NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
MERSYNOFEN-CMIV01-09AUG19
Active ingredients: ibuprofen and paracetamol
Consumer Medicine Information (CMI)
This leaflet provides important information about using Mersynofen. You should also speak to your doctor or pharmacist if you would like further informationor if you have any concerns or questions about using Mersynofen.
Where to find information in this leaflet:
1. Why am I using Mersynofen?
2. What should I know before I use Mersynofen?
3. What if I am taking other medicines?
4. How do I use Mersynofen?
5. What should I know while using Mersynofen?
6. Things you should not do
7. Are there any side effects?
8. Product details
Why am I using Mersynofen?
Mersynofen contains the active ingredients ibuprofen and paracetamol.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Paracetamol works to stop the pain messages from getting through to the brain.
Your doctor may have prescribed this medicine for another use.
Mersynofen is an analgesic (pain reliever). It works to relieve acute (short term)pain and/or inflammation associated with headache, migraine headache, tension headache,sinus pain, toothache, dental procedures, backache, muscular aches and pains, periodpain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and painsassociated with colds and flu.
This medicine is not addictive.
What should I know before I use Mersynofen?
Warnings
Do not use Mersynofen if:
you are allergic to paracetamol, ibuprofen, aspirin or any other medicine for pain relief, or any of the ingredients listed at the end of this leaflet
Always check the ingredients to make sure you can use this medicine.
Always check the ingredients to make sure you can use this medicine.
you have liver or kidney disease
you have heart problems
you have asthma
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.
you have recently vomited blood or material that looks like coffee grounds
you have recently bled from the back passage (rectum), had black sticky bowel motions or bloody diarrhoea.
you are using other paracetamol-containing products
you are severely dehydrated after having vomited, had diarrhoea or not enough to drink
if the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering
Check with your doctor or pharmacist if you:
have any other medical conditions, especially asthma, diabetes, liver or kidney disease or heart problems
take any medicines for any other condition
Tell your doctor or pharmacist if you have an infection.
Mersynofen may hide signs of infections such as fever and pain.
It is therefore possible that Mersynofen 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.
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 Mersynofen if you are pregnant or intend to become pregnant.
Like most medicines of this kind, Mersynofen is not recommended to be used during pregnancy.
Check with your doctor or pharmacist about taking Mersynofen if you are breast-feedingor planning to breast-feed.
Small amounts of ibuprofen and paracetamol may pass into the breast milk
If you have not told your doctor or pharmacist about any of the above, tell them beforestart taking Mersynofen.
Use in the elderly
Do not take if you are aged 65 years or older.
Use in children
Do not give Mersynofen to children aged under 12 years.
Do not give Mersynofen to dehydrated adolescents.
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 Mersynofen may interfere with each other. These include:
other paracetamol containing products, analgesics, other medicines for pain relief
warfarin, a medicine used to prevent blood clots
antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs)
lithium, a medicine used to treat mood swings and some types of depression
medicines used to lower blood pressure such as diuretics
medicines used to lower cholesterol such as cholestyramine
methotrexate, a medicine used to treat arthritis and some types of cancer
medicines used to treat heart failure
corticosteroids such as prednisone, prednisolone and cortisone, which reduces the activity of your immune system
zidovudine, a medicine used to treat HIV infection
aspirin, salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs)
medicines used to treat diabetes
metoclopramide, a medicine used to control nausea and vomiting
medicines used to treat epilepsy or fits
chloramphenicol an antibiotic used to treat ear and eye infections
ciclosporin or tacrolimus, medicines used to treat immune system conditions
alcohol
These medicines may be affected by Mersynofen or may affect how well Mersynofen works. You may need different amounts of your medicines, or you may need to take different medicines.
If you have not told your doctor or pharmacist about any of these things, tell him/herbefore you take any Mersynofen.
Check with your doctor or pharmacist if you are not sure about what medicines, vitaminsor supplements you are taking and if these affect Mersynofen.
How do I use Mersynofen?
How much to take
The label on your pack of Mersynofen will tell you how to take your medicine and how often.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.
The usual dose of Mersynofen is:
Adults under 65 and children from 12 years:
1 tablet.
This dosage may be repeated every 8 hours if necessary.
You should not take more than 3 tablets in 24 hours.
Do not take more than the recommended dose.
Not recommended for adults 65 years of age and over or children under 12 years of age.
How to take Mersynofen
Swallow tablets with a little water or other liquid.
How long to take it
Only take Mersynofen when required for pain.
Take the lowest dose that helps with your pain for the shortest time necessary to relieve your symptoms.
If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen.
Adults:
Do not take Mersynofen for more than 3 days at a time.
Adolescents (12 to 17 years):
Do not take Mersynofen for more than 2 days at a time.
If your symptoms persist, worsen or new symptoms develop, talk to your pharmacistor doctor.
If you take too much Mersynofen
If you think that you have taken too much Mersynofen, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 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.
What should I know while using Mersynofen?
Things you should do
If you are about to be started on any new medicine, tell your doctor and pharmacistthat you are taking Mersynofen.
Talk to your doctor or pharmacist if your symptoms don’t improve.
Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.
If you become pregnant while you are using this medicine, tell your doctor or pharmacistimmediately.
If you develop a skin rash, mucosal wounds or any other sign of allergy while youare using this medicine, stop taking the product and tell your doctor or pharmacistimmediately.
Things you should not do
Do not take for more than 3 days at a time (2 days for adolescents 12 to 17 years)unless your doctor or pharmacist tells you to.
Do not take more than the recommended dose unless your doctor or pharmacist tellsyou to.
Things to be aware of
Taking this medicine may increase the risk of you getting unwanted effects, such as stomach or heart problems.
Do not take Mersynofen to treat any other complaints unless your pharmacist or doctortells you to.
Do not give your medicine to anyone else, even if they have the same condition asyou.
Driving or using machines
Be careful driving or operating machinery until you know how this medicine affectsyou.
This medicine may cause dizziness in some people
Drinking alcohol
Only drink small quantities of alcohol (beer, wine or spirits) while taking paracetamol.
Drinking large quantities of alcohol while taking paracetamol may increase the risk of liver side effects.
Looking after your medicine
Store 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 windowsills.
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.
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.
Less serious side effects
|
Less serious side effects
|
What to do
|
|---|---|
|
Gastrointestinal related:
nausea
indigestion
heart burn
stomach pain
diarrhoea
loss of appetite
wind or constipation
Head and neurology related:
dizziness
drowsiness
headache
nervousness
Allergy related:
skin rashes
sweating
|
Speak to your doctor if you have any of these less serious side effects and they worryyou.
|
Serious side effects
|
Serious side effects
|
What to do
|
|---|---|
|
Allergy related:
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
flushing of the face
Heart related:
fluid retention
Breathing related:
shortness of breath
wheezing or difficulty breathing
Skin related:
you are getting sunburnt more quickly than usual.
Gastrointestinal related:
vomiting blood or bleeding from the back passage
|
Call your doctor straight away, or go straight to the Emergency Department at yournearest hospital if you notice any of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making youfeel 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 stoptaking any of your medicines.
Product details
This medicine is only available from your pharmacist.
What Mersynofen contains
|
Active ingredients
(main ingredient)
|
Ibuprofen and paracetamol.
|
|---|---|
|
Other ingredients
(inactive ingredients)
|
Maize starch, magnesium stearate , microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, sodium lauryl sulfate, purified talc, opadry QX Quick and Flexible Film Coating System 321A180025 White, and opadry fx special effects film coating system 63F97546 Silver.
|
Do not take this medicine if you are allergic to any of these ingredients.
What Mersynofen looks like
Mersynofen is a white to off white, capsule shaped, film coated tablet with a break bar on one side (AUST R 321566).
Mersynofen is available in a range of sizes up to 30 tablets.
Who distributes Mersynofen
Sanofi Consumer Healthcare,
87 Yarraman Place
Virginia, QLD 4014, Australia
Toll Free Number (medical information): 1800 818 806
Email: [email protected]
Toll Free Number (medical information): 1800 818 806
Email: [email protected]
This leaflet was prepared in October 2020
mersynofen-cmiv2-16oct20
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