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LOPERAMIDE 2MG TABLETS

Active substance(s): LOPERAMIDE HYDROCHLORIDE / LOPERAMIDE HYDROCHLORIDE / LOPERAMIDE HYDROCHLORIDE

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PHARMACODE AREA

PHARMACODE AREA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Coordination abnormality
!
Constriction of the pupils of
!
the eyes
PHARMACODE AREA

Loperamide hydrochloride

PHARMACODE AREA

Loperamide 2mg Tablets

your doctor. He or she may want
to examine you to check on why
you have diarrhoea.

Partial or complete blockage
!

of the small/large intestine
Long-lasting (chronic)
Rapid widening of the large
diarrhoea
!
intestine
Adults:
Your
doctor
will
tell
you
patients who have taken too
Read all of this leaflet carefully
Abdominal swelling
how
many
Loperamide
Tablets
to
!
much loperamide, the active
before you start taking this
Swelling/burning sensation of
take.
This
will
depend
on
how
!
ingredient in Loperamide Tablets.
medicine because it contains
the tongue/mouth
serious
your
condition
is.
You
will
important information for you.
Blisters and skin lesions
probably
start
with
a
dose
of
!
Replacing fluid and salts
!
Keep this leaflet. You may
(including Stevens-Johnson
between
2
(two)
and
4
(four)
Loperamide Tablets only treat the
need to read it again.
syndrome, Toxic epidermal
tablets
spread
out
over
a
day.
symptoms of diarrhoea. When
!
If you have any further
necrolysis and Erythema
Your
doctor
will
find
the
dose
that
you have diarrhoea, your body
questions, ask your doctor or
multiforme)
suits
you
best.
He
or
she
may
loses large amounts of fluid and
pharmacist.
Swelling of the deeper layers
then
suggest
you
take
the
tablets
!
salts. You should therefore
!
You must contact a doctor if
skin (Angioedema)
twice
a
day.
Never
take
more
replace this lost fluid by drinking
your symptoms worsen or do
Hives (urticaria)
than
8
tablets
in
any
24
hour
!
not improve after 2 (two) days. more than normal. This is
Itchy skin (pruritus)
period.
!
especially important for children.
!
This medicine has been
Lack of ability to urinate
!
Your doctor may also give you a
prescribed for you only. Do
(urinary retention)
Children:
Loperamide
Tablets
not pass it on to others. It may special powder containing sugar
Fatigue
are
not
recommended
for
long!
and salts (known as oral
harm them, even if their signs
lasting
(chronic)
diarrhoea.
rehydration therapy) to help your
of illness are the same as
Reporting of side effects
body replace the fluid and salts
yours.
If you get any side effects, talk to
If
you
take
more
Loperamide
!
If you get any side effects, talk lost during diarrhoea.
your doctor or pharmacist. This
Tablets
than
you
should
to your doctor or pharmacist.
includes any possible side effects
If
you
have
taken
too
many
Other medicines and
This includes any possible
not listed in this leaflet. You can
Loperamide
Tablets,
immediately
Loperamide
Tablets
side effects not listed in this
also
report side effects directly
contact
a
doctor
or
hospital
for
Tell your doctor or pharmacist if
leaflet. See section 4.
via
the
Yellow Card Scheme at:
advice.
Symptoms
may
include:
you are taking or have recently
www.mhra.gov.uk/yellowcard.
increased
heart
rate,
irregular
taken or might take any other
What is in this leaflet:
By reporting side effects, you can
heartbeat, changes to your
medicines. This includes
1. What Loperamide Tablets are
help provide more information on
heartbeat
(these
symptoms
can
medicines that you buy without a
and what they are used for
the safety of this medicine.
have
potentially
serious,
lifeprescription or herbal medicines.
2. What you need to know
threatening
consequences),
In particular, tell your doctor or
before you take Loperamide
5. How to store Loperamide
muscle stiffness, uncoordinated
pharmacist if you are taking any
Tablets
Tablets
movements,
drowsiness,
difficulty
of the following:
3. How to take Loperamide
urinating,
or
weak
breathing.
!
ritonavir (used to treat HIV),
Tablets
Children react more strongly to
Keep this medicine out of the
!
quinidine (used to treat
4. Possible side effects
large
amounts
of
Loperamide
sight and reach of children.
abnormal heart rhythms or
5. How to store Loperamide
Tablets
than
adults.
If
a
child
malaria),
Tablets
takes too much or shows any of
This medicine does not require
!
oral desmopressin (used to
6. Contents of the pack and
the above symptoms, call a
any special storage conditions. If
treat excessive urination),
other information
doctor
immediately.
the tablets become discoloured
!
itraconazole or ketoconazole
or show any other signs of
1. What Loperamide Tablets
(used to treat fungal
deterioration, consult your
If
you
forget
to
take
are and what they are used
infections),
pharmacist who will tell you what
Loperamide
Tablets
for
!
gemfibrozil (used to control
to do.
You
should
only
take
this
cholesterol levels in your
medicine
as
required
following
blood).
The name of your medicine is
the dosage instructions above
Do not use Loperamide Tablets
Loperamide 2mg Tablets (called
carefully.
If
you
forget
to
take
a
after the expiry date which is
Loperamide Tablets with food,
Loperamide Tablets in this
dose,
take
a
dose
after
the
next
stated on the carton after EXP.
drink and alcohol.
leaflet). The active ingredient is
loose
stool
(bowel
movement).
The expiry date refers to the last
Loperamide Tablets can be taken
loperamide hydrochloride. It
Do
not
take
a
double
dose
to
day of that month.
with or without food.
belongs to a group of medicines
make
up
for
a
forgotten
dose.
Drinking extra fluids is
which helps reduce diarrhoea by
Do not throw away any medicines
recommended while you have
slowing down an overactive
If
you
stop
taking
Loperamide
via wastewater or household
diarrhoea. Check with your doctor
bowel. It also helps the body to
Tablets
waste. Ask your pharmacist how
absorb more water and salts from if you have questions.
Your
doctor
can
judge
best
when
to throw away medicines you no
Alcohol should be avoided as
the bowel.
and
how
you
must
stop
taking
longer use. These measures will
loperamide may cause
Loperamide
Tablets.
Always
help protect the environment.
drowsiness or dizziness and
Loperamide Tablets are used to
contact
your
doctor
before
you
alcohol may intensify these
treat sudden short-lived (acute)
6. Contents of the pack and
want to stop taking the medicine.
attacks of diarrhoea in adults and effects.
other information
children over 6 years of age and
If
you
have
any
further
questions
Pregnancy and breast-feeding
for the treatment of long-lasting
on the use of this product, ask
What Loperamide Tablets
If you are pregnant, think you
(chronic) diarrhoea in adults.
your
doctor
or
pharmacist.
contain
may be pregnant or are planning
The active substance is
to have a baby, ask your doctor
2. What you need to know
4.
Possible
side
effects
loperamide, each tablets contains
or pharmacist for advice before
before you take
2 mg loperamide as loperamide
taking this medicine.
Loperamide Tablets
Like all medicines, this medicine
hydrochloride.
can
cause
side
effects,
although
Do not take this medicine if you
Do not take Loperamide
not everybody gets them.
The other ingredients are lactose
are breast-feeding as small
Tablets
Stop
taking
Loperamide
monohydrate, maize starch, talc,
amounts may get into your milk.
!
If you are allergic to
Tablets
and
tell
your
doctor
magnesium stearate, povidone,
loperamide or any of the other Talk to your doctor about a
straight
away
if
you
notice
or
brilliant blue (E133), quinoline
suitable treatment.
ingredients of this medicine
suspect
any
of
the
following.
yellow (E104), colloidal
(listed in section 6).
You
may
need
urgent
medical
anhydrous silica and sodium
Driving and using machines
!
If you have severe diarrhoea
treatment.
starch glycolate.
This medicine may make you feel
after taking antibiotics.

dizzy, tired or sleepy. If affected
!
If you are having a flare up of
!
Sudden swelling of the face,
What Loperamide Tablets look
do not drive or operate
ulcerative colitis.
lips
or
throat.
like and contents of the pack
machinery.
!
If you have acute dysentery,
!
Hives
(also
known
as
nettle
Light green coloured, capsule
the symptoms of which may

Tell your doctor if you notice
Marketing Authorisation
Always take this medicine exactly
Warnings and precautions
any
of
the
following
side
Holder:
as your doctor or pharmacist has
Talk to your doctor or pharmacist
effects
while
using
Loperamide
Morningside Healthcare
before taking Loperamide Tablets told you. Check with your doctor
Tablets:
Ltd.
or pharmacist if you are not sure.
if:
115 Narborough Road
!
You suffer from liver problems.
Common
side
effects
(may
affect
Leicester, LE3 0PA, UK
Take this medicine by mouth.
!
You have AIDS and your
up
to
1
in
10
people):
Swallow the correct number of
stomach becomes swollen.
!
Headache
Manufacturer:
tablets with a drink of water. The
Stop taking the tablets
!
Dizziness
Morningside Pharmaceuticals
break line is to facilitate breaking
immediately and contact your
!
Constipation
Ltd.
for ease of swallowing.
doctor.
!
Nausea
(feeling
sick)
5 Pavilion Way,
!
You have an intolerance to
!
Flatulence
(passing
wind)
Loughborough,
LE11 5GW, UK
Short-lived (acute) diarrhoea
some sugars.
Adults and children over 6
!
If you have acute diarrhoea
Uncommon side effects (may
This leaflet was last revised in
years: Take 2 (two) tablets
and are not getting better
affect
up
to
1
in
100
people):
July 2017.
straight away. From then on take
within 2 days of taking your
!
Feeling
sleepy
1 (one) tablet after each episode
first dose of Loperamide
!
Abdominal pain/discomfort
Tablets, stop taking the tablets of diarrhoea. You can take this
!
Dry mouth
medicine for up to 5 days. Never
and go back to your doctor.
!
Vomiting
take more than 8 tablets in any
!
Indigestion
24 hour period
You may still be able to use
!
Rash
Loperamide Tablets, but you
Children between 2 and 5 years
should discuss this with your
Rare side effects (may affect up
old: Loperamide Tablets are not
doctor first.
to 1 in 1,000 people):
recommended for children
!
Hypersensitivity reaction
between 2 and 5 years old. Your
Do not take this product for
!
Serious allergic reaction which
doctor may recommend a
anything other than its intended
causes difficulty in breathing
different formulation, such as an
use (see section 1) and never
or dizziness
oral solution which is more
take more than the
!
Loss or decreased level of
suitable for children.
recommended amount (see
consciousness
section 3). Serious heart
!
Abnormal increase in muscle
If you are not getting better within
problems (symptoms of which
tension
2 days of taking your first dose of
include fast or irregular
Loperamide Tablets, go back to
heartbeat) have been reported in
PHARMACODE AREA

PHARMACODE AREA

rash or urticaria), severe
shaped, biconvex uncoated
Loperamide Tablets contain
include blood in your stools
irritation,
reddening
or
tablets, plain on one side and
lactose
and a high temperature.
blistering
of
your
skin.
These
score line on other side. The
Loperamide Tablets contain
!
If you are constipated or your
may
be
signs
of
a
severe
score line is only to facilitate
lactose. If your doctor has told
stomach appears swollen
allergic
reaction.
breaking for ease of swallowing
you that you are intolerant of
(particularly in children with
!
Blistering
of
your
skin,
mouth,
and not to divide into equal
some sugars, discuss it with
severe dehydration).
eyes
and
genitals.
doses.
them before taking this medicine.
!
If you (your child) are less
!
Stomach
pain
or
severe
than 6 years old (see section
swollen stomach.
Loperamide Tablets are available
3. How to take Loperamide
3 of this leaflet for more
!
Severe
constipation.
in
blister packs of 30 tablets.
Tablets
information).

PHARMACODE AREA

PHARMACODE AREA

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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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