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IMODIUM 2MG CAPSULES

Active substance(s): LOPERAMIDE HYDROCHLORIDE

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503682/PL1a

Imodium® 2 mg Capsules
(loperamide hydrochloride)

Patient Information Leaflet
The name of your medicine is Imodium 2 mg Capsules,
throughout this leaflet it will be referred to as Imodium.








This medicine is used for two different types of
diarrhoea. They have different age limits. See
Section1.
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.
1) WHAT THE MEDICINE IS FOR
Imodium 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.
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.
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.
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 and 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.
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
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.
3) HOW TO TAKE THIS MEDICINE
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.
Short-term diarrhoea
Age

Dose

Adults and children aged
12 and over




Take two capsules to start
treatment
Take one capsule after each
loose bowel movement.
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 aged under 12.

How long to take Imodium for short-term diarrhoea
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.
IBS diarrhoea
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).
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.




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
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 anyone takes too many Imodium capsules, contact your
doctor or nearest Accident and Emergency department taking
this leaflet with you.

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 (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.
• 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: (affects less than 1 in 10 but 1 or more in 100
people)
• Feeling sick, constipation or wind.
• Headache.
Uncommon: (affects less than 1 in 100 but 1 or more in
1,000 people)
• Dizziness or drowsiness.
• Vomiting, indigestion.
• Dry mouth.
Rare: (affects less than 1 in 1,000 but 1 or more in 10,000
people)
• Tiredness.
If you experience any side-effects not included in this leaflet
or are not sure about anything, talk to your doctor or
pharmacist.
5) STORING THIS MEDICINE
Keep out of the sight and reach of children.
Do not store above 25ºC.
Do not use your medicine after the date shown as the expiry
date on the packaging.
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.
If you notice any sign of deterioration or discolouration of the
capsules, tell your pharmacist immediately.
6) FURTHER INFORMATION
The active substance in Imodium® is loperamide
hydrochloride.
Each capsule contains 2 mg of loperamide hydrochloride.
Other ingredients are: lactose monohydrate, maize starch,
talc and magnesium stearate (E572).
The capsule itself is made up of titanium dioxide (E171), iron
oxide (E172), indigotine (E132), erythrosine (E127) and
gelatin.
What the medicine looks like
Imodium® capsules have a grey body with a dark green cap.
They are available in packs of 6, 12 or 18 capsules.
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
®

Imodium 2 mg Capsules
PL No: 18067/0376
Manufactured by Famar A.B.E., Anthousa, GR 15344,
Greece.
Imodium® is a registered trademark of Johnson &
Johnson.
This leaflet was last approved on 18th September 2012.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 693000.

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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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