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.
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read
before using this medicine.
1. Why am I using BRUFEN PLUS 200/12.8?
BRUFEN PLUS 200/12.8 contains the active ingredients ibuprofen and codeine phosphate
hemihydrate. 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.
For more information, see Section
1. Why am I using BRUFEN PLUS 200/12.8? in the full CMI.
2. What should I know before I use BRUFEN PLUS 200/12.8?
Do not use 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 addition, dependence and tolerance. For more information, see Section
2. What should I know before I use BRUFEN PLUS 200/12.8? in the full CMI.
3. What if I am taking other medicines?
4. How do I use 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 use BRUFEN PLUS 200/12.8? in the full CMI.
5. What should I know while using BRUFEN PLUS 200/12.8?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using 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 this medicine, 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 used 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 used 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
Using 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.
|
Active ingredient(s):
ibuprofen and codeine phosphate hemihydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using 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 using BRUFEN PLUS 200/12.8.
Where to find information in this leaflet:
1. Why am I using 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 use BRUFEN PLUS 200/12.8?
Warnings
Do not give BRUFEN PLUS 200/12.8 to children under the age of 12 years.
Do not use BRUFEN PLUS 200/12.8 if:
you are allergic to ibuprofen, codeine phosphate hemihydrate, other opioid analgesics
or any medicine including aspirin, other NSAID or any of the ingredients listed at
the end of this leaflet. Some of the symptoms of an allergic reaction may include:
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
Always check the ingredients to make sure you can use 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 the medicines you are taking any of these
medicines , ask your doctor or pharmacist.
you are in the last three months of pregnancy.
you are breastfeeding or planning to breastfeed.
you are vomiting blood or material that looks like coffee grounds
you are 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:
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
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.
Unless advised by your doctor, do not take BRUFEN PLUS 200/12.8 during the first 6
months of pregnancy. Your doctor will decide if you should take BRUFEN PLUS 200/12.8
during the first 6 months.
BRUFEN PLUS 200/12.8 is should not be taken during the last three months of pregnancy.
BRUFEN PLUS 200/12.8 given to the mother during labour can cause breathing problems
and signs of withdrawal in the newborn.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
BRUFEN PLUS 200/12.8 should not be taken while breastfeeding except on your doctor's
advice. Codeine passes into the breast milk.
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.
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)
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
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 different amounts of your medicines, or you may need 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 use 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 use 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.
If you use 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
excitability
blurred vision, ringing in the ears or rapid uncontrollable movements of the eyes.
If you think that you or someone else have used 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 using BRUFEN PLUS 200/12.8?
Things you should do
If you are about to be started on any new medicine, remind 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 this medicine and stop taking it immediately.
Remind any doctor, dentist or pharmacist who treat you that you are using BRUFEN PLUS
200/12.8.
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 your medicine 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 used 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 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 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
|
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
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
|
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
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
collioidal anhydrous silica
Opadry complete film coating system OY-58900 White (ARTG PI No: 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 January 2023.
BRUFEN® Plus is a Viatris company trade mark
BRUFEN PLUS 200/12.8_cmi\Jan23/00