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IBUPROFEN 200MG/5ML ORAL SUSPENSION

Active substance(s): IBUPROFEN

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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.
What you need to know 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.
Contents of the pack and other 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 anti-inflammatory 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. WHAT YOU NEED TO KNOW 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.

Warnings and Precautions
There is a risk of renal (kidney) impairment in dehydrated children.

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. Do not
exceed the recommended dose or duration of treatment.
You should discuss yours or your child’s treatment with your doctor or pharmacist before
taking this medicine if you are elderly or your child has:
 if you have heart problems including heart failure, angina (chest pain), or if you 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 attach ‘TIA’)
 if you have high blood pressure, diabetes, high cholesterol, have a family history of heart
disease or stroke, or if you are a smoker
 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.
Other medicines and Ibuprofen 200 mg/5 ml Oral Suspension
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. Ibuprofen 200mg/5ml Oral
Suspension may affect or be affected by some medicines. For example:
• Diuretics (drugs to help you pass water)
• Medicines that are anticoagulants (i.e. thin blood/prevent clotting e.g.
aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as
losartan)
• 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.

Some other medicines may also affect or be affected by the treatment of Ibuprofen 200mg/5ml Oral
Suspension. You should therefore always seek the advice of your or your child’s doctor or pharmacist
before you give Ibuprofen 200mg/5ml Oral Suspension with other medicines.
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.
WARNING: DO NOT EXCEED THE STATED DOSE
Babies under 3 months
3 – 6 months (weighing more than 5
kg)
6 – 12 months (weighing 8 – 10 kg)
1 – 4 years (weighing 10 – 15 kg)
4 – 7 years (weighing 15-20 kg)
7 – 12 years (weighing 20 – 40 kg)

Do not give except on the advice of a doctor
1.25 ml dose (50 mg) taken up to 3 times in 24 hours
1.25 ml dose (50 mg) taken up to 3 times in 24 hours
2.5 ml dose (100mg) taken up to 3 to 4 times in 24 hours
3.75 ml dose (150 mg) taken up to 3 times in 24 hours
5 ml dose (200 mg) taken up to 3 times in 24 hours

Over 12 years

5 ml to 10 ml dose (100mg – 499mg) taken 3 times in 24
hours.
Do not give more than 30 mls (1200 mg) in any 24 hours).

For infants aged 3 - 5 months medical advice should be sought if symptoms worsen or not later than
24 hours if symptoms persist.
If in children aged from 6 months and in adolescents this medicinal product is required for more than
3 days, or if symptoms worsen a doctor should be consulted.
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.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
5. HOW TO STORE IBUPROFEN 200 MG/5 ML ORAL SUSPENSION
Keep out of the sight and reach 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. CONTENTS OF THE PACK AND OTHER 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 revised in November 2015

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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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