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BRUFEN GRANULES 600MG

Active substance(s): IBUPROFEN

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S1700 Leaflet Brufen 20160729

Package Leaflet: Information for the User

BRUFEN®

GRANULES 600mg

(Ibuprofen)
Your medicine is known as Brufen Granules 600mg but will be
referred to as Brufen Granules throughout the following leaflet.
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

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 preparations, such as those you can buy
without a prescription

1. WHAT ARE BRUFEN GRANULES & WHAT ARE THEY
USED FOR?



any other anti-inflammatory pain killer, including aspirin

Brufen Granules belong to a group of medicines called antiinflammatory 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.



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).



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 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.

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 chicken pox 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.

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 contains 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 contains sodium:
Brufen Granules contains 8.6 mmol (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.

S1700 Leaflet Brufen 20160729

Rare (affects up to 1 in a 1000 people):
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.



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 on the blood cells (anaemia)

STOP TAKING Brufen Granules and seek immediate medical
help if you experience:



serious allergic reaction which causes difficulty in breathing or
dizziness



Signs of aseptic meningitis such as severe headache, high
temperature, stiffness of the neck or intolerance to bright light.



severe sore throat with high fever (agranulocytosis)



Signs of intestinal bleeding such as

Very rare (affects up to 1 in 10,000 people):



Passing blood in your faeces (stools/motions)





liver failure

Passing black tarry stools





heart failure

Vomiting any blood or dark particles that look like coffee
grounds



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

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).

Not known (frequency cannot be estimated from available
data):



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

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?


Keep out of the sight and reach of children.



Do not store above 25°C.



Do not use after the expiry date printed on the on the carton
label and the sachet label.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of 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.

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

worsening of ulcerative colitis or Crohn’s Disease (inflammation
of the colon)

6. FURTHER INFORMATION ABOUT BRUFEN GRANULES
What Brufen Granules contains

Other side effects



The active substance in Brufen Granules is Ibuprofen. Each
sachet contains 600 mg Ibuprofen in effervescent granule form.



Brufen Granules inactive ingredients: croscarmellose sodium,
microcrystalline cellulose, anhydrous sodium carbonate, malic
acid, sodium saccharin, sucrose, povidone, sodium
bicarbonate, orange flavour, sodium lauryl sulphate.

Common (affects up to 1 in 10 people):


rash



feeling dizzy or tired



stomach pain, indigestion, diarrhea, feeling sick, being sick,
wind, constipation



headache – if this happens while you are taking this medicine it
is important not to take any other medicine for pain to help with
this.



passing black tarry stools



passing blood in your faeces (stools/motions)

 vomiting any blood
Uncommon (affects up to 1 in a 100 people):

What Brufen Granules looks like and contents of the pack


Brufen Granules are white to off white granules with an orange
odour.



Brufen Granules are available in packs of 20 and 40 sachets.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



feeling drowsy



feeling anxious



feeling a tingling sensation or ‘pins and needles’



difficulty sleeping

Manufacturer



hives, itching



skin becomes sensitive to light

This product is manufactured by AbbVie S.R.L., 04011
Campoverde di Aprilia, Latina, Italy.



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

POM

PL: 19488/1700

Leaflet revision date: 29 July 2016
Brufen is a registered trademark of Abbott Laboratories Ltd., UK.
S1700 Leaflet Brufen 20160729

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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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