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BRUFEN TABLETS 200MG

Active substance(s): IBUPROFEN

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BRUFEN®TABLETS
Ibuprofen
200 mg

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 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

Leaflet Contents
1
2
3
4
5
6

What are Brufen Tablets & what are they used for?
What should you know before taking Brufen Tablets?
How should you take Brufen Tablets?
Possible side effects of Brufen Tablets.
How should you store Brufen Tablets?
Further information about Brufen Tablets.

1. What are Brufen Tablets & what are they used for?
Brufen Tablets belongs 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.
Brufen Tablets 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 Tablets is ibuprofen and each tablet contains 200 mg.
2. What should you know before taking Brufen Tablets?
If the answer to any of the following questions is 'YES' please tell your doctor or pharmacist
BEFORE taking any Brufen Tablets:






Are you pregnant or planning to become pregnant, or are you breast‐feeding? Brufen
tablets 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 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 Tablets 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 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. You should discuss
your treatment with your doctor or pharmacist before taking Brufen Tablets 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?
Is your child dehydrated? As 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 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

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 (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).
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 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 and children over 12 years ‐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 dose is 20 mg per kg of bodyweight each day, 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 my increase the dosage up to 40 mg/kg 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 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 TABLETS 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.
4. Possible side effects of Brufen Tablets
As with all medicines, Brufen Tablets 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 tablets for the shortest amount of time
necessary to control your symptoms.

STOP TAKING Brufen

Tablets and seek immediate medical help if you experience:
• 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 TABLETS 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 Tablets have been associated with a small increased risk of heart attack
(myocardial infarction) or stroke.
Medicines such as Brufen Tablets 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.
Very rarely Brufen Tablets 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.
Other side effects
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):

feeling drowsy

feeling anxious

feeling a tingling sensation or ‘pins and needles’

difficulty sleeping

hives, itching

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)
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’.

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 National
reporting systems listed below:
UK:

The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
MALTA:
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects, you can help provide more information on the safety of this medicine.
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 as your medicine could harm them. They should be kept in their
original packaging. Do NOT take Brufen Tablets after the ‘use by’ date shown on the carton. If
your doctor decides to stop your treatment, return any leftover tablets to your pharmacist. Only
keep the tablets if your doctor tells you to.
6. Further information about Brufen Tablets
The active substance in Brufen Tablets is Ibuprofen Ph.Eur. available as a 200 mg tablet. The
tablets are white, pillow shaped and film‐coated.
They are supplied in blister packs containing 60 tablets.
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).
Marketing Authorisation Holder: BGP Products 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 revised in February 2016.
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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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