Find similiar products:
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PLGB00031/0903 .
Tamiflu 6 mg/ml powder for oral suspension
Tamiflu 6 mg/ml powder for oral suspension
oseltamivir
1. What Tamiflu is and what it is used for
2. What you need to know before you take Tamiflu
3. How to take Tamiflu
4. Possible side effects
5. How to store Tamiflu
6. Contents of the pack and other information
Tamiflu contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors.
These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection.
Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.
Talk to your doctor if this applies to you. Do not take Tamiflu.
Before you take Tamiflu, make sure the prescribing doctor knows
During treatment with Tamiflu, tell a doctor immediately:
Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Tamiflu will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.
Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any. This includes medicines obtained without a prescription. The following medicines are particularly important:
You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Tamiflu is right for you.
The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so that your doctor can decide if Tamiflu is right for you.
Ask your doctor or pharmacist for advice before taking this medicine.
Tamiflu has no effect on your ability to drive or use machines.
Tamiflu contains sorbitol.
Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
5 ml oseltamivir suspension contains 0.9 g of sorbitol.
7.5 ml oseltamivir suspension contains 1.3 g of sorbitol.
10 ml oseltamivir suspension contains 1.7 g of sorbitol.
12.5 ml oseltamivir suspension contains 2.1 g of sorbitol.
Tamiflu contains sodium benzoate.
Sodium benzoate (E211) may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
5 ml oseltamivir suspension contains 2.5 mg of sodium benzoate.
7.5 ml oseltamivir suspension conains 3.75 mg of sodium benzoate.
10 ml oseltamivir suspension contains 5.0 mg of sodium benzoate.
12.5 ml oseltamivir suspension contains 6.25 mg of sodium benzoate.
This medicine contains less than 1 mmol sodium (23 mg) per single dose (based on a maximum dose of 75 mg), that is to say essentially ‘sodium-free’.
Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Always use the oral dispenser that is provided in the box and has markings indicating the dose in millilitres (ml).
Take Tamiflu as soon as possible, ideally within two days of the flu symptoms starting.
For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the whole 5-day course, even if you start to feel better quickly.
For patients with a weak immune system, treatment will continue for 10 days.
For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It is best to take this in the mornings with breakfast.
In special situations, such as widespread flu, or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.
The recommended dose is based on the patient’s body weight. You must use the amount of Tamiflu prescribed by the doctor. The oral suspension can be used by people who find it hard to take capsules. See the instructions overleaf to make up and give a dose.
For adults and adolescents 13 years and over and weighing 40 kg or more, the recommended dose for treating flu is 12.5 ml twice daily for 5 days.
For adults and adolescents 13 years and over and weighing 40 kg or more, the recommended dose for treating flu in patients with a weak immune system is 12.5 ml twice daily for 10 days.
For adults and adolescents 13 years and over and weighing 40 kg or more, the recommended dose for preventing flu is 12.5 ml once daily for 10 days.
A 12.5 ml dose can be made up of a 5 ml dose plus a 7.5 ml dose.
Children 1 to 12 years
For children aged 1 to 12 years and weighing 10 kg to 15 kg, the recommended dose for treating flu is 5.0 ml twice daily for 5 days.
For children aged 1 to 12 years and weighing 10 kg to 15 kg, the recommended dose for treating flu in children with a weak immune system is 5.0 ml twice daily for 10 days.
For children aged 1 to 12 years and weighing 10 kg to 15 kg, the recommended dose for preventing flu is 5.0 ml once daily for 10 days.
For children aged 1 to 12 years and weighing more than 15 kg and up to 23 kg, the recommended dose for treating flu is 7.5 ml twice daily for 5 days.
For children aged 1 to 12 years and weighing more than 15 kg and up to 23 kg, the recommended dose for treating flu in children with a weak immune system is 7.5 ml twice daily for 10 days.
For children aged 1 to 12 years and weighing more than 15 kg and up to 23 kg, the recommended dose for preventing flu is 7.5 ml once daily for 10 days.
For children aged 1 to 12 years and weighing more than 23 kg and up to 40 kg, the recommended dose for treating flu is 10.0 ml twice daily for 5 days.
For children aged 1 to 12 years and weighing more than 23 kg and up to 40 kg, the recommended dose for treating flu in children with a weak immune system is 10.0 ml twice daily for 10 days.
For children aged 1 to 12 years and weighing more than 23 kg and up to 40 kg, the recommended dose for preventing flu is 10.0 ml once daily for 10 days.
For children aged 1 to 12 years and weighing more than 40 kg, the recommended dose for treating flu is 12.5 ml twice daily for 5 days.
For children aged 1 to 12 years and weighing more than 40 kg, the recommended dose for treating flu in children with a weak immune system is 12.5 ml twice daily for 10 days.
For children aged 1 to 12 years and weighing more than 40 kg, the recommended dose for treating flu is 12.5 ml once daily for 10 days.
12.5 ml is made up of a 5 ml dose plus a 7.5 ml dose
Giving Tamiflu to infants less than 1 year old for preventing flu during flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.
A 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing infants less than 1 year old requiring 1 to 3 ml of Tamiflu oral suspension.
For infants aged between 0 and 12 months, weighing around 3 kg, the recommended dose for treating flu is 1.5 ml twice daily for 5 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 3 kg, the recommended dose for treating flu in patients with a weak immune system is 1.5 ml twice daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 3 kg, the recommended dose for preventing flu is 1.5 ml once daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 3.5 kg, the recommended dose for treating flu is 1.8 ml twice daily for 5 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 3.5 kg, the recommended dose for treating flu in patients with a weak immune system is 1.8 ml twice daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 3.5 kg, the recommended dose for preventing flu is 1.8 ml once daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 4 kg, the recommended dose for treating flu is 2.0 ml twice daily for 5 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 4 kg, the recommended dose for treating flu in patients with a weak immune system is 2.0 ml twice daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 4 kg, the recommended dose for preventing flu is 2.0 ml once daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 4.5 kg, the recommended dose for treating flu is 2.3 ml twice daily for 5 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 4.5 kg, the recommended dose for treating flu in patients with a weak immune system is 2.3 ml twice daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 4.5 kg, the recommended dose for preventing flu is 2.3 ml once daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 5 kg, the recommended dose for treating flu is 2.5 ml twice daily for 5 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 5 kg, the recommended dose for treating flu in patients with a weak immune system is 2.5 ml twice daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 5 kg, the recommended dose for preventing flu is 2.5 ml once daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 5.5 kg, the recommended dose for treating flu is 2.8 ml twice daily for 5 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 5.5 kg, the recommended dose for treating flu in patients with a weak immune system is 2.8 ml twice daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 5.5 kg, the recommended dose for preventing flu is 2.8 ml once daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 6 kg, the recommended dose for treating flu is 3.0 ml twice daily for 5 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 6 kg, the recommended dose for treating flu in patients with a weak immune system is 3.0 ml twice daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing around 6 kg, the recommended dose for preventing flu is 3.0 ml once daily for 10 days using a dispenser size of 3 ml.
For infants aged between 0 and 12 months, weighing more than 6 kg and up to 7 kg, the recommended dose for treating flu is 3.5 ml twice daily for 5 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 6 kg and up to 7 kg, the recommended dose for treating flu in patients with a weak immune system is 3.5 ml twice daily for 10 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 6 kg and up to 7 kg, the recommended dose for preventing flu is 3.5 ml once daily for 10 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 7 kg and up to 8 kg, the recommended dose for treating flu is 4.0 ml twice daily for 5 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 7 kg and up to 8 kg, the recommended dose for treating flu in patients with a weak immune system is 4.0 ml twice daily for 10 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 7 kg and up to 8 kg, the recommended dose for preventing flu is 4.0 ml once daily for 10 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 8 kg and up to 9 kg, the recommended dose for treating flu is 4.5 ml twice daily for 5 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 8 kg and up to 9 kg, the recommended dose for treating flu in patients with a weak immune system is 4.5 ml twice daily for 10 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 8 kg and up to 9 kg, the recommended dose for preventing flu is 4.5 ml once daily for 10 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 9 kg and up to 10 kg, the recommended dose for treating flu is 5.0 ml twice daily for 5 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 9 kg and up to 10 kg, the recommended dose for treating flu in patients with a weak immune system is 5.0 ml twice daily for 10 days using a dispenser size of 10 ml.
For infants aged between 0 and 12 months, weighing more than 9 kg and up to 10 kg, the recommended dose for preventing flu is 5.0 ml once daily for 10 days using a dispenser size of 10 ml.
Stop taking Tamiflu and contact a doctor or pharmacist immediately.
In most cases of overdose, people have not reported any side effects. When side effects were reported, they were similar to those from normal doses, as listed in section 4.
Overdose has been reported to have occurred more frequently when Tamiflu was given to children than to adults and adolescents. Caution should be exercised when preparing liquid Tamiflu for children and when administering Tamiflu capsules or liquid Tamiflu to children.
Do not take a double dose to make up for a forgotten dose.
There are no side effects when you stop Tamiflu. But if Tamiflu is stopped earlier than your doctor told you, the symptoms of flu may come back. Always complete the course that your doctor prescribed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects listed below may also be caused by influenza.
The following serious side effects have been rarely reported since oseltamivir has been marketed:
If you notice any of these symptoms, get medical help immediately.
The most frequently (very common and common) reported side effects of Tamiflu are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues. The frequency of these effects is reduced if the medicinal product is taken with food.
Rare but serious effects: get medical help at once
(These may affect up to 1 in 1,000 people)
During Tamiflu treatment, rare events have been reported that include
These are reported primarily among children and adolescents and often started suddenly and resolved rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events have also been reported in patients with influenza who were not taking Tamiflu.
If you notice any of these symptoms, especially in younger people, get medical help immediately.
Very common side effects
(may affect more than 1 in 10 people)
Common side effects
(may affect up to 1 in 10 people)
Uncommon side effects
(may affect up to 1 in 100 people)
Rare side effects
(may affect up to 1 in 1,000 people)
Very common side effects
(may affect more than 1 in 10 people)
Common side effects
(may affect up to 1 in 10 people)
Uncommon side effects
(may affect up to 1 in 100 people)
The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). Additionally, diarrhoea and diaper rash have been reported.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. However,
Tell your doctor as soon as possible.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
Powder: Do not store above 30°C.
After reconstitution, store below 25 °C for 10 days.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Powder for oral suspension
The powder is a granulate or clumped granulate with a white to light yellow colour.
Tamiflu 6 mg/ml powder for oral suspension is available in a bottle containing 13 g powder for mixing with 55 ml of water.
The box also contains 1 plastic measuring jug (55 ml), 1 plastic bottle adapter (to help get the drug into the dispenser), 1 plastic 3 ml oral dispenser and 1 plastic 10 ml oral dispenser (to give the correct amount of medicine via the mouth). Shown on the oral dispenser are millilitre (ml) markings of the medicine (see figures in Instructions for the user).
For details on how to prepare the oral suspension and how to measure and take the medicine, read Instructions for the user, over the page.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in February 2023
There are two stages to taking Tamiflu oral suspension.
Your pharmacist may have prepared the medicine for you when you collected your prescription. If not, you can do it easily yourself. See the first set of instructions. You only need to do this once, at the beginning of your course.
Shake the suspension well and draw the appropriate recommended dose into the dispenser. See the second set of instructions. You will need to do this every time you need a dose.
You will need:
You now have a bottle of Tamiflu oral suspension ready to measure out a dose. You will not need to prepare it again unless you start a new bottle.
You will need:
Always use the oral dispenser provided with your medicine to measure a correct dose.
Slowly pull out the plunger to draw medicine into the dispenser.
Stop at the mark that shows the dose you need.
Turn the whole unit upright.
Remove the dispenser from the bottle.
Take the dispenser apart straight after dosing, and rinse both parts of the dispenser under running tap water. Do not boil the oral dispenser to avoid damage of the dispenser. Allow dispenser to air dry before next use.
Contact your doctor or pharmacist if dispenser is lost or damaged, and they will advise you on how to continue to take your medication.
gb-pl-tamiflu-clean-230302-6mgml-POS