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LOPERAMIDE HYDROCHLORIDE CAPSULES 2 MG

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LOPERAMIDE HYDROCHLORIDE
CAPSULES 2 mg

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3. HOW TO TAKE LOPERAMIDE HYDROCHLORIDE
CAPSULES 2 mg
Always read the label on your medicine and follow your doctor's
instructions carefully. Ask your pharmacist if you are not sure
about anything.
The dose of Loperamide Hydrochloride that you will need will
depend on whether your diarrhoea is a sudden, short-lived
attack (acute) or a long-lasting condition (chronic).
Acute diarrhoea
Adults: take two capsules to begin with and then 1 capsule after
each episode of diarrhoea for up to 5 days. Never take more than
8 capsules in any 24 hour period.
Children aged 9-12 years: take one capsule 4 times daily until
diarrhoea is controlled or for up to 5 days. Never take more than
this dose.
Children aged 4-8 years: Not recommended for use in
children aged 4-8 years. Your doctor will prescribe a suitable
alternative.
If your symptoms are not getting better within 2 days of taking
your first dose of Loperamide Hydrochloride, you should see
your doctor again. The reason is that your doctor may want to
examine you to further check on the cause of the diarrhoea.
Chronic diarrhoea
Adults only: your doctor will tell you how much Loperamide
Hydrochloride to take. The initial dose will probably be between
two and four capsules per day taken in divided doses, but will
depend on each individual's needs. When your doctor is
satisfied that you are receiving the daily dose that best suits you,
he or she will probably suggest that the frequency at which you
take Loperamide Hydrochloride is twice a day. Never take more
than 8 capsules in any 24 hour period.
Children: NOT recommended.
If you take more Loperamide Hydrochloride Capsules 2 mg
than you should
If you, or anyone else, take too much Loperamide Hydrochloride, contact your doctor or local hospital without delay.
If you forget to take Loperamide Hydrochloride Capsules
2 mg
If you forget to take a dose, take it as soon as you remember,
unless it is nearly time for your next dose. Never take two doses
to make up for forgotten doses. If you are worried ask your
pharmacist or doctor for advice.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Loperamide Hydrochloride can cause side
effects, although not everybody gets them.
Serious Side effects:
Allergic reactions to Loperamide Hydrochloride are very rare
(less than 1 in 10,000 patients affected). An allergic reaction can
be recognised, by skin rash, itching, shortness of breath or
swollen face. If any of these signs occur, stop taking Loperamide Hydrochloride and see your doctor immediately.
Severe bloated tummy or stoppage of bowel activity or difficulty
urinating (passing water) have been reported. If this should
occur, stop taking Loperamide Hydrochloride and contact
your doctor.

If you have severe stomach pain or bloating, with a swollen
abdomen, fast heart beat, low blood pressure (dizziness on
standing) and high fever stop taking Loperamide
Hydrochloride and contact your doctor immediately.
If you experience very painful skin blistering that may peel stop
taking Loperamide and contact your doctor or hospital
immediately as this may be a very serious skin disorder.
Very rare side effects (less than 1 in 10,000 patients):
• Tummy cramps
• Feeling sick
• Being sick
• Indigestion
• Constipation
• Flatulence (wind)
• Tiredness
• Drowsiness
• Dizziness
• Swelling of any part of the body
• Dry mouth
• Skin reactions, including nettle rash.
• Loss of or depressed level of consciousness
Dry mouth has also been reported in some patients.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
5. HOW TO STORE LOPERAMIDE HYDROCHLORIDE
CAPSULES 2 mg
As with all medicines, Loperamide Hydrochloride should be kept
in a safe place where children cannot see or reach it.
Do not store above 25°C. Store the medicine in its original
container.
Do not use the medicine after the expiry date printed on the
packaging. Always return any left over medicine to your
pharmacist. Only keep it if your doctor tells you to.
6. FURTHER INFORMATION What Loperamide Hydrochloride Capsules 2 mg contains
The active substance(s) is Loperamide Hydrochloride
What Loperamide Hydrochloride Capsules 2 mg looks like
and contents of the pack
Hard gelatin capsules. A white powder encapsulated within a
Size “4” Hard Gelatin Capsules with a mauve opaque body and
a dark green opaque cap, printed “Loperamide 2” [Circular
manner] on the cap in black. Contents of pack: 10 capsules
packed in a blister and 3 such blisters packed in a carton
Marketing Authorisation Holder and Manufacturer
Co-pharma Limited
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, UK, WD 18 9SS
This medicinal product is authorised in the Member States
of the EEA under the following names: Not applicable
This leaflet was last approved in: September 2011.

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[Loperamide Hydrochloride]
Read all of this leaflet carefully before you start taking
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, health
care provider or pharmacist.
• This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist
In this leaflet:
1. What Loperamide Hydrochloride Capsules 2 mg is and what
it is used for
2. Before you take Loperamide Hydrochloride Capsules 2 mg
3. How to take Loperamide Hydrochloride Capsules 2 mg
4. Possible side effects
5. How to store Loperamide Hydrochloride Capsules 2 mg
6. Further information
1. WHAT LOPERAMIDE HYDROCHLORIDE CAPSULES
2 mg IS AND WHAT IT IS USED FOR
Loperamide Hydrochloride is one of a group of medicines called
"anti-diarrhoeals" which are used to treat diarrhoea.
Loperamide Hydrochloride is used to treat sudden, short-lived
(acute) attacks of diarrhoea in adults and children 4 years and
over and long-lasting (chronic) diarrhoea in adults. It works by
making the stools more solid and less frequent.
REMEMBER - This medicine has been prescribed for you
only. Do not give it to anyone else.
2. BEFORE YOU TAKE LOPERAMIDE HYDROCHLORIDE
CAPSULES 2 mg
Always inform your doctor if you are pregnant, think you might
be pregnant or are trying to become pregnant.
Do not use Loperamide Hydrochloride Capsules:
• If you are allergic to Loperamide or any other ingredient in
this product
• In children under the age of 4.
• If your doctor has told you that you have a condition where
slowing of the stomach or intestine should be avoided. For
example: constipation, bloated tummy (particularly in
children with severe dehydration or AIDS patients),
inflammation of the bowel (eg. any form ofcolitis)
Loperamide Hydrochloride should not be used on its own in
acute dysentery, the symptoms of which may include blood in
your stools and a high temperature.
If in doubt about any of the above, ask your doctor or pharmacist.

Take special care with Loperamide Hydrochloride Capsules
2 mg
Tell your doctor before taking any Loperamide Hydrochloride
• If you suffer from liver disease. You may need to be more
closely supervised during treatment and the dosage may
have to be altered.
• If you have AIDs and notice signs of stomach distension
(swelling) whilst taking Loperamide, stop taking them and
see your doctor immediately.
Loperamide Hydrochloride only treats the symptoms of
diarrhoea. When you have diarrhoea, your body loses large
amounts of fluid and salts. You should therefore replace
this lost fluid by taking more liquids than you normally
would. This is especially important for children.
Your doctor may have also given you a special powder
containing sugar and salts (known as oral rehydration therapy)
to help your body replace the fluid and salts lost during
diarrhoea.
If you have been told by your doctor that you have an intolerance
to some sugars, you should check with your doctor before taking
this medicine.
Taking other medicines
Always tell your doctor or pharmacist if you are unsure about
taking any other medicines as you should not take any other
anti-diarrhoeal preparations whilst taking Loperamide
Hydrochloride (except for oral rehydration therapy - see under
'Take special care' above).
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Especially:
• Quinidine used in heart conditions
• Ritonavir used in the treatment of HIV and AIDs
• Desmopressin used to treat bed-wetting
Taking Loperamide Hydrochloride Capsules 2 mg with food
and drink
Swallow the correct number of capsules whole with some liquid
Pregnancy
If you are pregnant, think you might be pregnant or are planning
to become pregnant, you should talk to your doctor who will
decide if you can take Loperamide Hydrochloride.
Breast-feeding
Do not take Loperamide Hydrochloride if you are breast feeding
as small amounts of the medicine may get into your milk. You
should talk to your doctor about suitable treatment.
Driving and using machines Use caution when driving or
operating machinery if you feel dizzy, tired or sleepy after taking
Loperamide Hydrochloride.
Important information about some of the ingredients in this
medicine
This medicine contains lactose (a type of sugar). If you have
been told by your doctor that you have an intolerance to some
sugars, you should talk to your doctor before taking this
medicine.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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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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