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IBUPROFEN 100 MG/5 ML PAEDIATRIC ORAL SUSPENSION BP

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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PATIENT INFORMATION LEAFLET
IBUPROFEN
100 mg/5 ml Paediatric Oral Suspension
Read all of this leaflet carefully before you start giving this medicine because it contains important information for you.
This medicine is available without prescription. However, you still need to give Ibuprofen Paediatric Oral Suspension carefully to get the
best results from it. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you:
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must talk to a doctor if you do not feel better or if you feel worse after 1 day (infants 3-6 months weighing more than 5 kg) or 3
days (children aged over 6 months).
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 Paediatric Oral Suspension is and what it is used for
2.
What you need to know 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.
Contents of the pack and other information
1. What Ibuprofen Paediatric Oral Suspension is and what it is used for
Ibuprofen 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 used for the treatment of fever and of mild to moderate pain in children aged from 3 months
(weighing over 5 kg) to 12 years.
2. What you need to know before you give Ibuprofen Paediatric Oral Suspension
Do NOT give this medicine if your child:

is allergic (hypersensitive) to ibuprofen or any of the other ingredients in this medicine (see Section 6)

has had an asthma attack, runny nose, skin reactions (e.g. reddening, hives) after taking aspirin or other non-steroidal
anti-inflammatory painkillers

has (or has had two or more episodes of) a stomach ulcer, perforation or bleeding

has severe kidney, heart or liver problems

is suffering from dehydration as there is a risk of renal impairment

is in the last 3 months of pregnancy

is under 3 months of age

has an inherited intolerance to some sugars
If any of these apply, ask for advice from a doctor or pharmacist before using this medicine.
Warnings and precautions
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 Paediatric Oral Suspension if your child:

has 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”).

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

has liver, kidney or bowel problems

has lupus (SLE) or a mixed connective tissue disease

has a chronic inflammatory bowel disease such as ulcerative colitis, Crohn's disease

has asthma or allergic diseases of the lungs

has chicken-pox
Other medicines and Ibuprofen Paediatric Oral Suspension
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including medicines obtained
without a prescription. Ibuprofen Paediatric 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

Mifepristone (drugs to bring about an abortion)

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 prednisone)

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

Ciclosporin or Tacrolimus (used to suppress the body’s immune system)

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

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 Paediatric Oral Suspension. You should therefore always
seek the advice of your doctor or pharmacist before you use Ibuprofen Paediatric Oral Suspension with other medicines.
The following additional information is relevant to the active ingredient, ibuprofen.
Taking Ibuprofen Paediatric Oral Suspension with food and drink
If possible you should not drink alcohol during treatment with Ibuprofen Paediatric Oral Suspension, as side effects, particularly those that
affect the gastro-intestinal tract or the central nervous system may be increased.
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.
Only a small amount of ibuprofen and its breakdown 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. Ibuprofen Paediatric Oral
Suspension belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible on stopping the medicine.
Driving and using machines
Ibuprofen may cause drowsiness and dizziness. Make sure your reactions are normal before driving, operating machinery or doing other
jobs which could be dangerous if you are not fully alert.
Ibuprofen Paediatric Oral Suspension contains Maltitol (E965), Sodium methyl hydroxybenzoate (E219) and Sodium propyl
hydroxybenzoate (E217)

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.

Sodium methyl hydroxybenzoate (E219) and Sodium propyl hydroxybenzoate (E217) may cause allergic reactions
(possibly delayed).
3. How to give Ibuprofen Paediatric Oral Suspension
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or
pharmacist if you are not sure.
Shake the bottle well before measuring the dose. A double-ended spoon with measures of 2.5 ml and 5 ml is provided to ensure accuracy.
Doses should be given approximately every 6-8 hours.
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.

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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.
3 – 6 months
(weighing more than 5 kg)

One 2.5 ml dose (50 mg) taken 3 times in 24 hours

6 – 12 months
(weighing 8 – 10 kg)

One 2.5 ml dose (50 mg) taken 3 times in 24 hours

1 – 3 years
(weighing 10 – 15 kg)

One 5.0 ml dose (100 mg) taken 3 times in 24 hours

4 – 6 years
(weighing 15 – 20 kg)

One 7.5 ml dose (150 mg) taken 3 times in 24 hours

7 - 9 years
(weighing 20 - 30 kg)

One 10 ml dose (200 mg) taken 3 times in 24 hours

10 – 12 years
(weighing 30 - 40 kg)

One 15 ml dose (300 mg) taken 3 times in 24 hours

For oral administration and short term use only.
WARNING: DO NOT EXCEED THE STATED DOSE
If you forget to give Ibuprofen Paediatric Oral Suspension
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 Ibuprofen Paediatric Oral Suspension 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, this medicine 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:

Passing 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.

Aseptic meningitis (stiff neck, headache, nausea, vomiting, fever and disorientation)

Swelling of the face

Ringing in the ears (tinnitus)

Kidney problems
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, dizziness, sleeplessness, agitation, irritability or tiredness

Visual disturbances

Sensitivity to light (photosensitivity)

Ulcers (sometimes with bleeding)
Rare:

Flatulence, diarrhoea or constipation
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

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 Paediatric Oral Suspension
Keep this medicine out of 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 to 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 Paediatric Oral Suspension contains
The active ingredient is Ibuprofen. Each 5 ml of oral suspension contains 100 mg of Ibuprofen.
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
(contains propylene glycol).
What Ibuprofen Paediatric Oral Suspension looks like and contents of the pack
Ibuprofen Paediatric Oral Suspension is a 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. A double
ended spoon with measures of 2.5 ml and 5 ml is provided.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
This medical product is authorised in the Member states of the EEA under the following name:
FI: Burana 20 mg/ml Oraalisuspensio
LT: IbuViva 100 mg/5 ml geriamoji suspensija
PL: Milifen
SE: Ibuprofen Apofri
IE: Fenopine 100 mg/5 ml Oral Suspension
PL Number: 04917/0080
This leaflet was last revised in April 2017

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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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