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BRUFEN RETARD 800MG TABLETS

Active substance(s): IBUPROFEN / IBUPROFEN / 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 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 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 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).

Expand Transcript

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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