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Active substance(s): IBUPROFEN

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100 mg/5 ml Paediatric Oral Suspension
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine is available without prescription.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
What Ibuprofen Paediatric Oral Suspension is and what it is used for
Before you give Ibuprofen Paediatric Oral Suspension
How to give Ibuprofen Paediatric Oral Suspension
Possible side effects
How to store Ibuprofen Paediatric Oral Suspension
Further information

Ibuprofen 100 mg/5 ml Paediatric Oral Suspension contains Ibuprofen as the active ingredient. This belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen Paediatric Oral Suspension is given to children as a painkiller for relief of mild to moderate muscular pain, headache,
earache, sore throat, dental pain and backache.
This medicine can also be used in minor injuries such as sprains and strains. It also reduces the temperature in fever (e.g. colds,
influenza and post-immunisation fever).
Do NOT give this medicine if your child:

has an allergy or hypersensitivity to ibuprofen or any of the other ingredients in this medicine (see Section 6)

has had an allergic reaction or wheezing after taking aspirin or other non-steroidal anti-inflammatory painkillers

has ever had a stomach ulcer or other gastric (stomach) complaint

is taking any other non-steroidal anti-inflammatory pain killers (NSAIDs)

has ever had kidney, heart or severe liver problems.
If any of these apply, ask for advice from a doctor or pharmacist before using this medicine.

Take special care if your child suffers from:

high blood pressure, kidney or liver problems

lupus or a mixed connective tissue disease

a chronic inflammatory intestinal disease such as ulcerative colitis, Crohn's disease or gastrointestinal bleeding


heart problems, previous stroke or if you think that you or your child might be at risk of these conditions (for
example if you or your child have high blood pressure, diabetes or high cholesterol) you should discuss the
treatment with your doctor or pharmacist.

Taking other medicines
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines
obtained without a prescription. In particular, tell your doctor if your child is taking any of the following:
• Low-dose aspirin (up to 75mg a day)
• Diuretics (drugs to help you pass water)
• Anticoagulants, e.g Warfarin and Anti-platelet drugs such as Clopidogrel (drugs that thin the blood)
• Antihypertensives (drugs used to treat high blood pressure)
• Lithium or Selective serotonin reuptake inhibitors (SSRI’s e.g. Fluoxetine) (used to treat mood disorders)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and some cancers)
• Zidovudine (used to treat HIV)
• Corticosteroids (anti-inflammatory drugs, such as Hydrocortisone)
• Cardiac glycosides (drugs used in the treatment of heart problems, such as Digoxin)
• Ciclosporin or Tacrolimus (used to supress the body’s immune system)
• Mifepristone (used to terminate a pregnancy)
• Quinolone antibiotics (used to treat a wide range of infections e.g. Ciprofloxacin)
• any other Ibuprofen preparations, including those you can buy without a prescription.

This product is intended for children aged between 3 months and 12 years.
If you are an adult taking this product:
The above warnings and information apply and in addition the following also applies:

Do NOT take this product if you are taking aspirin at doses above 75mg daily. If you are on low dose aspirin (up to
75mg daily) speak to your doctor or pharmacist before you take this product.

Ibuprofen 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.

Do not take if you are in the last three months of pregnancy.
Speak to your doctor or pharmacist before taking if;

you are in the first six months of pregnancy

you are elderly

you are a smoker

you are trying to get 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.
Pregnancy and breast-feeding
Ibuprofen should NOT be taken in the last 3 months of pregnancy, as it may be harmful to the unborn child. Pregnant
women intending to use this product should seek medical advice before use as it should only be taken on doctor’s 3LF
advice during the first 6 months of pregnancy.

Important information about some of the ingredients of this medicine

Maltitol, may have a mild laxative effect (calorific value 2.3 kcal/g). If you have been told that you or your
child have an intolerance to some sugars, contact your doctor before taking/giving this medicine.

Sodium methyl hydroxybenzoate (E219) and Sodium propyl hydroxybenzoate (E217), may cause allergic
reactions (possibly delayed).
Shake the bottle well before measuring the dose. A measuring spoon is provided to ensure accuracy.

This medicine should NOT be given if your child weighs less than 5kg. The usual daily dose in children is 20mg per kg of
bodyweight in divided doses.
For short term use only. Consult a doctor promptly if symptoms persist or worsen.
DOSAGE: Children (A spoon is provided to measure doses of 2.5 ml or 5 ml)
3-6 months (weighing over 5kg)
2.5 ml 3 times a day
Do not give for more than 24 hours.
6 months - 1 year
2.5 ml 3 times a day
1 year - 2 years
2.5 ml 3 to 4 times a day Do not give to children aged 6
months and older for more than
3 years - 7 years
5 ml 3 to 4 times a day
3 days.
8 years - 12 years
10 ml 3 to 4 times a day
Do not give to babies under 3 months

Post-immunisation fever: One small spoonful (2.5ml), followed by another small spoonful (2.5ml) six hours later if necessary.
Not more than 2 doses should be given in 24 hours. If fever is not reduced, consult a doctor.
If you forget to give this medicine
If you forget to give a dose, give it as soon as you remember, unless it is almost time for the next dose. Never give a double
dose to make up for the missed dose.
If you give more medicine than you should
If your child or someone else accidentally takes a lot more than the stated dose (an overdose), you should contact a doctor
immediately, or go to the nearest hospital casualty department, and take the bottle with you if you can.
Like all medicines, Ibuprofen can cause side-effects although not everybody gets them.
The most common side-effect is irritation of the stomach which can cause problems in some patients.
If your child suffers from the following, stop giving the medicine and seek immediate medical help:

Pass blood in their faeces (stools/motions)

Pass black tarry stools

Vomit blood or dark particles that look like ground coffee

Unexplained wheezing, shortness of breath, skin rash (which may be severe and include blistering or peeling of
the skin), itching or bruising, lightheadedness, racing of the heart or fluid retention e.g. swollen ankles, not passing
enough urine.

stiff neck, headache, nausea, vomiting, fever and disorientation
If your child experiences any of the following, stop giving the medicine and tell your doctor immediately:

If your child’s skin starts to turn red or they develop a varied skin reaction or their skin starts to blister or peel,
this is very rare.

Unexplained stomach pain, indigestion, heartburn, feeling sick and/or vomiting

Yellowing of the eyes and/or skin

Severe sore throat with high fever or unexplained bleeding, bruising and tiredness.
Other unusual effects may include the following:


Ibuprofen 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.

Flatulence, diarrhoea or constipation
Very Rare:

Occasionally hypersensitivity reactions may occur which can cause skin rashes

Liver and kidney problems may occur with Ibuprofen

Crohn's disease or ulcerative colitis or other stomach problems may be exacerbated
If any of these side effects gets worse, or if you notice a side effect not listed in this leaflet, tell your doctor or pharmacist.
Keep out of reach and sight of children. Do not use after the expiry date shown on the bottle. Do not store above 25˚C.
What Ibuprofen Paediatric Oral Suspension contains
The active ingredient is Ibuprofen 100 mg per 5 ml.
The other ingredients are: Glycerol (E422), Xanthan Gum, Maltitol (E965), Polysorbate 80, Saccharin Sodium (E954), Citric
Acid Monohydrate, Sodium Methyl Hydroxybenzoate (E219), Sodium Propyl Hydroxybenzoate (E217), Purified Water and
Strawberry Flavour.
What Ibuprofen Paediatric Oral Suspension looks like and contents of the pack
Ibuprofen Paediatric Oral Suspension is a colour-free, white oral suspension.
This medicine comes in amber glass or polyethylene bottles of: 50 ml, 100 ml, 150 ml or 200 ml, with a child-resistant closure.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL Number: 04917/0080
Leaflet prepared: July 2008

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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.