contains the active ingredient oseltamivir phosphate

CONSUMER MEDICINE INFORMATION

This leaflet answers some common questions about TALMINEX.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has prescribed TALMINEX after considering its likely benefit to you, as well as the potential risks.

If you have any concerns about taking this medicine, talk to your doctor, nurse or pharmacist.

Keep this leaflet with your medicine.

You may need to read this information again.

TALMINEX is an antiviral medicine containing the active ingredient oseltamivir phosphate.

It 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 medicine has been prescribed for you.

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.

Do not have TALMINEX if you have an allergy to:

Any medicine containing oseltamivir

Any of the ingredients listed at the end of this leaflet

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

skin rash, itching or hives.

Do not use TALMINEX after the expiry date (EXP) printed on the pack.

Do not use TALMINEX if the packaging is torn or shows signs of tampering.

If you are not sure whether you should use TALMINEX, talk to your doctor or pharmacist.

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.

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.

Tell your doctor if:

1.you have allergies to:

any other medicines

any other substances, such as foods, preservatives or dyes.

2.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.

3.you are breastfeeding or planning to breastfeed.

TALMINEX may pass into breast milk. Your doctor will discuss the risks and benefits of using TALMINEX if you are breastfeeding.

4.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

If you have not told your doctor about any of the above, tell them before you use TALMINEX.

Tell your doctor if you are taking any other medicines including any medicines you buy without a prescription from your 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.

Carefully follow all directions given to you by your doctor or pharmacist.

They may differ from the information 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.

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 6mg/mL oral suspension is the preferred product (see separate Oseltamivir 6mg/mL 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.

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 table below), which is body weight dependent (see table above).

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.

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.

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.

Taking your medicine at the same time each day will help you remember when to take the capsules.

Continue taking TALMINEX capsules until your doctor tells you to stop or your course of treatment is complete.

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.

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

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.

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.

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.

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are taking TALMINEX.

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 at your nearest hospital 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.

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 TALMINEX 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 windowsills.

Heat and dampness can destroy some medicines.

Keep TALMINEX capsules where young children cannot reach it.

A locked cupboard at least 1.5 metres above the ground is a good place to store medicines

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 tablets that are left over.

TALMINEX capsules are available in the following strengths: 30 mg, 45 mg and 75 mg.

TALMINEX comes in blister packs containing 10 capsules.

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”.

Active ingredient – oseltamivir

30 mg capsules contain 30 mg oseltamivir (as phosphate).

45 mg capsules contain 45 mg oseltamivir (as phosphate).

75 mg capsules contain 75 mg oseltamivir (as 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)

TALMINEX contains sulfites. They are gluten and lactose free.

Alphapharm Pty Ltd

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.mylan.com.au 

TALMINEX 30 mg capsules

AUST R 312888

TALMINEX 45 mg capsules

AUST R 3128889

TALMINEX 75 mg capsules

AUST R 312887

This leaflet was prepared in June 2020.