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BRUFEN RETARD 800MG TABLETS

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Brufen® Retard 800mg Tablets
(ibuprofen)
Your medicine is available as the above name but will be
referred to as Brufen Retard throughout this leaflet.
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 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 belong 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 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 smoke).
 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.

3.

Can you take Brufen Retard with other medicines?
Some medicines that are anti-coagulants (i.e thin blood/prevent
clotting e.g. aspirin/acetylsalicuclic acid, warafin, ticlodipine),
some medicines that reduce high blood pressure (ACEinhibitors 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 your 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 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 gilbenclamide
(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 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.

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.

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 YOU 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 only 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 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 you
doctor or pharmacist. You can minimize the risk of side effects
by taking the least amount of tablets 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 the 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 you should store Brufen Retard?

 Keep out of the sight and reach of children
 Do not store above 25°C.
 Store in the original package in order to protect from
moisture.
 Do not use the Brufen Retard after the expiry date printed
on the packaging. The expiry date refers to the last day of
that month.
 If your solution become discoloured or shows any other
signs of deterioration, consult your pharmacist who will tell
you what to do.
 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

Each tablet contains 800mg of Ibuprofen in a sustained-release
formulation. Also contains: xanthan gum, povidone, colloidal
anhydrous silica, talc, stearic acid, hypromellose and titanium
dioxide (E171).
What Brufen Retard looks like and the contents of the
pack:
Brufen retard are white, capsule-shaped, film-coated prolonged
-release tablets, plain on both sides.
They are available in packs containing 60 tablets.
Manufacturer
Brufen Retard is manufactured by AbbVie Deutschland GmbH
& Co. KG Knollstrasse, 67061, Ludwigshafen, Germany.
or
FAMAR S.A 7 Anthoussas Ave., 153 44 Anthousa Attiki,
Greece.
Procured from within the EU and repackaged by the Product
licence Holder: G Pharma Ltd, Dakota Avenue, Salford
M50 2PU.
PL 16369/1631

POM

Leaflet revision: 1st February 2016
Brufen is a registered trademark of Mylan Healthcare GmbH.

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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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