Tamiflu Oral Suspension®
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.
Tamiflu contains the active ingredient oseltamivir. Tamiflu is used to treat and prevent
influenza (an infection caused by influenza virus). For more information, see Section
1. Why am I using Tamiflu? in the full CMI.
Do not use if you have ever had an allergic reaction to Tamiflu 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.
For more information, see Section 2. What should I know before I use Tamiflu? in the full 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.
For more information, see Section 2. What should I know before I use Tamiflu? in the full CMI.
Some medicines may interfere with Tamiflu and affect how it works. A list of these
medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Take Tamiflu oral suspension exactly as your doctor has prescribed.
Use the measuring dispenser provided to take Tamiflu.
Taking Tamiflu with food may reduce the potential for some or all of side effects.
More instructions can be found in Section 4. How do I use Tamiflu? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Tamiflu.
If symptoms do not improve and you still feel unwell after taking Tamiflu, talk to
your doctor.
Tell your doctor if you have kidney failure, impairment, or any other problems with
your kidneys.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked.
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Things you should not do
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Do not stop using this medicine suddenly.
Do not give Tamiflu Oral Suspension to anyone else even if they have the same condition
as you.
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Driving or using machines
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Be careful driving or operating machinery until you know how Tamiflu affects you.
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Looking after your medicine
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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.
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For more information, see Section 5. What should I know while using Tamiflu? in the full CMI.
Tell your doctor as soon as possible if you do not feel well while you are taking
Tamiflu oral suspension. Common side effects include nausea, vomiting, headache and
pain. Tell your doctor immediately or go to your nearest Emergency Department if you
notice signs or symptoms of a serious allergic reaction such as rash, itching or hives
on the skin, swelling of the face, lips, tongue or other parts of the body, shortness
of breath, wheezing or trouble breathing.
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.
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.
Tamiflu Oral Suspension®
Active ingredient: oseltamivir
Consumer Medicine Information (CMI)
This leaflet provides important information about using Tamiflu.
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 Tamiflu.
Where to find information in this leaflet:
Tamiflu contains the active ingredient oseltamivir. Tamiflu is an antiviral medicine.
Tamiflu is used for treatment and prevention of influenza (an infection caused by
influenza virus). It has no effect on the common cold or other respiratory virus infections.
Tamiflu attacks the influenza virus and prevents it from spreading inside your body.
Give Tamiflu suspension as directed by your child's doctor or pharmacist.
The usual dose of Tamiflu is one dose taken TWICE a day. The dose may vary depending
on your child's weight.
Tamiflu is absorbed to the key sites of influenza infection and treats the cause.
Taking Tamiflu can prevent you from catching the flu, or if you have already caught
the flu, taking Tamiflu means you feel better faster.
You will also be less likely to develop complications of influenza, such as bronchitis,
pneumonia, sinusitis and ear infection. Typical symptoms of influenza include fever,
headache, muscle aches, sore throat, cough and extreme tiredness.
Tamiflu will help reduce the chances of you passing the flu onto someone else.
Ask your doctor or pharmacist if you have any questions about why Tamiflu has been
prescribed for you.
Tamiflu is not addictive.
Ask your doctor about having the influenza vaccination.
Vaccination every year is the best way to prevent influenza.
Do not use Tamiflu if:
you are allergic to oseltamivir, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of 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.
the package is torn or shows signs of tampering
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.
Check with your doctor if you:
have any other medical conditions, especially kidney failure, kidney impairment or
kidney disease
weakened immune system, caused by medical condition or medication you are taking
take any medicines for any other condition
you have a hereditary intolerance to fructose
One 75mg dose of Tamiflu 6mg/mL oral suspension contains 2.1g of sorbitol. If you
have hereditary fructose intolerance, Tamiflu 6mg/mL oral suspension is not recommended.
Sorbitol may have a laxative effect and cause diarrhoea.
you are allergic to any other medicines, foods, dyes or preservatives
if you have a suppressed immune system
If you have not told your doctor about any of the above, tell them before you start
taking Tamiflu oral suspension.
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.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Tamiflu may pass into breast milk. Your doctor will discuss the risks and benefits
of using Tamiflu if you are breast-feeding.
Use in the elderly
Although there is limited experience with use of Tamiflu in patients 65 years and
older, the dose recommended for use in elderly patients is the same as that recommended
for adults.
Use in children
Do not give Tamiflu oral suspension to children under 1 year of age for the prevention
of influenza.
Safety and effectiveness of Tamiflu oral suspension in children under 1 year of age
has not been established when used for the prevention of influenza.
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 Tamiflu and affect how 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 including:
immunosuppressants, medicines used to suppress the immune system
probenecid, a medicine used to treat gout
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Tamiflu.
How much to use
Take Tamiflu oral suspension exactly as your doctor has prescribed.
Follow the instructions provided and use Tamiflu until your doctor tells you to stop.
If you have kidney disease, your doctor may prescribe you a lower dose of Tamiflu.
Treatment of Influenza
Adults and adolescents
Adults and adolescents who are unable to swallow capsules may receive Tamiflu 6mg/mL
oral suspension. The usual treatment dose is 75mg twice daily for 5 days. This should
be taken as a 30mg dose plus a 45mg dose in the morning and a 30mg dose plus a 45mg
dose at night, using the oral dispenser provided. A 30mg dose is equivalent to 5.0mL
of suspension. A 45mg dose is equivalent to 7.5mL of suspension.
Children
Give Tamiflu suspension as directed by your child's doctor or pharmacist.
The usual dose of Tamiflu for treatment of influenza is one dose taken TWICE a day
for 5 days. The dose may vary depending on your child's weight.
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 for up to 6 weeks.
Adults and adolescents
Adults and adolescents who are unable to swallow capsules may receive Tamiflu 6mg/mL
oral suspension. The usual prevention dose is 75mg once daily for 10 days. This should
be taken as a 30mg dose plus a 45mg dose, using the oral dispenser provided. A 30
mg dose is equivalent to 5.0mL of suspension. A 45mg dose is equivalent to 7.5mL of
suspension.
Children 1 year of age and older
Give Tamiflu suspension as directed by your child's doctor or pharmacist.
The usual dose of Tamiflu for prevention of influenza is one dose taken ONCE a day
for 10 days. The dose may vary depending on your child's weight.
For dosing 3 mL and 10 mL oral dispensers (dosing syringes) have been provided in
the carton.
Do not give Tamiflu to children under 1 year of age for the prevention of influenza.
Safety and effectiveness in children under 1 year of age have not been established.
How to take it
Shake the suspension well every time you use it to ensure you get the right dose.
The powder in the suspension may settle during storage.
Tamiflu can be taken with or without food. However, you may find Tamiflu is easier
on your stomach when taken with food.
Your pharmacist may have prepared the oral suspension for you when you collected your
prescription. However, if they have not done this then you can do it easily yourself.
You only need to prepare the suspension once, at the beginning of your course.
After that, all you need to do is shake the suspension well and draw up the appropriate
recommended dose.
Figure 1
Tap the closed bottle gently several times to loosen the powder.
1. Measure 55mL of water by filling the measuring cup to the indicated level (measuring cup included in the box). You should always use 55mL of water, irrespective of the recommended dose you are taking. It is best to use bottled water or boiled water that has been cooled.
2. Add all 55mL of water into the bottle, recap the bottle and shake the closed bottle well for 15 seconds. The powder plus 55mL of water will make a total volume of 65mL.
3. Remove the cap and push the bottle adapter into the neck of the bottle.
4. Place the cap tightly over the top of the bottle, which now includes the bottle adapter. This will make sure that the bottle adapter fits in the bottle in the right position.
How to measure and give a dose of oral suspension
Figure 2
Figure 3
Figure 4
1. Shake the closed bottle of Tamiflu oral suspension well before use.
2. Take the dispenser (see Figure 2) and push the plunger completely down toward the tip of the dispenser.
3. Remove the cap from the bottle of oral suspension.
4. Insert the bottle adaptor into the neck of the bottle (see Figure 3).
5. Insert the tip of the dispenser into the bottle adapter.
6. Turn the entire unit (bottle and dispenser) upside down (see Figure 4).
7. Slowly pull out the plunger to the graduation marks in mL 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. Allow dispenser to air dry before next use.
12. Do not boil the oral dispenser to avoid damage of the dispenser.
13. Contact your doctor or pharmacist if the dispenser is lost. If the dispenser is damaged, do not use it, contact your doctor or pharmacist and they will advise you on how to continue to take your medication.
Each bottle of Tamiflu 6mg/mL oral suspension contains 390mg of oseltamivir in a final
volume of 65mL suspension. Depending on the dose your doctor has prescribed for you
or your child, you may have suspension left over. Discard any unused suspension once
you have completed your treatment course.
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.
If you have kidney problems, you doctor may tell you to take Tamiflu less often.
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 have a weakened immune system, your doctor may tell you to take a longer course.
If you forget to use Tamiflu
Tamiflu should be used regularly at the same time each day.
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.
Do not take a double dose to make up for the dose you missed.
If you use too much Tamiflu
If you think that you have used too much Tamiflu, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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. 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
Things you should do
Tell your doctor if:
- you have kidney failure or impairment or any other problems with your kidneys.
- you become pregnant while taking Tamiflu.
- if for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and may change your treatment
unnecessarily.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked.
Call your doctor straightaway if you:
feel your symptoms have worsened after starting Tamiflu.
Remind any doctor, dentist or pharmacist you visit that you are using Tamiflu.
Things you should not do
Do not stop using this medicine suddenly 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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Tamiflu
affects you.
However, Tamiflu is not expected to affect your ability to drive a car or operate
machinery.
Looking after your medicine
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.
The Tamiflu suspension may however be kept in the fridge (between 2 - 8°C) for up
to 17 days. Do not freeze the suspension.
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.
When to discard your medicine (as relevant)
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.
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.
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.
This is not a complete list of all possible side effects.
Less serious side effects
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Less serious side effects
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What to do
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Stomach
nausea (feeling like vomiting)
vomiting
stomach ache, indigestion
diarrhoea
Nervous system
dizziness/spinning sensation (vertigo)
headache
insomnia (difficulty sleeping)
Nose
sinusitis (stuffy nose and/or feeling of tension or fullness in the nose, cheeks and
behind the eyes, sometimes with a throbbing ache)
runny nose or nose bleeds
Throat
cough
bronchitis
asthma (breathlessness, wheezing, a cough sometimes brought on by exercise and a feeling
of tightness in the chest)
Ear
ear problems or ear infection
Eyes
conjunctivitis (discharge from the eyes with itching and crusty eyelids)
visual disturbances
Body
fatigue
aches and pains
Skin
mild skin rash
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
Taking Tamiflu with food may reduce the potential for some or all of these side effects.
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Serious side effects
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Serious side effects
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What to do
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Stomach
diarrhoea with blood, along with fever and severe stomach pain
Skin and other allergies
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the
face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble
breathing.
yellowing of the skin and/or eyes, itching and dark coloured urine.
Infection
chest infection with fever, chills, shortness of breath, cough, phlegm and occasional
blood.
Psychological
convulsions, confusion, drowsiness, abnormal behaviour, delusions, hallucinations,
agitation, anxiety and nightmares.
These symptoms may also occur in influenza patients not treated with Tamiflu.
Patients (especially children and adolescents) and their caregivers should look out
for signs of abnormal behaviour and contact a doctor immediately.
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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.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
Reporting side effects
After you have received medical advice for any side affects 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.
This medicine is only available with a doctor's prescription.
What Tamiflu contains
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Active ingredient
(main ingredient)
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Oseltamivir
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Other ingredients
(inactive ingredients)
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sorbitol
sodium dihydrogen citrate
xanthan gum
sodium benzoate
saccharin sodium
titanium dioxide
Tutti Frutti flavour
Tamiflu powder for oral suspension is gluten free and lactose free.
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Potential allergens
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Tamiflu oral suspension contains benzoates, saccharin and sorbitol. Maximum recommended
daily dose of Tamiflu (150mg) exceeds 2g of sorbitol. Products containing sorbitol
may have a laxative effect or cause diarrhoea..
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Do not take this medicine if you are allergic to any of these ingredients.
What Tamiflu looks like
Tamiflu oral suspension is a white to light yellow liquid.
Tamiflu 6mg/mL oral suspension comes in a bottle with an adapter, oral dispensers
and a measuring cup. Tamiflu is also available as 30mg, 45mg and 75mg capsules.
Tamiflu 6mg/mL oral suspension is registered with the TGA as AUST R 188016.
