2. What should I know before I take BRUFEN PLUS 200/12.8?
Do not take if you have ever had an allergic reaction to BRUFEN PLUS 200/12.8 or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
You may develop addiction, dependence and tolerance. For more information, see Section
2. What should I know before I take BRUFEN PLUS 200/12.8? in the full CMI.
3. What if I am taking other medicines?
4. How do I take BRUFEN PLUS 200/12.8?
The usual dose of BRUFEN PLUS 200/12.8 is 2 tablets followed by, if necessary, 1 or
2 tablets every 4 hours.
More instructions can be found in Section
4. How do I take BRUFEN PLUS 200/12.8? in the full CMI.
5. What should I know while taking BRUFEN PLUS 200/12.8?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking BRUFEN PLUS
200/12.8.
If your symptoms do not improve after a few days, talk to your doctor.
If you become pregnant while taking BRUFEN PLUS 200/12.8, stop taking it and tell
your doctor immediately.
|
|
Things you should not do
|
Do not take more than 6 tablets in 24 hours.
BRUFEN PLUS 200/12.8 is not recommended for use in children under the age of 12 years.
You should not take BRUFEN PLUS 200/12.8 for more than three days at a time.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how BRUFEN PLUS 200/12.8
affects you.
BRUFEN PLUS 200/12.8 may cause dizziness, light-headedness or drowsiness in some people.
If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
|
|
Drinking alcohol
|
You must not drink alcohol while taking BRUFEN PLUS 200/12.8.
|
|
Looking after your medicine
|
Store below 30°C
Store in a cool dry place away from moisture, heat or sunlight.
|
6. Are there any side effects?
Contact your doctor immediately or go to the Emergency Department at your nearest
hospital if any of the following happen: asthma, shortness of breath, wheezing or
difficulty breathing, swelling of the face, lips, tongue or other parts of the body,
rash, itching or hives on the skin, fainting. These may be the sign of an allergic
reaction.
Tell your doctor or pharmacist if you notice any of the following and they worry
you: nausea or vomiting, constipation, or dizziness, light-headedness, drowsiness.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
|
WARNING:
Limitations of Use
BRUFEN PLUS 200/12.8 should only be taken when your doctor decides that other treatment
options are not able to effectively manage your pain or you cannot tolerate them.
Hazardous and Harmful Use
BRUFEN PLUS 200/12.8 poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will monitor you regularly during treatment.
Life Threatening Respiratory Depression
BRUFEN PLUS 200/12.8 can cause life-threatening or fatal breathing problems (slow,
shallow, unusual or no breathing), even when taken as recommended. These problems
can occur at any time during use, but the risk is higher when first starting BRUFEN
PLUS 200/12.8 and after a dose increase, if you are older, or have an existing problem
with your lungs. Your doctor will monitor you and change the dose as appropriate.
Use of Other Medicines While Using BRUFEN PLUS 200/12.8
Taking BRUFEN PLUS 200/12.8 with other medicines that can make you feel drowsy such
as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines,
antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin),
cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing
problems, coma and death. Your doctor will minimise the dose and duration of use;
and monitor you for signs and symptoms of breathing difficulties and sedation. You
must not drink alcohol while using BRUFEN PLUS 200/12.8.
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Active ingredient(s):
ibuprofen and codeine phosphate hemihydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking BRUFEN PLUS 200/12.8. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking BRUFEN PLUS 200/12.8.
Where to find information in this leaflet:
1. Why am I taking BRUFEN PLUS 200/12.8?
BRUFEN PLUS 200/12.8 contains the active ingredients ibuprofen and codeine phosphate
hemihydrate. Ibuprofen belongs to a family of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). This group of medicines work by relieving pain, inflammation (e.g.
swelling, redness, soreness) and fever. Codeine is an opioid analgesic that works
in the brain and spinal cord to relieve pain.
BRUFEN PLUS 200/12.8 is used to provide temporary relief of acute to moderate pain
and inflammation in patients over the age of 12 years.
Once taken, your body processes the codeine into its active form, morphine, in the
liver. In about 8% of people, they may experience less pain relief compared to others
as their body doesn't convert codeine to morphine very well.
2. What should I know before I take BRUFEN PLUS 200/12.8?
Warnings
Do not give BRUFEN PLUS 200/12.8 to children under the age of 12 years.
Do not take BRUFEN PLUS 200/12.8 if:
you are allergic to ibuprofen, codeine phosphate hemihydrate, other opioid analgesics
or any medicine including aspirin, other NSAIDs or any of the ingredients listed at
the end of this leaflet. Some of the symptoms of an allergic reaction may include:
asthma, wheezing or shortness of breath
swelling of the face, lips, tongue or other parts of the body which may cause difficulty
in swallowing or breathing.
Skin rash, itching or hives on the skin
fainting
Always check the ingredients to make sure you can take this medicine.
you are also taking other medicines that contain one or more NSAID medicine, whether
prescribed by your doctor or obtained without prescription.
Many medicines used to treat headache, period pain and other aches and pains contain
aspirin or NSAIDs. If you are not sure if you are taking any of these medicines, ask
your doctor or pharmacist.
you are pregnant or you are breastfeeding or planning to breastfeed.
you are vomiting blood or material that looks like coffee grounds, or have a history
of this.
You have or have had bleeding from the rectum (back passage), have black sticky bowel
motions (stools) or bloody diarrhoea.
you have a stomach or duodenal ulcer or have had one in the past.
you have or have had a history of ulcerative colitis or Crohn's disease.
you have chronic constipation or severe diarrhoea
you have shallow breathing.
you consume large amounts of alcohol regularly.
you have severe heart, liver or kidney failure.
you are an ultra-rapid CYP2D6 metaboliser.
you are currently taking a Monoamine oxidase inhibitors (MAOIs) or within 14 days
of stopping treatment with a MAOI.
you are aged between 12 and 18 years of age and have compromised respiratory function
including having had your tonsils or adenoids removed.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering. If it has expired or is damaged, return it to
your pharmacist for disposal.
Check with your doctor if you:
Experience signs of an allergic reaction to this medicine, including breathing problems,
swelling of the face and neck region (angioedema), and chest pain. Stop BRUFEN PLUS
200/12.8 immediately and contact your doctor or medical emergencies straight away
if you notice any of these signs.
have or have had any other medical conditions:
difficulty breathing, wheezing, chronic cough, allergies, asthma or other breathing
conditions
a history of drug dependence, including alcohol dependence
skin rash (dermatitis) and skin irritation
a history of stomach ulcer
stomach problems or recent gastrointestinal surgery
liver disease
kidney disease
heart problems/failure including swelling of ankles or feet
thyroid problems or low blood pressure
a head injury or intercranial pressure
prostate problems
a tendency for convulsions, fits
a recent head injury
have central sleep apnoea (a sleep-related breathing disorder which can cause pauses
in breathing during sleep), as a reduced dose of BRUFEN PLUS 200/12.8 may be required.
Tell your doctor if you experience severe upper abdominal pain radiating to the back,
nausea, vomiting, or fever, as this could be symptoms associated with inflammation
of the pancreas and biliary tract system.
Stop use and tell your doctor if you experience side effects including difficulty
swallowing, regurgitation, and chest pain, as these may be signs of a problem with
your oesophagus.
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson
syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic
symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported
in association with ibuprofen treatment. Stop using BRUFEN PLUS 200/12.8 and seek
medical attention immediately if you notice any of the symptoms related to these serious
skin reactions described in section 6.
BRUFEN PLUS 200/12.8 may cause changes in levels of hormones which may manifest as
problems with sexual intercourse including reduced sex drive, as well as changes in
the menstrual cycle and reduced fertility.
Stop use and tell your doctor if you experience symptoms such as nausea, vomiting,
weight loss, fatigue, weakness, dizziness or feeling faint. These may be signs of
adrenal insufficiency.
Tell your doctor if you take sedatives (medicines used to help you relax or sleep).
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Tell your doctor if you are over 65 years of age.
If you have not told your doctor about any of the above, tell them before you start
taking BRUFEN PLUS 200/12.8.
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?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
BRUFEN PLUS 200/12.8 should not be taken during pregnancy.
Prolonged use of BRUFEN PLUS 200/12.8 at the end of pregnancy may result in withdrawal
syndrome in the neonate which may be delayed for several hours to several days after
birth. Symptoms in the neonate include stiff muscles, shaking, agitation, convulsions,
breathing problems, and slow heartbeat.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
BRUFEN PLUS 200/12.8 should not be taken while breastfeeding.
Addiction
You can become addicted to BRUFEN PLUS 200/12.8 even if you take it exactly as prescribed.
BRUFEN PLUS 200/12.8 may become habit forming causing mental and physical dependence.
If abused it may become less able to reduce pain.
Dependence
As with all other opioid containing products, your body may become used to you taking
BRUFEN PLUS 200/12.8. Taking it may result in physical dependence. Physical dependence
means that you may experience withdrawal symptoms if you stop taking BRUFEN PLUS 200/12.8
suddenly, so it is important to take it exactly as directed by your doctor.
If you are taking BRUFEN PLUS 200/12.8 for longer than the recommended time or at
higher than recommended doses, you are at risk of serious harms. These include serious
harms to the stomach/gut and kidneys, as well as very low levels of potassium in your
blood. These can be fatal (see section 6).
Tolerance
Tolerance to BRUFEN PLUS 200/12.8 may develop, which means that the effect of the
medicine may decrease. If this happens, more may be needed to maintain the same effect.
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 may interfere with BRUFEN PLUS 200/12.8 and affect how it works.
These include:
medicines used to help you relax, sleep or relieve anxiety, such as benzodiazepines,
barbiturates and sedatives
aspirin, salicylates or other NSAID medicines
aminoglycoside antibiotics, medicines used to treat bacterial infections
atropine
warfarin, clopidogrel, ticlopidine or other medicines used to stop blood clots or
thin the blood
medicines that are used to treat high blood pressure, e.g. ACE inhibitors, diuretics
(fluid tablets) or heart problems including heart failure
methotrexate, a medicine used to treat arthritis and some types of cancer
zidovudine, a medicine used to treat HIV infection
mifepristone
quinolone, a medicine used to treat bacterial infections
medicines used to relieve stomach cramps or spasms
medicines used to treat diarrhoea (e.g. kaolin, pectin, loperamide)
medicines used to prevent travel sickness, such as hydroxyzine
metoclopramide, a medicine used to treat nausea and vomiting
medicines that affect serotonin levels (serotonergic medicines such as triptans, selective
serotonin- and norepinephrine- reuptake inhibitors (SNRIs) and tricyclic antidepressants)
selective serotonin reuptake inhibitors (SSRIs) and monoamine oxidase inhibitors (MAOIs),
medicines used to treat depression such as moclobemide
phenothiazines and antipsychotic agents, medicines used to treat mental disorders
medicines used to treat neuropathic pain (gabapentinoids such as gabapentin and pregabalin),
as they may increase the depressant effects of codeine
lithium and other medicines used to treat depression or anxiety, e.g. MAOIs (even
if taken within the last 14 days)
medicines such as prednisone, prednisolone, cortisone, ciclosporin and tacrolimus
which reduce the activity of your immune system
quinidine, a medicine used to treat abnormal or irregular heartbeat
medicines used to treat diabetes
probenecid, a medicine used to treat gout
phenytoin, a medicine used to treat epilepsy
medicines used to treat Parkinson's disease
other opioids to treat pain or suppress cough
colestyramine, a medicine used to treat high cholesterol
cimetidine, a medicine used to reduce stomach acid production
herbal medicines such as ginkgo biloba
mexiletine, a medicine used to treat abnormal heart beat
naloxone, a medicine used in the treatment of an opioid overdose
These medicines may be affected by BRUFEN PLUS 200/12.8 or may affect how well it
works. You may need to take different amounts of your medicines, or you may need to
take different medicines. Your doctor and pharmacist have more information on medicines
to be careful with or avoid while taking this medicine.
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 PLUS 200/12.8.
4. How do I take BRUFEN PLUS 200/12.8?
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to take
The usual dose of BRUFEN PLUS 200/12.8 is 2 tablets followed by, if necessary, 1 or
2 tablets every 4 hours.
Do not take more than 6 tablets in 24 hours.
If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.
Follow the instructions provided and take BRUFEN PLUS 200/12.8 until your doctor tells
you to stop.
How to take BRUFEN PLUS 200/12.8
Swallow the tablets whole with a glass of water. It can be taken with food or on an
empty stomach.
How long to take BRUFEN PLUS 200/12.8
You should not take BRUFEN PLUS 200/12.8 for more than three days at a time unless
instructed to by your doctor.
If your symptoms persist, worsen or new symptoms develop, talk to your doctor.
Talk to your doctor about pain control if BRUFEN PLUS 200/12.8 is not helping.
If you take too much BRUFEN PLUS 200/12.8
If you or someone else take too much (overdose), and experience one or more of the
symptoms below, immediately call triple zero (000) for an ambulance. Keep the person
awake by talking to them or gently shaking them every now and then. You should follow
the above steps even if someone other than you has accidentally taken BRUFEN PLUS
200/12.8 that was prescribed for you. If someone takes an overdose they may experience
one or more of the following symptoms:
slow, unusual or difficult breathing
drowsiness, dizziness or unconsciousness
slow or weak heartbeat
nausea or upset stomach, vomiting and/or gastric irritation
convulsions or fits
confusion, loss of coordination, tremors, weakness, seizures, headaches, vision impairment
excitability
blurred vision, ringing in the ears or rapid uncontrollable movements of the eyes.
If you think that you or someone else have taken too much BRUFEN PLUS 200/12.8, you
may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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.
Depending on your body’s individual ability to break down codeine, you may experience
signs of overdose even when you take BRUFEN PLUS 200/12.8 as recommended by your doctor.
If overdose symptoms occur, seek immediate medical advice.
When seeking medical attention, take this leaflet and remaining medicine with you
to show the doctor. Also tell them about any other medicines or alcohol which have
been taken.
5. What should I know while taking BRUFEN PLUS 200/12.8?
Things you should do
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking BRUFEN PLUS 200/12.8.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine. It may affect other medicines used during surgery.
If your symptoms do not improve after a few days, talk to your doctor. Your doctor will assess your condition and decide if you should continue to take BRUFEN
PLUS 200/12.8.
Call your doctor straight away if you:
become pregnant while taking BRUFEN PLUS 200/12.8 and stop taking it immediately.
Things you should not do
Do not take high doses of the medicine for long periods of time unless your doctor
tells you to. Products containing codeine should not be taken for prolonged periods.
Codeine may be habit forming.
Do not give BRUFEN PLUS 200/12.8 to anyone else, even if they have the same condition
as you.
Do not take BRUFEN PLUS 200/12.8 to treat any other complaints unless your doctor
tells you to.
Do not take more than the recommended dose unless your doctor tells you to.
Excessive use can be harmful and increase the risk of heart attack, stroke or liver
damage.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BRUFEN
PLUS 200/12.8 affects you.
BRUFEN PLUS 200/12.8 may cause dizziness, light-headedness or drowsiness in some people.
If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous. If you drink alcohol, dizziness, light- headedness and/or
drowsiness may be worse.
Drinking alcohol
Tell your doctor if you drink alcohol.
Using BRUFEN PLUS 200/12.8 with alcohol may result in severe dizziness, light-headedness
or drowsiness, decreased awareness, breathing difficulties, coma and death.
Withdrawal
Continue taking your medicine for as long as your doctor tells you. If you stop taking
this medicine suddenly, your pain may worsen and you may experience some or all of
the following withdrawal symptoms:
nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating
Products containing codeine should not be taken for prolonged periods; codeine may
be habit forming.
Brufen Plus 200/12.8 given to the mother during labour can cause breathing problems
and signs of withdrawal in the newborn.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°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.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take 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 about side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Gastrointestinal related:
stomach upset including nausea (feeling sick), vomiting
heartburn, indigestion
constipation
diarrhoea, pain in the stomach
loss of appetite
Head and neurology related:
sleeplessness, nightmares
changes in mood, for example depression, restlessness, irritability
sore or dry mouth or tongue
dizziness, light-headedness, drowsiness
headache
hearing disturbance
central sleep apnoea
Respiratory related:
shallow breathing
cough suppression
central sleep apnoea
Skin related:
a rash that always appears in the exact same spot on your skin (fixed eruption)
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Gastrointestinal related:
severe pain or tenderness in the stomach
vomiting blood or material that looks like coffee grounds
bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
pancreatitis and spasm of the sphincter of Oddi (severe upper abdominal pain possibly
radiating to the back, nausea, vomiting or fever).
Allergy related:
shallow breathing or shortness of breath
flushing of the face
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
asthma, wheezing, shortness of breath, pain or tightness in the chest
symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur
more quickly than usual
Heart related:
fast heart beat
chest pain, which can be a sign of a potentially serious allergic reaction called
Kounis syndrome.
|
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.
|
|
Serious side effects
|
What to do
|
|
Skin related:
yellowing of the skin and eyes, known as jaundice
sudden or severe itching, skin rash, hives, skin peeling
severe skin reactions which may present as:
reddish non-elevated target-like or circular patches on the trunk with blisters, ulcers
of the mouth, throat, nose, genitals and eyes; and may be accompanied by fever and
flu-like symptoms.
widespread rash, high body temperature and enlarged lymph nodes.
red scaly rash with bumps under the skin and blisters accompanied by fever.
Urinary related:
a change in the colour of your urine, blood in the urine
a change in the amount or frequency of urine passed, burning feeling when passing
urine
fluid retention
unusual weight gain, swelling of ankles or legs
Infection related:
signs of frequent or worrying infections such as fever, severe chills, sore throat
or mouth ulcers
Bleeding related:
bleeding or bruising more easily than normal, reddish or purplish blotches under the
skin
signs of anaemia, such as tiredness, being short of breath and looking pale
Head and neurology related:
unusual or extreme mood swings
dizziness, light-headedness
severe dizziness, spinning sensation
severe or persistent headache
difficulty hearing, deafness
tingling or numbness of the hands or feet
Eyes related:
eye problems such as blurred vision, sore red eyes, itching
Pregnancy related:
low amniotic fluid in the womb during pregnancy
newborns with impaired kidney function
|
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.
|
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.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What BRUFEN PLUS 200/12.8 contains
|
Active ingredient
(main ingredient)
|
Ibuprofen and codeine phosphate hemihydrate
|
|
Other ingredients
(inactive ingredients)
|
pregelatinised maize starch
microcrystalline cellulose
croscarmellose sodium
colloidal anhydrous silica
Opadry complete film coating system OY-58900 White (ID 3446)
|
Do not take this medicine if you are allergic to any of these ingredients.
What BRUFEN PLUS 200/12.8 looks like
BRUFEN PLUS 200/12.8 are white to off-white capsule-shaped, biconvex, film-coated
tablets (AUST R 298439).
BRUFEN PLUS 200/12.8 are available in blister packs containing 30 tablets.
Who distributes BRUFEN PLUS 200/12.8
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 March 2026.
BRUFEN® is a Viatris company trade mark
BRUFEN PLUS 200/12.8_cmi\Mar26/00