BRUFEN SYRUP 100MG/5ML

Active substance: IBUPROFEN

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S1321 Brufen LEAFLET 20131119

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.



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. 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.

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





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.

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?

Can you take Brufen with other medicines?

3. How should you take Brufen Syrup?

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:

4. Possible side effects of Brufen Syrup.
5. How should you store Brufen Syrup?
6. Further information about Brufen Syrup.
1. WHAT BRUFEN SYRUP IS & WHAT IT IS USED FOR?
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.



diuretics (water tablets)



cardiac glycosides, such as digoxin, used to treat heart
conditions



lithium

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.



zidovudine (an anti-viral drug)



steroids (used in the treatment of inflammatory conditions)



methotrexate (used to treat certain cancers)

The active ingredient in Brufen Syrup is ibuprofen. Each 5ml
spoonful of Brufen Syrup contains 100mg ibuprofen.



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).

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?

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.

Medicines such as Brufen Syrup have been associated with a small
increased risk of heart attack (myocardial infarction) or stroke.

3. HOW SHOULD YOU TAKE BRUFEN SYRUP?

Very rarely Brufen Syrup may cause aseptic meningitis
(inflammation of the protective membrane surrounding the brain).

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.

Blood disorders, kidney problems, liver problems or severe skin
reactions may occur rarely with ibuprofen.

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

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.

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.

The usual dose in children is 20 mg per kg of bodyweight each day,
in divided doses. This can be given as follows:

By reporting side effects, you can help provide more information on
the safety of this medicine.

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

5. HOW SHOULD YOU STORE BRUFEN SYRUP?

8-12 years: Two 5 ml (200 mg) doses three/four times a day



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

The doctor may choose to increase this dose in children with
juvenile rheumatoid arthritis.



Do not store above 25°C.



Store in the original package to protect from light.



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.

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. 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 THE 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.



Severe sore throat with high fever.



Blurred or disturbed vision or seeing/hearing strange things.



Fluid retention (e.g. swollen ankles).

6. FURTHER INFORMATION ABOUT BRUFEN SYRUP
What Brufen Syrup contains


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

PL No: 19488/1321

Leaflet revision date: 19 November 2013.
Brufen is a registered trade mark of Abbott GmbH & Co. KG,
Germany.
S1321 Brufen LEAFLET 20131119

S1321 Ibuprofen LEAFLET 20131119

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.



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 Ibuprofen 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. 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.

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 Ibuprofen 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





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.

Tell your doctor or pharmacist if you experience any side effects

Leaflet contents:
1. What is Ibuprofen Syrup & what is it used for?
2. What should you know before taking Ibuprofen Syrup?

Can you take Ibuprofen with other medicines?

3. How should you take Ibuprofen Syrup?

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:

4. Possible side effects of Ibuprofen Syrup.
5. How should you store Ibuprofen Syrup?
6. Further information about Ibuprofen Syrup.
1. WHAT IBUPROFEN SYRUP IS & WHAT IT IS USED FOR?
Ibuprofen 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.



diuretics (water tablets)



cardiac glycosides, such as digoxin, used to treat heart
conditions



lithium

Ibuprofen 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.



zidovudine (an anti-viral drug)



steroids (used in the treatment of inflammatory conditions)



methotrexate (used to treat certain cancers)

The active ingredient in Ibuprofen Syrup is ibuprofen. Each 5ml
spoonful of Ibuprofen Syrup contains 100mg ibuprofen.



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).

2. WHAT SHOULD YOU KNOW BEFORE TAKING IBUPROFEN
SYRUP?
If the answer to any of the following questions is 'YES' please
tell your doctor or pharmacist BEFORE taking any Ibuprofen
Syrup:








Are you pregnant or planning to become pregnant, or are you
breast-feeding? Ibuprofen 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 Ibuprofen 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?

Other information about Ibuprofen 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 Ibuprofen Syrup whilst
pregnant or breast feeding should be avoided. Ibuprofen 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: Ibuprofen 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.

Medicines such as Ibuprofen Syrup have been associated with a
small increased risk of heart attack (myocardial infarction) or stroke.

3. HOW SHOULD YOU TAKE IBUPROFEN SYRUP?

Very rarely Ibuprofen Syrup may cause aseptic meningitis
(inflammation of the protective membrane surrounding the brain).

ALWAYS take Ibuprofen 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.

Blood disorders, kidney problems, liver problems or severe skin
reactions may occur rarely with ibuprofen.

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.
Ibuprofen has also been shown to sometimes worsen the
symptoms of Crohn’s disease or colitis.
Reporting of side effects

Children - Ibuprofen 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.

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.

The usual dose in children is 20 mg per kg of bodyweight each day,
in divided doses. This can be given as follows:

By reporting side effects, you can help provide more information on
the safety of this medicine.

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

5. HOW SHOULD YOU STORE IBUPROFEN SYRUP?

8-12 years: Two 5 ml (200 mg) doses three/four times a day



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

The doctor may choose to increase this dose in children with
juvenile rheumatoid arthritis.



Do not store above 25°C.



Store in the original package to protect from light.



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.

This dose should not exceed 40mg/kg bodyweight daily in divided
doses.
IF YOU TAKE MORE IBUPROFEN 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 IBUPROFEN 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 IBUPROFEN SYRUP
As with all medicines, Ibuprofen 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 Ibuprofen 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 THE 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.



Severe sore throat with high fever.



Blurred or disturbed vision or seeing/hearing strange things.



Fluid retention (e.g. swollen ankles).

6. FURTHER INFORMATION ABOUT IBUPROFEN SYRUP
What Ibuprofen Syrup contains


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

PL No: 19488/1321

Leaflet revision date: 19 November 2013.
S1321 Ibuprofen LEAFLET 20131119

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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