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TESCO PARACETAMOL 120 MG/5 ML ORAL SUSPENSION

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Orbis
Title: Mandanol Infant Paracetamol
120mg/5ml Suspension Leaflet
Date: 06/12/2013

Colours (Printed)

Pantone Process Black C

Size: 297 x 210mm (W x H)
Code: 3262/1/MA

Patient Information Leaflet

3262/1/MA

Mandanol Infant Paracetamol
120mg/5ml
Oral Suspension
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, you still need to use Mandanol Infant
Paracetamol Oral Suspension (now called Paracetamol Oral Suspension throughout the leaflet)
carefully to get the best results from it.
● Keep this leaflet. You may need to read it again.
● Ask your pharmacist if you need more information or advice.
● You must contact a doctor if your or your child’s symptoms worsen or do not improve after 3 days.
● If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
1.
What this medicine is for
2.
Before using this medicine
3.
How to take this medicine
4.
Possible side effects
5.
Storing your medicine
6.
Further information

1. What this medicine is for
Paracetamol belongs to a group of medicines
called analgesics that help to ease pain.
It is used to treat mild to moderate pain
including teething pain. It is also used to bring
down fever (high temperature) including fever
caused by immunisation.

2. Before using this medicine
This medicine is suitable for most people but
a few people should not use it. If you are in
any doubt, talk to your doctor or pharmacist.
X Do not take or give your child this medicine...
• if you/your child has ever had a bad reaction
to any of the ingredients (see section 6).
• if you/your child is taking anything else with
paracetamol in it. Paracetamol is often
included in cold and flu remedies, and in
other medicines you can buy, (such
medicines have "contains paracetamol"
printed on the pack).
If any of these apply, get advice from a
pharmacist or doctor without using
Paracetamol Oral Suspension.

! Talk to your doctor or pharmacist…

• If you/your child has serious kidney or liver
problems.
• If you/your child are dependent on alcohol

! Taking other medicines:
!Tell your doctor or pharmacist if you are taking
any other medicines including herbal
medicines and those that you may have
bought yourself.

! Paracetamol can interfere with the action of
some other drugs and some drugs can have
an effect on paracetamol. The drugs which
can cause some problems when taken
together with paracetamol are:

- barbiturates (sleeping tablets)
- tricyclic antidepressants (e.g. amitriptyline)
- cholestyramine (used in the treatment of
high cholesterol levels)
- warfarin (used to thin the blood and prevent
clotting)
- domperidone and metoclopramide (used in
the treatment of nausea and vomiting).
! Pregnancy and Breast-feeding
• Ask your doctor or pharmacist for advice
before taking this medicine if you are
pregnant or think you might be pregnant.
• Ask your doctor or pharmacist for advice
before taking this medicine if you are
breast-feeding.
! Driving and using machines
Your medicine is unlikely to affect your ability
to drive or to operate machinery.

! Important information about some of the

ingredients of Paracetamol Oral Suspension
• Maltitol liquid: If you have been told by your
doctor that you or your child have intolerance
to some sugars, contact your doctor before
taking this medicine.
• Sodium methyl parahydroxybenzoate (E219)
and Sodium propyl parahydroxybenzoate
(E217): May cause allergic reactions
(possibly delayed).

3. How to take this medicine
Check the table below to see how much of the
medicine to use.
• For oral use only
• It is important to shake the bottle for at
least 10 seconds before use
• Never give more medicine than shown in the
table
• Do not give this medicine with any other
paracetamol-containing product
• Do not overfill the spoon.
• Always use the spoon supplied with the pack.
The big spoon measures 5ml and the small
spoon measures 2.5ml.
5ml

2.5ml

For post-vaccination fever for babies aged
between 2 – 3 months:
One 2.5 ml spoonful (small end). If necessary,
after 4-6 hours, give a second 2.5 ml dose
• Do not give to babies less than 2 months of
age
• Do not give more than 2 doses
• Leave at least 4 hours between doses
• If further doses are needed, talk to your
doctor or pharmacist.
For Pain and Fever Relief:
Child’s age

How much to give

3 - 6 months:

One 2.5ml spoonful (small end)
four times a day.

6 - 24 months: One 5ml spoonful (large end)
four times a day.
2 - 4 years:

One 5ml spoonful (large end) and
one 2.5ml spoonful (small end)
four times a day.

4 - 6 years:

Two 5ml spoonfuls (large end)
four times a day.

Colours (Non-Printed)

•Do not give more than 4 doses in any
24 hour period
•Leave at least 4 hours between doses
•Do not give this medicine to your child for
more than 3 days without speaking to your
doctor or pharmacist.

! If you give more Paracetamol Oral

Suspension than you should
If you accidentally take or give an overdose of
this medicine, either call your doctor straight
away, or go to your nearest hospital casualty
department. Always take any remaining
medicine, the container and the label with you,
so that the medicine can be identified.

Talk to a doctor at once if your child takes
too much of this medicine even if they seem
well. This is because too much Paracetamol
can cause delayed, serious liver damage.
There may be no symptoms during the first
24 hours although loss of colour, feeling sick,
vomiting and abdominal pain may occur.

! If you forget to give Paracetamol Oral

Suspension
Give the next dose when needed provided that
the last dose was given at least 4 hours ago.
Do not give a double dose.
If you are worried, or not sure of when or how
to use this medicine, ask your doctor or
pharmacist for advice.

4. Possible side effects
Paracetamol Oral Suspension can have side
effects, like all medicines, although these
don’t affect everyone and are usually mild.
If any of the following happen, stop giving
Paracetamol Oral Suspension and tell your
doctor immediately or go to the casualty
department at your nearest hospital.
• Swelling of the hands, feet, ankles, face, lips,
mouth, or throat which may cause difficulty
in swallowing or breathing.
These are all very serious side effects. If you
or your child have them, you may have a
serious allergic reaction to Paracetamol Oral
Suspension. You may need urgent medical
attention or hospitalisation.
All of these very serious side effects are very
rare.

Orbis Consumer Products Ltd
Cunard Road, Park Royal London, NW10 6PN

Orbis

Orbis

Title: Mandanol Infant Paracetamol
120mg/5ml Suspension Leaflet

Artwork checked by:................................................

Date:................................................

Date: 06/12/2013
Size: 297 x 210mm (W x H)
Code: 3262/1/MA

Artwork approved by:................................................

Date:................................................

Tell your doctor as soon as possible if you
notice any of these:
• skin rashes or other signs of allergy.
• becoming unusually tired, unexpected
bruising or bleeding and getting more
infections (such as colds) than usual.
These are very rare side effects in people
taking paracetamol.
If your child shows any of these signs, stop
giving paracetamol and talk to your doctor.
Long term use:
People who use medicines containing
paracetamol every day for a long time (several
months or more) could get certain side effects,
including liver and kidney damage.
People taking paracetamol in the usual way for
shorter periods have not had these problems.
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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. Storing your medicine
• Keep out of the reach and sight of children
• Do not store above 25ºC. Store the
container in the outer carton. Discard after
2 months of first opening.
• Do not use Paracetamol Oral Suspension
after the expiry date which is stated on the
bottle after Exp:. The expiry date refers to
the last day of that month.
• Medicines should not be disposed via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.

6. Further information
Each 5ml of suspension contains 120mg
Paracetamol.
It also contains glycerol, polysorbate 80,
xanthan gum (E415), maltitol liquid (E965),
sodium saccharin (E954), citric acid
monohydrate, sodium methyl
parahydroxybenzoate (E219), sodium propyl
parahydroxybenzoate (E217), strawberry
flavour (containing propylene glycol) and
purified water.
Each bottle contains 100ml of oral suspension.
The Marketing Authorisation for Paracetamol
Oral Suspension (PL 20941/0003) is held by
Edict Consulting Ltd., 49 Ivinghoe Road,
Bushey, Herts WD23 4SW.
It is manufactured by Orbis Consumer Products
Ltd, Cunard Road, Park Royal, London
NW10 6PN. It is distributed by M&A
Pharmachem Ltd Bolton BL5 2AL.

Contact us at the above
address for information in
large print, audio or braille
Leaflet Updated: December 2013

3262/1/MA

Colours (Printed)

Colours (Non-Printed)

Pantone Process Black C

Orbis Consumer Products Ltd
Cunard Road, Park Royal London, NW10 6PN

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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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