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ORBIS IBUPROFEN FOR CHILDREN100MG/5ML ORAL SUSPENSION

Active substance(s): IBUPROFEN

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Orbis
Title:

Orbis Ibuprofen Leaflet
Oral Suspension/Leaflet

Date:

06/12/2013

Size:

297 x 210mm (W x H)

Colours (Printed)

Pantone Process Black C

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

Code: 3107/4

3107/4

Patient Information Leaflet

Orbis Ibuprofen For Children
100mg/5ml
Oral Suspension
Read all of this leaflet carefully because it contains important information on how to use
this medicine.
This medicine is available without a prescription. However, you still need to use Orbis
Ibuprofen For Children 100mg/5ml Oral Suspension (Now called Orbis Ibuprofen For
Children 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.
● For children over 6 months you must contact a doctor if your child’s symptoms worsen or
do not improve after 3 days.
● For children 3-6 months you must contact a doctor if your child’s symptoms worsen or
do not improve after 24 hours.
● 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 is Orbis Ibuprofen For Children and what it is used for
2. Before using Orbis Ibuprofen For Children
3. How to use Orbis Ibuprofen For Children
4. Possible side effects
5. Storing Orbis Ibuprofen For Children
6. Further information

1. What is Orbis Ibuprofen For
Children and what it is used for

2. Before using Orbis Ibuprofen For

Orbis Ibuprofen For Children belongs to a
group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). It is used
as a pain killer (an analgesic) to relieve pain.
This pain could be mild to moderate muscular
pain, teething pain, toothache and minor
injuries such as sprains and strains.

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.

Orbis Ibuprofen For Children can also be used
to bring down fever (high temperature) –
including post-immunisation fever.

Children

X

Do not give this medicine to babies or
children who ...
• weigh less than 5 kg
• have ever had a bad reaction to any of the
ingredients (see section 6)
• have or have ever had a stomach ulcer or
other gastric complaint
• have or have ever had an allergic reaction
or wheezing after taking Ibuprofen, Aspirin
or other anti-inflammatory pain killers
• are taking other NSAID painkillers or Aspirin
with a daily dose above 75mg
• suffer from severe kidney, liver or heart
problems.

!

Talk to your doctor or pharmacist before
giving Orbis Ibuprofen For Children if your
child …

• has asthma or has suffered from asthma
• has kidney, liver, heart or blood pressure
problems
• has bowel problems
• has Systemic Lupus Erythematosus (SLE)
a condition to the immune system affecting
connective tissue resulting in joint pains,
skin changes and disorder of other organs.

!

If adults take this medicine:
The following additional warnings are included
in case an adult takes this product.

X Do not take this product if you:

• are in the last 3 months of pregnancy.

!

Talk to your doctor or pharmacist before
taking this medicine:
• If you are in the first 6 months of
pregnancy
• If you are planning to become pregnant.
Ibuprofen belongs to a group of medicines
which may impair fertility in women. This
effect is reversible on stopping the
medicine. It is unlikely that Ibuprofen, used
occasionally, will affect your chances of
becoming pregnant, however, tell your
doctor before taking this medicine if you
have problems becoming pregnant.
• If you are breast feeding
• If you are a smoker.

Taking other medicines

Tell your doctor or pharmacist if your child is
taking or has recently taken any other
medicines including those obtained without a
prescription. This includes herbal medicines.
This is because Orbis Ibuprofen For Children
can affect the way some medicines work.
Also, some other medicines can affect the way
Orbis Ibuprofen For Children works.
In particular, do not give this medicine and tell
your doctor or pharmacist if your child is
taking any of the following:
•Aspirin
•Other NSAIDs
•Medicines used to thin the blood such as
Warfarin
•Water tablets (diuretics)
•Medicines for high blood pressure
•Corticosteroids
•Medicines for depression called Selective
serotonin reuptake inhibitors (SSRIs) such as
paroxetine and fluoxetine or Lithium
•Medicines to prevent blood clots from
forming such as clopidogrel
•Digoxin (for heart failure)
•methotrexate (for arthritis, psoriasis or some
cancers)
•tacrolimus (for transplant and eczema)
•ciclosporin (for transplant, arthritis or
psoriasis)
•mifepristone (for termination of pregnancy)
•antibiotics called quinolones (such as
ciprofloxacin)
•Zidovudine (used to treat HIV infection).
If you are not sure about the medicine your
child is taking, show the bottle or pack to your
pharmacist.

Important

• Medicines such as Orbis Ibuprofen For
Children may be associated with a small
increased risk of heart attack
("myocardial infarction") or stroke. Any risk
is more likely with high doses and prolonged
treatment. Do not exceed the recommended
dose or duration of treatment (3 days).
If your child has heart problems, previous
stroke or you think that your child might be
at risk of these conditions (for example if
your child has high blood pressure, diabetes
or high cholesterol or is a smoker) you
should discuss the treatment with a doctor
or pharmacist.

!

Colours (Non-Printed)

Driving and operating machinery
• This medicine is unlikely to affect your
ability to drive or to operate machinery.
Important information about some of the
ingredients of Orbis Ibuprofen For Children
• Maltitol liquid (E965): If you have been told
by your doctor that you or your child have
intolerance to some sugars, contact your
doctor before giving this medicinal product.
• Sodium methyl parahydroxybenzoate (E219)
and sodium propyl parahydroxybenzoate
(E217): May cause allergic reactions
(possibly delayed).
Continued, please turn over

Orbis
Title:

Orbis Ibuprofen Leaflet
Oral Suspension/Leaflet

Date:

06/12/2013

Size:

297 x 210mm (W x H)

Colours (Printed)

Pantone Process Black C

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

Code: 3107/4

3. How to use Orbis Ibuprofen
For Children
Orbis Ibuprofen For Children should be taken
by mouth. Shake the bottle well before
measuring the dose. Use the enclosed double
ended spoon to measure the dose. The big
spoon measures 5ml and the small spoon
measures 2.5ml.
• Do not give to babies under 3 months
• Do not give to babies who weigh less than
5 kg.

For Post Immunisation Fever

One small 2.5ml spoonful. A second dose of
one small 2.5ml spoonful can be given
6 hours later if necessary.
• Do not give more than 2 doses in 24 hours
• If the fever is not reduced you should
consult your doctor.

For Pain and Fever Relief

The usual daily dose in children is 20mg per
kg of bodyweight in divided doses which can
be given as follows:
Age

Dosage

Under 3 months

Not recommended

Infants from 3 months
up to 6 months
weighing more than
5kg':
Infants from 6 months
up to 12 months:

One small 2.5ml spoonful
three times a day.
Do not use for more than
24 hours
One small 2.5ml spoonful
three times a day

Children from 1 year
up to 4 years:
Children from 4 years
up to 7 years:

One large 5ml spoonful
three times a day
One large 5ml spoonful and
one small 2.5ml spoonful
three times a day
Two large 5ml spoonfuls
three times a day

Children from 7 years
up to 12 years:

• Do not give to babies under 3 months
• Do not give to babies who weigh less than
5 kg.
• Doses should usually be given every
6-8 hours as required. Leave at least 4
hours between doses.
• For short term use only:
♦ Do not give to babies aged 3-6 months
for more than 24 hours.
♦ Do not give to children aged 6 months or
over for more than 3 days
• If symptoms persist or worsen, consult your
doctor promptly.
Do not exceed the stated dose.

If you give more Orbis Ibuprofen For Children
than you should
If you, your child or someone you know
accidentally takes a lot more than the stated
dose (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.
If you forget to give Orbis Ibuprofen For
Children
If you forget to give a dose, give it as soon as
you remember, unless it is almost time for the
next dose. Don't give two doses at the same
time.
If you are worried or are not sure of when or
how to use this medicine, ask your doctor or
pharmacist for advice.

4. Possible side effects
Like all medicines, Orbis Ibuprofen For
Children can cause side effects although not
everybody gets them.
The following effects are very rare (less than
1 in 10,000 people) but if your child
experiences any of the following side effects
then STOP giving this medicine immediately
and contact your doctor or pharmacist.
•Peptic ulceration or perforation: Symptoms
can include severe abdominal pain, vomiting
blood (or liquid with what looks like coffee
grounds), blood in the faeces
(stools/motions) or passing black tarry
stools.
•Inflammation of the brain lining. Symptoms
can include stiff neck, headache, nausea,
vomiting, fever or feeling disorientated.
•Severe allergic reactions. Symptoms can
include dizziness or fainting, faster heart
rate, swelling of the face, tongue and throat.
•Worsening of asthma and wheezing or
difficulty breathing.

Other Possible Side Effects
Less than 1 in 100 people may experience the
following uncommon side effects:
•Allergic Reactions: Hives, skin rashes and
itching.
•Stomach: Abdominal pain, indigestion,
heartburn and nausea.
•Nervous system: Headache.
Less than 1 in 1000 people may experience
the following rare side effects:
•Diarrhoea, wind, constipation and vomiting.
Less than 1 in 10,000 people may experience
the following very rare side effects:
•Reduction in blood cells, which can make
the skin pale or yellow, cause fever, sore
throat, mild mouth ulcers, flu-like symptoms,
exhaustion or weakness, easy bruising, or
bleeding from the skin or nose.
•High blood pressure, heart failure or chest
pain.
•Liver problems. Symptoms could include
yellowing of the skin or the whites of the
eyes.
•Kidney problems. Symptoms could include
swelling of the ankles.
•Severe skin reactions. Symptoms could
include blistering.
Medicines such as Orbis Ibuprofen For Children
may be associated with a small increased risk
of heart attack ("myocardial infarction") or
stroke.
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.

Colours (Non-Printed)

5. Storing Orbis Ibuprofen For
Children
• Keep out of the reach and sight of children
• Do not store above 25°C. Store in the
original container.
• Do not use Orbis Ibuprofen For Children 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
Orbis Ibuprofen For Children is a white
suspension with an aroma of strawberries.
Each 5ml of suspension contains 100mg
Ibuprofen.
It also contains the following inactive
ingredients: 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 and purified water.
Each bottle contains 100ml of oral
suspension. A double ended 5ml and 2.5ml
polypropylene spoon is also included to help
measure the dose.
Product licence holder (PL 17862/0010) and
manufacturer of Orbis Ibuprofen For Children
is:
Orbis Consumer Products Ltd., Cunard Road,
Park Royal, London, NW10 6PN

Contact us at the above
address for information in
large print, audio or Braille
Leaflet Updated December 2013
3107/4

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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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