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LOPERAMIDE 2MG CAPSULES

Active substance: LOPERAMIDE HYDROCHLORIDE

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Information for the user

How to take this medicine

Acute Diarrhoea Relief Capsules
Loperamide Hydrochloride 2mg

If the foil is broken, do not take that capsule.

Read this leaflet carefully because it contains important
information for you.
This medicine is available without prescription for you to treat
a mild condition without a doctor’s help.
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
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.
It can be used for the relief of acute diarrhoea in adults and
children aged 12 years and over.
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.

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)

• If you have IBS but have not had this condition previously
diagnosed by a doctor
• If you have IBS, which has previously been diagnosed by a
doctor, but you notice any of the following new symptoms:
- 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

Age
Adults and
children of
12 years and
over

Adults only
(18 years and
over)

Other important information
Diarrhoea is a common symptom of a number of serious
conditions in the stomach and bowel.
If your diarrhoea lasts for a long time or keeps returning, 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)

What for
Short term
diarrhoea

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

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

How often
Don’t take
more than
6 capsules in
any 24 hours.
Don’t take
for more
than
24 hours.
Two capsules Don’t take
to start with. more than
6 capsules in
After that,
any 24 hours.
take one
capsule as
Don’t take
needed until
for more
stools
than
become solid. 14 days.

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

Swallow the capsules whole with water.

• Difficulty passing urine, tensing of the muscles

Do not give to children under 12 years.

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

Do not take more than the dose recommended in the table above.
Talk to your doctor if your short term diarrhoea lasts for more
than 24 hours.
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.

How to store this medicine
Do not store above 30°C
Store in the original package.
Keep this medicine out of the sight and reach of children.

If you take too many capsules

Do not use after the Use By date on the end flap of the carton
(marked ‘EXP’).

Talk to a doctor straight away. Take your medicine and this leaflet
with you.

What is in this medicine

After you take this medicine

Each capsule contains: Loperamide Hydrochloride 2mg. This
is the active ingredient.

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)
Talk to your pharmacist if these other less serious side effects
concern you:

These capsules also contain lactose monohydrate,
pregelatinised 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).

Common side effects:
(less than 1 in every 10 people are affected)
• Headache, dizziness
• Feeling sick, constipation, wind

• 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.

Who makes this medicine
This medicine is manufactured for the Marketing Authorisation Holder Max Remedies Ltd by Max Healthcare Ltd,
William Nadin Way, Swadlincote, Derbyshire, DE11 0BB.
Leaflet revised August 2013
If you would like any further information about this product please contact Max Healthcare Ltd at the above address.
P13939

31028038

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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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