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IMODIUM IBS RELIEF 2 MG CAPSULES SOFT

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

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FOR POSITION ONLY
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
 If your doctor has confirmed that you have
Irritable Bowel Syndrome (IBS), this product
can help you treat attacks of IBS diarrhoea
associated with this condition. See also Section
2 Extra Warnings for IBS patients.
 This medicine can also be used to treat shortterm diarrhoea. The age limit and treatment
period for this is different. 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
 Follow the dosage instructions carefully.
See Section 3

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

2 Before taking this medicine
i

This medicine is suitable for most people, but
a few people should not use it:
!

Do not take this medicine…

X

X

 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.

 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).

i 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.

X
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.

 If you have ever had a bad reaction to any
of the ingredients.
 If you are under 18 years for an IBS patient
(or under 12 years for short-term diarrhoea).

i IBS diarrhoea
!

Warnings for everyone

i

 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…

X

 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 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.

FOR POSITION ONLY

 
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® IBS Relief 2mg Soft Capsules.

Some of the ingredients can cause
problems
IMODIUM® IBS Relief 2 mg Soft Capsules
contain soya lecithin. If you are allergic to soya
or peanut, do not use this medicinal product.

i

Extra warnings for IBS patients

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

i

X

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
X
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

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. Do not chew.
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
Age
Dose
Adults aged
Take two capsules to start
18 and over
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.

i 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

X

one attack lasts for longer than 48 hours, stop
taking IMODIUM® and talk to your doctor.

Short-term diarrhoea
Age
Dose
Adults and
Take two capsules to start
children aged treatment.
12 and over 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.

i 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.

X

If anyone takes too much of this medicine
If you have taken too many IMODIUM IBS Relief
2mg Soft 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® IBS Relief 2mg Soft 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.

4 Possible side-effects
IMODIUM® IBS Relief 2 mg Soft Capsules 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.
 Miosis (narrowing of the pupils of the eye).

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.
Dietary soya-products are known to cause
allergic reactions including severe anaphylaxis in
persons with soya allergy. Patients with known
allergy to peanut protein carry an enhanced risk
for severe reactions to soya preparations.

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. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard

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
to protect the environment.

6 Further information
What’s in this medicine
The active ingredient in IMODIUM®
IBS Relief 2 mg Soft Capsules is:
Loperamide hydrochloride 2 mg per capsule.
Other ingredients are: Propylene glycol
monocaprylate, propylene glycol, gelatin,
glycerol, soya lecithin, medium chain triglycerides,
brilliant blue (E133) and purified water.

What the medicine looks like

By reporting side effects you can help provide
more information on the safety of this medicine.

IMODIUM® IBS Relief 2 mg Soft Capsules are clear
blue liquid filled capsules available in packs of 6 or
12. The pack of 12 is only available in pharmacies.

5 Storing this medicine

Other effects that may occur

Product Licence holder: McNeil Products
Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

Keep out of the sight and reach of children.

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

Do not store above 25°C. Store in the original
package to protect from moisture. Keep blister in
the outer carton to protect from light.

Manufacturer: Catalent France, Beinheim SA,
74 rue Principale, F-67930, Beinheim - France.

If you notice any of the above, stop using the
medicine and talk to a doctor.

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

16-0321

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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