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Active substance(s): IBUPROFEN

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Brufen® Syrup

Ibuprofen 100 mg/5ml

Brufen Syrup can also be used to treat other painful conditions
such as toothache, pain after operations, period pain and
headache, including migraine. It can also be used for the
short term treatment of fever in children over the age of 1 year.
The active ingredient in Brufen Syrup is ibuprofen. Each 5ml
spoonful of Brufen Syrup contains 100mg ibuprofen.
2. What should you know before taking Brufen Syrup?

Read all of this leaflet carefully before
you start taking this medicine
• Keep this leaflet as you may need to
read it again
• This leaflet provides a summary of the
information currently available about
Brufen Syrup
• For further information or advice ask
your doctor or pharmacist
• This medicine is for you only and
should never be given to anyone else,
even if they appear to have the same
symptoms as you
• Tell your doctor or pharmacist if you
experience any side effects


Leaflet Contents
1. What is Brufen Syrup & what is it used for?
2. What should you know before taking Brufen Syrup?
3. How should you take Brufen Syrup?
4. Possible side effects of Brufen Syrup.
5. How should you store Brufen Syrup?
6. Further information about Brufen Syrup.
1. What is Brufen Syrup & what is it used for?
Brufen Syrup belongs to a group of medicines called antiinflammatory pain killers. It can be used to relieve pain
and inflammation in conditions such as osteoarthritis,
rheumatoid arthritis (including juvenile rheumatoid
arthritis or Still’s disease), arthritis of the spine, ankylosing
spondylitis, swollen joints, frozen shoulder, bursitis,
tendinitis, tenosynovitis, lower back pain, sprains and

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If the answer to any of the following questions
is ‘YES’ please tell your doctor or pharmacist
BEFORE taking any Brufen Syrup:
• Are you pregnant or planning to become pregnant, or
are you breast-feeding? Brufen Syrup may make it more
difficult to become pregnant. You should inform your doctor
if you are planning to become pregnant or if you have
problems becoming pregnant.
• Are you sensitive (allergic) to any of the ingredients in the
syrup? These are listed in Section 6. Some people may
be sensitive to the E110, methyl hydroxybenzoate, propyl
hydroxybenzoate or sodium benzoate and if you develop
an unexpected rash, sore eyes, sore mouth or difficulty
breathing whilst taking the medicine stop taking it and
contact your doctor for advice.
• Do you have, or have you previously had, a stomach ulcer
or other gastric complaint? Do not take Brufen Syrup if
you currently have a peptic ulcer (ulcer in your stomach
or duodenum) or bleeding in your stomach, or have had
two or more episodes of peptic ulcers, stomach bleeding
or perforation in the past.
• Do you have a condition which increases your tendency
to bleeding?
• Do you suffer from asthma or have you ever had an allergic
reaction or suffered from wheezing after taking ibuprofen,
aspirin or other anti-inflammatory pain killers?
• Do you suffer from swelling and irritation inside the nose?
• Do you suffer from liver or kidney disease?
• Do you suffer from heart disease?
Medicines such as Brufen Syrup 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. You should discuss your
treatment with your doctor or pharmacist before taking
Brufen Syrup if you:

- have heart problems including heart failure, angina (chest
pain) or you have had a heart attack, bypass surgery or
peripheral artery disease (poor circulation in the legs or
feet due to narrow or blocked arteries).
- have any kind of stroke or think that you might be at risk
of these conditions (e.g. if you have a family history of
heart disease or stroke, high blood pressure, diabetes,
high cholesterol or are a smoker).
• Do you have systemic lupus erythematosus (SLE, sometimes
known as lupus) or a connective tissue disease (autoimmune
diseases affecting connective tissue)?
• Do you have chicken pox or shingles?
• Have you been told by your doctor that you have an
intolerance to some sugars? Due to the content of sorbitol
(70 mg per ml or 2.8 g per dose) and sucrose (660 mg per
ml or 26.4g per dose) it is not recommended for those with
hereditary fructose intolerance, glucose malabsorption
syndrome or sucraseisomaltase deficiency.
• Is your child dehydrated? As there is a risk of kidney damage
in dehydrated children and adolescents.
Can you take Brufen with other medicines?
Some medicines that are anti-coagulants (i.e. thin blood/prevent
clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine),
some medicines that reduce high blood pressure (ACE-inhibitors
such as captopril, beta-blockers such as atenolol, or angiotensinII receptor antagonists such as losartan) and other medicines
may affect or be affected by treatment with ibuprofen. You should
therefore always seek the advice of your doctor or pharmacist
before you use ibuprofen with other medicines. In particular you
should tell your doctor or pharmacist if you are taking any of
the following medicines in addition to those mentioned above:
• diuretics (water tablets)
• cardiac glycosides, such as digoxin, used to treat heart
• lithium
• zidovudine (an anti-viral drug)
• steroids (used in the treatment of inflammatory conditions)
• methotrexate (used to treat certain cancers and rheumatoid
• medicines known as immunosuppressants such as
ciclosporin and tacrolimus (used to dampen down your
immune response)
• medicines known as selective serotonin reuptake inhibitors
(SSRIs), used for the treatment of depression
• antibiotics called quinolones such as ciprofloxacin
• aminoglycosides (a type of antibiotic)


• mifepristone
• any other ibuprofen, such as those you can buy without a
• any other anti-inflammatory pain killer, including aspirin
• cholestyramine (a drug used to lower cholesterol)
• medicines known as sulphonylureas such as glibenclamide
(used to treat diabetes)
• voriconazole or fluconazole (type of anti-fungal drugs)
• gingko biloba herbal medicine (there is a chance you may
bleed more easily if you are taking this with ibuprofen).
Other information about Brufen Syrup:
The syrup contains small amounts of glycerin (glycerol). In high
doses, glycerin may sometimes cause headache, stomach upset
and diarrhoea. As such, you should not take more than the stated
dose unless your doctor advises you to. The syrup contains
sucrose and therefore may be harmful to your teeth.
Pregnancy and breast-feeding: The use of Brufen Syrup whilst
pregnant or breast feeding should be avoided. Brufen Syrup
should not be used in late (the last three months of) pregnancy
and should only be taken in the first six months of pregnancy
on the advice of your doctor.
Driving and Using Machines: Brufen Syrup may make you
feel dizzy or drowsy. If it affects you in this way do not drive,
operate machinery or do anything that requires you to be alert.
3. How should you take Brufen Syrup?
ALWAYS take Brufen Syrup exactly as your doctor has told
you. If you are not sure refer to the label on the carton or check
with your doctor or pharmacist. Ensure the bottle Is thoroughly
shaken before use. Take with or after food.
Adults and children over 12 years -The usual dosage is 4 to 6
spoonfuls (5 ml) taken three times a day. Your doctor may choose
to increase or decrease this depending on what you are being
treated for; but no more than 24 spoonfuls (120 ml/2400 mg)
should be taken in one day.
Children - Brufen Syrup should NOT be taken by children
weighing less than 7 kg. When used to treat fever, the syrup
should not be used long term or given to children under the
age of 1 year.
The usual dose in children is 20 mg per kg of bodyweight each
day, in divided doses. This can be given as follows:
1-2 years: One 2.5 ml (50 mg) dose three/four times a day
3-7 years: One 5 ml (100 mg) dose three/four times a day
8-12 years: Two 5 ml (200 mg) doses three/four times a day


The doctor may choose to increase this dose in children with
juvenile rheumatoid arthritis. This dose should not exceed 40mg/
kg bodyweight daily in divided doses.
You should avoid excessive use of painkillers. If you usually
take painkillers , especially combinations of different painkillers,
you may damage your kidneys, tell your doctor if you are
already taking another painkiller before taking this medicine
and your doctor will decide whether you should take this
medicine. This risk may be increased if you are dehydrated.
(AN OVERDOSE) you should contact a doctor or go to the
nearest hospital casualty department IMMEDIATELY taking
your syrup with you.
as soon as you remember, unless it is almost time for your next
dose. If it is, do not take the missed dose at all. Never double up
on a dose to make up for the one you have missed.
4. Possible side effects of Brufen Syrup
As with all medicines, Brufen Syrup may cause side effects,
although they .are usually mild and not everyone will suffer from
them. If any side effects become serious or if you notice any
side effects that are not listed in this leaflet, please tell your
doctor or pharmacist. You can minimise the risk of side effects
by taking the least amount of syrup for the shortest amount of
time necessary to control your symptoms.
STOP TAKING Brufen Syrup and seek immediate medical
help if you experience:
• Signs of aseptic meningitis such as severe headache, high
temperature, stiffness of the neck or intolerance to bright
• Signs of intestinal bleeding such as
• Passing blood in your faeces (stools/motions)
• Passing black tarry stools
• Vomiting any blood or dark particles that look like coffee
• Unexplained stomach pain (abdominal pain) or other
abnormal stomach symptoms, indigestion, heartburn, feeling
sick and/or vomiting.
• Unexplained wheezing, shortness of breath, skin rash, itching
or bruising (these may be symptoms of an allergic reaction).
• Yellowing of the eyes and/or skin (jaundice).
• Severe sore throat with high fever (these may be

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symptoms of a condition known as agranulocytosis).
• Blurred or disturbed vision (visual impairment) or seeing/
hearing strange things (hallucinations).
• Fluid retention e.g. swollen ankles (this may be a sign of
kidney problems).
• Severe spreading skin rash (Stevens-Johnson Syndrome
and erythema multiforme, symptoms include severe skin
rash, blistering of skin, including inside mouth, nose,
and genitals, as well as skin peeling which may be
accompanied with symptoms such as aching, headaches,
and feverishness).
Medicines such as Brufen Syrup have been associated with
a small increased risk of heart attack (myocardial infarction)
or stroke.
Medicines such as Brufen Syrup have in exceptional cases
been associated with severe skin problems for patients with
chicken pox or shingles
Blood disorders, kidney problems, liver problems or severe
skin reactions may occur rarely with ibuprofen
Very rarely Brufen Syrup may cause aseptic meningitis
(inflammation of the protective membrane surrounding the
Brufen has also been shown to sometimes worsen the
symptoms of Crohn’s disease or colitis.
A burning feeling in the throat or mouth may happen briefly
after taking this medicine.
Other side effects
Common (affects up to 1 in 10 people):
• rash
• feeling dizzy or tired
• stomach pain , indigestion, diarrhoea, feeling sick, being
sick, wind, constipation
• headache - if this happens while you are taking this
medicine it is important not to take any other medicines
for pain to help with this.
• passing black tarry stools
• passing blood in your faeces (stools/motions)
• vomiting any blood
Uncommon (affects up to 1 in a 100 people):
• feeling drowsy
• feeling anxious
• feeling a tingling sensation or ‘pins and needles’
• difficulty sleeping
• hives, itching

• skin becomes sensitive to light
• visual disturbances, hearing problems
• hepatitis, yellowing of your skin or eyes, reduced liver
• reduced kidney function, inflammation of the kidneys,
kidney failure
• sneezing, blocked, itchy or runny nose (rhinitis)
• stomach or gut ulcer, hole in the wall of the digestive
• inflammation of your stomach lining
• small bruises on your skin or inside your mouth, nose or
• difficulty breathing, wheezing or coughing, asthma or
worsening of asthma
• ringing in ears (tinnitus)
• sensation of feeling dizzy or spinning (vertigo)
• mouth ulcers
• serious allergic reaction which causes swelling of the
face or throat
Rare ( affects up to 1 in a 1000 people):
• feeling depressed or confused
• fluid retention (oedema)
• a brain infection called ‘non-bacterial meningitis’
• loss of vision
• changes in blood count - the first signs are: high
temperature, sore throat, mouth ulcers, flu‑like symptoms,
feeling very tired, bleeding from the nose and the skin
• reduction in blood cells (anaemia)
• serious allergic reaction which causes difficulty in
breathing or dizziness
• severe sore throat with high fever ( agranulocytosis)
Very rare (affects up to 1 in 10,000 people):
• liver failure
• heart failure
• heart attack
• inflammation of the pancreas
• skin problems (which can also affect inside your mouth,
nose or ears) such as ‘Stevens-Johnson syndrome’, ‘toxic
epidermal necrolysis’ or ‘erythema multiforme’.
• high blood pressure
Not known (frequency cannot be estimated from
available data):
• worsening of ulcerative colitis or Crohn’s Disease
(inflammation of the colon)


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 National reporting systems listed:
The Yellow Card Scheme at:
ADR Reporting
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. How should you store Brufen Syrup?
Your Brufen Syrup should be stored at normal room
temperature (below 25ºC) and protected from direct light. It
should be kept in a safe place out of the reach and sight of
children as your medicine could harm them.
It should be kept in its original packaging. Do NOT take Brufen
Syrup after the ‘expiry’ date shown on the bottle. Once the
bottle is opened, the Brufen Syrup must be used within 12
If your doctor decides to stop your treatment, return any left
over product to your pharmacist. Only keep it if your doctor
tells you to.
6. Further information about Brufen Syrup
The active substance in Brufen Syrup is Ibuprofen BP. Each
bottle contains 500 ml of syrup.
Brufen Syrup inactive ingredients: purified water, sucrose,
glycerine, sorbitol, light kaolin, agar, citric acid monohydrate,
sodium benzoate, methyl hydroxybenzoate, polysorbate 80,
propyl hydroxybenzoate, orange flavour, sunset yellow (E110).
Marketing Authorisation Holder: BGP Products Ltd,
Abbott House, Vanwall Business Park, Vanwall Road,
Maidenhead, Berkshire, SL6 4XE, UK.
Manufacturer: AbbVie S.r.l., S.R. 148 Pontina km 52
snc, 04011 campoverde di Aprilia (LT), Italy.
Leaflet last revised February 2016.



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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.