TALMINEX capsules
Oseltamivir phosphate
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Talminex capsule.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Talminex against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Talminex is used for
Talminex is an antiviral medicine containing the active ingredient oseltamivir.
Talminex 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.
Talminex belongs to a group of medicines called neuraminidase inhibitors. These medicines
attack the influenza virus and prevent it from spreading inside your body.
Talminex is absorbed to the key sites of influenza infection and treats the cause.
Taking Talminex 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 this Talminex has been prescribed
for you.
Talminex is not addictive.
This medicine is available only with a doctor's prescription.
Ask your doctor about having the influenza vaccination.
Vaccination every year is the best way to prevent influenza.
When you must not take it
Do not have Talminex if you have had an allergic reaction to:
oseltamivir
any of the ingredients listed at the end of this leaflet
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.
Do not use Talminex if the packaging is torn or shows signs of tampering.
Do not use Talminex if 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.
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 oseltamivir in children under 1 year of age have not been
established when used for the prevention of influenza.
Before you start to take it
Tell your doctor if:
1. you are pregnant or plan to become pregnant.
It is not known whether oseltamivir is harmful to an unborn baby when taken by a pregnant
woman. If there is a need to take oseltamivir 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.
Oseltamivir may pass into breast milk. Your doctor will discuss the risks and benefits
of using oseltamivir if you are breast-feeding.
3. you have any other health problems, especially the following:
kidney failure, kidney impairment or kidney disease.
if you have a weakened immune system, caused by a medical condition or medication
you are taking.
4. 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 use
Talminex.
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 Talminex 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 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.
How to take Talminex capsules
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
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.
How much to take
Take Talminex exactly as your doctor has prescribed.
If you have kidney disease your doctor may prescribe you a lower dose of Talminex.
TREATMENT OF INFLUENZA
Adults and adolescents
The recommended oral dose of Talminex for adults and adolescents 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 (see separate Oseltamivir 6 mg/mL powder for oral suspension Consumer
Medicine Information).
Children 1 year of age or older
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 may
vary depending 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
The recommended oral 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 or older
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 sugar-free 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.
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 below), which is body weight dependent.
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. Immediately after administration, take the dispenser apart and rinse both parts of the dispenser under running tap water. Air dry prior to next use.
5. 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
6. 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.
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.
Patients who are unable to swallow capsules may receive oseltamivir 6 mg/mL oral suspension
(available in other brands).
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, your doctor may tell you take Talminex less often.
Taking your medicine at the same time each day will help you remember when to take
the 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 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 Talminex immediately telephone
your doctor or Poisons Information Centre (telephone 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
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
Talminex.
Tell your doctor if you become pregnant while taking Talminex.
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 Talminex.
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 Talminex capsules 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 Talminex to anyone else even if they have the same condition as you.
Do not use Talminex 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 Talminex affects you.
However, Talminex 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 Talminex capsules.
Talminex 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
dizziness/spinning sensation (vertigo)
headache
stomach ache, indigestion
diarrhoea
cough
bronchitis
asthma (breathlessness, wheezing, a cough sometimes brought on by exercise and a feeling
of tightness in the chest)
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
ear problems or ear infection
conjunctivitis (discharge from the eyes with itching and crusty eyelids)
visual disturbances
insomnia (difficulty sleeping)
fatigue
aches and pains
mild skin rash
These are the more common side effects of Talminex. Mostly these are mild.
Taking Talminex with food may reduce the potential for some or all of these side effects.
Tell your doctor immediately, or go to Accident and Emergency department if you notice
any of the following:
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
chest infection with fever, chills, shortness of breath, cough, phlegm and occasional
blood
convulsions, confusion, drowsiness, abnormal behaviour, delusions, hallucinations,
agitation, anxiety and nightmares. These symptoms may also occur in influenza patients
not treated with Talminex.
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.
Diarrhoea with blood, along with fever and severe stomach pain
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.
Storage
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 your capsules in a cool dry place where the temperature stays below 25°C.
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 damp can destroy some medicines.
Keep Talminex capsules where young children cannot reach it.
A locked cupboard at least one-and-a half metres above the ground is a good place
to store medicines.
Disposal
If your doctor tells you to stop taking Talminex or the capsules have passed their
expiry date, ask your pharmacist what to do with any capsules that are left over.
Product description
Talminex capsules are available in the following strengths: 30 mg, 45 mg and 75 mg.
Talminex comes in blister packs containing 10 capsules.
What it looks like
Talminex 30 mg capsules have a light yellow opaque colour body with black colour band,
imprinted with “M” and light yellow opaque colour cap imprinted with “30 mg”.
Talminex 45 mg capsules have a grey opaque colour body with black colour band, imprinted
with “M” and a grey opaque colour cap imprinted with “45 mg”.
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”.
Ingredients
Active ingredient - 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).
Inactive ingredients
Capsule contents:
pregelatinised maize starch
povidone
croscarmellose sodium
purified talc
sodium stearyl fumarate
Capsule shell
gelatin
titanium dioxide (171)
black iron oxide (172)
red iron oxide (172)
yellow iron oxide (172)
black ink (TekPrint SW-9008)
Talminex capsules contain sulfites. They are gluten free and lactose free.
