and gelatin.

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.

5 Storing this medicine
Keep this medicine 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.

What the medicine looks like
IMODIUM® Classic 2mg Capsules are green /
grey capsules marked ‘Imodium’ and ‘JANSSEN’.
They are available in packs of 8, 12 or 18 capsules.
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.
GB - AW_117796
16-0316

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4 Possible side-effects

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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