Oral Suspension
contains the active ingredient oseltamivir
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
questions about . It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
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What TAMIFLU is used for
TAMIFLU contains the active ingredient oseltamivir.
TAMIFLU is used for the treatment and prevention of influenza (an infection caused by the influenza virus). It has no effect
on the common cold or other respiratory virus infections.
TAMIFLU belongs to a group of medicines called neuraminidase inhibitors. These medicines attack the influenza virus and prevent
it from spreading inside your body.
TAMIFLU is absorbed to the key sites of influenza infection and treats the cause. Taking TAMIFLU means you feel better faster.
You will also be less likely to develop complications of influenza, such as bronchitis, pneumonia and sinusitis.
Typical symptoms of influenza include fever, headache, muscle aches, sore throat, cough and generally feeling unwell.
Ask your doctor if you have any questions about why TAMIFLU has been prescribed for you.
TAMIFLU is not addictive.
This medicine is available only with a doctor's prescription.
Before you take TAMIFLU
When you must not take it
Do not take TAMIFLU if:
1.
you have had an allergic reaction to TAMIFLU or any ingredients listed at the end of this leaflet
2.
the package is torn or shows signs of tampering
3.
the expiry date (EXP) printed on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure if you should be taking TAMIFLU, talk to your doctor.
Use in the elderly
Although there is limited experience with use of TAMIFLU in patients 65 years and older, the same dose is recommended for
use in elderly patients.
Use in children
Do not give TAMIFLU oral suspension to children under 1 year of age.
Safety and effectiveness of TAMIFLU oral suspension in children under 1 year of age has not been established.
Before you start to take it
Tell your doctor if:
1.
you are pregnant or plan to become pregnant
It is not known whether TAMIFLU is harmful to an unborn baby when taken by a pregnant woman. If there is a need to take TAMIFLU
when you are pregnant, your doctor will discuss the risks and benefits to you and the unborn baby.
2.
you are breast-feeding or plan to breast-feed
TAMIFLU may pass into breast milk. Your doctor will discuss the risks and benefits of using TAMIFLU if you are breast-feeding.
3.
you have any other health problems, especially the following:
kidney failure, kidney impairment or kidney disease.
4.
you have a hereditary intolerance to fructose
One 45 mg dose of TAMIFLU oral suspension contains 1.3 g of sorbitol. Two 45 mg doses in one day is equivalent to 2.6 g of
sorbitol. If you have a hereditary fructose intolerance this is above the recommended daily maximum limit of sorbitol.
5.
you are allergic to any other medicines, foods, dyes or preservatives.
If you have not told your doctor about any of the above, tell them before you start taking TAMIFLU oral suspension.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you have bought from a pharmacy, supermarket or
health food shop.
These medicines may be affected by TAMIFLU oral suspension, or may affect how well it works. You may need to use different
amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking TAMIFLU oral suspension.
It is safe to take aspirin, paracetamol and cough medicines with TAMIFLU oral suspension. However, medical advice should be
sought before giving aspirin to children with viral illness.
How to take TAMIFLU oral suspension
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
Start taking TAMIFLU oral suspension as soon as possible after you have been diagnosed with influenza.
The earlier you start treatment with TAMIFLU oral suspension, the shorter will be the duration of your influenza.
How much to take
Take TAMIFLU oral suspension exactly as your doctor has prescribed.
TREATMENT OF INFLUENZA
Adults and adolescents
Adults and adolescents who are unable to swallow capsules may receive TAMIFLU oral suspension. The usual treatment dose is
75 mg twice daily for 5 days. This should be taken as a 30 mg dose plus a 45 mg dose in the morning and a 30 mg dose plus
a 45 mg dose at night, using the oral dispenser provided. A 75 mg dose is 6.25 mL of suspension.
Children 1 year of age or older
Children who are unable to swallow capsules may receive TAMIFLU oral suspension. The recommended oral treatment dose of TAMIFLU
oral suspension for children 1 year of age or older is:
Body weight 15kg or less
Recommended dose twice daily for 5 days - 30mg (equivalent to 2.50mL of suspension)
Body weight from 15kg to 23kg
Recommended dose twice daily for 5 days - 45mg (equivalent to 3.75mL of suspension)
Body weight 23kg to 40kg
Recommended dose twice daily for 5 days - 60mg (equivalent 5.00mL of suspension)
Body weight 40kg or more
Recommended dose twice daily for 5 days - 75mg (equivalent 6.25mL of suspension)
PREVENTION OF INFLUENZA
For prevention of influenza TAMIFLU oral suspension is taken once a day at the recommended dose while protection is required.
Safety and effectiveness have been shown in patients taking TAMIFLU oral suspension for up to 6 weeks.
Adults and adolescents
Adults and adolescents who are unable to swallow capsules may receive TAMILFU oral suspension. The usual prevention dose is
75 mg once daily for 10 days. This should be taken as a 30 mg dose plus a 45 mg dose, using the oral dispenser provided. A
75 mg dose is 6.25 mL of suspension.
Children 1 year of age or older
Children who are unable to swallow capsules may receive TAMIFLU oral suspension. The recommended oral prevention dose of TAMIFLU
oral suspension for children 1 year of age or older is:
Body weight 15kg or less
Recommended dose once daily for 10 days - 30mg (equivalent to 2.50mL of suspension)
Body weight from 15kg to 23kg
Recommended dose once daily for 10 days - 45mg (equivalent to 3.75mL of suspension)
Body weight 23kg to 40kg
Recommended dose once daily for 10 days - 60mg (equivalent 5.00mL of suspension)
Body weight 40kg or more
Recommended dose once daily for 10 days - 75mg (equivalent 6.25mL of suspension)
A dosing syringe marked with 30 mg, 45 mg and 60 mg dosing levels has been provided.
How to take it
Shake the suspension well every time you use it to ensure you get the right dose.
Water has been added to the powder by your pharmacist to make the suspension.
The powder in the suspension may settle during storage.
How to measure and give a dose of oral suspension
1. Shake the closed bottle of TAMIFLU oral suspension well before use.
2. Take the dispenser and push the plunger completely down toward the tip of the dispenser. The dispenser provided with your
medicine must always be used to measure the correct mg dose.
3. Remove the cap from the bottle of oral suspension.
4. Insert the bottle adaptor into the neck of the bottle.
5. Insert the tip of the dispenser into the bottle adapter.
6. Turn the entire unit (bottle and dispenser) upside down.
7. Slowly pull out the plunger to the graduation which marks the mg dose which your doctor or pharmacist has instructed you to
take.
8. Turn the entire unit upright.
9. Slowly remove the dispenser from the bottle.
10. Push the suspension directly into the mouth by pushing down the plunger of the dispenser. Swallow the medicine. You may drink
and eat something after taking the medicine.
11. Immediately after administration, take the dispenser apart and rinse both parts of the dispenser under running tap water.
Air dry prior to next use.
Each bottle contains 900 mg of oseltamivir in 75 mL of suspension. Depending on the dose your doctor has prescribed for you
or your child, you may have suspension left over.
When to take it
Treatment with TAMIFLU oral suspension should be started as soon as possible, but no later than 48 hours after the first symptoms
of influenza.
For influenza treatment, TAMIFLU oral suspension should be taken in the morning and in the evening.
For influenza prevention, TAMIFLU oral suspension should be taken once a day.
Taking your medicine at the same time each day will help you remember when to take your TAMIFLU oral suspension.
How long to take it
Continue taking TAMIFLU oral suspension until your doctor tells you to stop or your course of treatment is complete.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember and then go back to taking it as you would normally.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering your dose, ask your pharmacist for some hints.
In case of an overdose
If you think you or anyone else may have taken too much TAMIFLU oral suspension immediately telephone your doctor or Poisons
Information Centre (13 11 26), or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs
of discomfort or poisoning.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
The following are some symptoms of overdose which may or may not occur:
nausea (feeling like vomiting)
vomiting
While you are taking TAMIFLU oral suspension
Things you must do
Tell your doctor if you have kidney failure or impairment or any other problems with your kidneys.
Tell all doctors, dentists and pharmacists who are treating you that you are taking TAMIFLU oral suspension.
Tell your doctor if you become pregnant while taking TAMIFLU oral suspension.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you feel your symptoms have worsened after starting TAMIFLU oral suspension.
Be sure to keep all of your appointments with your doctor so that your progress can be checked.
Things you must not do
Do not stop taking TAMIFLU oral suspension or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give TAMIFLU oral suspension to anyone else even if they have the same condition as you.
Do not use TAMIFLU oral suspension to treat other complaints unless your doctor says to.
Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting
a pharmacist.
Things to be careful of
Be careful driving or operating machinery until you know how TAMIFLU oral suspension affects you.
However, TAMIFLU oral suspension is not expected to affect your ability to drive a car or operate machinery.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking TAMIFLU oral suspension.
TAMIFLU oral suspension helps most people with influenza but it may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment
if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
nausea (feeling like vomiting)
vomiting
stomach ache
These are the more common side effects of TAMIFLU oral suspension. Mostly these are mild.
Taking TAMIFLU oral suspension with food may reduce the potential for some or all of these side effects.
People with influenza, including those taking TAMIFLU oral suspension, may be at an increased risk of seizures, confusion,
hallucinations, and/or abnormal behaviour during their illness. These events may occur shortly after beginning TAMIFLU oral
suspension or may occur when influenza is not treated. These events are uncommon but may result in accidental injury to the
patient.
Patients, especially children and adolescents, should be closely monitored and their healthcare professional should be contacted
immediately if the patient shows any signs of unusual behaviour.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects
not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything on this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After taking TAMIFLU oral suspension
Storage
After water has been added to the TAMIFLU powder, the suspension only lasts for a limited time. After this time it may not
work as well.
If the TAMIFLU oral suspension is stored at room temperature (where the temperature stays below 25°C) the suspension must
be discarded after 10 days.
The TAMIFLU suspension may however be kept in the fridge (between 2-8°C) for up to 17 days. Do not freeze the suspension.
Keep TAMIFLU oral suspension in a cool dry place.
Do not store it, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep TAMIFLU oral suspension where young children cannot reach it.
A locked cupboard at least 1.5 metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking TAMIFLU oral suspension, or the suspension has passed its expiry date, ask your pharmacist
what to do with the rest of the suspension that is left over.
Product description
Availability
TAMIFLU oral suspension comes in a bottle with an adapter, an oral dispenser and a measuring cup.
The oral dispenser provided with TAMIFLU oral suspension should not be used for measuring doses of any other products.
TAMIFLU is also available as 30 mg, 45 mg and 75 mg capsules.
What TAMIFLU oral suspension looks like
TAMIFLU oral suspension is a white to light yellow liquid.
Ingredients
Active ingredient -
oseltamivir
Inactive ingredients -
sorbitol E420
sodium dihydrogen citrate (E331(a))
xanthan gum (E415)
sodium benzoate (E211)
saccharin sodium (E954)
titanium dioxide (E171)
Tutti Frutti flavour
TAMIFLU powder for oral suspension is gluten free and lactose free.
Distributor
TAMIFLU is distributed by:
Roche Products Pty Limited
ABN 70 000 132 865
4-10 Inman Road
Dee Why NSW 2099
AUSTRALIA
Customer enquiries: 1 800 233 950
Please check with your pharmacist for the latest Consumer Medicine Information.
Australian Registration Number
AUST R 94647
This leaflet was prepared on 25 March 2011
CMI 110325
PI 110309