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LOPERAMIDE HYDROCHLORIDE CAPSULES 2MG

Active substance(s): LOPERAMIDE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this
medicine:

LOPERAMIDE HYDROCHLORIDE
CAPSULES 2 mg



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.



If your diarrhoea lasts for more than 2 days.

[Loperamide Hydrochloride]
Read all of this leaflet carefully before you start taking this
medicine as it contains important information for you.


Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor, or
pharmacist or nurse.



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.



If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet:
1. What Loperamide Hydrochloride Capsules 2 mg is and what it
is used for
2. What you need to know 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. Contents of the pack and other 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.

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.
Other medicines and Loperamide Hydrochloride Capsules 2mg
Always tell your doctor or pharmacist if you are unsure about
taking any other medicines as you should not take any other antidiarrhoeal preparations whilst taking Loperamide Hydrochloride
(except for oral rehydration therapy - see under Warnings and
precautions above).
Please tell your doctor or pharmacist if you are taking or have
recently taken or might take 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.

Loperamide Hydrochloride Capsules 2 mg with food and drink
Swallow the correct number of capsules whole with some liquid.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LOPERAMIDE HYDROCHLORIDE CAPSULES 2 mg

Pregnancy

Always inform your doctor if you are pregnant, think you might be
pregnant or are trying to become pregnant.

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.

Do not use Loperamide Hydrochloride Capsules:


If you are allergic to Loperamide or any other ingredient in this
product (listed in section 6)



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 of colitis).

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.

Front Side Printing

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
These capsules may cause dizziness, sleepiness or tiredness.
If affected you should not drive or operate machinery or take
part in activities where these may put you or others at risk.
Loperamide Hydrochloride Capsules 2mg contain lactose
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.

Size : 180 x 210mm

Back Side Printing

If you experience loss of consciousness or a reduced level of
consciousness, or uncordinated movements stop taking
Loperamide Hydrocholride 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.
Common side effects (affects less than 1 in 10 patients)
·
Headache
·
Constipation
·
Nausea
·
Flatulence (wind).
Uncommon side effects (affects less than 1 in 100 patients)
·
Dizziness
·
Drowsiness
·
Stomach pain and discomfort (including cramps)
·
Vomiting
·
Indigestion
·
Skin rash
·
Dry mouth.
Rare side effects (affects less than 1 in 1000 patients)
·
Eye problems such as constriction of the pupils
·
Tiredness
·
Itching and hives.
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
By reporting side effects you can help provide more information
on the safety of this medicine.
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. CONTENTS OF THE PACK AND OTHER 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, WD18 9SS
This medicinal product is authorised in the Member States
of the EEA under the following names: Not applicable
This leaflet was last revised in 12/2015.

Size : 180 x 210mm

1027626

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, this medicine 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.

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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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