Skip to Content

UK Edition. Click here for US version.

BRUFEN 600MG GRANULES

Active substance(s): IBUPROFEN

View full screen / Print PDF » Download PDF ⇩
Transcript
 have any kind of stroke or think that you might be at risk of

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUFEN® 600mg Granules
(ibuprofen)
Your medicine is available as the above name but will be
referred to as Brufen Granules throughout this 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 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 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
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 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).



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
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
conditions
 lithium
 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)
 mifepristone
 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.
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.
DOSAGE:
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.

IF YOU TAKE MORE BRUFEN GRANULES THAN PRESCRIBED
(AN OVERDOSE) you should contact a doctor or go to the nearest
hospital casualty department IMMEDIATELY taking your granules
with you.
IF YOU FORGET TO TAKE YOUR BRUFEN GRANULES take 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.

 If your doctor decides to stop your treatment, return any left over

product to your pharmacist. Only keep them if your doctor tells
you to.
 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.

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
grounds

Manufacturer and Product Licence holder
Brufen Granules are manufactured by:
AbbVie S.r.L. S.R. 148 Pontina km 52 snc, 04011 Campoverde di
Aprilia (LT), Italy.

TELL YOUR DOCTOR AND STOP TAKING THE GRANULES 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).

Date of revision of this leaflet: 30/03/2016

Medicines such as Brufen Granules have been associated with a
small increased risk of heart attack (myocardial infarction) or stroke.
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:
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 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 shows any signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.

Procured from within the EU and repackaged by the Product Licence
holder: G-Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1395

POM

Brufen is a registered trademark of Abbott GmbH & Co. KG

 have any kind of stroke or think that you might be at risk of

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUFEN® 600mg Granules
(ibuprofen)
Your medicine is available as the above name but will be
referred to as Brufen Granules throughout this 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 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 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
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 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).



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
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
conditions
 lithium
 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)
 mifepristone
 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.
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.
DOSAGE:
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.

IF YOU TAKE MORE BRUFEN GRANULES THAN PRESCRIBED
(AN OVERDOSE) you should contact a doctor or go to the nearest
hospital casualty department IMMEDIATELY taking your granules
with you.
IF YOU FORGET TO TAKE YOUR BRUFEN GRANULES take 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.

 If your doctor decides to stop your treatment, return any left over

product to your pharmacist. Only keep them if your doctor tells
you to.
 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.

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
grounds

Manufacturer and Product Licence holder
Brufen Granules are manufactured by:
AbbVie S.r.L. S.R. 148 Pontina km 52 snc, 04011 Campoverde di
Aprilia (LT), Italy.

TELL YOUR DOCTOR AND STOP TAKING THE GRANULES 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).

Date of revision of this leaflet: 30/03/2016

Medicines such as Brufen Granules have been associated with a
small increased risk of heart attack (myocardial infarction) or stroke.
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:
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 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 shows any signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.

Procured from within the EU and repackaged by the Product Licence
holder: G-Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1395

POM

Brufen is a registered trademark of Abbott GmbH & Co. KG

Expand view ⇕

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.

Hide