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IBUPROFEN 600MG EFFERVESCENT GRANULES

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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Patient Information Leaflet

Brufen® 600mg Granules /
Ibuprofen 600mg Effervescent Granules
(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
 This leaflet provides a summary of the information currently available
about Brufen Granules
 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
 Your medicine is available using either of the above names but will be
referred to as Brufen Granules throughout the remainder of this leaflet.
Leaflet contents:
1) What are Brufen Granules & what are they used for?
2) What should you know before taking Brufen Granules?
3) How should you take Brufen Granules?
4) Possible side effects of Brufen Granules.
5) How should you store Brufen Granules?
6) Further information about Brufen Granules.
1) WHAT ARE BRUFEN GRANULES & WHAT ARE THEY USED
FOR?
Brufen Granules belong 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 Granules 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 Granules is ibuprofen and each sachet
contains 600 mg.
2) WHAT SHOULD YOU KNOW BEFORE TAKING BRUFEN
GRANULES?
If the answer to any of the following questions is ‘YES’ please tell
your doctor or pharmacist BEFORE taking any Brufen Granules:
 Are you pregnant or planning to become pregnant, or are you
breast-feeding? Brufen Granules 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 granules?
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 Granules 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 Granules 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
Granules 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 chickenpox or shingles?
 Has your doctor advised you to follow a low sodium diet?
 Have you been told by your doctor that you have an intolerance to
some sugars?
 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/acetylsalicylic acid, warfarin, ticlopidine), 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 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 Granules whilst pregnant or breast-feeding should be
avoided. Brufen Granules 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 Granules may make you feel dizzy or drowsy. If they affect you in
this way do not drive, operate machinery or do anything that requires you
to be alert.
Brufen Granules contain sucrose:
Sucrose is a sugar. If you have been told by your doctor that you cannot
tolerate or digest some sugars, talk to your doctor before taking this
medicine. Each sachet contains 3.3g sucrose. This should be taken into
account in patients with diabetes mellitus.
Brufen Granules contain sodium:
Brufen Granules contain 8.6mmol (197mg) sodium per sachet. This
should be taken into account if you are on a low sodium diet. You may
need to have less sodium in your diet because of the sodium in this
medicine.
3) HOW SHOULD YOU TAKE BRUFEN GRANULES?
ALWAYS take Brufen Granules 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 GRANULES by emptying the contents of the
sachet into a glass full of water to make an orange flavoured fizzy drink,
stir and drink immediately. Take with or after food.
DOSAGE:
Adults and children over 12 years – The usual dosage is 1 sachet
taken two or three times a day. Your doctor may choose to increase or
decrease this depending on what you are being treated for, but no more
than 4 sachets should be taken in one day.
Brufen Granules are NOT recommended 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 GRANULES THAN PRESCRIBED
(AN OVERDOSE) you should contact a doctor or go to the nearest
hospital casualty department IMMEDIATELY taking your granules with
you.
IF YOU FORGET TO TAKE YOUR BRUFEN GRANULES 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 GRANULES
As with all medicines, Brufen Granules 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 granules for the shortest
amount of time necessary to control your symptoms.
STOP TAKING Brufen Granules 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 THE GRANULES 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 Granules have been associated with a small
increased risk of heart attack (myocardial infarction) or stroke.
Medicines such as Brufen Granules 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 Granules may cause aseptic meningitis (inflammation
of the protective membrane surrounding the brain).
Brufen 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 a 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 GRANULES?
 Your granules 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.
 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
product 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 GRANULES

A burning feeling in the throat or mouth may happen briefly after taking
this medicine.

What Brufen Granules contain
Each sachet contains 600mg Ibuprofen in effervescent granule form.

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

The other ingredients are: sucrose, malic acid, sodium bicarbonate,
anhydrous sodium carbonate, orange flavour, sodium saccharin,
povidone and sodium lauryl sulphate.

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 Granules look like and contents of the pack
Brufen Granules are white, fine to coarse granules with an orange odour
Each pack contains 20 or 30 sachets.
Manufactured by
AbbVie S.r.l., Campoverde di Aprilia (Latina), Italy.
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: 33532/0471
Leaflet dated 18th August 2016
Leaflet coded XXXXXXXXXX

POM

Brufen® is a registered trademark of XXXXXXXXXXXXXXXXXXXX.

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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