Tamiflu 6 mg/ml Powder for Oral Suspension

• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu listed in section 6.

Talk to your doctor if this applies to you. Do not take Tamiflu.

Before you take Tamiflu, make sure the prescribing doctor knows

• if you are allergic to other medicines
• if you have problems with your kidneys. If so, your dose may need adjustment
• if you have a severe medical condition, which may require immediate hospitalisation
• if your immune system is not working
• if you have chronic heart disease or respiratory disease.

During treatment with Tamiflu, tell a doctor immediately:

• if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents). These may be signs of rare but serious side effects.

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:

• chlorpropamide (used to treat diabetes)
• methotrexate (used to treat e.g. rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout)

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.

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.

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 contains 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’.

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.

Adults, and adolescents 13 years and over

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

Infants less than 1 year (0 to 12 months)

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.

Very common side effects

(may affect more than 1 in 10 people)

• Headache
• Nausea.

Common side effects

(may affect up to 1 in 10 people)

• Bronchitis
• Cold sore virus
• Cough
• Dizziness
• Fever
• Pain
• Pain in limb
• Runny nose
• Sleeping difficulties
• Sore throat
• Stomach ache
• Tiredness
• Upper abdominal fullness
• Upper respiratory tract infections (inflammation of the nose, throat and sinuses)
• Upset stomach
• Vomiting.

Uncommon side effects

(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Convulsion
• Heart rhythm abnormalities
• Mild to severe liver function disorders
• Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).

Rare side effects

(may affect up to 1 in 1,000 people)

• Thrombocytopenia (low platelet count)
• Visual disturbances.

Very common side effects

(may affect more than 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting.

Common side effects

(may affect up to 1 in 10 people)

• Conjunctivitis (red eyes and discharge or pain in the eye)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach ache
• Upper abdominal fullness
• Upset stomach.

Uncommon side effects

(may affect up to 1 in 100 people)

• Inflammation of the skin
• Tympanic membrane (eardrum) disorder.

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,

• if you or your child are repeatedly sick, or
• if the influenza symptoms get worse or the fever continues

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is:
  oseltamivir (6 mg/ml oseltamivir after reconstitution).
• The other ingredients are:
  sorbitol (E420), sodium dihydrogen citrate (E331[a]), xanthan gum (E415), sodium benzoate (E211), saccharin sodium (E954), titanium dioxide (E171) and tutti frutti flavour (including maltodextrins [maize], propylene glycol, arabic gum E414 and natural identical flavouring substances [mainly consisting of banana, pineapple and peach flavour]) (see section 2 ‘Tamiflu contains sorbitol, sodium benzoate and sodium’).

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.

You will need:

• The bottle, containing Tamiflu powder (in the medicine pack), with the bottle cap attached
• A plastic measuring jug (in the medicine pack)
• The plastic bottle adapter (in the medicine pack)
• Water

• Tap the bottle to loosen the powder
  Tap the closed bottle gently several times to loosen the powder.
• Use the jug to measure 55 ml of water
  The measuring jug in the pack has a line marked to show you an exact amount.
  Fill it with water to the indicated level.
• Add all the water, close and shake
  Pour all of the water from the jug into the bottle, onto the powder.
  Always use 55 ml of water, whatever the dose you need.
  Put the cap back on the bottle. Shake the bottle well for 15 seconds.
• Press in the adapter
  Open the bottle and press the bottle adapter hard into the neck of the bottle.
• Close the bottle again
  Screw the cap tightly onto the top of the bottle, which now includes the adapter.
  This will make sure that the bottle adapter fits in the bottle in the right position.

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:

• A bottle of prepared Tamiflu oral suspension
• Depending on the required dose you will need the 3 ml oral dispenser (orange plunger, 0.1 ml graduation) or the 10 ml oral dispenser (transparent plunger 0.5 ml graduation) from the medicine pack.
• For doses from 1.0 ml to 3.0 ml, the 3 ml oral dispenser should be used. For doses above 3.0 ml to 10 ml, 10 ml oral dispenser should be used.

Always use the oral dispenser provided with your medicine to measure a correct dose.

The oral dispenser is for multiple use.

• Shake the bottle
  Check the cap is secure, and then shake the bottle of Tamiflu oral suspension.
  Always shake well before use.
• Prepare the oral dispenser
  Depending on the required dose, use the 3 ml dispenser (orange plunger) or the 10 ml oral dispenser (transparent plunger) provided in the pack.
  Push the plunger completely down toward the tip of the dispenser.
• Fill the dispenser with the correct dose
  Unscrew the cap from the bottle.
  Push the tip of the dispenser into the bottle adapter.
  Then turn the whole unit upside down (bottle and dispenser together).
  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.
• Deliver the medicine directly into the mouth
  To avoid choking/vomiting, ensure upright body position, place the oral dispenser into the mouth with the tip along the cheek, slowly push the plunger all the way down, and do not squirt forcefully into the back of the throat.
  Make sure all the medicine is swallowed.
  You may drink and eat something after taking the medicine.
• Close the bottle, keep it safe
  Put the cap back on the bottle. Keep it out of sight and reach of children.
  Store the medicine below 25 ºC for up to 10 days. See 5 How to store Tamiflu, overleaf.
• Clean dispenser
  Take the dispenser apart straight after dosing, and rinse both parts of the dispenser under running tap water until all residue is removed. If clean tap water is not available, rinse with clean water (e.g. distilled water).
  Do not sterilize the oral dispenser, or put into boiling water, to avoid damage of the dispenser.
  Allow dispenser to air dry before next use.
  For storage, keep dispenser dry and away from sunlight.

Do not throw away the oral dispenser as it needs to be used multiple times. Only after its final use, dispose of the oral dispenser according to local regulations.