Skip to Content

LOPERAMIDE 2 MG CAPSULES

Active substance(s): LOPERAMIDE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
TEVA UK Ref:

231-30-20438-A LEA LOPERAMIDE 2MG CAPS OTC (P)
Dimensions:
Length:
Width:

Teva Diarrhoea Relief
2 mg Capsules
Loperamide hydrochloride
Package leaflet:
Information for the user

323 mm
130 mm

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

Pharma code 244

Warnings and precautions
Talk to your doctor or pharmacist
Read all of this leaflet carefully
before you start taking this medicine before taking this medicine if you:
• have liver problems
because it contains important
• have AIDS.
information for you.
This medicine is available without
Other medicines and Teva Diarrhoea
prescription. However, you still need
Relief Capsules
to take Teva Diarrhoea Relief
Tell your doctor or pharmacist if you
Capsules carefully to get the best
are taking, have recently taken or
results from them.
might take any other medicine:
Always take this medicine exactly as
• quinidine (used to treat an
described in this leaflet or as your
uneven heart beat)
doctor or pharmacist have told you.
• ritonavir (used to treat HIV)
• Keep this leaflet. You may need to • itraconazole or ketoconazole
(used to treat fungal infections)
read it again.
• gemfibrozil (used to reduce high
• Ask your pharmacist if you need
fat levels (cholesterol and
more information or advice.
triglycerides) in the blood)
• If you get any side effects, talk to
• desmopressin (reduces the amount
your doctor or pharmacist. This
of urine produced by the kidneys).
includes any possible side effects
not listed in this leaflet. See
Teva Diarrhoea Relief Capsules
section 4.
contain lactose
• You must talk to a doctor if you
If you have been told by your doctor
do not feel better or if you feel
that you have an intolerance to
worse after 48 hours.
some sugars, contact your doctor
.
What is in this leaflet:
before taking this medicinal product.
1. What Teva Diarrhoea Relief
Pregnancy, breast-feeding and
Capsules are and what they are
fertility
used for
If you are pregnant or
2. What you need to know before
breast-feeding, think you may be
you take Teva Diarrhoea Relief
pregnant or are planning to have a
Capsules
baby, ask your doctor or pharmacist
3. How to take Teva Diarrhoea Relief
for advice before taking this
Capsules
medicine.
4. Possible side effects
5. How to store Teva Diarrhoea Relief Driving and using machines
Capsules
Teva Diarrhoea Relief Capsules may
6. Contents of the pack and other
make you feel tired, dizzy or drowsy.
information
Do not drive or use machinery until
you are sure you are not affected.

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

3

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 3 capsules per
20 kg of the child’s bodyweight, up
to a maximum of 8 capsules a day.

Version:

8

12 August 2016

Colours Used:

CUTTER
PANTONE® GREEN C
BLACK

If you still have diarrhoea after
48 hours treatment, you should
consult your doctor.
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.






(megacolon), a burning or
tingling sensation of the lips or
tongue (glossodynia)
stomach bloating (abdominal
distension)
problems passing water
(urinary retention)
tiredness (fatigue)
drowsiness (somnolence).

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
reporting side effects you can help
Children under 12 years
provide more information on the
Teva Diarrhoea Relief Capsules are
not recommended for use in children safety of this medicine.
under 12 years.
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.

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

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

Possible side effects

What Teva Diarrhoea Relief Capsules
contain:
Like all medicines, Teva Diarrhoea
• The active ingredient is
Relief Capsules can cause side effects,
loperamide hydrochloride.
although not everybody gets them.
• The other ingredients are maize
starch, lactose monohydrate,
If the following happens, stop taking
povidone (E1201), sodium starch
the capsules and tell your doctor
glycolate (Type A) and
immediately or go to the casualty
magnesium stearate (E572). The
department at your nearest hospital:
capsule shell contains gelatin,
• an allergic reaction (swelling of
titanium dioxide (E171), yellow
the lips, face or neck leading to
iron oxide (E172) and patent blue
severe difficulty in breathing; skin
V (E131). The printing ink contains
rash or hives)
shellac, simeticone, titanium
• blisters/bleeding/peeling of the
dioxide (E171) and propylene
lips, eyes, nose, mouth and
glycol (E1520).
genitals
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
Capsules are green and dark grey
Other side effects
capsules containing a fine white
Common (may affect up to 1 in 10
powder. They are printed ‘LOP2’.
people):

The
product is available in pack
• constipation, feeling sick
sizes of 10 and 12 capsules.
(nausea), wind (flatulence)
Not all pack sizes may be
• headache
marketed.
• dizziness.
Uncommon (may affect up to 1 in
100 people):
• stomach pain or discomfort,
dry mouth
• upper stomach pain, being sick
(vomiting)
• indigestion (dyspepsia)
• rash.

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder
and company responsible for
manufacture is TEVA UK Limited,
Eastbourne BN22 9AG England.

Rare (may affect up to 1 in 1,000
people):
• stomach bloating (abdominal
distension).

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

This leaflet was last revised: August
2016

20438-A
130 x 323

Expand view ⇕

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.

Hide