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Active substance(s): IBUPROFEN

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Patient Information Leaflet

Brufen® 600mg Effervescent Granules
Your medicine is called Brufen 600 mg Effervescent Granules but will be
referred to as Brufen Granules throughout the remainder of this leaflet.
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 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 you
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
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 Granules:

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 pregnant.

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 if 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, betablockers 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 conditions


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)


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 doctor.
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 8.6 mmol (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 you. 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
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.
OVERDOSE) you should contact a doctor or go to the nearest hospital
casualty department IMMEDIATELY taking your granules with you.
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

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.

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:
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 take your granules after the “use by date” shown on the carton or
Do not store above 25ºC.
If your doctor decides to stop the treatment, return any left over to your
pharmacist. Only keep the granules if your doctor tells you to.
If the granules show any signs of deterioration or discolouration, consult
your pharmacist for advice. If damaged please tell your doctor or
6. Further information about Brufen Granules
Brufen Granules are fine white granules with orange flavour.
The active ingredient in Brufen Granules is ibuprofen. Each sachet
contains 600 mg ibuprofen in effervescent granule form. Also contains:
microcrystalline cellulose, croscarmellose sodium, sucrose, malic acid,
sodium bicarbonate, anhydrous sodium carbonate, orange flavour,
sodium saccharin, povidone and sodium lauryl sulphate.
Each pack contains 20 sachets.
Brufen Granules are manufactured by Abbott S.r.L. S.R. 148 Pontina km
52 snc, 04011 Campoverde di Aprilia (LT), Italy or AbbVie S.r.L., Via
Pontina Km 52 I- 04010 – Campoverde di Aprilia - Latina, Italy. Procured
from within the EU. Product Licence holder: Quadrant Pharmaceuticals
Ltd. Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA.
Repackaged by Maxearn Ltd. Bolton, BL6 4SA.
PL 20774/1047



Leaflet revised 20 March 2017
Other side effects
Common (affects up to 1 in 10 people):


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 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 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)

Brufen is a registered trademark of Mylan Healthcare GmbH.

Blind or Partially Sighted?
Is this leaflet hard to see or read?
Contact Quadrant Pharmaceuticals
Ltd, Tel 01204 473081

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