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IBUPROFEN SYRUP 100MG/5ML

Active substance(s): IBUPROFEN

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S1321 Brufen LEAFLET 20160704

PACKAGE LEAFLET: INFORMATION FOR USER
®

BRUFEN SYRUP 100mg/5ml
(ibuprofen)
Your medicine is known as Brufen Syrup 100mg/5ml but will be
referred to as Brufen Syrup throughout the following 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



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 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)



mifepristone



any other ibuprofen, such as those you can buy without a
prescription

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.



any other anti-inflammatory pain killer, including aspirin

1. WHAT IS BRUFEN SYRUP & WHAT IS IT USED FOR?



cholestyramine (a drug used to lower cholesterol)

Brufen Syrup belongs to a group of medicines called antiinflammatory 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.



medicines known as sulphonylureas such as glibenclamide
(used to treat diabetes)



voriconazole or fluconazole (type of anti-fungal drugs)



gingko biloba herbal medicine (there is a chance you may bleed
more easily if you are taking this with ibuprofen).

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 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. The syrup contains sucrose
and therefore may be harmful to your teeth.

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, methyl hydroxybenzoate, propyl
hydroxybenzoate 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 swelling and irritation inside the nose?



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)?



Do you have chicken pox or shingles?



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 26.4g per dose)
it is not recommended for those with hereditary fructose
intolerance, glucose malabsorption syndrome or
sucraseisomaltase deficiency.



Is your child dehydrated? As there is a risk of kidney damage in
dehydrated children and adolescents.

Other information about Brufen Syrup:

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. 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 and children over 12 years -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.
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.
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. 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.

STOP TAKING Brufen Syrup and seek immediate medical help
if you experience:

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’.



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

TELL YOUR DOCTOR AND STOP TAKING BRUFEN SYRUP 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).



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 Syrup have been associated with a small
increased risk of heart attack (myocardial infarction) or stroke.
Medicines such as Brufen Syrup have in exceptional cases been
associated with severe skin problems for patients with chicken pox
or shingles
Blood disorders, kidney problems, liver problems or severe skin
reactions may occur rarely with ibuprofen

 high blood pressure
Not known (frequency cannot be estimated from available
data):


worsening of ulcerative colitis or Crohn’s Disease (inflammation
of the colon)
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 THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Store in the original package to protect from light.



Use within twelve months after first opening.



If your doctor stops your treatment, take any leftover
suspension back to the pharmacy for safe disposal.



Do not take your suspension after the expiry date on the
container. Take any suspension which is out of date back to the
pharmacy.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Very rarely Brufen Syrup 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.

6. FURTHER INFORMATION ABOUT BRUFEN SYRUP

A burning feeling in the throat or mouth may happen briefly after
taking this medicine.
Other side effects



Each 5ml of oral suspension contains 100mg ibuprofen.



Brufen Syrup also contains the following: methyl
hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
sunset yellow (E110), sodium benzoate, glycerin, sorbitol
solution 70% (non-crystallising) (E420), sucrose, citric acid
monohydrate granular, agar powder, light kaolin, polysorbate
80, orange flavour (D717) and purified water.

What Brufen Syrup contains

Common (affects up to 1 in 10 people):


rash



feeling dizzy or tired



stomach pain , indigestion, diarrhoea, feeling sick, being sick,
wind, constipation



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):

What Brufen Syrup looks like and contents of the pack


Brufen Syrup is an orange-coloured, orange-flavoured,
suspension.



Brufen Syrup is available in bottles of 200ml.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



feeling drowsy



feeling anxious



feeling a tingling sensation or ‘pins and needles’

Manufacturer



difficulty sleeping



hives, itching

This product is manufactured by AbbVie S.r.L., S.R. 148 Pontina
km 52 snc, 04011 Campoverde di Aprilia (LT), Italy.



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 of the 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 asthma



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
dizziness



severe sore throat with high fever ( agranulocytosis)

POM

PL 19488/1321

Leaflet revision date: 04 July 2016
Brufen® is a registered trade mark of Mylan Healthcare GmbH,
Germany.
S1321 Brufen LEAFLET 20160704

S1321 Ibuprofen LEAFLET 20160704

PACKAGE LEAFLET: INFORMATION FOR USER

IBUPROFEN SYRUP 100mg/5ml
(ibuprofen)
Your medicine is known as Ibuprofen Syrup 100mg/5ml but will be
referred to as Ibuprofen Syrup throughout the following 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



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 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)



mifepristone



any other ibuprofen, such as those you can buy without a
prescription

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.



any other anti-inflammatory pain killer, including aspirin

1. WHAT IS BRUFEN SYRUP & WHAT IS IT USED FOR?



cholestyramine (a drug used to lower cholesterol)

Brufen Syrup belongs to a group of medicines called antiinflammatory 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.



medicines known as sulphonylureas such as glibenclamide
(used to treat diabetes)



voriconazole or fluconazole (type of anti-fungal drugs)



gingko biloba herbal medicine (there is a chance you may bleed
more easily if you are taking this with ibuprofen).

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 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. The syrup contains sucrose
and therefore may be harmful to your teeth.

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, methyl hydroxybenzoate, propyl
hydroxybenzoate 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 swelling and irritation inside the nose?



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)?



Do you have chicken pox or shingles?



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 26.4g per dose)
it is not recommended for those with hereditary fructose
intolerance, glucose malabsorption syndrome or
sucraseisomaltase deficiency.



Is your child dehydrated? As there is a risk of kidney damage in
dehydrated children and adolescents.

Other information about Brufen Syrup:

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. 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 and children over 12 years -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.
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.
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. 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.

STOP TAKING Brufen Syrup and seek immediate medical help
if you experience:

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’.



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

TELL YOUR DOCTOR AND STOP TAKING BRUFEN SYRUP 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).



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 Syrup have been associated with a small
increased risk of heart attack (myocardial infarction) or stroke.
Medicines such as Brufen Syrup have in exceptional cases been
associated with severe skin problems for patients with chicken pox
or shingles
Blood disorders, kidney problems, liver problems or severe skin
reactions may occur rarely with ibuprofen

 high blood pressure
Not known (frequency cannot be estimated from available
data):


worsening of ulcerative colitis or Crohn’s Disease (inflammation
of the colon)
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 IBUPROFEN SYRUP?


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Store in the original package to protect from light.



Use within twelve months after first opening.



If your doctor stops your treatment, take any leftover
suspension back to the pharmacy for safe disposal.



Do not take your suspension after the expiry date on the
container. Take any suspension which is out of date back to the
pharmacy.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Very rarely Brufen Syrup 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.

6. FURTHER INFORMATION ABOUT IBUPROFEN SYRUP

A burning feeling in the throat or mouth may happen briefly after
taking this medicine.
Other side effects



Each 5ml of oral suspension contains 100mg ibuprofen.



Ibuprofen Syrup also contains the following: methyl
hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
sunset yellow (E110), sodium benzoate, glycerin, sorbitol
solution 70% (non-crystallising) (E420), sucrose, citric acid
monohydrate granular, agar powder, light kaolin, polysorbate
80, orange flavour (D717) and purified water.

What Ibuprofen Syrup contains

Common (affects up to 1 in 10 people):


rash



feeling dizzy or tired



stomach pain , indigestion, diarrhoea, feeling sick, being sick,
wind, constipation



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):

What Ibuprofen Syrup looks like and contents of the pack


Ibuprofen Syrup is an orange-coloured, orange-flavoured,
suspension.



Ibuprofen Syrup is available in bottles of 200ml.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



feeling drowsy



feeling anxious



feeling a tingling sensation or ‘pins and needles’

Manufacturer



difficulty sleeping



hives, itching

This product is manufactured by AbbVie S.r.L., S.R. 148 Pontina
km 52 snc, 04011 Campoverde di Aprilia (LT), Italy.



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 of the 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 asthma



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
dizziness



severe sore throat with high fever ( agranulocytosis)

POM

PL 19488/1321

Leaflet revision date: 04 July 2016
S1321 Ibuprofen LEAFLET 20160704

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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.

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