BRUFEN RETARD

Active substance: IBUPROFEN

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Add/Amend: To bring the current granted leaflet in line with the leaflet granted through variation 0005 which was assessed against
the UK PIL dated May 2014 and include the manufacturer updated through variation 0003.

Patient Information Leaflet

Brufen® Retard 800 mg Tablets
(ibuprofen)
Assessed against UK PIL dated May 2014
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 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. 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 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
tablets:
• 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. If you have heart
problems, previous stroke or think that you might be at risk of these
conditions (e.g. if you have high blood pressure, diabetes, high
cholesterol or are a smoker) you should discuss your treatment with
your doctor or pharmacist.
• Do you have systemic lupus erythematosus (SLE, sometimes known
as lupus) or a connective tissue disease (autoimmune diseases
affecting connective tissue)?
• 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/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)
• 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 preparations, 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 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 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.

Add/Amend: To bring the current granted leaflet in line with the leaflet granted through variation 0005 which was assessed against
the UK PIL dated May 2014 and include the manufacturer updated through variation 0003.
4) POSSIBLE SIDE EFFECTS OF BRUFEN RETARD

6) FURTHER INFORMATION ABOUT 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 tablets for the shortest
amount of time necessary to control your symptoms.

What Brufen Retard contains
Each tablet contains 800 mg of ibuprofen in a sustained-release
formulation.

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.

What Brufen Retard looks like and contents of the pack
Brufen Retard are white, pillow-shaped, sustained-release tablets.

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, 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 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?
• Do not store above 25°
C.
• Keep the tablets in a safe place out of the sight and reach of children,
your medicine could harm them.
• Store in the original packaging.
• 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.

The other ingredients are: Silica colloidal anhydrous, Povidone, Stearic
acid, Xanthan gum, Talc, Hypromellose and Titanium dioxide (E171).

Each pack contains blister packs of 30 or 60 tablets.
Manufacturer
Famar S.A., 7 Anthousas Ave, 153 44 Anthousa Attiki, Athens, Greece
AbbVie Deutchland GmbH & Co. KG, Knollstrasse, 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, UK
Repackaged by MPT Pharma Ltd.
®

PL: 33532/0469 Brufen Retard 800 mg Tablets
th

Leaflet date: 28 January 2015
Leaflet code: XXXXXXXXXX
®

Brufen is a registered trademark of Abbott GmbH & Co. KG.

POM

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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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