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Active substance(s): IBUPROFEN

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Ref: 1477/030517/1/F


Brufen Retard 800mg Sustained-Release Tablets
Patient Information Leaflet
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 Retard
* 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
Your medicine is called Brufen Retard 800mg Sustained-Relase Tablets and
will be referred to as Brufen Retard throughout the rest of this leaflet.
Leaflet Contents

What is Brufen Retard & what is it used for?


What should you know before taking Brufen Retard?


How should you take Brufen Retard?


Possible side effects of Brufen Retard.


How should you store Brufen Retard?


Further information about Brufen Retard.


What is Brufen Retard & what is it used for?

Brufen Retard belongs to a group of medicines called anti-inflammatory
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.
Brufen Retard can also be used to treat other painful conditions such as
toothache, pain after operations, period pain and headache, including
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 day.

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
* 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
it affects you in this way do not drive, operate machinery or do anything that
requires you to be alert.


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:
* 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 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
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
* 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 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. You should discuss your
treatment with your doctor or pharmacist before taking Brufen Retard if
- 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?
* Is your child dehydrated? As there is a risk of kidney damage in
dehydrated children and adolescents.

How should you take Brufen Retard?

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 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.
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.
OVERDOSE) you should contact a doctor or go to the nearest hospital
casualty department IMMEDIATELY taking your tablets with you.
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.


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 minimise the risk of
side effects by taking the least amount of Brufen Retard for the shortest
amount of time necessary to control your symptoms.

Ref: 1477/030517/1/B


Brufen Retard 800mg Sustained-Release Tablets
Patient Information Leaflet (continued)
STOP TAKING Brufen Retard and seek immediate medical help if you
* 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
* 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
* 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
Medicines such as Brufen Retard have been associated with a small
increased risk of heart attack (myocardial infarction) or stroke.

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 Yellow Card Scheme at:



Medicines such as Brufen Retard have in exceptional cases been
associated with severe skin problems for patients with chicken pox or


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


How should you store Brufen Retard?

Do not store above 25°C.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date shown on the carton and
blister label. If your doctor tells you to stop taking this medicine, take any
remaining medicine back to the pharmacist for safe disposal. Only keep
this medicine if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.

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

Further information about Brufen Retard

What this medicine contains:
Each tablet contains 800mg of ibuprofen in a sustained-release formulation.
Also contains xanthan gum, povidone, hypromellose, stearic acid,
colloidal anyhydrous silicon dioxide, talc and titanium dioxide (E171).
What this medicine looks like and contents of the pack
Each tablet is white, pillow-shaped film-coated, prolonged-release tablets,
plain on both sides.
Each pack contains 60 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by FAMAR AVE Anthoussa PLANT, 7
Anthoussa Ave., 153 44 Anthoussa Attiki, Greece and is procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.


PL 15184/1477

Brufen Retard 800mg
Sustained-Release Tablets

Brufen is a registered trademark of Abbott GmbH & Co. KG
Revision date: 03/05/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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