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IBUPROFEN 100MG/5ML PAEDIATRIC ORAL SUSPENSION

Active substance(s): IBUPROFEN

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PATIENT INFORMATION LEAFLET
IBUPROFEN 100mg/5ml Paediatric Oral Suspension
Ibuprofen 100 mg/5 ml
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to give Ibuprofen Oral Suspension to your child 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 child’s symptoms worsen or do not improve after a few days.
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:
1.
What Ibuprofen Paediatric Oral Suspension is and what it is used for
2.
Before you give Ibuprofen Paediatric Oral Suspension
3.
How to give Ibuprofen Paediatric Oral Suspension
4.
Possible side effects
5.
How to store Ibuprofen Paediatric Oral Suspension
6.
Further information
1.
WHAT IBUPROFEN PAEDIATRIC ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Ibuprofen Paediatric Oral Suspension 100 mg/5ml 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 pain reliever for relief of mild to moderate muscular pain, headache, sore throat, teething pain and toothache.
This medicine can also be used in minor injuries such as sprains and strains. It also reduces temperature in fever
(e.g. cold, influenza and post-immunisation fever).
2.
BEFORE YOU GIVE IBUPROFEN PAEDIATRIC ORAL SUSPENSION
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 and
end of Section 2: Important information about ingredients).

has had an allergic reaction or wheezing after taking aspirin or other non-steroidal anti-inflammatory painkillers.
(Symptoms of a rare allergic reaction are given under Section 4: Possible side effects).

has ever had a stomach ulcer or a history of bleeding into, or perforation of, the intestine especially after previous
NSAID treatment

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

has ever had severe kidney, heart or liver problems

has an inherited intolerance of some sugars

is less than 3 months old
If any of these apply, ask for advice from a doctor or pharmacist before using this medicine.
Take special care and consult your doctor or pharmacist if your child suffers from:

high blood pressure, kidney or liver problems

asthma or diabetes

lupus or mixed connective tissue disease

a chronic inflammatory intestinal disease such as ulcerative colitis or 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)
• 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.
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
angiotensin-II receptor antagonists such as losartan), and other medicines may affect or be affected by treatment with ibuprofen.
You should therefore always seek the advice of your doctor or pharmacist before you take ibuprofen with other medicines.
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 Paediatric Oral Suspension 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
advice during the first 6 months of pregnancy.
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Important information about some of the ingredients of this medicine

Maltitol (E965), may have a mild laxative effect (a 5ml dose contains 1.335g of maltitol). If your child has an
intolerance to some sugars, contact your doctor before giving this medicine.

Sodium methyl hydroxybenzoate (E219) and Sodium propyl hydroxybenzoate (E217), may cause
allergic reactions (possibly delayed).
3.
HOW TO GIVE IBUPROFEN PAEDIATRIC ORAL SUSPENSION
Each sachet contains 5ml, and should be massaged to mix the contents before opening. A double-ended measuring spoon
is provided to ensure accuracy. The small spoon measures a 2.5ml dose, and the larger spoon measures 5ml. To prepare doses
of 2.5ml, squeeze out the suspension from the sachet into the small measuring spoon, and throw away any which remains.
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, every 6 to 8 hours if required. Leave at least 4 hours between doses.
For short term use only. Consult a doctor promptly if symptoms persist or worsen.
WARNING: DO NOT EXCEED THE STATED DOSE
DOSAGE: Children (One sachet contains 5 ml)
3-6 months (weighing over 5kg) Half a 5ml sachet (2.5ml) 3 times a day
6–12 months
Half a 5ml sachet (2.5ml) 3 times a day
1–2 years
Half a 5ml sachet (2.5ml) 3 to 4 times a day
3–7 years
One sachet (5ml) 3 to 4 times a day
8–12 years
Two sachets (10 ml) 3 to 4 times a day
Do not give to babies under 3 months

Do not give for more than 24 hours.
Do not give to children aged 6
months and older for more than
3 days.

Post-immunisation fever: One half a sachet (2.5ml), followed by another half sachet (2.5ml) 6 hours later if necessary.
No 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 packet with you if you can.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Ibuprofen can cause side-effects although not everybody gets them.
You should STOP giving Ibuprofen Paediatric Oral Suspension and seek advice from your doctor if your child experiences a
very rare allergic reaction, including skin rashes, increased sensitivity to light, swelling of the face and tongue,
inflammation of the blood vessels, fever or shock. Skin and mucous membrane reactions may also occur.
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:

Passing blood in their faeces (stools/motions)

Passing black tarry stools

Vomiting 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:

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:
Uncommon:

Headache
Rare:

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 your child experiences any other unusual symptoms while taking Ibuprofen Paediatric Oral Suspension, tell your doctor or pharmacist.
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.
5.
HOW TO STORE IBUPROFEN PAEDIATRIC ORAL SUSPENSION
Keep out of reach and sight of children. Do not use after the expiry date shown on the pack. Do not store above 25°C.
6.
FURTHER INFORMATION
What Ibuprofen Paediatric Oral Suspension contains:
The active ingredient is ibuprofen 100mg per 5ml
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 sugar free, colour-free and strawberry flavoured oral suspension in 5ml sachets,
packed in boxes of 8, 10, 12, 16 or 20 sachets.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL Number: 04917/0051
This leaflet was prepared in November 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.

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