PATIENT INFORMATION LEAFLET IBUPROFEN

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:

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 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).

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)

•    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

•    asthma

•    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).

3.    HOW TO GIVE IBUPROFEN PAEDIATRIC ORAL SUSPENSION

Shake the bottle well before measuring the dose. A measuring spoon is provided to ensure accuracy.

Children

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.

I WARNING: DO NOT EXCEED THE STATED DOSE I

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.

4.    POSSIBLE SIDE EFFECTS

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:

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 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 bottle. Do not store above 25°C.

6.    FURTHER INFORMATION

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

PINEWOOD

HEALTHCARE

Clonmel, Ireland.

3LF