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Active substance(s): IBUPROFEN

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BRUFEN® 600mg Granules
Your medicine is available as the above name but will be
referred to as Brufen Granules throughout this leaflet.
Read all of this leaflet carefully before you start taking this
 Keep this leaflet as you may need to read it again
 This leaflet provides a summary of the information currently
available about Brufen Granules
 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
 Tell your doctor or pharmacist if you experience any side effects
Leaflet contents:
1. What are Brufen Granules & what are they used for?
2. What should you know before taking Brufen Granules?
3. How should you take Brufen Granules?
4. Possible side effects of Brufen Granules.
5. How should you store Brufen Granules?
6. Further information about Brufen Granules.
1. What are Brufen Granules & what are they used for?
Brufen Granules belong to a group of medicines called
anti-inflammatory pain killers. They 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 Granules can also be used to treat other painful conditions such
as toothache, pain after operations, period pain and headache,
including migraine.
The active ingredient in Brufen Granules is ibuprofen and each
sachet contains 600 mg.
2. What should you know before taking Brufen Granules?
If the answer to any of the following questions is 'YES' please tell
your doctor or pharmacist BEFORE taking any Brufen




Are you pregnant or planning to become pregnant, or are you
breast-feeding? Brufen Granules 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
Are you sensitive (allergic) to any of the ingredients in the
granules? These are listed in Section 6.
Do you have, or have you previously had, a stomach ulcer or other
gastric complaint?
Do not take Brufen Granules 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
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 Granules 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 Granules 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?
Has your doctor advised you to follow a low sodium diet?
Have you been told by your doctor that you have an intolerance to
some sugars?
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 angiotensin-II 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)
any other ibuprofen preparations, 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 (types of anti-fungal drugs)
gingko biloba herbal medicine (there is a chance you may bleed
more easily if you are taking this with ibuprofen).

Pregnancy and breast-feeding: The use of Brufen Granules whilst
pregnant or breast feeding should be avoided. Brufen Granules 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
Driving and Using Machines: Brufen Granules may make you feel
dizzy or drowsy. If they affect you in this way do not drive, operate
machinery or do anything that requires you to be alert.
Brufen contains sucrose:
Sucrose is a sugar. If you have been told by your doctor that you
cannot tolerate or digest some sugars, talk to your doctor before taking
this medicine. Each sachet contains 3.3g sucrose. This should be
taken into account in patients with diabetes mellitus.
Brufen contains sodium:
Brufen granules contains 8.6mmol (197mg) sodium per sachet. This
should be taken into account if you are on a low sodium diet. You may
need to have less sodium in your diet because of the sodium in this
3. How should you take Brufen Granules?
ALWAYS take Brufen Granules exactly as your doctor has told
If you are not sure refer to the label on the carton or check with your
doctor or pharmacist.
TAKE YOUR BRUFEN GRANULES by emptying the contents of
the sachet into a glass full of water to make an orange flavoured fizzy
drink, stir and drink immediately.
Take with or after food.
Adults and Children over 12 years - The usual dosage is 1 sachet
taken two or 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 4 sachets should be taken in one day.
Brufen Granules are NOT recommended for children under 12 years
of age.
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 granules
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 Granules
As with all medicines, Brufen Granules 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
granules for the shortest amount of time necessary to control
your symptoms.
STOP TAKING Brufen Granules 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
 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
 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 Granules have been associated with a small
increased risk of heart attack (myocardial infarction) or stroke.

Medicines such as Brufen Granules have in exceptional cases been
associated with severe skin problems for patients with chicken pox or
Blood disorders, kidney problems, liver problems or severe skin
reactions may occur rarely with ibuprofen.
Very rarely Brufen Granules 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.
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,
 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
 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
 severe sore throat with high fever (agranulocytosis)

Very rare (affects up to 1 in10,000 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 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: or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How should you store Brufen Granules?
 Keep out of the sight and reach of children.
 Do not use Brufen Granules after the expiry date which is stated on

the carton and sachet after EXP. The expiry date refers to the last
day of that month.
Do not store above 25°C.
If the granules become discoloured or show any signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.
If your doctor decides to stop your treatment, return any left over
product to your pharmacist. Only keep them if your doctor tells you
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Further information about Brufen Granules
The active substance in Brufen Granules is ibuprofen. Each sachet
contains 600mg of ibuprofen in effervescent granule form.
Brufen Granules inactive ingredients: microcrystalline cellulose,
croscarmellose sodium, malic acid, sodium saccharin, sucrose,
povidone, sodium bicarbonate, sodium carbonate anhydrous, orange
flavour and sodium lauryl sulphate.
Brufen Granules are white, effervescent, orange flavoured granules
provided in single dose sachets. Each pack contains 20 sachets.

Manufacturer and Product Licence holder
Brufen Granules are manufactured by:
AbbVie S.r.L. Via Pontina - Km 52 I-04010 Campoverdi di Aprilia Latina, Italy.
Procured from within the EU and repackaged by the Product Licence
holder: G-Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1395


Date of revision of this leaflet: 31/01/2018
Brufen is a registered trademark of Abbott GmbH & Co. KG

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