Active substance: IBUPROFEN

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Ibuprofen 800 mg
Sustained-Release Tablets

Read all of this leaflet carefully before
you start taking this medicine

Keep this leafl et as you may need to read
it again

This leaflet provides a summary of the
information currently available about Brufen

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

1. What is Brufen Retard & what is it used for?
Brufen Retard belongs to a group of medicines called antiinflammatory pain killers. They can be used to relieve pain and
inflammation in conditions such as osteoarthritis, rheumatoid arthritis
(including juvenile rheumatoid arthritis or Still’s disease), arthritis of the
spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis,
tendinitis, tenosynovitis, lower back pain, sprains and strains.

Brufen Retard can also be used to treat other painful conditions such
as toothache, pain after operations, period pain and headache,
including migraine.
The active ingredient in Brufen Retard is ibuprofen and each tablet
contains 800 mg in a sustained-release formulation. This is designed
to release ibuprofen gradually into your blood stream throughout the

For further information or advice ask your
doctor or pharmacist

Leaflet contents:
1. What is Brufen Retard & what is it used for?
2. What should you know before taking Brufen Retard?
3. How should you take Brufen Retard?
4. Possible side effects of Brufen Retard.
5. How should you store Brufen Retard?
6. Further information about Brufen Retard.

2. What should you know before taking Brufen Retard?
If the answer to any of the following
questions is ‘YES’ please tell your
doctor or pharmacist BEFORE taking
any Brufen Retard tablets:

Are you pregnant or planning to become pregnant, or are you
breast-feeding? Brufen Retard 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
Are you sensitive (allergic) to any of the ingredients in
the tablets? 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 Retard 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 Retard 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.
Do you have systemic lupus erythematosus (SLE, sometimes
known as lupus) or a connective tissue disease (autoimmune
diseases affecting connective tissue)?
Can you take Brufen Retard 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
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)
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).




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Pregnancy and breast-feeding: The use of Brufen Retard whilst
pregnant or breast feeding should be avoided. Brufen Retard 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
Driving and Using Machines: Brufen Retard may make you feel
dizzy or drowsy. If the tablets 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 Retard?
ALWAYS take Brufen Retard 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 RETARD TABLETS with a glass of water.
You should swallow the tablets whole without chewing, breaking,
crushing or sucking on them to help prevent feeling discomfort in the
mouth or irritation in the throat. The tablets are best taken in the
early evening, well before retiring to bed. Take your Brufen Retard
with or after food.
Your dosage will depend on what you are being treated for, the usual
dose is two tablets taken as a single dose each day, preferably in the
evening. In severe or acute conditions, your doctor may prescribe one
extra tablet to be taken each morning in addition to the usual dose.
Brufen Retard is NOT suitable for children under 12 years of age.
(AN OVERDOSE) you should contact a doctor or go to the nearest
hospital casualty department IMMEDIATELY taking your tablets with
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.

minimise the risk of side effects by taking the least amount of tablets
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 Retard 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
• Unexplained stomach pain or other abnormal stomach symptoms,
indigestion, heartburn, feeling sick and/or vomiting
• Unexplained wheezing, shortness of breath, skin rash, itching or
• 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).

If your doctor decides to stop your treatment, return any left over
tablets to your pharmacist. Only keep the tablets if your doctor tells you to.
6. Further information about Brufen Retard
The active substance in Brufen Retard is Ibuprofen, in a sustainedrelease (slow-release) formulation. The tablets are available in calendar
packs, each containing 56 tablets.
Brufen Retard ingredients: Each tablet contains 800mg of Ibuprofen
PhEur, xanthan gum, povidone, hypromellose, stearic acid, colloidal
anyhydrous silica, talc and Opaspray White M-1-7111B (containing
hypromellose and titanium dioxide).
Marketing Authorisation Holder:
Abbott Laboratories Ltd.,
Abbott House, Vanwall Business Park,
Vanwall Road, Maidenhead, Berkshire, SL6 4XE, UK.
Manufacturer: Famar S.A., 7 Anthousas Ave.,
153 44 Anthousa, Attiki, Greece.
Leaflet was last approved in March 2012.

Medicines such as Brufen Retard 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 Retard 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, diarrhoea, constipation,
flatulence (wind), unexpected sensitivity of the skin to the sun,
tiredness, malaise, mood swings and swelling and irritation inside the nose.
Brufen Retard has also been shown to sometimes worsen the
symptoms of Crohn’s disease or colitis.
5. How should you store Brufen Retard?

4. Possible side effects of Brufen Retard
As with all medicines, Brufen Retard 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

Your tablets should be stored at normal room temperature (below
25 °C) in a safe place out of the reach and sight of children, your
medicine could harm them.
They should be kept in their original packaging, do NOT take Brufen
Retard after the ‘use by’ date shown on the carton.





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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.