LOPERAMIDE 2MG CAPSULES

Active substance: LOPERAMIDE HYDROCHLORIDE

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0001-leaflet-6-V4_0001-leaflet-6-V4 03/07/2012 11:10 Page 1

Information for the user
Acute Diarrhoea Relief Capsules
Loperamide Hydrochloride 2mg
Read this leaflet carefully because it contains important information
for you.

• If you have IBS but have not had this condition previously diagnosed
by a doctor

This medicine is available without prescription for you to treat a mild
condition without a doctor’s help.

• If you have IBS, which has previously been diagnosed by a doctor, but
you notice any of the following new symptoms:

However, you still need to use it carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• Please see your doctor if your symptoms get worse or do
not improve.

What this medicine is for

- If you are 40 years or over and it is some time since your last attack
of IBS, or if the symptoms are different this time
- If you have recently passed blood from the bowel
- If you have severe constipation
- If you are feeling sick or being sick
- If you have lost your appetite or lost weight, especially if losing
weight without trying
- If you have difficulty or pain on passing urine
- If you have a fever
- If you have recently travelled abroad

This medicine contains Loperamide Hydrochloride, which belongs to
a group of medicines called antidiarrhoeals, which help to relieve the
symptoms of sudden, short-term diarrhoea (acute diarrhoea). It works
by making the stools (motions) more solid and less frequent.

Other important information

It can be used for the relief of acute diarrhoea in adults and children
aged 12 years and over.

Diarrhoea is a common symptom of a number of serious conditions
in the stomach and bowel.

It can also be used by adults of 18 years and over who have irritable
bowel syndrome (IBS), which has been previously diagnosed by a
doctor, to relieve short term diarrhoea associated with it.

If your diarrhoea lasts for a long time or keeps returning, talk to
your doctor.

Before you take this medicine
These capsules can be taken by adults and children from the age of
12 years. However, diarrhoea is a common symptom of a number of
serious stomach and bowel conditions and therefore some people
should not take this medicine or should seek the advice of their
pharmacist or doctor first.

Do not take
• If you are allergic to loperamide or to any of the ingredients in this
medicine (see “What is in this medicine”)
• If you are having a flare up of an inflammatory bowel condition,
such as ulcerative colitis
• If you have very smelly stools, blood or pus in your stools, stomach
pain, or a fever
• If you have dysentery (a disease caused by eating and drinking
contaminated food and water) – you may have a fever and blood in
your stools
• If you have severe diarrhoea after taking antibiotics
• If you have a swollen stomach
• If you are constipated, or have any condition which may cause
constipation or where constipation should be avoided
• If you have paralysis (non movement) of the bowel muscles, or an
obstruction of the bowel
• If you have an intolerance to some sugars, unless your doctor tells
you to (this medicine contains lactose)
• If you are pregnant or breastfeeding, unless your doctor tells you to
Talk to your pharmacist or doctor
• If you have liver problems
• If you have AIDS (you may be more likely to experience some of the
side effects - if your stomach becomes swollen stop taking the
capsules and talk to your doctor)

This medicine only treats the symptoms of diarrhoea and should not be
taken for long periods of time.
Diarrhoea can cause the body to lose large amounts of fluids, which
need replacing by drinking more fluid than usual.
When your body loses more fluid than normal, the amount of salts
(electrolytes) in your body also changes and this can cause dehydration
and electrolyte imbalance. This can be treated using a type of medicine
called ‘oral rehydration treatment’, which helps to bring the fluid and
salt levels back to normal. Your pharmacist may recommend that you
take this rehydration treatment, especially if you are elderly.
Driving and using machines: These capsules may cause dizziness,
sleepiness or tiredness. If affected, you should not drive, operate
machinery or take part in activities where such symptoms may put you
or others at risk.
Information about some of the ingredients in this medicine: The colour
ponceau 4R (E124) in this medicine may cause allergic reactions.

If you take other medicines
Before you take these capsules, make sure that you tell your pharmacist
about ANY other medicines you might be using at the same time,
particularly the following:
• Ritonavir (used to treat HIV)
• Quinidine (for heart rhythm problems), gemfibrozil (for reducing
blood fat levels)
• Itraconazole, ketoconazole (for fungal infections)
• Desmopressin (for treating excessive urination or bed wetting)
• Other medicines for diarrhoea, constipation, or for other stomach
and bowel conditions
If you are unsure about interactions with any other medicines, talk to
your pharmacist. This includes medicines prescribed by your doctor and
medicine you have bought for yourself, including herbal and
homeopathic remedies.

0001-leaflet-6-V4_0001-leaflet-6-V4 03/07/2012 11:10 Page 2

Uncommon side effects:
(less than 1 in every 100 people are affected)

How to take this medicine
If the foil is broken, do not take that capsule.
Age

What for

How many

How often

Adults and
children of 12
years and over

Short term
diarrhoea

Two capsules
to start with.
After that, take
one capsule
after each
loose bowel
movement.

Don’t take
more than 6
capsules in any
24 hours.

Adults only (18
years and over)

Diarrhoea
associated with
irritable bowel
syndrome,
which has been
diagnosed by
a doctor

Two capsules to
start with.
After that, take
one capsule as
needed until
stools become
solid.

Don’t take for
more than 24
hours.
Don’t take
more than 6
capsules in any
24 hours.
Don’t take for
more than 14
days.

• Dry mouth, being sick, indigestion, stomach discomfort, stomach
or upper abdominal pain
• Feeling very sleepy or wanting to sleep
• Skin rash
Rare side effects:
(less than 1 in every 1000 people are affected)
• Obstruction of the bowel, dilation of the bowel, paralysis (non
movement) of the bowel muscles which may stop bowel movements
• Swelling of the stomach and abdomen
• Allergic skin reactions such as itchy, red, raised rash (which can
sometimes be severe and include peeling, swelling, blistering and
lesions of the skin)
• General feeling of tiredness, loss or decreased levels of consciousness,
lack of coordination, lack of response to stimulation

Swallow the capsules whole with water.

• Difficulty focussing

Do not give to children under 12 years.

• Difficulty passing urine, tensing of the muscles

Do not take more than the dose recommended
in the table above.

If any problem becomes severe, or you notice other side effects not
stated here, talk to your pharmacist or doctor.

Talk to your doctor if your short term diarrhoea lasts for more
than 24 hours.

How to store this medicine

If you need to take this medicine for diarrhoea associated with IBS for
more than 14 days, or if you notice new symptoms, or symptoms
worsen, talk to your doctor.

If you take too many capsules
Talk to a doctor straight away. Take your medicine and this leaflet
with you.

After you take this medicine
Most people can take this medicine without any problems but
sometimes you may notice some side effects.
If you have any of the following serious side effects, stop taking the
medicine and see a doctor straight away:
• Swelling of the face, neck, tongue, throat or difficulty breathing
(severe allergic reactions)

Do not store above 30oC
Store in the original package.
Keep this medicine out of the sight and reach of children.
Do not use after the Use By date on the end flap of the carton
(marked ‘EXP’).

What is in this medicine
Each capsule contains: Loperamide Hydrochloride 2mg. This is the
active ingredient.
These capsules also contain lactose monohydrate, pregalatinised maize
starch, magnesium stearate. The capsule contains gelatin, ponceau 4R
(E124), indigo carmine (E132), titanium dioxide (E171), yellow and
black iron oxides (E172), printing ink (containing black iron oxide
(E172), shellac, propylene glycol).
The pack contains 6 hard capsules (green/grey).

Talk to your pharmacist if these other less serious side effects
concern you:
Common side effects:
(less than 1 in every 10 people are affected)
• Headache, dizziness
• Feeling sick, constipation, wind

Who makes this medicine
The medicine is manufactured for the Marketing Authorisation Holder Max Remedies Ltd, Stoney Gate House,
2 Greenfield Road, Holmfirth, West Yorkshire HD9 2JT by Max Healthcare Ltd, Waterside, Digley Road, Holmbridge, HD9 2QN.
Leaflet Revised June 2012.
If you would like any further information about this product, please contact Max Healthcare Ltd, Waterside, Digley Road,
Holmbridge, HD9 2QN.

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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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