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IBUPROFEN 200MG/5ML ORAL SUSPENSION

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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Ibuprofen 200 mg/5 ml Oral Suspension contains Maltitol (E965)

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.

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 because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for your only. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is 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

3.
How to give/take Ibuprofen 200 mg/5 ml Oral Suspension
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Shake the bottle well before measuring the dose. A measuring device is provided to ensure accuracy.
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. For infants aged 3 - 5 months medical advice should be
sought if symptoms worsen or not later than 24 hours if symptoms persist.
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

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 Ibuprofen 200 mg/5 ml Oral Suspension 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 dehydration as there is a risk of renal impairment

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.
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack
or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen 200 mg/5 ml Oral
Suspension if you:

have heart problems including heart failure, angina (chest pain), or if you have 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 attack ‘TIA’)

have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if
you are a smoker

have kidney, liver or bowel problems

have lupus (SLE) or a mixed connective tissue disease

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

have asthma or allergic diseases of the lungs

have chicken-pox

have 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.
Drinking alcohol while taking Ibuprofen may increase your risk of certain side effects.
There is a risk of renal impairment in dehydrated children and adolescents.
Other medicines and Ibuprofen 200 mg/5 ml Oral Suspension
Tell your doctor or pharmacist if you or your child are taking, has recently taken or might take any other medicines,
including medicines obtained without a prescription. Ibuprofen 200 mg/5 ml Oral Suspension may affect or be
affected by some medicines. For example:
• Diuretics (drugs to help you pass water)
• Medicines that are anti-coagulants (i.e. thin blood/prevent blood clotting e.g. aspirin/acetylsalicylic
acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as
atenolol medicines, angiotensin-II receptor antagonists such as losartan)
• 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 200 mg/5 ml Oral Suspension.
You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen 200 mg/5 ml
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.
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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)
Over 12 years

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 to 4 times in 24 hours
2.5 ml dose (100 mg) taken up to 3 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
5 ml to 10 ml dose (200 mg - 400 mg) taken 3 times in 24 hours.
Do not give more than 30 mls (1200 mg) in any 24 hours.

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 Ibuprofen 200 mg/5 ml Oral Suspension
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 Ibuprofen 200 mg/5 ml Oral Suspension 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, pharmacist or nurse. 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 this medicine out of the sight and reach of children. Do not use this medicine 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. Do not throw away any
medicines via wastewater.
Ask your pharmacist how throw away medicines you no longer use. 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 and Manufacturer:
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
This medicinal product is authorised in the member states of the EEA under the following names:
FI: Burana 40 mg/ml Oraalisuspenio
LT: IbuViva Forte 200 mg/5 ml geriamoji suspensija
PL Number: 04917/0100
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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