Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking BRUFEN PAIN?
BRUFEN PAIN contains the active ingredient ibuprofen. BRUFEN PAIN is used for the
temporary relief of pain and/or inflammation associated with headache, migraine headache,
tension headache, sinus pain, toothache, dental procedures, backache, muscular aches
and pains, period pain, sore throat, tennis elbow, arthritis, rheumatic pain, and
the aches and pains associated with colds and flu. It also reduces fever.
2. What should I know before I take BRUFEN PAIN?
Do not use if you have allergy to ibuprofen, aspirin, NSAIDs or any of the ingredients
listed at the end of the CMI.
Talk to your doctor or pharmacist if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with BRUFEN PAIN and affect how it works.
4. How do I take BRUFEN PAIN?
Adults and Children from 12 years: One tablet every 4 to 6 hours as necessary. Do
not take more than 3 tablets in 24 hours.
Do not give to children under 12.
Do not exceed recommended dose. Excessive use can be harmful and increase the risk
of heart attack, stroke or liver damage.
5. What should I know while taking BRUFEN PAIN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using BRUFEN PAIN.
If you become pregnant while taking this medicine tell your doctor immediately.
If you are going to have surgery, make sure the surgeon and anaesthetist knows you
are taking BRUFEN PAIN. NSAID medicines can slow down blood clotting.
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Things you should not do
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Do not take BRUFEN PAIN with any other medicines containing ibuprofen, aspirin or
other anti-inflammatory medicines unless your doctor tells you to.
Do not take more than the recommended dose unless your pharmacist or doctor tells
you to.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how BRUFEN
PAIN affects you. BRUFEN PAIN may cause dizziness in some people. If this happens,
do not drive or operate machinery.
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Drinking alcohol
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Tell your doctor or pharmacist if you drink alcohol.
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Looking after your medicine
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Keep your medicine in a cool dry place where the temperature stays below 25°C.
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6. Are there any side effects?
Side effects are uncommon. The most common of these include headache, nausea, abdominal
pain and heartburn.
Active ingredient(s):
Ibuprofen
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BRUFEN PAIN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using BRUFEN PAIN.
Where to find information in this leaflet:
1. Why am I taking BRUFEN PAIN?
BRUFEN PAIN contains the active ingredient ibuprofen. BRUFEN PAIN belongs to a group of medicines called non-steroidal anti- inflammatory
drugs (or NSAIDs).
BRUFEN PAIN is used for the temporary relief of pain and/or inflammation associated
with headache, migraine headache, tension headache, sinus pain, toothache, dental
procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow,
arthritis, rheumatic pain, and the aches and pains associated with colds and flu.
It also reduces fever.
2. What should I know before I take BRUFEN PAIN?
Warnings
Do not use BRUFEN PAIN if:
you are allergic to ibuprofen, aspirin, NSAIDs or any of the ingredients listed at
the end of this leaflet.
Many medicines used to treat headache, period pain and other aches and pains contain
aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines,
ask your pharmacist.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
shortness of breath;
wheezing or difficulty breathing;
swelling of the face, lips, tongue or other parts of the body; and rash, itching or
hives on skin.
you have asthma that is sensitive to aspirin or NSAIDs
you have a peptic ulcer (ie stomach or duodenal ulcer), or a recent history of one,
or have had peptic ulcers before;
you have recently (or have previously) vomited blood or material that looks like coffee
grounds
you have recently (or previously) bled from the back passage (rectum), had black sticky
bowel motions (stools) or bloody diarrhoea
you have a condition resulting in an increased tendency to bleed
you have or have had a history of, Ulcerative Colitis or Crohn’s Disease
you have severe kidney disease
you have severe heart failure
you have severe liver disease
you are being treated for pain following heart bypass surgery
Check with your doctor or pharmacist if you:
have any other medical conditions
take any medicines for any other condition
have asthma
have heart disease or high blood pressure
have heartburn, indigestion, stomach ulcer or any other stomach problems
are vomiting blood or bleeding from the back passage
have severe skin reactions such as Stevens-Johnson syndrome
have vision problems
have liver or kidney disease
have a tendency to bleed or other blood problems
have bowel or intestinal problems such as ulcerative colitis
have heart failure
have swelling of ankles or feet
have diarrhoea
If you are over 65 years of age, talk to your pharmacist or doctor about taking BRUFEN
PAIN. Taking this medicine may increase the risk of you getting unwanted effects,
such as stomach or heart problems.
Tell your doctor or pharmacist if you currently have an infection.
If you take BRUFEN PAIN while you have an infection, it may hide some of the signs
and symptoms of an infection. This may make you think, mistakenly, that you are better or that it is not serious.
Tell your doctor or pharmacist if you plan to have surgery.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
BRUFEN PAIN is only available from your pharmacist.
BRUFEN PAIN is not addictive.
Pregnancy and breastfeeding
Do not take BRUFEN PAIN if you are pregnant, or intend to become pregnant or during
the first 6 months of pregnancy, except on doctor’s advice. Do not use at all in the
last three months of pregnancy.
It may affect your developing baby if you take it during pregnancy. It may also impair
female fertility.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Like most NSAID medicines, BRUFEN PAIN is not recommended while you are breast-feeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and ibuprofen may interfere with each other. These include:
warfarin or clopidogrel, medicines used to stop blood clots
lithium, a medicine used to treat mood swings and some types of depression
SSRIs such as sertraline, medicines used to treat depression
medicines used to treat high blood pressure or other heart conditions
methotrexate, a medicine used to treat arthritis and some types of cancer
medicines used to treat heart failure such as digoxin
medicines such as prednisone, prednisolone and cortisone, which reduce the activity
of your immune system
cyclosporine or tacrolimus, medicines used to treat certain problems with the immune
system or to help prevent organ transplant rejection
aminoglycosides, medicines used to treat certain infections
quinolone antibiotics, medicines used to treat certain infections
mifepristone, a medicine used to bring about an abortion
zidovudine, a medicine used to treat HIV infection
aspirin, salicylates and other non- steroidal anti-inflammatory drugs (NSAIDs)
medicines used to treat diabetes
probenecid, a medicine used to treat gout
phenytoin, a medicine used to treat epilepsy.
These medicines may be affected by BRUFEN PAIN, or may affect how well it works. You
may need to take different amounts of your medicine, or you may need to take different
medicines. Your doctor or pharmacist will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BRUFEN PAIN.
4. How do I take BRUFEN PAIN?
How much to take
Adults and Children from 12 years: One tablet every 4 to 6 hours as necessary.
Do not take more than 3 tablets in 24 hours.
Do not give to children under 12.
Follow the instructions provided with the medicine.
Do not exceed the recommended dosage.
Excessive use can be harmful and increase the risk of heart attack, stroke and liver
damage.
When to take BRUFEN PAIN
Take BRUFEN PAIN by mouth with water.
BRUFEN PAIN should not be used for more than 3 days at a time, except on medical advice.
If you take too much BRUFEN PAIN
If you think that you have taken too much BRUFEN PAIN, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking BRUFEN PAIN?
Things you should do
If you become pregnant while taking this medicine tell your doctor immediately.
If you are going to have surgery, make sure the surgeon and anaesthetist know you
are taking BRUFEN PAIN.
NSAID medicines can slow down blood clotting.
Tell your pharmacist or doctor if your symptoms do not improve. Your pharmacist or
doctor will assess your conditions and decide if you should continue to take the medicine.
Remind any doctor, dentist or pharmacist you visit that you are using BRUFEN PAIN.
Things you should not do
Do not take BRUFEN PAIN with any other medicines containing ibuprofen, aspirin or
other anti-inflammatory medicines unless your doctor tells you to.
Do not take BRUFEN PAIN to treat any other complaints unless your pharmacist or doctor
tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not take more than the recommended dose unless your pharmacist or doctor tells
you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BRUFEN
PAIN affects you.
BRUFEN PAIN may cause dizziness in some people. If this happens, do not drive or operate
machinery.
Drinking alcohol
Tell your doctor or pharmacist if you drink alcohol.
Looking after your medicine
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions.
Less serious side effects
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Less serious side effects
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What to do
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Stomach related:
nausea or vomiting
cramps, wind, constipation or diarrhoea
heartburn, or pain in the upper part of your stomach
loss of appetite
Head related:
buzzing or ringing in the ears or other trouble hearing
headache
sleeplessness,
changes in mood, for example depression, confusion, nervousness
dizziness
sleepiness
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Speak to your doctor or pharmacist if you have any of these less serious side effects
and they worry you.
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Serious side effects
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Serious side effects
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What to do
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Blood related:
vomiting blood or material that looks like coffee grounds
bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
blood disorders may occur with this medicine.
bleeding or bruising more easily than normal, reddish or purplish blotches under the
skin
signs of anaemia, such as tiredness, headaches, being short of breath and looking
pale
Skin related:
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens
Johnson Syndrome)
symptoms of sunburn (such as redness, itching swelling, blistering) which may occur
more quickly than usual
Heart related:
This medicine may be associated with a small increased risk of heart attack (myocardial
infarction)
fast or irregular heartbeats, also called palpitations
Stomach related:
severe pain or tenderness in the stomach
nausea, stomach ache
Head related:
severe or persistent headache
Immune system related:
headache and stiff neck
fever, generally feeling unwell,
signs of frequent or worrying infections such as fever, severe chills, sore throat
or mouth ulcers
Eye related:
eye problems such as blurred vision, sore red eyes, itching
Liver related:
yellowing of the skin and/or eyes, also called jaundice
Kidney related:
unusual weight gain, swelling of ankles or legs
fluid retention
tingling of the hands and feet
Allergy related:
asthma, wheezing, shortness of breath or difficulty breathing
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
hives, itching or skin rash
stomach ache, fever, chills, nausea and vomiting
fainting
If you are allergic to aspirin or NSAID medicines and take BRUFEN PAIN, these allergy
related symptoms may be severe.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
7. Product details
This medicine is available over-the-counter without a doctor's prescription.
What BRUFEN PAIN contains
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Active ingredient
(main ingredient)
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Ibuprofen
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Other ingredients
(inactive ingredients)
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Microcrystalline cellulose
Povidone
Croscarmellose sodium
Sodium lauryl sulfate
Colloidal anhydrous silica
Stearic acid
Macrogol 6000
Hypromellose
Titanium dioxide
Purified talc
Lactose monohydrate
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Potential allergens
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Lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What BRUFEN PAIN looks like
BRUFEN PAIN tablets (AUST R 401754) are white to off- white, pillow-shaped, film coated
tablets, plain on both sides.
Who distributes BRUFEN PAIN
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in January 2024.
BRUFEN® is a Viatris company trade mark
BRUFEN PAIN_cmi\Jan24/00