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BRUFEN 100 MG/5 ML SYRUP

Active substance(s): IBUPROFEN

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2. What should you know before taking Brufen Syrup?

PATIENT INFORMATION LEAFLET

Brufen® 100 mg/5 ml Syrup /
Ibuprofen 100 mg/5 ml Syrup
(ibuprofen)

If the answer to any of the following questions is ‘YES’ please tell
your doctor or pharmacist BEFORE taking any Brufen Syrup:




This medicine is known as any of the above names but will be
referred to as Brufen Syrup throughout the following leaflet.


IMPORTANT INFORMATION
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 anti-inflammatory
painkillers. 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 strains.
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.



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 26.4 g 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, betablockers such as atenolol, or angiotensin-lI 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 conditions
• lithium
• zidovudine (an anti-viral drug)
• steroids (used in the treatment of inflammatory conditions)
• methotrexate (used to treat certain cancers and rheumatoid arthritis)
• 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
prescription
• 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.
DOSAGE:
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.
IF YOU TAKE MORE BRUFEN SYRUP THAN PRESCRIBED (AN
OVERDOSE) you should contact a doctor or go to the nearest hospital
casualty department IMMEDIATELY taking your syrup with you.
IF YOU FORGET TO TAKE YOUR BRUFEN SYRUP take it 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 light.
• 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 grounds
TELL YOUR DOCTOR AND STOP TAKING BRUFEN SYRUP IF YOU
EXPERIENCE:
• 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 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.



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

Very rarely Brufen Syrup may cause aseptic meningitis (inflammation of
the protective membrane surrounding the brain).



Brufen has also been shown to sometimes worsen the symptoms of
Crohn's disease or colitis.

Not known (frequency cannot be estimated from available data):
• worsening of ulcerative colitis or Crohn’s Disease (inflammation of
the colon)

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 function
• 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 tract
• inflammation of your stomach lining
• small bruises on your skin or inside your mouth, nose or ears
• 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

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 on the Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How should you store Brufen Syrup?
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package. Protect from light.
Do NOT take Brufen Syrup after the 'expiry' date shown on the bottle.
The expiry date refers to the last day of that month.
Once the bottle is opened, the Brufen Syrup must be used within 12
months.
If your doctor decides to stop your treatment, return any leftover product
to your pharmacist. Only keep it if your doctor tells you to.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment
If your medicine becomes discoloured or show signs of any deterioration,
consult your doctor or pharmacist who will tell you what to do.
6. Further information about Brufen Syrup
The active ingredient in Brufen Syrup is ibuprofen. Each 5 ml contains
100 mg of ibuprofen.
Brufen Syrup Inactive Ingredients: methyl parahydroxybenzoate
(E218), propyl parahydroxybenzoate (E216), sucrose, citric acid
monohydrate, sodium benzoate, agar, glycerol, sorbitol solution (E420)
70%, light kaolin, polysorbate 80, sunset yellow FCF (E110), orange
aroma and purified water.
What Brufen Syrup looks like and contents of the pack
Brufen Syrup is an orange coloured, orange flavoured suspension
available in an opaque amber PET bottle with a white tamper resistant
metal screw cap, with a 5 ml graduated plastic oral syringe.
Brufen Syrup is available in 200 ml bottle.
PL: 15814/1181

POM

Manufactured by Abbvie S.r.L., Campoverde di Aprilia, Latina, Italy.
Procured from within the EU and repackaged by the Product Licence
holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts
WD24 4PR.
Leaflet revision and issue date (Ref.): 11.07.2016.
Brufen is a registered trademark of Abbott GmbH & Co. KG, Germany.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

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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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