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BRUFEN RETARD 800 MG SUSTAINED-RELEASE TABLETS

Active substance(s): IBUPROFEN

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PATIENT INFORMATION LEAFLET

BRUFEN® RETARD 800 mg
SUSTAINED-RELEASE
TABLETS

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?

(ibuprofen)
This medicine is available as the above name but will be
referred to as Brufen Retard throughout this leaflet.

Brufen Retard belongs to a group of medicines called antiinflammatory 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.

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

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 the 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 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)?
• 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/acetylsalicyclic acid, warfarin, ticlodipine),
some medicines that reduce high blood pressure (ACEinhibitors such as captopril, beta-blockers such as atenolol, or
angiotensin-Il 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)
• medicines known as immunosuppressants such as
ciclosporin and tacrolimus (used to dampen down your
immune response)
• medicines known as selective serotonin reuptake inhibitors
(SSRls), 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 (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 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.
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 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 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.
If you suffer from any of the following at any time during
your treatment STOP TAKING Brufen Retard and seek
immediate medical help:
• Severe headache, high temperature, stiffness of the neck or
intolerance to bright 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 Retard have been associated with a
small increased risk of heart attack (myocardial infarction) or
stroke.
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).
Other side effects may include headache, hallucinations,
dizziness, tingling of hands and feet, ringing in the ears,
depression, confusion, difficulty sleeping, anxiety, impaired
hearing, a temporary sensation of burning in the mouth or
throat, diarrhoea, constipation, flatulence (wind), unexpected
sensitivity of the skin to the sun, tiredness, malaise, mood
swings and swelling and irritation inside the nose. Brufen
Retard has also been shown to sometimes worsen the
symptoms of Crohn’s disease or colitis.

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 on the Yellow
Card Scheme website: 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?
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging in
order to protect from moisture.
Do NOT take Brufen Retard after the 'EXP' date shown on the
carton or blister. The expiry date refers to the last day of that
month.
If your doctor decides to stop your treatment, return any left
over tablets to your pharmacist. Only keep the tablets if your
doctor tells you to.
Do not throw them away with your normal household water or
waste. This will help to protect the environment.
If your medicine becomes discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will tell you
what to do.
6. Further information about Brufen Retard
The active substance in Brufen Retard is ibuprofen and each
tablet contains 800 mg of ibuprofen in a sustained-release
formulation. This is designed to release ibuprofen gradually into
your blood stream throughout the day.
Brufen Retard ingredients: xanthan gum, povidone, stearic
acid, colloidal anhydrous silica, talc, hypromellose and titanium
dioxide (E171).
Brufen Retard is a white, pillow-shaped, film-coated tablet with
no markings. It is available in blister packs containing 30 and 60
tablets.
PL: 15814/1196

POM

Manufactured by AbbVie Deutschland GmbH & Co. KG,
Ludwigshafen, Germany OR FAMAR S.A., 7 Anthoussas Ave.,
Anthousa Attiki, Greece.
Procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.):21.03.2016.
Brufen is a registered Trademark of Abbott GmbH & Co. KG.
To request a copy of this leaflet in Braille, large print or audio
please call 01923 332 796.

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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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