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Norimode Tablets
(Loperamide Hydrochloride USP 2mg Tablets)
Please read this entire leaflet carefully before you use Norimode.

Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should 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:


What this medicine is and what it is
used for

Norimode belongs to a group of medicines called
’antidiarrhoeals’ which are used to treat diarrhoea.
Norimode is used to treat sudden, short−lived (acute)
attacks of diarrhoea in adults and children over 9 years of
age. It is also used to treat sudden flare−ups of long−lasting
(chronic) diarrhoea in adults.
It reduces diarrhoea by slowing down an overactive bowel.
It also helps the body to absorb more water and salts from
the bowel.



What this medicine is and what it is used for
Before you take
How to take

obtained without a prescription and you are unsure about
taking Norimode, you should contact your doctor or
Norimode should not be taken with the following:
Other antidiarrhoea preparations, except for oral
rehydration therapy (see "Replacing fluids and salts" in
section 3)
Norimode may cause serious side effects if taken with
the following:
Quinidine, for abnormal and increased heart rhythm
Digoxin, for heart failure
Ritonavir or Tipranavir, for HIV infection and AIDS
Itraconazole and Ketoconazole, for fungal infections
Gemfibrozil, used to lower levels of cholesterol and
other lipids (fats) in the blood.

Before you take

Do not take Norimode if:
you are allergic to Loperamide or any of the other
ingredients (see ‘Important information about some of
the ingredients’, section 2 and 6)
you need to keep the bowel movements normal to
avoid complications such as blockage of the bowel and
abnormal or rapid widening of the colon
you have acute ulcerative colitis (a form of inflammatory
bowel disease) which can cause abdominal pain,
bloody diarrhoea, fever and weight loss
you have constipation, blockage of the bowel or a
bloated tummy (in particular, in children with severe
you have a bacterial infection of the small intestine and
colon (caused by bacteria such as salmonella, shigella
and campylobacter)
you have inflammation of the colon after taking
antibiotics (symptoms may include watery or bloody
you have dysentery, which may include blood in your
stools and a high temperature
Take special care if:
you have or think you may have lost body fluids and
salts through diarrhoea. Particularly important for
children and frail or elderly patients with severe
diarrhoea (see ‘Replacing fluids and salts’, section 3)
you have liver disease. You should consult your doctor
or pharmacist before taking Norimode as it may cause
side effects
you have inflammatory bowel disease (inflammation of
the intestines), which can cause abdominal pain and
bloody diarrhoea
you have a bloated tummy and you have AIDS. You
should stop taking the capsules immediately and
contact your doctor
If any of the above apply to you, please consult your
doctor or pharmacist.
Taking other medicines
Norimode may interact with other medicines.
If you are taking other medicines, including medicines

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Possible side effects
How to store
Further information

Norimode increases the blood levels of the following:
Oral desmopressin, for reducing urine production
Pregnancy and breast−feeding
If you are pregnant or planning to become pregnant, you
are advised not to take Norimode. It is not known if it is safe
to take, especially during the first 3 months of pregnancy.
If you are breast−feeding, you should not take Norimode,
as small amounts of this medicine get into your breast milk.
Driving and using machinery
This medicine may make you feel tired, dizzy or drowsy.
If affected, you are advised not to drive or operate
Important information about some of the ingredients of
Lactose: If you have been told by your doctor that you
have intolerance to some sugars, contact your doctor
before taking this medicine.


How to take

You should always take this medicine as prescribed by
your doctor. Read and follow the instructions on the
pharmacist’s label. If you are not sure about anything,
please ask your doctor or pharmacist.
Norimode is for oral use only
Swallow the tablets whole with some liquid
Normal dosage
Acute diarrhoea
2 tablets (4mg) initially, followed by 1 tablet (2mg) after
each loose stool for up to 5 days
The usual dosage is 3 to 4 tablets (6 − 8mg) a day
The maximum dose for adults is 8 tablets (16mg) in 24



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Children aged 9−17 years:
1 tablet (2mg) initially, followed by 1 tablet (2mg) after
each loose stool for up to 5 days
The usual dosage is 3 to 4 capsules (6 − 8mg) a day
The maximum dose for children is related to body
weight (3 tablets per 20kg). but should not exceed 8
capsules (16mg) a day
Children under 9 years:
This medicine should not be given to children under 9 years.
Loperamide (active ingredient) must not be given to
children under 2 years of age.
Chronic diarrhoea
Adults only:
The initial dose is usually 2 tablets (4mg) a day
The initial dose should be adjusted until 1 − 2 solid
stools a day are obtained. This is usually achieved with
a maintenance dose of 1 − 6 capsules (2mg − 12mg)
The maximum dose for adults with chronic diarrhoea is
8 tablets (16mg) a day
Elderly and patients with kidney problems:
Same dose as for adults.
Patients with liver problems
See ’Take special care’ (section 2)
Norimode should not be given to children for the treatment
of chronic diarrhoea
Do not take Norimode for longer than 5 days.
If you have acute diarrhoea and your symptoms do not
improve within 48 hours, you should stop taking Norimode
and contact your doctor.
Replacing fluids and salts
When you have diarrhoea your body loses large amounts
of fluid and salts. In addition to your medicine, you should
take more liquids which contain sugar and salts, than
Drink plenty of clear fluids containing salt and sugar
(special oral rehydration powders are available from
pharmacists), unsweetened fruits juices or clear soups
Avoid excessive plain water
Do not drink alcohol or milk
Do not eat fruit, green vegetables or fatty foods
Two or three days after symptoms have disappeared
you may return to your normal diet
If you take more Norimode than you should
Contact your doctor or go to your nearest casualty
department immediately. Take the carton and this leaflet
with you, so that people will know what you have taken.
Symptoms of an overdose include:
Constipation, difficulty passing urine, feeling bloated,
stupor, difficulty co−ordinating movements, pupils of the
eyes become smaller, increased muscle tension, difficulty
sleeping, breathing problems or abnormally slow breathing.
If you forget to take Norimode
Take it as soon as you remember. Never double up a dose
to make up for the dose you have missed.


Possible side effects

Like all medicines Norimode can cause side effects,
although not everybody gets them.
Stop taking your medicine and contact your doctor
immediately or nearest hospital if you experience the
following (rare side effects):
Bloated tummy and you have AIDS
Allergic reactions such as swollen face, lips
or eyelids and serious reactions such as passing out,
difficulty breathing and dizziness
Blistering of the skin, mouth, eyes and genitals
(Stevens Johnson Syndrome or toxic epidermal

Common side effects (affect less than 1 in 10 people)
Feeling sick (nausea)
Stomach wind (flatulence)
Uncommon side effects (affect less than 1 in 100 people)
Stomach pain or discomfort
Dry mouth
Being sick (vomiting)
Rare side effects (affect less than 1 in 1,000 people)
Loss of consciousness
Reduced ability to respond to stimulation (stupor) or
reduced consciousness
Abnormal increase in muscle tension
Difficulty co−ordinating movement
Pupils of the eyes become smaller
Blockage of the bowel
Enlargement of the large intestine, which may cause
constipation, bloating and tenderness of the stomach or
fever (megacolon or toxic megacolon)
Painful or burning feeling of the tongue
Bloated tummy
Itchy rash (urticaria) or itching (pruritus)
Difficulty in urinating (passing water)
If any of the side effects listed become serious or you
notice any side effects not listed, please contact your
doctor or pharmacist.


How to store

Store out of reach and sight of children.
Keep this medicine in a dry, cool place (below 25°C) away
from the light.
Do not take after the expiry date, which is stated on the
carton after EXP.


Further information

What Norimode Tablets contain:
Active ingredient:
Loperamide Hydrochloride USP 2mg
Other ingredients:
Ludipress, consisting of lactose monohydrate 94% and
polyvinypyrrollidone 6% and magnesium stearate.
(see ’Important information about some of the
ingredients’, section 2, page 2)
What Norimode Tablets look like and the contents of
the pack
Norimode tablets are round, white, biconvex tablets
marked "T3" on one side and marked with a line on the
other side.
The pack contains 30 tablets.
Marketing Authorisation Holder & Manufacturer
Tillomed Laboratories Ltd,
3 Howard Road,
Eaton Socon, St. Neots,
Cambridgeshire, PE19 8ET
Product Licence Number
PL 11311/0016

Date of last revision: April 2012

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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.