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.
1. Why am I using TALMINEX?
TALMINEX contains the active ingredient oseltamivir. TALMINEX is used to treat and
prevent influenza (an infection caused by influenza virus).
2. What should I know before I use TALMINEX?
Do not use if you have ever had an allergic reaction to TALMINEX 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.
3. What if I am taking other medicines?
Some medicines may interfere with TALMINEX and affect how it works.
4. How do I use TALMINEX?
Taking TALMINEX with food may reduce the potential for some or all of side effects.
Do not break or chew the capsules before swallowing.
If you are unable to swallow capsules, your doctor may prescribe TALMINEX 6 mg/mL
oral suspension.
5. What should I know while using TALMINEX?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TALMINEX.
If symptoms do not improve and you still feel unwell after taking TALMINEX, 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 TALMINEX capsules 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 TALMINEX affects you.
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Looking after your medicine
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Keep your capsules in the blister pack until it is time to take them.
Keep TALMINEX capsules in a cool dry place where the temperature stays below 25°C.
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6. Are there any side effects?
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.
Active ingredient(s):
oseltamivir
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using TALMINEX. 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 TALMINEX.
Where to find information in this leaflet:
1. Why am I using TALMINEX?
TALMINEX contains the active ingredient oseltamivir. TALMINEX is an antiviral medicine.
TALMINEX is used to 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.
TALMINEX belongs to a group of medicines called neuraminidase inhibitors. These medicines
attack the influenza virus and prevent it from spreading inside your body. Take TALMINEX
capsules as directed by your doctor or pharmacist.
TALMINEX is absorbed to the key sites of influenza infection and treats the cause.
TALMINEX will help reduce the chances of you passing the flu onto someone else. Taking
TALMINEX can prevent you from catching the flu, or if you have already caught the
flu, taking TALMINEX may help 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 or pharmacist if you have any questions about why TALMINEX has been
prescribed for you.
TALMINEX is not addictive.
Ask your doctor about having the influenza vaccination.
Vaccination every year is the best way to prevent influenza.
2. What should I know before I use TALMINEX?
Warnings
Do not use TALMINEX 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 TALMINEX, 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 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 TALMINEX capsules.
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 TALMINEX is harmful to an unborn baby when taken by a pregnant
woman. If there is a need to take TALMINEX 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.
TALMINEX may pass into breast milk. Your doctor will discuss the risks and benefits
of using TALMINEX if you are breastfeeding.
Use in the elderly
Although there is limited experience with use of TALMINEX 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 TALMINEX to children under 1 year of age for the prevention of influenza.
Safety and effectiveness of TALMINEX in children under 1 year of age have not been
established when used for the prevention of influenza.
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 TALMINEX 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 TALMINEX 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 TALMINEX capsules.
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 TALMINEX.
4. How do I use TALMINEX?
How much to use
Take TALMINEX exactly as your doctor has prescribed.
Follow the instructions provided and use TALMINEX until your doctor tells you to stop.
If you have kidney disease, your doctor may prescribe you a lower dose of TALMINEX.
When to use TALMINEX
TALMINEX should be used to treat and prevent influenza.
Start taking TALMINEX as soon as possible within the first two days of the onset of
the first symptoms of influenza or exposure to someone with influenza.
The earlier you start treatment with TALMINEX, the shorter the duration of your influenza.
Treatment of Influenza
Adults and adolescents 13 years of age and older
The recommended oral dose of TALMINEX for adults and adolescents 13 years of age and
older is 75 mg twice a day for 5 days.
Children under 1 year of age
Oseltamivir 6 mg/mL powder for oral suspension (available in other brands) is the
preferred product.
Children 1 year of age and older and less than 13 years of age
Give TALMINEX as directed by your child's doctor or pharmacist.
The usual dose of TALMINEX is one dose taken TWICE a day for 5 days. The dose depends
on your child's weight.
Prevention of Influenza
For prevention of influenza, TALMINEX capsules are taken once a day at the recommended
dose while protection is required. Safety and effectiveness have been shown in patients
taking TALMINEX for up to 6 weeks.
Adults and adolescents 13 years of age and older
The recommended prevention dose of TALMINEX for adults and adolescents 13 years and
older is 75 mg once a day for 10 days.
Children 1 year of age and older and less than 13 years of age
Give TALMINEX as directed by your child's doctor or pharmacist.
The usual dose of TALMINEX is one dose taken ONCE a day for 10 days. The dose may
vary depending on your child's weight.
Do not give TALMINEX 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
Swallow capsules whole with a glass of water with or without food.
It does not matter whether you take TALMINEX with food or not. However, if TALMINEX
upsets your stomach, it is better to take TALMINEX with food.
Do not break or chew the capsules before swallowing.
If you cannot swallow the capsule whole:
For adults, adolescents or children 1 year of age or older who are unable to swallow
capsules please follow these instructions to ensure proper dosing:
1. hold the required dosage capsule over a small bowl, carefully pull the capsule open
and pour the powder into the bowl.
2. add a suitable, small amount (1 teaspoon maximum) of sweetened food product such as
regular or sugarfree chocolate syrup, honey (only for children two years or older),
light brown or table sugar dissolved in water, dessert toppings, sweetened condensed
milk, apple sauce or yogurt to mask the bitter taste of the medicine.
3. stir the mixture well and give the entire contents of the bowl to the patient. The
mixture must be swallowed immediately after its preparation. If there is some mixture
left inside the bowl, rinse the bowl with a small amount of water and have the patient
drink this remaining mixture. It is not necessary to take an undissolved white powder,
as this is inactive.
For children 1 year of age or older requiring doses different to that available in
capsule form, please follow these instructions to ensure proper dosing:
1. hold one TALMINEX 75 mg capsule over a small bowl, carefully pull the capsule open
and pour the powder into the bowl.
2. add 5 mL water to the powder using a syringe with markings (called a "graduated syringe")
to show how much fluid has been drawn up. Stir for about two minutes.
3. draw up into the syringe the correct amount of mixture from the bowl based on the
recommended dose required (see table below), which is body weight dependent (below).It is not necessary to draw up any undissolved white powder.
Recommended dose 30mg:
Amount of TALMINEX mixture for one dose - 2mL
Recommended dose 45mg:
Amount of TALMINEX mixture for one dose - 3mL
Recommended dose 60mg:
Amount of TALMINEX mixture for one dose - 4mL
Push down on the plunger of the syringe, to empty its entire contents into a second
bowl.
Discard any unused mixture.
4. in the second bowl, add a suitable, small amount (1 teaspoon maximum) of sweetened
food product to the mixture to mask the bitter taste of the medicine.
The appropriate dose must be mixed by the caregiver with an equal quantity of sweetened
food product such as regular or sugar-free chocolate syrup, light brown or table sugar
dissolved in water, dessert toppings, sweetened condensed milk, apple sauce or yoghurt
to mask the bitter taste of the medicine.
5. stir this mixture well and give the entire contents of the second bowl to the patient.
This mixture must be swallowed immediately after its preparation. If there is some
mixture left inside the bowl, rinse the bowl with a small amount of water and have
the patient drink this remaining mixture.
Patients who are unable to swallow capsules may receive TALMINEX 6 mg/mL oral suspension.
When to take it
Treatment with TALMINEX capsules should be started as soon as possible, but no later
than 48 hours after the first symptoms of influenza.
For influenza treatment, TALMINEX capsules should be taken in the morning and in the
evening.
For influenza prevention, TALMINEX capsules should be taken once a day.
If you have kidney problems, you doctor may tell you to take TALMINEX less often.
Taking your medicine at the same time each day will help you remember when to take
your TALMINEX capsules.
How long to take it
Continue taking TALMINEX capsules 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 TALMINEX
TALMINEX 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 TALMINEX
If you think that you have used too much TALMINEX, 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.
The following are some symptoms of overdose which may or may not occur:
nausea (feeling like vomiting)
vomiting
5. What should I know while using TALMINEX?
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 straight away if you:
feel your symptoms have worsened after starting TALMINEX.
Remind any doctor, dentist or pharmacist you visit that you are using TALMINEX.
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 to anyone else even if they have the same condition as you.
Do not use Tamiflu 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 TALMINEX
affects you.
However, TALMINEX is not expected to affect your ability to drive a car or operate
machinery.
Looking after your medicine
Keep your capsules in the blister pack until it is time to take them. If you take
the capsules out of the blister pack they may not keep well.
Keep Tamiflu capsules 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.
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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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) should be closely monitored and their
healthcare professional should be contacted immediately if the patient shows any signs
of unusual behaviour..
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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 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 with a doctor's prescription.
What TALMINEX contains
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Active ingredient
(main ingredient)
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Oseltamivir
30 mg capsules contain 30 mg oseltamivir (present as 39.4 mg oseltamivir phosphate).
45 mg capsules contain 45 mg oseltamivir (present as 59.1 mg oseltamivir phosphate).
75 mg capsules contain 75 mg oseltamivir (present as 98.5 mg oseltamivir phosphate)
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Other ingredients
(inactive ingredients)
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Capsule contents:
pregelatinised maize starch
povidone
croscarmellose sodium
purified talc
sodium stearyl fumarate
Capsule shell:
pregelatinised maize starch
povidone
croscarmellose sodium
purified talc
sodium stearyl fumarate
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Potential allergens
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sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What TALMINEX looks like
TALMINEX 75 mg capsules have a grey opaque colour body with black colour band, imprinted
with “M” and a light yellow opaque colour cap imprinted with “75 mg” (AUST R 312887).
Each blister pack contains 10 capsules.
Who distributes TALMINEX
Sponsor
Accelagen Pty Ltd
Suite 2.02
785 Toorak Road
Hawthorn East
Victoria 3123 Australia
Distributor
TALMINEX is distributed in Australia by:
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 June 2024.
TALMINEX® is a Viatris company trade mark
TALMINEX_cmi\Jun24/00