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BRUFEN RETARD

Active substance(s): IBUPROFEN

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FOR POSITION ONLY

Brufen® Retard
Ibuprofen 800 mg
Sustained-Release Tablets

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 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

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.
1. 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 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 day.

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:
• 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 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 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 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?
• 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

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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 it affects 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 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

FOR POSITION ONLY

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.

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

IF YOU TAKE MORE BRUFEN RETARD THAN PRESCRIBED (AN
OVERDOSE) you should contact a doctor or go to the nearest hospital
casualty department IMMEDIATELY taking your tablets with you.

Brufen Retard has also been shown to sometimes worsen the
symptoms of Crohn’s disease or colitis.

IF YOU FORGET TO TAKE YOUR BRUFEN RETARD TABLETS
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 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.
STOP TAKING Brufen Retard 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 RETARD 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 Retard have been associated with a small
increased risk of heart attack (myocardial infarction) or stroke.
Medicines such as Brufen Retard have in exceptional cases been
associated with severe skin problems for patients with chicken pox
or shingles

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

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

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• 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 Retard?
Your tablets should be stored at normal room temperature (below
25 °C) 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 Retard 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 Retard
The active substance in Brufen Retard is Ibuprofen, in a sustained
release (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:
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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