Active ingredient(s):
paracetamol and ibuprofen
Consumer Medicine Information (CMI)
This leaflet provides important information about using IBUPANE. 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 IBUPANE.
Where to find information in this leaflet:
1. Why am I using IBUPANE?
IBUPANE contains two active ingredients paracetamol and ibuprofen. IBUPANE belongs to a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). This group of medicines work by relieving pain, inflammation (swelling,
redness, soreness) and fever. Paracetamol works to stop the pain messages from getting
through to the brain and also acts in the brain to reduce fever.
IBUPANE is used for temporary relief of acute (short term) 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, rheumatic pain and arthritis, and the aches and pains associated with colds
and flu. Reduces fever.
2. What should I know before I use IBUPANE?
Warnings
Do not use IBUPANE if you are allergic to paracetamol, ibuprofen, aspirin, other NSAIDs
or any of the ingredients listed at the end of this leaflet.
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
Rash, itching or hives on the skin
Stomach ache, fever, chills, nausea and vomiting, fainting
If you are allergic to aspirin or NSAIDs medicines and take IBUPANE tablets these
symptoms may be severe.
Always check the ingredients to make sure you can use this medicine.
Do not take this medicine if you have any of the following conditions:
Heart problems
Liver or kidney disease
Asthma, bronchitis, emphysema or other acute breathing difficulties
Bleeding from the rectum (back passage), have black sticky bowel motions (stools)
or bloody diarrhoea
If you have a stomach ulcer or duodenal ulcer or if you have had either of these conditions
or gastric bleeding or other gastrointestinal diseases in the past
If you have had bleeding episodes which cannot be explained
Recent vomiting of blood or material that look like coffee grounds
Some of the symptoms of liver problems may include:
Nausea
Feeling tired
Itching of the skin
Yellow colouring of your skin
“Flu-like” symptoms
Tenderness in your abdomen
If you develop any of these symptoms or heart problems, talk to your doctor.
Do not take IBUPANE tablets if you are also taking any other medicines that contain
one or more NSAID medicine or if you are taking any other medicine for pain relief,
whether prescribed by your doctor or obtained without prescription.
Several 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 contain these
ingredients, ask your pharmacist.
Do not give IBUPANE tablets to children aged under 12 years.
Do not take if you are aged 65 years or older.
Do not give IBUPANE tablets to dehydrated adolescents.
Do not take this medicine if you regularly drink large quantities of alcohol.
Check with your doctor or pharmacist if you:
have allergies to any ingredients listed under "Product Details" at the end of this
leaflet.
have severe skin reactions such as extensive skin rash known as DRESS with following
reactions such as fever, rash, enlargement of lymph nodes and/or facial swelling,
kidney problems, blood disorder, inflammation of the heart, muscle weakness/pain
suffer from hayfever, nasal polyps or have chronic respiratory disorders. These may
increase the risk of an allergic reaction occurring.
Have, or have had, any of these conditions:
Liver, kidney or heart problems
Asthma, or have suffered in the past from asthma.
You drink large quantities of alcohol
You have a history or drug or alcohol abuse
Recent surgery on the stomach or intestines
Previous history of ulcers
Diabetes
Autoimmune problems (where your own immune system mistakenly attacks substances naturally
occurring in your body)
Have recently had major surgery
have a metabolic disorder
have a blood platelet disorder
If you currently have any of these conditions you should not take this medicine.
take any medicines for any other condition
are breastfeeding or planning to breast-fed.
are over 65 years of age and have kidney or respiratory problems
are not sure whether you should start taking IBUPANE.
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
Do not take this medicine if you are pregnant or plan to become pregnant.
Like most medicines of this kind, IBUPANE is not recommended to be used during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Small amounts of ibuprofen and paracetamol pass into the breast milk.
Use of IBUPANE may cause the baby to have kidney problems leading to a low amount
of amniotic fluid inside the uterus and in some cases kidney problems in the newborn.
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 IBUPANE and affect how it works. These include:
other paracetamol containing products, analgesics, other medicines for pain relief
Aspirin, salicylates or other NSAID medicines.
Warfarin or other medicines used to stop blood clots or thin the blood.
antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs)
Zidovudine a medicine used to treat HIV infection.
Lithium and other medicines used to treat depression or anxiety e.g. MAOIs (even if
taken within the last 14 days).
Medicines to treat epilepsy or fits
Metoclopramide, a medicine used to control nausea and vomiting
Propantheline, a drug used to treat stomach ulcers
Chloramphenicol, an antibiotic used to treat ear and eye infections
Medicines used to relieve stomach cramps or spasms
Corticosteroids such as prednisone, prednisolone and cortisone, which reduce the activity
of your immune system
Probenecid, as drug used to treat high uric acid levels in blood associated with gout
Colestyramine, as drug used to reduce blood cholesterol
Methotrexate, a medicine used to treat arthritis and some types of cancer
Diuretics, also called fluid tablets
Alcohol
Medicines used to treat high blood pressure or heart failure or other heart conditions
Medicines used to treat diabetes. These medicines may be affected by IBUPANE tablets
or affect how well IBUPANE tablets work.
IBUPANE may hide signs of infections such as fever and pain. It is therefore possible
that IBUPANE may delay appropriate treatment of infection, which may lead to an increased
risk of complications.
This has been observed in patients with serious lung infections (also called pneumonia)
caused by bacteria and bacterial skin infections related to chickenpox. If you take
this medicine while you have an infection and your symptoms of the infection persist
or worsen, consult a doctor without delay.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
If you have not told your pharmacist or doctor about any of these things, tell him/her
before you take any IBUPANE tablets.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect IBUPANE.
4. How do I use IBUPANE?
How much to take
Adults under 65 and children over 12 years:
1 tablet three times a day when necessary (every 8 hours).
Follow the instructions provided and use IBUPANE until your doctor tells you to stop.
Do not exceed the recommended dosage.
Adults: Do not take this medicine for longer than 3 days at a time unless advised
to by a doctor.
Adolescents 12 - 17 years: Do not take this medicine for longer than 2 days at a time,
unless advised to by a doctor.
Do not take more than 3 tablets in a 24 hour period.
As with other NSAIDs, excessive or prolonged use of ibuprofen may increase the risk
of heart attack, stroke or liver damage.
If your symptoms persist, worsen or new symptoms develop, talk to your doctor or pharmacist.
How to take IBUPANE
Swallow tablet whole with a little water or other liquid.
The directions given to you by your pharmacist or doctor may be different from the
information in this leaflet. If you are unsure what dose to take, ask your pharmacist
or doctor.
If you use too much IBUPANE
If you think that you have used too much IBUPANE, 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.
You may need urgent medical attention because of the risk of delayed, serious liver
damage and kidney failure with an overdose of paracetamol and ibuprofen.
Keep telephone numbers of these places handy.
If you take too many tablets you may feel nauseous or have upset stomach, experience
vomiting and gastric irritation, feel light headed, dizzy or drowsy. Excitability,
convulsions, and unconsciousness may be experienced in rare cases.
5. What should I know while using IBUPANE?
Things you should do
Take IBUPANE tablets exactly as your pharmacist or doctor has told you to.
If IBUPANE tablets are not adequately controlling your pain, do not increase the dose.
Please talk to your doctor or pharmacist if your symptoms do not improve. Your doctor
or pharmacist will assess your condition and decide if you should continue to take
the medicine.
Tell your doctor or pharmacist if you become pregnant while taking IBUPANE tablets.
Remind any doctor, dentist or pharmacist you visit that you are using IBUPANE.
Things you should not do
Do not give this medicine to children under 12 years of age or for adults 65 years
of age and over.
Do not take this medicine for longer than 3 days at a time (2 days for adolescents
12 to 17 years) unless advised to by a doctor.
Do not take more than the recommended dose unless your doctor or pharmacist tells
you to.
Do not use this medicine to treat any other complaint unless your doctor or pharmacist
tells you to.
Do not give your medicine to anyone else even if they have the same symptoms as you.
Do not take this medicine if you are taking other medicines that contain aspirin,
paracetamol, ibuprofen, salicylates or other anti-inflammatory medicines or other
medicines for pain relief.
Things to be careful of
Taking this medicine may increase the risk of you getting unwanted effects, such as
stomach or heart problems.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how IBUPANE
affects you.
IBUPANE may cause dizziness or drowsiness in some people, especially after the first
dose.
If affected do not drive a car, operate machinery or do anything else that could be
dangerous if you are dizzy or drowsy. Children should not ride bikes if affected and
should be supervised to avoid potential harm.
Drinking alcohol
Tell your doctor or pharmacist if you drink alcohol.
Avoid drinking alcohol. Drinking large quantities of alcohol while taking paracetamol
may increase the risk of liver side effects.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them.
Keep IBUPANE tablets 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.
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?
Tell your doctor or pharmacist as soon as possible if you do not feel well while taking
IBUPANE tablets.
This medicine helps most people with relief of pain, but it may have unwanted side
effects in a few people.
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.
It is rare to get side effects from ibuprofen and paracetamol if taken for a short
period of time and in the doses in OTC medicines.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
This list includes the more common side effects of your medicine. They are usually
mild.
Serious / rare side effects
This list includes serious side effects that may require medical attention. Serious
side effects are rare for low doses of this medicine and when used for a short period
of time.
Very serious side effects
This list includes very serious side effects. You may need
urgent medical attention or hospitalisation. These side
effects are very rare for low doses of this medicine and
when used for a short period of time.
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 available over-the-counter without a doctor's prescription.
What IBUPANE contains
|
Active ingredient
(main ingredient)
|
Each IBUPANE tablet contains:
Paracetamol 500 mg
Ibuprofen 200 mg
|
|
Other ingredients
(inactive ingredients)
|
Pregelatinised maize starch
Povidone
Crospovidone
Microcrystalline cellulose
Colloidal anhydrous silica
Magnesium stearate
Hypromellose
Purified talc
Titanium dioxide
OPADRY fx special effects film coating system 63F97546 SILVER (ARTG PI No: 106945)
|
Do not take this medicine if you are allergic to any of these ingredients.
What IBUPANE looks like
IBUPANE is white to off white, oval shaped biconvex, film-coated pearlescent tablet
plain on both sides (AUST R 267396).
It is available in packs of 12 and 24 tablets.
Who distributes IBUPANE
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in September 2023.
IBUPANE® is a Viatris company trade mark
IBUPANE_cmi\Sep23/00