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CARE IBUPROFEN FOR CHILDREN ORAL SUSPENSION

Active substance(s): IBUPROFEN

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23135311

04.02.2016
Date

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Helvetica
Process Black

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2

This product is intended for children aged
between 6 months and 12 years.
If you are an adult taking this product you
should be aware of all the factors and the
following information:
• Do not take if you are in the last three
months of pregnancy.

Proof No.

338 x 148mm flat (29 x 148mm folded)

 

­­
Can adults take this medicine?

338 x 148mm flat (29 x 148mm folded)

Dimensions



• It also contains parahydroxybenzoates which
may cause allergic reactions (possibly
delayed).

Dimensions

23135311

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• This medicine contains maltitol and sorbitol.
If you have been told by your doctor that
your child has an intolerance to some sugars,
contact your doctor before giving this medicine.

23135311

IG Code

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Important information about some
­­­­­­ of the ingredients

100ml

100ml

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This medicine may rarely cause dizziness and
headaches. If you are affected do not drive or
operate machinery.

IG Code

Pack Size

­­

your child has….

• H
 ad heart problems including heart failure,
angina (chest pain), or if they have had a
heart attack, bypass surgery, peripheral
artery disease (poor circulation in the legs
or feet due to narrow or blocked arteries), or
any kind of stroke (including ‘mini-stroke’ or
transient ischaemic attack “TIA”).
• K
 idney or liver problems, as a lower dose
than normal may be needed.
• A
 history of asthma, allergies, high blood
pressure, diabetes, high cholesterol, have a
family history of heart disease or stroke.
• L upus, an allergic condition which causes
joint pain, skin rashes and fever.
• Bowel problems, colitis or Crohn’s disease.


Driving and using machines….

Pack Size

• Keep this leaflet. You may need to read it
again.
MHRA Header Box
• Ask your pharmacist if you need any more
information Care
or advice.
Ibuprofen for Children Oral
Product
• If any of theSuspension
side effects gets serious, or if
Title
you notice any side effects not listed in this
leaflet, please
tell your doctor or pharmacist.
Component
Leaflet



Talk to your doctor or pharmacist if

Ibuprofen appears in breast milk in small
amounts, but such small amounts are unlikely
to affect breast-fed infants.

Leaflet

Now read the rest of the leaflet before you
use this medicine. It includes other
information which might be especially
important for you.

Anti-inflammatory/pain-killer medicines like
Ibuprofen may be associated with a small
increased risk of heart attack (myocardial
infarction) or stroke, particularly when used at
high doses and/or 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
they might be at risk of these conditions (for
example have high blood pressure, diabetes or
high cholesterol) you should discuss their
treatment with your doctor or pharmacist.
There is a risk of renal impairment in
dehydrated children.

Ibuprofen may impair fertility if used when
trying to become pregnant. This effect is
reversed when you stop taking the medicine.

Component

Talk to your doctor….
• If your child is taking or is allergic to any
other painkiller.
• If your child has asthma.

Warning

• Aspirin or any other anti-inflammatory
medicines as the risk of side effects may be
increased if used with Ibuprofen.
• Some medicines that are anti-coagulants (i.e.
thin blood/prevent clotting e.g.
aspirin/acetylsalicylic acid, warfarin, ticlopidine).
• Some medicines that reduce high blood
pressure (ACE-inhibitors such as captopril,
beta-blockers such as atenolol, or angiotensinII receptor antagonists such as losartan).
• Diuretics which help remove fluids from the body.
• Antibiotics for infection.
• Steroids for inflammation.
• SSRIs for depression.
• Cardiac glycosides for heart problems.
• Methotrexate, for cancer treatment.
• Ciclosporin or tacrolimus to prevent
transplant rejection.
• Mifepristone for termination of pregnancy.
• Zidovudine for the treatment of HIV and AIDS.
• Lithium for manic depression.
Some other medicines may also affect or be
affected by the treatment of Ibuprofen for
Children. You should therefore always seek
the advice of your doctor or pharmacist before
you give/use Ibuprofen for Children with other
medicines.

Talk to your doctor or pharmacist before taking
if:
• You are in the first six months of pregnancy.
• You are trying to get pregnant.
• You are elderly.
• You are a smoker. 

Colours Used

Do not give….
• For longer than 3 days.
• To infants under 6 months old.
• To anyone who is allergic to the ingredients.
See section 6.
• To anyone who is allergic to aspirin.

2. Before you use this medicine

Talk to your doctor or pharmacist if
­­­ your child is taking….

Care Ibuprofen for Children Oral
Suspension

Important information about Ibuprofen for
Children
• This medicine reduces fever and relieves mild
to moderate pain in infants and children
between 6 months and 12 years old.
• Follow the dosage instructions carefully.
Children of different ages need different
amounts. See section 3.

• An allergy to any of the ingredients listed in
section 6.
• An allergy to aspirin.
• A
 history of breathing problems, runny nose
or rashes particularly after taking aspirin or
other anti-inflammatory medicines.
• A stomach ulcer or a history of stomach
ulcers.
• S
 tomach bleeding or perforation, related to
previous NSAIDs treatment.
• Severe heart, kidney or liver failure.
• Or the child is under 6 months old.
• D
 o not give this medicine with any other
NSAID painkillers or aspirin with a daily dose
above 75mg.



Product
Title

FRONT FACE TOP

(Ibuprofen 100mg/5ml)

This medicine contains Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAIDs).
It has pain relieving and anti-inflammatory
properties and also acts to bring down high
temperature.
The medicine reduces fever including high
temperature caused by vaccinations.
It also relieves mild to moderate pain such as
headache, sore throat, teething pains and
toothache, cold and flu symptoms, minor aches
and sprains.

Do not use the medicine if your
child has….

MHRA Header Box

Care Ibuprofen for
Children Oral Suspension

1. What the medicine is for

Product
Title
If

Care Ibuprofen for Children Oral

Suspension
you give
too much

If you accidentally give too much, see a doctor

Component
Leaflet
straight away. Take
the pack with you to show

which
medicine100ml
your child has swallowed.
Pack
Size
IG Code

23135311

Dimensions

338 x 148mm flat (29 x 148mm folded)

Reporting of side effects
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.

Marketing authorisation holder and
manufacturer
Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.

This leaflet was last revised in February 2016
23135311

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04.02.2016
Date

Fonts Used

Ibuprofen for Children is a white cloudy
suspension.
It is supplied in 100ml bottles.

2

should be consulted.

What the medicine looks like

338 x 148mm flat (29 x 148mm folded)

If this medicinal product is required for more

than 3Header
days, or
if symptoms worsen a doctor
MHRA
Box

If you notice these or any other side effect not
included above, stop use and tell your doctor or
pharmacist. They will tell you what to do.

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DO NOT EXCEED THE STATED DOSE.

Other possible side effects
• Feeling sick.
• Indigestion or heartburn.
• Stomach pain or other stomach problems.
• W
 orsening of the symptoms of asthma,
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inflammation of the colon and crohn’s
disease.
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• General swelling.
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• High blood pressure.
• Heart failure.

Medicines such as Ibuprofen for Children may
be associated with a small increased risk of
heart attack (myocardial infarction) or stroke.

Dimensions

For fever following vaccination
• One 2.5ml spoonful. Repeat after 6 hours if
necessary.
• Do not give more than 2 doses in 24 hours.
• If the high temperature is not reduced see
your doctor.

The other ingredients are:
sodium methyl parahydroxybenzoate (E219),
sodium propyl parahydroxybenzoate,
citric acid anhydrous, saccharin sodium,
sodium benzoate (E211), dispersible cellulose,
juicy orange flavour, polysorbate 80 (E433),
maltitol liquid (which contains maltitol and
sorbitol), xanthan gum (E415) and purified
water.

23135311

Do not give to children under 6 months unless
your doctor tells you to.

The active ingredient per 5ml is: ibuprofen 100mg.

IG Code

Children under 6 months

What is in the medicine

100ml

One 2.5ml spoonful three times a day.

6. Further information

Pack Size

Infants from 6 - 12 months

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One 2.5ml spoonful three or four times a day.

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Children from 1 - 2 years

If you think your child has any of the following
serious side effects or symptoms, STOP
TAKING this medicine immediately and see a
doctor as soon as possible.
• Fast heart beat.
• L ow blood pressure (causing light
headedness).
• Severe shock.
• Unexplained wheezing or shortness of breath.
• A
 llergic reactions including rashes or itching,
bruising, blistering or peeling and swelling of
the face, lips, tongue, throat or difficulty in
swallowing.
• Blood

in the faeces (stools/motions).
• Pass black tarry stools.
• V
 omit any blood or dark particles that look
like coffee grounds.

Leaflet

REVERSE FACE TOP

One 5ml spoonful three or four times a day.

Important side effects

Very Rarely
• S
 tomach ulcers, bleeding or swelling of the
stomach lining.
• Meningitis.
• Kidney damage (look for passing less or
more urine than normal, cloudy urine, blood
in the urine, pain in the back and/or swelling
particularly of the legs).
• Liver problems (look for yellowing of the
skin and eyes, pale stools/motions and dark
urine).
• Blood cell disorders whose symptoms
include fever, sore throat, mouth ulcers, flulike symptoms, severe exhaustion,
unexplained bleeding, bruising or a purple
skin rash.

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Children from 3 - 7 years

Like all medicines, Ibuprofen for Children can have
side effects, although these don’t affect everyone.

• Keep this medicine out of the sight and reach
of children.
• Do not store above 25°C.
• Do not use after the expiry date shown on
the carton. The expiry date refers to the last
day of that month.
• Medicine should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of any unused
medicine. These measures will help to
protect the environment.

Colours Used

Two 5ml spoonfuls three or four times a day.

4. Possible side effects

5. Storing this medicine

Care Ibuprofen for Children Oral
Suspension

Children from 8 - 12 years

Give the next dose as soon as you remember.
Do not give a double dose. You can then carry
on with the normal dose at the correct time.

Rarely
• Headache.
• Dizziness.
• Hearing disturbance.
• Diarrhoea.
• Wind.
• Constipation.
• Being sick.

Product
Title

• Shake the bottle before each use.
• Give this medicine to your child by mouth
with or after food.
• Use the spoon provided to measure 2.5ml or
5ml.

If you forget a dose

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3. How to use this medicine

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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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