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 information
or if you have any concerns or questions about using Mersynofen.
Where to find information in this leaflet:
1. 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, period
pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and pains
associated with colds and flu.
This medicine is not addictive.
2. 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.
you have a history of hypersensitivity reactions e.g. wheezing, chronic cough, swelling
of the face or throat, red or itchy skin, skin rash, or a runny or stuffy nose when
using aspirin, or other non-steroidal anti-inflammatory drugs or analgesic products.
you have liver or kidney disease
you have pre-existing 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 have had bleeding episodes which cannot be explained
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 a severe and 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
have any other medical conditions, especially asthma, diabetes, liver or kidney disease
or heart, gastrointestinal or autoimmune problems (where your own immune system mistakenly
attacks substances naturally occurring in your body).
take any medicines for any other condition
have recently had major surgery
suffer from hayfever, nasal polyps or have chronic respiratory disorders. These may
increase the risk of an allergic reaction occurring
have a metabolic disorder
have a blood platelet disorder consume large amounts of alcohol
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.
Serious skin reactions including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis
(TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported
in association with ibuprofen treatment. Stop using ibuprofen and seek medical attention
immediately if you notice any of the symptoms related to these serious skin reactions
described in Section
6. Are there any side effects?
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.
Use of Mersynofen 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.
Check with your doctor or pharmacist about taking Mersynofen if you are breast-feeding
or 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 before
start 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.
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 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, ACE inhibitors, beta-receptor
blockers and angiotensin-II antagonists
medicines that contain probenecid or sulfinpyrazone
salicylates or non-steroidal anti-inflammatory drugs (NSAIDS), such as aspirin
digoxin, a medicine used to treat irregular heart rhythms
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 (seizures)
chloramphenicol an antibiotic used to treat ear and eye infections
ciclosporin or tacrolimus, medicines used to treat immune system conditions
alcohol
CYP2C9 inhibitors such as voriconazole and fluconazole
uricosurics which may delay the excretion of ibuprofen
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/her
before you take any Mersynofen.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Mersynofen.
4. 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
For oral use only
Swallow tablets with a little water or other liquid.
It is recommended that patients with sensitive stomachs take Mersynofen with food.
If taken shortly after eating it may take a little longer for Mersynofen to work.
Do not take more Mersynofen than recommended until it is time to take the next dose.
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 pharmacist
or doctor.
Prolonged use of any type of pain relievers for headaches can make it worse. If this
is experienced or suspected, medical advice should be obtained or discontinued.
The habit of taking medicines for pain relief particularly in combination with other
pain-relievers may lead to permanent kidney problems including kidney failure therefore
it should be avoided.
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. You are
at risk of serious harms to the stomach/gut and kidneys, as well as very low levels
of potassium in your blood.
Merysnofen when taken at higher than recommended doses (for a short or prolonged period
of time), can cause damage to your kidneys and affect them removing acids properly
from your blood into the urine (renal tubular acidosis). It can also cause very low
levels of potassium in your blood. Signs and symptoms include muscle weakness and
light-headedness
5. 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 pharmacist
that 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 pharmacist
immediately.
If you develop a skin rash, mucosal wounds or any other sign of allergy while you
are using this medicine, stop taking the product and tell your doctor or pharmacist
immediately.
If you have chest pain, seek immediate medical advice from your doctor or pharmacist.
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 tells
you 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 doctor
tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Be careful driving or operating machinery until you know how this medicine affects
you.
This medicine may cause tiredness or 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.
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.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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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
chest pain, which can be a sign of a potentially serious allergic reaction called
Kounis syndrome
Breathing related:
shortness of breath
wheezing or difficulty breathing
Skin related:
getting sunburnt more quickly than usual
increased sensitivity of the skin to sun
drug induced reddish, scaly, pus-filled bumps
reddish non-elevated, target-like or circular patches on the trunk, often with central
blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious
skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome,
Toxic Epidermal Necrolysis)
widespread rash, high body temperature (fever > 38°C) and enlarged lymph nodes (Drug
Reaction with Eosinophilia and Systemic Symptoms (DRESS) or drug hypersensitivity
syndrome)
Round or oval patches of redness and swelling, blistering (hives), itching of the
skin (Fixed Drug Eruption)
Gastrointestinal related:
vomiting blood or bleeding from the back passage
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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.
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 from your pharmacist.
What Mersynofen contains
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]
This leaflet was prepared in February 2024.
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