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WILKO DIARRHOEA RELIEF CAPSULES

Active substance(s): LOPERAMIDE HYDROCHLORIDE

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TEVA UK Ref:

231-30-80074-A LEA LOPERAMIDE (DIAQUITTE) CAPS 2mg PEACH

Version:

3

24 February 2016

PAGE 1: FRONT FACE (INSIDE OF REEL)

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
Diaquitte 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.
• 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 24 hours
Pharma code 617

What is in this leaflet:

1. What Diaquitte Capsules are and what
they are used for
2. What you need to know before you take
Diaquitte Capsules
3. How to take Diaquitte Capsules
4. Possible side effects
5. How to store Diaquitte Capsules
6. Contents of the pack and other
information

1

What Diaquitte Capsules are and
what they are used for

Diaquitte Capsules contain Loperamide,
which belongs to a group of drugs called
antidiarrhoeals.
Diaquitte Capsules are used to treat the
symptoms of sudden short-lived (acute)
cases of diarrhoea in adults and children
aged 12 years and over.

2

• 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)
Diaquitte Capsules contain lactose
Patients who are intolerant to lactose should
note that Diaquitte Capsules contain a small
amount of lactose. If your doctor has told
you that you have an intolerance to some
sugars, contact your doctor or pharmacist
for advice before taking this medicine.
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
Diaquitte Capsules may make you feel tired,
dizzy or drowsy. Do not drive or use
machinery until you are sure you are not
affected.

3

How to take Diaquitte Capsules

If your doctor has prescribed this medicine,
always take Diaquitte 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. This is particularly important
in frail or elderly patients. 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.

What you need to know before
you take Diaquitte Capsules

The capsules should be swallowed
preferably with a drink of water. If
symptoms persist after 24 hours, consult
Do not take Diaquitte Capsules if you:
• are allergic (hypersensitive) to loperamide your doctor.
or any of the other ingredients of this
Acute Diarrhoea
medicine (listed in section 6)
• Adults (including the elderly)
• have acute dysentery, which is
Two capsules should be taken to start with,
characterised by blood in your stools and followed by a further capsule after each
a high temperature
episode of diarrhoea. Do not take more than
• have acute ulcerative colitis (inflammation 6 capsules a day.
of the large intestine, accompanied by
• Children 12-17 years
ulcers)
One capsule should be taken to start with,
• have a bacterial infection of the intestines, followed by a further capsule after each
such as salmonella poisoning
episode of diarrhoea. Do not take more than
• have an infection of the large intestine
3 capsules per 20 kg of the child’s
following the use of antibiotics
bodyweight, up to a maximum of 6 capsules
• have constipation, or any form of
a day.
inflammation or blockage of the bowel
If you still have diarrhoea after 24 hours
• have abdominal distension, which
treatment, you should consult your doctor.
produces a bloated stomach
• these capsules should not be taken by
If you take more Diaquitte Capsules than
children under 12 years old.
you should
If you (or someone else) swallow a lot of the
Warnings and precautions
capsules all together, or if you think a child
Talk to your doctor or pharmacist before
has swallowed any of the capsules, contact
taking this medicine if you:
your nearest hospital casualty department
• have liver problems
or your doctor immediately. An overdose is
• have AIDS.
likely to cause constipation, problems
Other medicines and Diaquitte Capsules
passing water, tight muscles, drowsiness,
Tell your doctor or pharmacist if you are
slow breathing and abnormal co-ordination.
taking, have recently taken or might take
Please take this leaflet, any remaining
any other medicine:
capsules and the container with you to the
• quinidine (used to treat an uneven heart
hospital or doctor so that they know which
beat)
capsules were consumed.

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Diaquitte 2 mg Capsules

TEVA UK Ref:

Version:

231-30-80074-A LEA LOPERAMIDE (DIAQUITTE) CAPS 2mg PEACH

3

24 February 2016

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

4

Possible side effects

Like all medicines, Diaquitte Capsules can
cause side effects, although not everybody
gets them.
If the following happens, stop taking the
capsules and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty in
breathing; skin rash or hives)
• blisters/bleeding/peeling of the lips, eyes,
nose, mouth and genitals.
These are very serious but rare side effects.
You may need urgent medical attention or
hospitalisation.
Other side effects
Common (may affect up to 1 in 10 people):
• constipation, feeling sick (nausea), wind
(flatulence)
• headache
• 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

6

Contents of the pack and other
information

What Diaquitte Capsules contain:
• The active ingredient is loperamide
hydrochloride.
The other ingredients are maize starch,
lactose monohydrate, povidone (E1201),
sodium starch glycolate (Type A) and
magnesium stearate (E572). The capsule
shell contains gelatin, titanium dioxide
(E171), yellow iron oxide (E172) and patent
blue V (E131). The printing ink contains
shellac, simeticone, titanium dioxide (E171)
and propylene glycol (E1520).
What Diaquitte Capsules look like and
contents of the pack:
• The Diaquitte Capsules are green and dark
grey capsules containing a fine white
powder. They are printed ‘LOP2’.
• The product is available in a pack size of
6 capsules.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder and
company responsible for manufacture: TEVA
UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: February 2016
PL 00289/0247

Rare (may affect up to 1 in 1,000 people):
• stomach bloating (abdominal distension)
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)
• 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 provide more
information on the safety of this medicine.

5

How to store Diaquitte 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 Diaquitte 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.

80074-A
160 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-00289-0247-loperamide-2mg-capsules-EMP-diaquitte

APPROVALS
Signed by
Annette Huggett

REG0183586

Meaning of Signature
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Server Date
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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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