BRUFEN TABLETS 200MG

Active substance: IBUPROFEN

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BRUFEN® TABLETS
Ibuprofen
200, 400 & 600 mg

Brufen Tablets belong to a group of medicines called anti-inflammatory
pain killers. They can be used to relieve pain and inflammation in
conditions such as osteoarthritis, rheumatoid arthritis (including
juvenile rheumatoid arthritis or Still’s disease), arthritis of the spine
(ankylosing spondylitis), swollen joints, frozen shoulder, bursitis,
tendinitis, tenosynovitis, lower back pain, sprains and strains.



Keep this leaflet as you may need to read
it again



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



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

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







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 Tablets 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)?
Have you been told by your doctor that you have an intolerance to
some sugars?

Can you take Brufen with other medicines? Some medicines that
are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/
The active ingredient in Brufen Tablets is ibuprofen and each tablet acetylsalicyclic acid, warfarin, ticlodipine), some medicines that reduce
contains either 200, 400 or 600 mg.
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
2. What should you know before taking Brufen Tablets?
with ibuprofen. You should therefore always seek the advice of your
doctor or pharmacist before you use ibuprofen with other medicines.
If the answer to any of the following
In particular you should tell your doctor or pharmacist if you are taking
questions is ‘YES’ please tell your
any of the following medicines in addition to those mentioned above:
doctor or pharmacist BEFORE taking
·
diuretics (water tablets)
any Brufen Tablets:
·
cardiac glycosides, such as digoxin, used to treat heart conditions
·
lithium
• Are you pregnant or planning to become pregnant, or are you ·
zidovudine (an anti-viral drug)
breast-feeding? Brufen Tablets may make it more difficult to ·
steroids (used in the treatment of inflammatory conditions)
become pregnant. You should inform your doctor if you are ·
methotrexate (used to treat certain cancers)
planning to become pregnant or if you have problems becoming ·
medicines known as immunosuppressants such as ciclosporin
and tacrolimus (used to dampen down your immune response)
pregnant.
medicines known as selective serotonin reuptake inhibitors (SSRIs),
• Are you sensitive (allergic) to any of the ingredients in the tablets? ·
used for the treatment of depression
These are listed in Section 6.
antibiotics called quinolones such as ciprofloxacin
• Do you have, or have you previously had, a stomach ulcer or other ·
·
aminoglycosides (a type of antibiotic)
gastric complaint?
·
mifepristone
Do not take Brufen Tablets if you currently have a peptic ulcer ·
any other ibuprofen preparations, such as those you can buy
(ulcer in your stomach or duodenum) or bleeding in your stomach,
without a prescription
or have had two or more episodes of peptic ulcers, stomach ·
any other anti-inflammatory pain killer, including aspirin
bleeding or perforation in the past.
·
cholestyramine (a drug used to lower cholesterol)
medicines known as sulphonylureas such as glibenclamide (used
• Do you have a condition which increases your tendency to bleeding? ·

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FRONT

MKP-00779-2011_d2



1. What are Brufen Tablets & what are they used for?

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



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

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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).
Pregnancy and breast-feeding: The use of Brufen whilst pregnant
or breast feeding should be avoided.
Brufen 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 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 Tablets?
ALWAYS take Brufen Tablets 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 Tablets with or after food, with a glass of water. Brufen
Tablets should be swallowed whole and not chewed, broken,crushed
or sucked to help prevent discomfort in the mouth or irritation in the
throat.
DOSAGE:
Adults - The usual dosage is 600 to 1800 mg spread throughout the
day. Your doctor may choose to increase this depending on what you
are being treated for, but no more than 2400 mg should be taken in
one day.
Children - The usual daily dosage is 20 mg per kg of bodyweight,
given in divided doses. Brufen Tablets should NOT be taken by
children weighing less than 7 kg.
In cases of severe juvenile arthritis your doctor may increase the
dosage up to 40 mg/kg in divided doses.
IF YOU TAKE MORE BRUFEN TABLETS THAN PRESCRIBED
(AN OVERDOSE) you should contact a doctor or go to the nearest
hospital casualty department IMMEDIATELY taking your tablets with
you.
IF YOU FORGET TO TAKE YOUR BRUFEN TABLET
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.

They should be kept in their original packaging, do NOT take Brufen
Tablets after the ‘use by’ date shown on the carton.
As with all medicines, Brufen Tablets may cause side effects, although If your doctor decides to stop your treatment, return any left over
they are usually mild and not everyone will suffer from them. If any side tablets to your pharmacist. Only keep the tablets if your doctor tells you to.
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 6. Further information about Brufen Tablets.
minimise the risk of side effects by taking the least amount of tablets
The active substance in Brufen Tablets is Ibuprofen Ph.Eur. available
for the shortest amount of time necessary to control your symptoms.
as either 200, 400 or 600 mg tablets.
If you suffer from any of the following at any time during your treatment The tablets are white, pillow-shaped and film-coated.
STOP TAKING Brufen Tablets and seek immediate medical help:
• Severe headache, high temperature, stiffness of the neck or They are supplied in blister packs containing either 60 or 100 tablets.
4. Possible side effects of Brufen Tablets

intolerance to 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 TABLETS IF
YOU EXPERIENCE:
• Unexplained stomach pain or other abnormal stomach symptoms,
indigestion, heartburn, feeling sick and/or vomiting
• Unexplained wheezing, shortness of breath, skin rash, itching or
bruising
• Yellowing of the eyes and/or skin.
• Severe sore throat with high fever
• Blurred or disturbed vision or seeing/hearing strange things.
• Fluid retention (e.g. swollen ankles)
Medicines such as Brufen Tablets have been associated with a small
increased risk of heart attack (myocardial infarction) or stroke.

Marketing Authorisation Holder:
Abbott Laboratories Ltd.,
Abbott House, Vanwall Business Park,
Vanwall Road, Maidenhead, Berkshire, SL6 4XE, UK.
Manufacturer:
FAMAR S.A., 7 Anthousas Av.,
153 44 Anthousa Attiki, Greece.
Leaflet was last approved in March 2012

Blood disorders, kidney problems, liver problems or severe skin
reactions may occur rarely with ibuprofen.
Very rarely Brufen Tablets 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 has also been shown to sometimes worsen the symptoms of
Crohn’s disease or colitis.
5. How should you store Brufen Tablets?
Your tablets should not be stored above 25°C. They should be kept in
a safe place out of the reach and sight of children, your medicine could
harm them.

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BACK

MKP-00779-2011_d2

Brufen Tablets inactive ingredients: microcrystalline cellulose,
croscarmellose sodium, lactose monohydrate, colloidal anhydrous
silica, sodium laurilsulfate, magnesium stearate, Opaspray white
M-1-7111B (comprising hypromellose 2910 and titanium dioxide), dry
colour dispersion, white 06A28611 (or a combination of Opaspray
white M-1-7111B, hypromellose and talc).

MKP-00779-2011

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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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