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TEVA DIARRHOEA RELIEF 2 MG CAPSULES

Active substance(s): LOPERAMIDE HYDROCHLORIDE

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TEVA UK Ref:

231-30-20438-A LEA LOPERAMIDE 2MG CAPS OTC (P)
Dimensions:
Length:
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Teva Diarrhoea Relief
2 mg Capsules
Loperamide hydrochloride
Package leaflet:
Information for the user

Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.
This medicine is available without
prescription. However, you still need
to take Teva Diarrhoea Relief
Capsules carefully to get the best
results from them.
Always take this medicine exactly as
described in this leaflet or as your
doctor or pharmacist have told you.

Pharma code 244

• Keep this leaflet. You may need to
read it again.
• Ask your pharmacist if you need
more information or advice.
• If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See
section 4.
• You must talk to a doctor if you
do not feel better or if you feel
worse after 48 hours.
.
What is in this leaflet:
1. What Teva Diarrhoea Relief
Capsules are and what they are
used for
2. What you need to know before
you take Teva Diarrhoea Relief
Capsules
3. How to take Teva Diarrhoea Relief
Capsules
4. Possible side effects
5. How to store Teva Diarrhoea Relief
Capsules
6. Contents of the pack and other
information

1

What Teva Diarrhoea Relief
Capsules are and what they
are used for

Teva Diarrhoea Relief Capsules
contain Loperamide, which belongs
to a group of drugs called
antidiarrhoeals.
Teva Diarrhoea Relief Capsules are
used:
• to treat the symptoms of
short-lived (acute) cases of
diarrhoea in adults and children
aged 12 years and over
• to treat acute diarrhoea
associated with Irritable Bowel
Syndrome in adults following
diagnosis by a doctor.

2

What you need to know
before you take Teva
Diarrhoea Relief Capsules

Do not take Teva Diarrhoea Relief
Capsules if you:
• are allergic (hypersensitive) to
loperamide or any of the other
ingredients of this medicine
(listed in section 6)
• have acute dysentery, which is
characterised by blood in your
stools and a high temperature
• have acute ulcerative colitis
(inflammation of the large
intestine, accompanied by ulcers)
• have a bacterial infection of the
intestines, such as salmonella
poisoning
• have an infection of the large
intestine following the use of
antibiotics
• have constipation, or any form of
inflammation or blockage of the
bowel

REG0175157

323 mm
130 mm

Warnings and precautions
Talk to your doctor or pharmacist
before taking this medicine if you:
• have liver problems
• have AIDS.
Other medicines and Teva Diarrhoea
Relief Capsules
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicine:
• quinidine (used to treat an
uneven heart beat)
• ritonavir (used to treat HIV)
• itraconazole or ketoconazole
(used to treat fungal infections)
• gemfibrozil (used to reduce high
fat levels (cholesterol and
triglycerides) in the blood)
• desmopressin (reduces the amount
of urine produced by the kidneys).
Teva Diarrhoea Relief Capsules
contain lactose
If you have been told by your doctor
that you have an intolerance to
some sugars, contact your doctor
before taking this medicinal product.
Pregnancy, breast-feeding and
fertility
If you are pregnant or
breast-feeding, think you may be
pregnant or are planning to have a
baby, ask your doctor or pharmacist
for advice before taking this
medicine.
Driving and using machines
Teva Diarrhoea Relief Capsules may
make you feel tired, dizzy or drowsy.
Do not drive or use machinery until
you are sure you are not affected.

How to take Teva Diarrhoea
Relief Capsules

If your doctor has prescribed this
medicine, always take Teva
Diarrhoea Relief Capsules exactly as
your doctor has told you. Otherwise
follow the instructions below.
If you are not sure how to take this
medicine, talk to your doctor or
pharmacist.
If you see a doctor or go into
hospital, let him or the staff know
what medicines you are taking.
When you have diarrhoea, your
body loses large amounts of fluid
and salts which need to be replaced.
Drink plenty of fluids but preferably
not plain water. You can replace the
lost salts by taking oral rehydration
therapy, which is a powder
containing salts and sugar. Ask your
pharmacist for advice about these.
The capsules should be swallowed
preferably with a drink of water.
Acute Diarrhoea
• Adults (including the elderly)
Two capsules should be taken to
start with, followed by a further
capsule after each episode of
diarrhoea. Do not take more than 8
capsules a day.
• Children 12-17 years
One capsule should be taken to start
with, followed by a further capsule
after each episode of diarrhoea. Do
not take more than 8 capsules a day.
If you still have diarrhoea after
48 hours treatment, you should
consult your doctor.

Version 0.3

7

10 May 2016

Colours Used:

• have abdominal distension, which
produces a bloated stomach
• these capsules should not be
taken by children under 12 years
old.

3

Version:

Approved

CUTTER
PANTONE® GREEN C
BLACK

Irritable Bowel Syndrome
• Adults (including the elderly)
Two capsules should be taken to
start with. The usual dose is 2 to 4
capsules a day in divided doses. Do
not take more than 8 capsules a day.

• stomach bloating (abdominal
distension)
• problems passing water
(urinary retention)
• tiredness (fatigue)
• drowsiness (somnolence).

If the pattern of your symptoms
changes you should return to your
doctor. You should also return to
your doctor if your episodes of acute
symptoms continue for more than
two weeks or if you require
treatment for more than two weeks.

Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. 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
Children under 12 years
reporting side effects you can help
Teva Diarrhoea Relief Capsules are
provide more information on the
not recommended for use in children
safety of this medicine.
under 12 years.
If you take more Teva Diarrhoea
Relief Capsules than you should
If you (or someone else) swallow a
lot of the capsules all together, or if
you think a child has swallowed any
of the capsules, contact your nearest
hospital casualty department or your
doctor immediately. An overdose is
likely to cause constipation,
problems passing water, tight
muscles, drowsiness, slow
breathing, and abnormal
co-ordination. Please take this
leaflet, any remaining capsules and
the container with you to the
hospital or doctor so that they know
which capsules were consumed.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4

Possible side effects

5

How to store Teva Diarrhoea
Relief Capsules

Keep this medicine out of the sight
and reach of children. These capsules
should be stored in the package or
container supplied. Do not transfer
them to another container.
Do not use Teva Diarrhoea Relief
Capsules after the expiry date that is
stated on the outer packaging. The
expiry date refers to the last day of
that month.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help to protect
the environment.

6

Contents of the pack and
other information

What Teva Diarrhoea Relief Capsules
contain:
Like all medicines, Teva Diarrhoea
Relief Capsules can cause side effects, • The active ingredient is
loperamide hydrochloride.
although not everybody gets them.
• The other ingredients are maize
If the following happens, stop taking
starch, lactose monohydrate,
the capsules and tell your doctor
povidone (E1201), sodium starch
immediately or go to the casualty
glycolate (Type A) and
department at your nearest hospital:
magnesium stearate (E572). The
• an allergic reaction (swelling of
capsule shell contains gelatin,
the lips, face or neck leading to
titanium dioxide (E171), yellow
severe difficulty in breathing; skin
iron oxide (E172) and patent blue
rash or hives)
V (E131). The printing ink contains
• blisters/bleeding/peeling of the
shellac, simeticone, titanium
lips, eyes, nose, mouth and
dioxide (E171) and propylene
genitals
glycol (E1520).
These are very serious but rare side
What
Teva Diarrhoea Relief Capsules
effects. You may need urgent
look
like
and contents of the pack:
medical attention or hospitalisation.
• The Teva Diarrhoea Relief
Other side effects
Capsules are green and dark grey
Common (may affect up to 1 in 10
capsules containing a fine white
people):
powder. They are printed ‘LOP2’.
• constipation, feeling sick
• The product is available in pack
(nausea), wind (flatulence)
sizes of 10 and 12 capsules.
• headache
Not all pack sizes may be
• dizziness.
marketed.
Uncommon (may affect up to 1 in
100 people):
• stomach pain or discomfort,
dry mouth
• upper stomach pain, being sick
(vomiting)
• indigestion (dyspepsia)
• rash.
Rare (may affect up to 1 in 1,000
people):
• stomach bloating (abdominal
distension).

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder
and company responsible for
manufacture is TEVA UK Limited,
Eastbourne BN22 9AG England.
This leaflet was last revised: April
2016
PL 00289/1979

Not known (Frequency cannot be
estimated from the available data):
• loss of consciousness, stupor,
reduced consciousness
• reduced pupil size (miosis)
• bowel obstruction (ileus),
enlarged intestine
(megacolon), a burning or
tingling sensation of the lips or
tongue (glossodynia)

20438-A
130 x 323

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-pil-uk-pl-00289-1979-loperamide-2mg-capsules-brand

APPROVALS
Signed by
Annette Huggett

REG0175157

Meaning of Signature
Regulatory Affairs Approval

Version 0.3

Approved

Server Date
12-May-2016 02:49:57 PM

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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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