PACKAGE LEAFLET: INFORMATION FOR THE USER Ibuprofen 200 mg/5 ml Oral Suspension

Read all of this leaflet carefully before you start taking/giving this medicine.

-    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 symptoms persist or worsen after 1 day (infants aged 3-6 months) or 3 days (children aged 6 months to 12 years) or 10 days (for those aged over 12 years)

-    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 200 mg/5 ml Oral Suspension is and what it is used for

2.    Before you give/take Ibuprofen 200 mg/5 ml Oral Suspension

3.    How to give/take Ibuprofen 200 mg/5 ml Oral Suspension

4.    Possible side effects

5.    How to store Ibuprofen 200 mg/5 ml Oral Suspension

6.    Further information

1.    WHAT IBUPROFEN 200 MG/5 ML ORAL SUSPENSION IS AND WHAT IT IS USED FOR

Ibuprofen 200 mg/5 ml Oral Suspension contains Ibuprofen as the active ingredient. This belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). Ibuprofen 200 mg/5 ml Oral Suspension is given to children under 12 as a painkiller for relief of mild to moderate muscular pain, headache, teething pain and toothache. It also reduces the temperature in fever (e.g. colds, influenza and post-immunisation fever). For adults and children over 12 it can also be used for backache, migraines, neuralgia and relief from non-serious arthritic conditions.

2.    BEFORE YOU GIVE/TAKE IBUPROFEN 200 MG/5 ML ORAL SUSPENSION Do NOT give/take this medicine if you or your child:

•    has an allergy or hypersensitivity to ibuprofen or any of the other ingredients in this medicine (see Section 6 and Section 2: Important information about ingredients)

•    has had an allergic reaction or wheezing e.g. an asthma attack, runny nose, skin reaction or swelling after taking aspirin or other non-steroidal anti-inflammatory painkillers

•    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

•    is suffering from severe dehydration

•    has an inherited intolerance to some sugars

•    is less than 3 months old, except on the advice of a doctor

•    suffers from a blood disorder

•    are in the last three months of pregnancy

•    are trying to conceive.

Take special care and check with your doctor or pharmacist before    taking this medicine if you    are elderly or your child suffers from:

•    high    blood pressure, heart problems or a    stroke    because there    is a    small increased    risk of    heart problems    and stroke    with    ibuprofen

•    kidney, liver or bowel problems

•    lupus (SLE) or a mixed connective tissue disease

•    a chronic inflammatory bowel disease such as ulcerative colitis or Crohn's disease

•    asthma or allergic diseases of the lungs

•    has    chicken-pox

•    has    a disorder of porphyrin metabolism.

Speak to your doctor or pharmacist before taking if 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.

If any of these apply, ask for advice from a doctor or pharmacist before using this medicine.

Medicines such as Ibuprofen 200 mg/5 ml 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. If you have 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, high cholesterol or are a smoker) you should discuss the treatment with your doctor or pharmacist.

Drinking alcohol while taking Ibuprofen may increase your risk of certain side effects.

Taking other medicines

Please tell your doctor or pharmacist if you or your child are taking or has recently taken any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you or your child are taking any of the following:

•    Low-dose aspirin (up to 75 mg a day)

•    Diuretics (drugs to help you pass water)

•    Anticoagulants e.g. Warfarin and Heparin and Anti-platelet drugs such as Clopidogrel and Ticlopidine (drugs that thin the blood)

•    Antihypertensives (drugs used to treat high blood pressure e.g. Captopril or Propranolol)

•    Lithium, Phenytoin 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 prednisone)

•    Cardiac glycosides (drugs used in the treatment of heart problems, such as Digoxin)

•    Ciclosporin or Tacrolimus (used to supress the body's immune system)

•    Quinolone antibiotics (used to treat a wide range of infections e.g. Ciprofloxacin)

•    Probenecid and sulfinpyrazone (used to treat gout)

•    Moclobemide (used to treat depression)

•    Aminoglycosides (an antibiotic)

•    Cholestyramine (used to reduce cholesterol)

•    Baclofen (used to relax muscles)

•    Sulphonylureas (used to treat diabetes)

•    Ritonavir (used to treat HIV infection and AIDS)

•    Bisphosphonates (used to prevent loss of bone mass)

•    Oxpentifylline (used to treat poor circulation to arms and legs)

•    any other Ibuprofen preparations or NSAID painkillers, including those you can buy without a prescription.

If you are not sure about any of the medicines your child is taking, ask your pharmacist for advice.

Pregnancy and breast-feeding

Ibuprofen should NOT be taken during 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.

Only small amounts of ibuprofen and its break down products pass into breast milk. As no harmful effects to infants are known to date, it is not usually necessary to stop breast-feeding during short-term use of ibuprofen at the recommended doses.

Important information about some of the ingredients of this medicine

•    Maltitol (E965), 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.

3.    HOW TO GIVE/TAKE IBUPROFEN 200 MG/5 ML ORAL SUSPENSION

Shake the bottle well before measuring the dose. A measuring device is provided to ensure accuracy. Contact your doctor for advice if symptoms persist or worsen for more than 10 days in those aged over 12 years. For children aged 6 months to 12 years contact a doctor if symptoms persist or worsen after 3 days. For infants aged 3 months to 6 months contact a doctor if symptoms persist or worsen after 24 hours.

This medicine should NOT be given if your child weighs less than 5 kg. The usual daily dose in children is 20 - 30 mg per kg of bodyweight in divided doses. Leave at least 4 hours between doses. For oral and short term use only.

I WARNING: DO NOT EXCEED THE STATED DOSE I

Post-immunisation fever: One 1.25 ml, followed by another 1.25 ml 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/take this medicine

If you forget to give/take a dose, give/take 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/take more medicine than you should

If you or your child 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 any of the following occur, stop giving/taking the medicine and seek immediate medical help:

•    Passing blood in the stools (faeces/motions)

•    Passing black tarry stools

•    Vomiting blood or dark particles that look like coffee grounds

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

•    stiff neck, headache, nausea, vomiting, fever and disorientation

•    swelling of the face.

If any of the following occur, stop giving/taking the medicine and tell your doctor:

•    If you or 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, dizziness, sleeplessness, agitation, irritability or tiredness

•    Visual disturbances Rare:

•    Flatulence, diarrhoea or constipation

•    Ringing in the ears (tinnitus)

•    Kidney damage, increased    blood uric acid levels.

Very Rare:

•    Occasionally hypersensitivity reactions may occur which can cause skin rashes as well as asthma attacks, swelling of the tongue and breathlessness

•    Liver problems may occur with    Ibuprofen

•    Passing less urine than normal, increased proteins in the blood (detected by tests)

•    Crohn's disease or ulcerative colitis or other stomach problems may be exacerbated

•    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

•    Depression or psychotic reactions

•    Hair loss

•    High blood pressure.

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 200 MG/5 ML ORAL SUSPENSION

Keep out of the reach and sight of children. Do not use after the expiry date shown on the bottle, the expiry date refers to the last day of that month. Do not store above 25°C. Medicines should not be disposed of via wastewater, ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Ibuprofen 200 mg/5 ml Oral Suspension contains

The active ingredient is Ibuprofen 200 mg per 5 ml.

The other ingredients are: Glycerol (E422), Xanthan Gum, Maltitol (E965), Polysorbate 80, Saccharin Sodium (E954), Citric Acid Monohydrate, Sodium Benzoate (E211), Magnesium Aluminium Silicate, Purified Water and Strawberry Flavour (contains propylene glycol).

What Ibuprofen 200 mg/5 ml Oral Suspension looks like and contents of the pack

Ibuprofen 200 mg/5 ml Oral Suspension is a colour-free, white oral suspension. This medicine comes in amber glass bottles containing: 60 ml, 80 ml, 100 ml, 150 ml or 200 ml with a child-resistant closure. Not all pack sizes may be marketed. A double ended spoon with measures of 1.25 ml, 2.5 ml and 5 ml is provided. This medicine should be used within 3 months of first opening.

Marketing Authorisation Holder

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

Manufacturer

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PL Number: 04917/0099

This leaflet was last approved in September 2011

PINEWOOD

HEALTHCARE

Clonmel, Ireland.