BRUFEN RETARD 800 MG PROLONGED RELEASE TABLETS

Patient Information Leaflet

Brufen® Retard 800 mg Prolonged Release Tablets
(ibuprofen)
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
 The name of this medicine is Brufen® Retard 800 mg Prolonged
Release Tablets but will be referred to as Brufen Retard throughout the
remainder of this leaflet
 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 breastfeeding? 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 antiinflammatory 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 Retard with other medicines?
Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting
e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine), some medicines
that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers 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 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 doctor.
Driving and Using Machines:
Brufen Retard 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 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.
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 RETARD 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 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.
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).
Brufen Retard has also been shown to sometimes worsen the symptoms
of Crohn’s disease or colitis.

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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
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 room temperature (do not store above
25°C).
 They should be kept in a safe place out of the sight and reach of
children, your medicine could harm them.
 Store in the original packaging in order to protect from moisture.
 Do not use this medicine after its expiry date. The expiry date refers to
the last day of that month.
 If your medicine becomes discoloured or shows any sign of
deterioration, return them to your pharmacist.
 If your doctor decides to stop your treatment, return any leftover tablets
to your pharmacist. Only keep them 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 no longer
required. These measures will help to protect the environment.
6) FURTHER INFORMATION ABOUT BRUFEN RETARD

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

What Brufen Retard contains
Each tablet contains the active ingredient ibuprofen 800 mg in a
prolonged release formulation.
The other ingredients are: colloidal anhydrous silica, povidone, stearic
acid, xanthan gum, hypromellose, talc, opaspray white M-1-7111B
(containing: hypromellose, titanium dioxide)
What Brufen Retard looks like and contents of the pack
Brufen Retard are white pillow-shaped, film-coated, prolonged release
tablets. They come in PVC/PVDC/aluminium blister strips in a printed
carton.
Each pack contains 60 tablets.
Manufactured by
FAMAR S.A., 7 Anthousas Ave, 153 44 Anthousa Attiki, Greece
AbbVie Deutschland GmbH & Co. KG, Knollstrasse 50, 67061
Ludwigshafen, Germany
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXX
PL: 33532/0412

POM
rd

Leaflet dated 23 December 2016
Leaflet coded XXXXXXXXXX
Brufen® is a registered trademark of XXXXXXXXXXXXXXXXXXXX.

To request a copy of this leaflet in Braille, large print
or audio please call 01922 745645 and ask for the
Regulatory Department.