BRUFEN 600MG EFFERVESCENT GRANULES

Active substance: IBUPROFEN

View full screen / Print PDF » Download PDF ⇩

Transcript
(leaflet continued)
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?
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 antifungal 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 you suffer from any of the following at
any time during your treatment STOP
TAKING Brufen Granules and seek
immediate medical help:
severe headache, high temperature,
stiffness of the neck or intolerance to bright
light.
Pass blood in your faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look
like coffee grounds.
TELL YOUR DOCTOR AND STOP TAKING
THE GRANULES IF YOU EXPERIENCE:
Unexplained stomach pain or other
abnormal stomach symptoms, indigestion,
heartburn, feeling sick and/or vomiting.
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 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 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 continued overleaf)

Brufen Granules can also be used to treat
other painful conditions such as toothache,
pain after operations, period pain and
headache, including migraine.
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.
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.
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

PP7/1047/V2

Brufen is a registered trademark of Abbott
GmbH & Co. KG.
Leaflet revised 2nd May 2014
PL 20774/1047

POM

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.

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

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 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. If you have heart problems,
previous stroke or think that you might be at
risk of these conditions (e.g. if you have
high blood pressure, diabetes, high
cholesterol or are a smoker) you should
discuss your treatment with your doctor or
pharmacist.
(leaflet continued overleaf)
The active ingredient in Brufen Granules is
ibuprofen and each sachet contains
600 mg.

Brufen® 600mg Effervescent Granules
(ibuprofen)
Patient Information Leaflet

(leaflet continued)

(leaflet continued)
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?
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 antifungal 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 you suffer from any of the following at
any time during your treatment STOP
TAKING Brufen Granules and seek
immediate medical help:
severe headache, high temperature,
stiffness of the neck or intolerance to bright
light.
Pass blood in your faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look
like coffee grounds.
TELL YOUR DOCTOR AND STOP TAKING
THE GRANULES IF YOU EXPERIENCE:
Unexplained stomach pain or other
abnormal stomach symptoms, indigestion,
heartburn, feeling sick and/or vomiting.
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 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 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 continued overleaf)

Brufen Granules can also be used to treat
other painful conditions such as toothache,
pain after operations, period pain and
headache, including migraine.
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.
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.
PP7/1047/V2

Brufen is a registered trademark of Abbott
GmbH & Co. KG.
Leaflet revised 2nd May 2014
PL 20774/1047

POM

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.
(leaflet continued)

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

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 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. If you have heart problems,
previous stroke or think that you might be at
risk of these conditions (e.g. if you have
high blood pressure, diabetes, high
cholesterol or are a smoker) you should
discuss your treatment with your doctor or
pharmacist.
(leaflet continued overleaf)
The active ingredient in Brufen Granules is
ibuprofen and each sachet contains
600 mg.

Brufen® 600mg Effervescent Granules
(ibuprofen)
Patient Information Leaflet

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
(web2)