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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

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

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
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 antiinflammatory 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 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 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)?
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?
There is a risk of kidney damage in dehydrated children and

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


zidovudine (an anti-viral drug)

steroids (used in the treatment of inflammatory conditions)

methotrexate (used to treat certain cancers)

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)
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.
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
Brufen Granules are NOT recommended for children under 12
years of age.
PRESCRIBED (AN OVERDOSE) you should contact a doctor or
go to the nearest hospital casualty department IMMEDIATELY
taking your granules with you.
them 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.

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. S.R. 148 Pontina km 52 snc, 04011 Campoverde
di Aprilia (LT), 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

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

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 or other abnormal stomach
symptoms, indigestion, heartburn, feeling sick and/or

Unexplained wheezing, shortness of breath, skin rash,
itching or bruising.

Yellowing of the eyes and/or skin.

Severe sore throat with high fever.

Blurred or disturbed vision or seeing/hearing strange things.

Fluid retention (e.g. swollen ankles).
Medicines such as Brufen Granules have been associated with a
small increased risk of heart attack (myocardial infarction) 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).
Other side effects may include headache, hallucinations,
dizziness, tingling of hands and feet, ringing in the ears,
depression, confusion, difficulty sleeping, anxiety, impaired
hearing, a temporary sensation of burning in the mouth or throat,
diarrhoea, constipation, flatulence (wind), unexpected sensitivity
of the skin to the sun, tiredness, malaise, mood swings and
swelling and irritation inside the nose.
Brufen has also been shown to sometimes worsen the symptoms
of Crohn’s disease or colitis.
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 sachet.
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 pharmacist.
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.


Leaflet revised 4th February 2016
Brufen is a registered trademark of Abbott GmbH & Co. KG.

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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.