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BRUFEN 100MG/5ML SYRUP

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUFEN® 100 mg / 5 ml SYRUP
(Ibuprofen)
The name of your medicine is Brufen 100mg/5ml Syrup but
will be referred to as Brufen Syrup throughout the
remainder of 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 Syrup
● 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 is Brufen Syrup & what is it used for?
2. What should you know before taking Brufen Syrup?
3. How should you take Brufen Syrup?
4. Possible side effects of Brufen Syrup.
5. How should you store Brufen Syrup?
6. Further information about Brufen Syrup.
1.

What is Brufen Syrup & what is it used for?

Brufen Syrup belongs to a group of medicines called
anti-inflammatory pain killers. It 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 Syrup can also be used to treat other painful conditions
such as toothache, pain after operations, period pain and
headache, including migraine. It can also be used for the short
term treatment of fever in children over the age of 1 year.
The active ingredient in Brufen Syrup is ibuprofen. Each 5ml
spoonful of Brufen Syrup contains 100mg ibuprofen.
2.

What should you know before taking Brufen Syrup?

If the answer to any of the following questions is 'YES'
please tell your doctor or pharmacist BEFORE taking any
Brufen Syrup:
● Are you pregnant or planning to become pregnant, or are
you breast-feeding? Brufen Syrup 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
syrup? These are listed in Section 6. Some people may be
sensitive to the E110 or sodium benzoate and if you develop
an unexpected rash, sore eyes, sore mouth or difficulty
breathing whilst taking the medicine, stop taking it and
contact your doctor for advice.
● Do you have, or have you previously had, a stomach ulcer or
other gastric complaint?
Do not take Brufen Syrup 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 Syrup 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 Syrup 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)?
● Have you been told by your doctor that you have an
intolerance to some sugars? Due to the content of sorbitol
(70 mg per ml or 2.8 g per dose) and sucrose (660 mg per
ml or 26.4 g per dose) it is not recommended for those with
hereditary fructose intolerance, glucose malabsorption
syndrome or sucraseisomaltase deficiency.
● 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, 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).
Other information about Brufen Syrup:
The syrup contains small amounts of glycerin (glycerol). In high
doses, glycerin may sometimes cause headache, stomach
upset and diarrhoea. As such, you should not take more than
the stated dose unless your doctor advises you to.

Pregnancy and breast-feeding: The use of Brufen Syrup
whilst pregnant or breast feeding should be avoided. Brufen
Syrup 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 Syrup may make you
feel dizzy or drowsy. If it affects you in this way do not drive,
operate machinery or do anything that requires you to be alert.
3.

Medicines such as Brufen Syrup 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.

How should you take Brufen Syrup?

ALWAYS take Brufen Syrup 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. Ensure the bottle is thoroughly
shaken before use. Take with or after food.
DOSAGE:
Adults - The usual dosage is 4 to 6 spoonfuls (5 ml) taken 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 24 spoonfuls (120 ml/2400 mg) should be taken in one
day.
Children - Brufen Syrup should NOT be taken by children
weighing less than 7 kg. When used to treat fever, the syrup
should not be used long term or given to children under the age
of 1 year.
The usual dose in children is 20 mg per kg of bodyweight each
day, in divided doses. This can be given as follows:
1-2 years: One 2.5 ml (50 mg) dose three/four times a day
3-7 years: One 5 ml (100 mg) dose three/four times a day
8-12 years: Two 5 ml (200 mg) doses three/four times a day
The doctor may choose to increase this dose in children with
juvenile rheumatoid arthritis.
This dose should not exceed 40mg/kg bodyweight daily in
divided doses.
IF YOU TAKE MORE BRUFEN SYRUP THAN PRESCRIBED
(AN OVERDOSE) you should contact a doctor or go to the
nearest hospital casualty department IMMEDIATELY taking
your syrup with you.
IF YOU FORGET TO TAKE YOUR BRUFEN SYRUP take it 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.

● Severe sore throat with high fever.
● Blurred or disturbed vision or seeing/hearing strange things.
● Fluid retention (e.g. swollen ankles).

Possible side effects of Brufen Syrup

As with all medicines, Brufen Syrup 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 syrup 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 Syrup 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 BRUFEN SYRUP
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.

Very rarely Brufen Syrup 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 Syrup?







KEEP OUT OF SIGHT AND REACH OF CHILDREN
Do not store above 25°C.
Protect from light.
Store in the original package.
Once the bottle is opened, the Brufen Syrup should be used
within 12 months.
● If the medicine becomes discoloured or shows any other
signs of deterioration, consult your pharmacist before taking
it. Any unused medicine should be returned to your
pharmacist for safe disposal. Only keep the medicine if your
doctor tells you to.
6.

Further information about Brufen Syrup

● The active ingredient in your medicine is Ibuprofen.
● Each 5ml of syrup contains 100mg ibuprofen BP.
● Your medicine also contains the following inactive
ingredients: methyl para-hydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), sucrose, citric acid
monohydrate, sodium benzoate, agar, glycerol, sorbitol
solution (E420) 70%, light kaolin clay, polysorbate 80,
sunset Yellow FCF (E110), orange flavouring and purified
water.
Each bottle contains 200ml of Brufen 100mg/5ml Syrup and
either a 5ml/2.5ml spoon or a 5ml graduated syringe.
Manufacturer
This product is manufactured by: AbbVie S.r.L., Strada Statale
Pontina - Km 52, I-04010 Campoverde di Aprilia, Latina,
Italy. Procured from within the EU and repackaged by the
Product Licence Holder: G-Pharma Ltd, Salford M50 2PU.
PL NO: 16369/0624
Brufen® 100 mg / 5 ml Syrup

POM

12/04/2015

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUFEN® 100 mg / 5 ml SYRUP
(Ibuprofen)
The name of your medicine is Brufen 100mg/5ml Syrup but
will be referred to as Brufen Syrup throughout the
remainder of 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 Syrup
● 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 is Brufen Syrup & what is it used for?
2. What should you know before taking Brufen Syrup?
3. How should you take Brufen Syrup?
4. Possible side effects of Brufen Syrup.
5. How should you store Brufen Syrup?
6. Further information about Brufen Syrup.
1.

What is Brufen Syrup & what is it used for?

Brufen Syrup belongs to a group of medicines called
anti-inflammatory pain killers. It 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 Syrup can also be used to treat other painful conditions
such as toothache, pain after operations, period pain and
headache, including migraine. It can also be used for the short
term treatment of fever in children over the age of 1 year.
The active ingredient in Brufen Syrup is ibuprofen. Each 5ml
spoonful of Brufen Syrup contains 100mg ibuprofen.
2.

What should you know before taking Brufen Syrup?

If the answer to any of the following questions is 'YES'
please tell your doctor or pharmacist BEFORE taking any
Brufen Syrup:
● Are you pregnant or planning to become pregnant, or are
you breast-feeding? Brufen Syrup 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
syrup? These are listed in Section 6. Some people may be
sensitive to the E110 or sodium benzoate and if you develop
an unexpected rash, sore eyes, sore mouth or difficulty
breathing whilst taking the medicine, stop taking it and
contact your doctor for advice.
● Do you have, or have you previously had, a stomach ulcer or
other gastric complaint?
Do not take Brufen Syrup 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 Syrup 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 Syrup 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)?
● Have you been told by your doctor that you have an
intolerance to some sugars? Due to the content of sorbitol
(70 mg per ml or 2.8 g per dose) and sucrose (660 mg per
ml or 26.4 g per dose) it is not recommended for those with
hereditary fructose intolerance, glucose malabsorption
syndrome or sucraseisomaltase deficiency.
● 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, 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).
Other information about Brufen Syrup:
The syrup contains small amounts of glycerin (glycerol). In high
doses, glycerin may sometimes cause headache, stomach
upset and diarrhoea. As such, you should not take more than
the stated dose unless your doctor advises you to.

Pregnancy and breast-feeding: The use of Brufen Syrup
whilst pregnant or breast feeding should be avoided. Brufen
Syrup 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 Syrup may make you
feel dizzy or drowsy. If it affects you in this way do not drive,
operate machinery or do anything that requires you to be alert.
3.

Medicines such as Brufen Syrup 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.

How should you take Brufen Syrup?

ALWAYS take Brufen Syrup 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. Ensure the bottle is thoroughly
shaken before use. Take with or after food.
DOSAGE:
Adults - The usual dosage is 4 to 6 spoonfuls (5 ml) taken 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 24 spoonfuls (120 ml/2400 mg) should be taken in one
day.
Children - Brufen Syrup should NOT be taken by children
weighing less than 7 kg. When used to treat fever, the syrup
should not be used long term or given to children under the age
of 1 year.
The usual dose in children is 20 mg per kg of bodyweight each
day, in divided doses. This can be given as follows:
1-2 years: One 2.5 ml (50 mg) dose three/four times a day
3-7 years: One 5 ml (100 mg) dose three/four times a day
8-12 years: Two 5 ml (200 mg) doses three/four times a day
The doctor may choose to increase this dose in children with
juvenile rheumatoid arthritis.
This dose should not exceed 40mg/kg bodyweight daily in
divided doses.
IF YOU TAKE MORE BRUFEN SYRUP THAN PRESCRIBED
(AN OVERDOSE) you should contact a doctor or go to the
nearest hospital casualty department IMMEDIATELY taking
your syrup with you.
IF YOU FORGET TO TAKE YOUR BRUFEN SYRUP take it 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.

● Severe sore throat with high fever.
● Blurred or disturbed vision or seeing/hearing strange things.
● Fluid retention (e.g. swollen ankles).

Possible side effects of Brufen Syrup

As with all medicines, Brufen Syrup 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 syrup 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 Syrup 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 BRUFEN SYRUP
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.

Very rarely Brufen Syrup 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 Syrup?







KEEP OUT OF SIGHT AND REACH OF CHILDREN
Do not store above 25°C.
Protect from light.
Store in the original package.
Once the bottle is opened, the Brufen Syrup should be used
within 12 months.
● If the medicine becomes discoloured or shows any other
signs of deterioration, consult your pharmacist before taking
it. Any unused medicine should be returned to your
pharmacist for safe disposal. Only keep the medicine if your
doctor tells you to.
6.

Further information about Brufen Syrup

● The active ingredient in your medicine is Ibuprofen.
● Each 5ml of syrup contains 100mg ibuprofen BP.
● Your medicine also contains the following inactive
ingredients: methyl para-hydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), sucrose, citric acid
monohydrate, sodium benzoate, agar, glycerol, sorbitol
solution (E420) 70%, light kaolin clay, polysorbate 80,
sunset Yellow FCF (E110), orange flavouring and purified
water.
Each bottle contains 200ml of Brufen 100mg/5ml Syrup and
either a 5ml/2.5ml spoon or a 5ml graduated syringe.
Manufacturer
This product is manufactured by: AbbVie S.r.L., Strada Statale
Pontina - Km 52, I-04010 Campoverde di Aprilia, Latina,
Italy. Procured from within the EU and repackaged by the
Product Licence Holder: G-Pharma Ltd, Salford M50 2PU.
PL NO: 16369/0624
Brufen® 100 mg / 5 ml Syrup

POM

12/04/2015

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.

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