Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Oseltamivir may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
•
Tamiflu is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community. Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu. Tamiflu may be prescribed for adults, adolescents, children and infants (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.
• •
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.
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2.
e Tamiflu
Do not take Tamiflu: • 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. Warnings and precautions: 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 flu vaccine 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. Other medicines and Tamiflu 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) Pregnancy and breast-feeding 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. Driving and using machines 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. 2 uk-pl-tamiflu-clean-251120-6mgml-pos
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 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. Tamiflu contains sodium 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'. 3.
Tamiflu
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. The recommended doses 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.
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Adults, and adolescents 13 years and over Body weight
Treating flu: dose for 5 days
40 kg or more
12.5 ml** twice daily
Treating flu (Immunocompromised Patients): dose for 10 days* 12.5 ml** twice daily
Preventing flu: dose for 10 days 12.5 ml** once daily
*For patients with a weak immune system, treatment is for 10 days. **12.5 ml is made up of a 5 ml dose plus a 7.5 ml dose
Children 1 to 12 years Body weight
Treating flu: dose for 5 days
Preventing flu: dose for 10 days
5.0 ml twice daily 7.5 ml twice daily
Treating flu (Immunocompromised Patients): dose for 10 days* 5.0 ml twice daily 7.5 ml twice daily
10 kg to 15 kg More than 15 kg, up to 23 kg More than 23 kg, up to 40 kg More than 40 kg
10.0 ml twice daily
10.0 ml twice daily
10.0 ml once daily
12.5 ml** twice daily
12.5 ml** twice daily
12.5 ml** once daily
5.0 ml once daily 7.5 ml once daily
*For children with a weak immune system, treatment is 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.
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Body weight
Treating flu: dose for 5 days
3 kg 3.5 kg 4 kg 4.5 kg 5 kg 5.5 kg 6 kg > 6 to 7 kg > 7 to 8 kg > 8 to 9 kg > 9 to 10 kg
1.5 ml twice daily 1.8 ml twice daily 2.0 ml twice daily 2.3 ml twice daily 2.5 ml twice daily 2.8 ml twice daily 3.0 ml twice daily 3.5 ml twice daily 4.0 ml twice daily 4.5 ml twice daily 5.0 ml twice daily
Treating flu (Immunocompromised Patients): dose for 10 days* 1.5 ml twice daily 1.8 ml twice daily 2.0 ml twice daily 2.3 ml twice daily 2.5 ml twice daily 2.8 ml twice daily 3.0 ml twice daily 3.5 ml twice daily 4.0 ml twice daily 4.5 ml twice daily 5.0 ml twice daily
Preventing flu: dose for 10 days
Dispenser size to use
1.5 ml once daily 1.8 ml once daily 2.0 ml once daily 2.3 ml once daily 2.5 ml once daily 2.8 ml once daily 3.0 ml once daily 3.5 ml once daily 4.0 ml once daily 4.5 ml once daily 5.0 ml once daily
3 ml 3 ml 3 ml 3 ml 3 ml 3 ml 3 ml 10 ml 10 ml 10 ml 10 ml
*For patients with a weak immune system, treatment is for 10 days.
If you take more Tamiflu than you should 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. If you forget to take Tamiflu Do not take a double dose to make up for a forgotten dose. If you stop taking Tamiflu 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. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the
listed below may also be caused by influenza. The following serious side effects have been rarely reported since oseltamivir has been marketed: • Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties • Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool colour, changes in behaviour • Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing 5 uk-pl-tamiflu-clean-251120-6mgml-pos
•
Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly lifethreatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure • Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood • Neuropsychiatric disorders, as described below. 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 • Convulsions and delirium, including altered level of consciousness • Confusion, abnormal behaviour • Delusions, hallucinations, agitation, anxiety, nightmares 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. • Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above. If you notice any of these symptoms, especially in younger people, get medical help immediately. Adults and adolescents 13 and over 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 6 uk-pl-tamiflu-clean-251120-6mgml-pos
• • •
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. Children 1 to 12 years 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. Infants less than 1 year 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 7 uk-pl-tamiflu-clean-251120-6mgml-pos
• if the influenza symptoms get worse or the fever continues Tell your doctor as soon as possible. Reporting of side effects 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. 5.
Tamiflu
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. 6.
What Tamiflu contains • •
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').
What Tamiflu looks like and contents of the pack 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). 8 uk-pl-tamiflu-clean-251120-6mgml-pos
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. Marketing Authorisation Holder and Manufacturer Roche Products Limited 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW United Kingdom This leaflet was last revised in September 2025
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Instructions for the user Do not use if packaging is damaged, or any supplies provided are missing or damaged.
•
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. 10 uk-pl-tamiflu-clean-251120-6mgml-pos
•
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. Stage 2: Measure and give the correct dose 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.
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•
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. 12 uk-pl-tamiflu-clean-251120-6mgml-pos
•
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.
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Tamiflu 6 mg/ml Powder for Oral Suspension comes as oral solution containing 6mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Tamiflu 6 mg/ml Powder for Oral Suspension is oseltamivir.
This leaflet reproduces the patient information leaflet approved for Tamiflu 6 mg/ml Powder for Oral Suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment of influenza
Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.
Prevention of influenza
- Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.
- The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
- Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2).
Tamiflu is not a substitute for influenza vaccination.
The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations (see section 5.1).
Posology
Tamiflu suspension and Tamiflu hard capsules are bioequivalent formulations. 75 mg doses can be administered as either
- one 75 mg capsule or
- one 30 mg capsule plus one 45 mg capsule or
- by administering one 30 mg dose plus one 45 mg dose of suspension.
Adults, adolescents or children (> 40 kg) who are able to swallow capsules may receive appropriate doses of Tamiflu capsules.
Treatment
Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
For adolescents (13 to 17 years of age) and adults: The recommended oral dose is 75 mg oseltamivir twice daily for 5 days (or 10 days in immunocompromised patients).
Paediatric population
For infants and children1 year of age or older: The recommended dose of Tamiflu 6 mg/ml oral suspension is indicated in the table below. Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension.
The following weight-adjusted dosing regimens are recommended for infants and children 1 year of age or older:
Body weight
Recommended dose for 5 days
Recommended dose for 10 days*
Immunocompromised Patients
Amount of oral suspension to withdraw
10 kg to 15 kg
30 mg twice daily
30 mg twice daily
5 ml twice daily
> 15 kg to 23 kg
45 mg twice daily
45 mg twice daily
7.5 ml twice daily
> 23 kg to 40 kg
60 mg twice daily
60 mg twice daily
10 ml twice daily
> 40 kg
75 mg twice daily
75 mg twice daily
12.5 ml twice daily
*The recommended duration in immunocompromised patients (≥1 year old) is 10 days. See Special Populations, Immunocompromised Patients for more information.
Children weighing > 40 kg and who are able to swallow capsules may receive treatment with the adult dosage of 75 mg capsules twice daily for 5 days as an alternative to the recommended dose of Tamiflu suspension.
For infants less than 1 year of age: The recommended treatment dose for infants 0 - 12 months of age is 3 mg/kg twice daily. This is based upon pharmacokinetic and safety data indicating that this dose in infants 0 - 12 months provides plasma concentrations of the pro-drug and active metabolite that are anticipated to be clinically efficacious with a safety profile comparable to that seen in older children and adults (see section 5.2).
A 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing children 0 - 12 months of age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension. For higher doses the 10 ml syringe should be used. The following dosing regimen is recommended for treatment of infants below 1 year of age:
Dosing table of oseltamivir for children less than 1 year of age : 3 mg/kg twice daily
Body Weight*
Recommended dose for 5 days
Recommended dose for 10 days**
Immunocompromised patients
Amount of oral suspension to withdraw
Dispenser size to use
3 kg
9 mg twice daily
9 mg twice daily
1.5 ml twice daily
3 ml
3.5 kg
10.5 mg twice daily
10.5 mg twice daily
1.8 ml twice daily
3 ml
4 kg
12 mg twice daily
12 mg twice daily
2.0 ml twice daily
3 ml
4.5 kg
13.5 mg twice daily
13.5 mg twice daily
2.3 ml twice daily
3 ml
5 kg
15 mg twice daily
15 mg twice daily
2.5 ml twice daily
3 ml
5.5 kg
16.5 mg twice daily
16.5 mg twice daily
2.8 ml twice daily
3 ml
6 kg
18 mg twice daily
18 mg twice daily
3.0 ml twice daily
3 ml
> 6 - 7 kg
21 mg twice daily
21 mg twice daily
3.5 ml twice daily
10 ml
> 7 - 8 kg
24 mg twice daily
24 mg twice daily
4.0 ml twice daily
10 ml
> 8 - 9 kg
27 mg twice daily
27 mg twice daily
4.5 ml twice daily
10 ml
> 9 - 10 kg
30 mg twice daily
30 mg twice daily
5.0 ml twice daily
10 ml
* This table is not intended to contain all possible weights for this population.
**The recommended duration in immunocompromised infants (0-12 months old) is 10 days. See Special Populations, Immunocompromised Patients for more information.
This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions.
Prevention
Post-exposure prevention
For adolescents (13 to 17 years of age) and adults: The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days. Therapy should begin as soon as possible within two days of exposure to an infected individual.
For infants and children 1 year of age or older: Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension.
The recommended post-exposure prevention dose of Tamiflu is:
Body weight
Recommended dose for 10 days
Immunocompromised Patients
Recommended dose for 10 days
Amount of oral suspension to withdraw
10 kg to 15 kg
30 mg once daily
30 mg once daily
5 ml once daily
> 15 kg to 23 kg
45 mg once daily
45 mg once daily
7.5 ml once daily
> 23 kg to 40 kg
60 mg once daily
60 mg once daily
10 ml once daily
> 40 kg
75 mg once daily
75 mg once daily
12.5 ml once daily
Children weighing > 40 kg and who are able to swallow capsules may receive prophylaxis with a 75 mg capsule once daily for 10 days as an alternative to the recommended dose of Tamiflu suspension.
For infants less than 1 year of age: The recommended prophylaxis dose for infants less than 12 months during a pandemic influenza outbreak is half of the daily treatment dose. This is based upon clinical data in children > 1 year of age and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza (see Section 5.2 for exposure simulation).
In case of a pandemic, a 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing children below 1 year of age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension. For higher doses the 10 ml syringe should be used.
The following dosing regimen is recommended for infants less than 1 year of age:
Dosing table of oseltamivir for children below one year of age: 3 mg/kg once daily
Body Weight*
Recommended dose for 10 days
Immunocompromised Patients
Recommended dose for 10 days
Amount of oral suspension to withdraw
Dispenser size to use
3 kg
9 mg once daily
9 mg once daily
1.5 ml once daily
3 ml
3.5 kg
10.5 mg once daily
10.5 mg once daily
1.8 ml once daily
3 ml
4 kg
12 mg once daily
12 mg once daily
2.0 ml once daily
3 ml
4.5 kg
13.5 mg once daily
13.5 mg once daily
2.3 ml once daily
3 ml
5 kg
15 mg once daily
15 mg once daily
2.5 ml once daily
3 ml
5.5 kg
16.5 mg once daily
16.5 mg once daily
2.8 ml once daily
3 ml
6 kg
18 mg once daily
18 mg once daily
3.0 ml once daily
3 ml
> 6 - 7 kg
21 mg once daily
21 mg once daily
3.5 ml once daily
10 ml
> 7 - 8 kg
24 mg once daily
24 mg once daily
4.0 ml once daily
10 ml
> 8 - 9 kg
27 mg once daily
27 mg once daily
4.5 ml once daily
10 ml
> 9 - 10 kg
30 mg once daily
30 mg once daily
5.0 ml once daily
10 ml
* This table is not intended to contain all possible weights for this population.
This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions.
Prevention during an influenza epidemic in the community
Prevention during an influenza epidemic has not been studied in children below 12 years of age. The recommended dose for adults and adolescents for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks (or up to 12 weeks in immunocompromised patients).
Special populations
Hepatic impairment
No dose adjustment is required either for treatment or for prevention in patients with hepatic dysfunction. No studies have been carried out in paediatric patients with hepatic disorder.
Renal impairment
Treatment of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment. Recommended doses are detailed in the table below.
Creatinine clearance
Recommended dose for treatment
> 60 (ml/min)
75 mg twice daily
> 30 to 60 (ml/min)
30 mg (suspension or capsules) twice daily
> 10 to 30 (ml/min)
30 mg (suspension or capsules) once daily
≤ 10 (ml/min)
Not recommended (no data available)
Haemodialysis patients
30 mg after each haemodialysis session
Peritoneal dialysis patients*
30 mg (suspension or capsules) single dose
* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used. Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist.
Prevention of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment as detailed in the table below.
Creatinine clearance
Recommended dose for prevention
> 60 (ml/min)
75 mg once daily
> 30 to 60 (ml/min)
30 mg (suspension or capsules) once daily
> 10 to 30 (ml/min)
30 mg (suspension or capsules) every second day
≤ 10 (ml/min)
Not recommended (no data available)
Haemodialysis patients
30 mg after every second haemodialysis session
Peritoneal dialysis patients*
30 mg (suspension or capsules) once weekly
* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used. Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist.
There is insufficient clinical data available in infants and children (12 years of age and younger) with renal impairment to be able to make any dosing recommendation.
Elderly
No dose adjustment is required, unless there is evidence of moderate or severe renal impairment.
Immunocompromised patients
Treatment: For treatment of influenza, the recommended duration for immunocompromised patients is 10 days (see sections 4.4, 4.8, 5.1). No dose adjustment is necessary. Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
Seasonal prophylaxis: Longer duration of seasonal prophylaxis up to 12 weeks has been evaluated in immunocompromised patients (see sections 4.4, 4.8 and 5.1).
Method of administration
For dosing, a 3 ml and 10 ml oral dispenser is provided in the box.
It is recommended that Tamiflu powder for oral suspension be constituted by a pharmacist prior to dispensing to the patient (see section 6.6).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Oseltamivir is effective only against illness caused by influenza viruses. There is no evidence for efficacy of oseltamivir in any illness caused by agents other than influenza viruses (see section 5.1).
Tamiflu is not a substitute for influenza vaccination. Use of Tamiflu must not affect the evaluation of individuals for annual influenza vaccination. The protection against influenza lasts only as long as Tamiflu is administered. Tamiflu should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community.
Susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable (see section 5.1). Therefore, prescribers should take into account the most recent information available on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use Tamiflu.
Severe concomitant condition
No information is available regarding the safety and efficacy of oseltamivir in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalisation.
Immunocompromised patients
The efficacy of oseltamivir in either treatment or prophylaxis of influenza in immunocompromised patients has not been firmly established(see section 5.1).
Cardiac / respiratory disease
Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population (see section 5.1).
Paediatric population
No data allowing a dose recommendation for premature children (<36 weeks post-conceptual age) are currently available.
Severe renal impairment
Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of age) and adults with severe renal impairment. There is insufficient clinical data available in infants and children (1 year of age or older) with renal impairment to be able to make any dosing recommendation (see sections 4.2 and 5.2).
Neuropsychiatric events
Neuropsychiatric events have been reported during administration of Tamiflu in patients with influenza, especially in children and adolescents. These events are also experienced by patients with influenza without oseltamivir administration. Patients should be closely monitored for behavioural changes, and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see section 4.8).
Excipients
This medicinal product contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take thismedicinal product.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
This medicinal product contains sodium benzoate. Sodium benzoate (E211) may increase jaundice in newborn babies (up to 4 weeks old).
Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of the CYP450 and glucuronidase systems (see section 5.2), suggest that clinically significant drug interactions via these mechanisms are unlikely.
Probenecid
No dose adjustment is required when co-administering with probenecid in patients with normal renal function. Co-administration of probenecid, a potent inhibitor of the anionic pathway of renal tubular secretion, results in an approximate 2-fold increase in exposure to the active metabolite of oseltamivir.
Amoxicillin
Oseltamivir has no kinetic interaction with amoxicillin, which is eliminated via the same pathway, suggesting that oseltamivir interaction with this pathway is weak.
Renal elimination
Clinically important drug interactions involving competition for renal tubular secretion are unlikely, due to the known safety margin for most of these substances, the elimination characteristics of the active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of these pathways. However, care should be taken when prescribing oseltamivir in subjects when taking co-excreted agents with a narrow therapeutic margin (e.g. chlorpropamide, methotrexate, phenylbutazone).
Additional information
No pharmacokinetic interactions between oseltamivir or its major metabolite have been observed when co-administering oseltamivir with paracetamol, acetylsalicylic acid, cimetidine, antacids (magnesium and aluminium hydroxides and calcium carbonates), rimantadine or warfarin (in subjects stable on warfarin and without influenza).
Pregnancy
Influenza is associated with adverse pregnancy and foetal outcomes, with a risk of major congenital malformations, including congenital heart defects. A large amount of data on oseltamivir exposure of pregnant women from post-marketing reports and observational studies (more than 1000 exposed outcomes during the first trimester) indicate no malformative nor feto/neonatal toxicity by oseltamivir.
However, in one observational study, while the overall malformation risk was not increased, the results for major congenital heart defects diagnosed within 12 months of birth were not conclusive. In this study, the rate of major congenital heart defects following oseltamivir exposure during the first trimester was 1.76% (7 infants out of 397 pregnancies) compared to 1.01% in unexposed pregnancies from the general population (Odds Ratio 1.75, 95% Confidence Interval 0.51 to 5.98). The clinical significance of this finding is not clear, as the study had limited power. Additionally, this study was too small to reliably assess individual types of major malformations; moreover women exposed to oseltamivir and women unexposed could not be made fully comparable, in particular whether or not they had influenza.
Animal studies do not indicate reproductive toxicity (see section 5.3).
The use of Tamiflu may be considered during pregnancy if necessary and after considering the available safety and benefit information (for data on benefit in pregnant women please refer to section 5.1 “Treatment of influenza in pregnant women”), and the pathogenicity of the circulating influenza virus strain.
Breastfeeding
In lactating rats, oseltamivir and the active metabolite are excreted in milk. Very limited information is available on children breast-fed by mothers taking oseltamivir and on excretion of oseltamivir in breast milk. Limited data demonstrated that oseltamivir and the active metabolite were detected in breast milk, however the levels were low, which would result in a subtherapeutic dose to the infant. Considering this information, the pathogenicity of the circulating influenza virus strain and the underlying condition of the breastfeeding woman, administration of oseltamivir may be considered, where there are clear potential benefits to breastfeeding mothers.
Fertility
Based on preclinical data, there is no evidence that Tamiflu has an effect on male or female fertility (see section 5.3).
Tamiflu has no influence on the ability to drive and use machines.
Summary of the safety profile
The overall safety profile of Tamiflu is based on data from 6049 adult/adolescent and 1473 paediatric patients treated with Tamiflu or placebo for influenza, and on data from 3990 adult/adolescent and 253 paediatric patients receiving Tamiflu or placebo/no treatment for the prophylaxis of influenza in clinical trials. In addition, 245 immunocompromised patients (including 7 adolescents and 39 children) received Tamiflu for the treatment of influenza and 475 immunocompromised patients (including 18 children, of these 10 Tamiflu and 8 placebo) received Tamiflu or placebo for the prophylaxis of influenza.
In adults/adolescents, the most commonly reported adverse reactions (ARs) were nausea and vomiting in the treatment studies, and nausea in the prevention studies. The majority of these ARs were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days. In children, the most commonly reported adverse reaction was vomiting. In the majority of patients, these ARs did not lead to discontinuation of Tamiflu.
The following serious adverse reactions have been rarely reported since oseltamivir has been marketed: Anaphylactic and anaphylactoid reactions, hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice), angioneurotic oedema, Stevens-Johnson syndrome and toxic epidermal necrolysis, gastrointestinal bleeding and neuropsychiatric disorders.
(Regarding neuropsychiatric disorders, see section 4.4.)
Tabulated list of adverse reactions
The ARs listed in the tables below fall into the following categories: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000). ARs are added to the appropriate category in the tables according to the pooled analysis from clinical studies.
Treatment and prevention of influenza in adults and adolescents:
In adult/adolescent treatment and prevention studies, ARs that occurred the most frequently at the recommended dose (75 mg bid for 5 days for treatment and 75 mg od for up to 6 weeks for prophylaxis) are shown in Table 1.
The safety profile reported in subjects who received the recommended dose of Tamiflu for prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, despite a longer duration of dosing in the prophylaxis studies.
Table 1 Adverse reactions in studies investigating Tamiflu for treatment and prevention of influenza in adults and adolescents or through post-marketing surveillance
System Organ Class (SOC)
Adverse reactions according to frequency
Very common
Common
Uncommon
Rare
Infections and infestations
Bronchitis, Herpes simplex, Nasopharyngitis, Upper respiratory tract infections, Sinusitis
Blood and lymphatic system disorders
Thrombocytopenia
Immune system disorders
Hypersensitivity reaction
Anaphylactic reactions, Anaphylactoid reactions
Psychiatric disorders
Agitation, Abnormal behaviour, Anxiety, Confusion, Delusions, Delirium, Hallucination, Nightmares, Self-injury
Nervous system disorders
Headache
Insomnia
Altered level of consciousness, Convulsion
Eye disorders
Visual disturbance
Cardiac disorders
Cardiac arrhythmia
Respiratory, thoracic and mediastinal disorders
Cough, Sore throat, Rhinorrhea
Gastrointestinal disorders
Nausea
Vomiting
Abdominal pain (incl. upper abdominal pain), Dyspepsia
Gastrointestinal bleedings, Haemorrhagic colitis
Hepatobiliary disorders
Elevated liver enzymes
Fulminant hepatitis, Hepatic failure, Hepatitis
Skin and subcutaneous tissue disorders
Eczema, Dermatitis, Rash, Urticaria
Angioneurotic oedema, Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis
General disorders and administration site conditions
Pain
Dizziness (incl. vertigo), Fatigue, Pyrexia, Pain in limb
Treatment and prevention of influenza in children:
A total of 1473 children (including otherwise healthy children aged 1-12 years old and asthmatic children aged 6-12 years old) participated in clinical studies of oseltamivir given for the treatment of influenza. Of those, 851 children received treatment with oseltamivir suspension. A total of 158 children received the recommended dose of Tamiflu once daily in a post-exposure prophylaxis study in households (n = 99), a 6-week paediatric seasonal prophylaxis study (n = 49) and a 12-week paediatric seasonal prophylaxis study in immunocompromised subjects (n = 10).
Table 2 shows the most frequently reported ARs from paediatric clinical trials.
Table 2 Adverse reactions in studies investigating Tamiflu for treatment and prevention of influenza in children (age/weight-based dosing [30 mg to 75 mg o.d.])
System Organ Class (SOC)
Adverse reactions according to frequency
Very common
Common
Uncommon
Rare
Infections and infestations
Otitis media,
Nervous system disorders
Headache
Eye disorders:
Conjunctivitis (including red eyes, eye discharge and eye pain)
Ear and labyrinth disorders:
Earache
Tympanic membrane disorder
Respiratory, thoracic and mediastinal disorders
Cough, Nasal congestion
Rhinorrhoea
Gastrointestinal disorders
Vomiting
Abdominal pain (incl. upper abdominal pain), Dyspepsia, Nausea
Skin and subcutaneous tissue disorders
Dermatitis (including allergic and atopic dermatitis)
Description of selected adverse reactions
Psychiatric disorders and nervous system disorders
Influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
In patients with influenza who were receiving Tamiflu, there have been postmarketing reports of convulsions and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases resulting in self-injury or fatal outcomes. These events were reported primarily among paediatric and adolescent patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to those events is unknown. Such neuropsychiatric events have also been reported in patients with influenza who were not taking Tamiflu.
Hepato-biliary disorders
Hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with influenza-like illness. These cases include fatal fulminant hepatitis/hepatic failure.
Other special populations
Paediatric population (infants less than one year of age)
In two studies to characterise the pharmacokinetics, pharmacodynamics and safety profile of oseltamivir therapy in 135 influenza infected children less than one year of age, the safety profile was similar among age cohorts with vomiting, diarrhoea and diaper rash being the most frequently reported adverse events (see section 5.2). Insufficient data are available for infants who have a post-conceptual age of less than 36 weeks.
Safety information available on oseltamivir administered for treatment of influenza in infants less than one year of age from prospective and retrospective observational studies (comprising together more than 2,400 infants of that age class), epidemiological databases research and postmarketing reports suggest that the safety profile in infants less than one year of age is similar to the established safety profile of children aged one year and older.
Older people and patients with chronic cardiac and/or respiratory disease
The population included in the influenza treatment studies is comprised of otherwise healthy adults/adolescents and patients “at risk” (patients at higher risk of developing complications associated with influenza, e.g. older people and patients with chronic cardiac or respiratory disease). In general, the safety profile in the patients “at risk” was qualitatively similar to that in otherwise healthy adults/adolescents.
Immunocompromised patients
The treatment of influenza in immunocompromised patients were evaluated in two studies receiving standard dose or high dose regimens (double dose or triple dose) of Tamiflu (see section 5.1). The safety profile of Tamiflu observed in these studies was consistent with that observed in previous clinical trials where Tamiflu was administered for treatment of influenza in non-immunocompromised patients across all age groups (otherwise healthy patients or “at risk” patients [i.e., those with respiratory and/or cardiac co-morbidities]). The most frequent adverse reaction reported in immunocompromised children was vomiting (28%).
In a 12-week prophylaxis study in 475 immunocompromised patients, including 18 children 1 to 12 years of age and older, the safety profile in the 238 patients who received oseltamivir was consistent with that previously observed in Tamiflu prophylaxis clinical studies.
Children with pre-existing bronchial asthma
In general, the adverse reaction profile in children with pre-existing bronchial asthma was qualitatively similar to that of otherwise healthy children.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions (see details below).
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Reports of overdoses with Tamiflu have been received from clinical trials and during post-marketing experience. In the majority of cases reporting overdose, no adverse events were reported.
Adverse events reported following overdose were similar in nature and distribution to those observed with therapeutic doses of Tamiflu, described in section 4.8 Undesirable effects.
No specific antidote is known.
Paediatric population
Overdose has been reported more frequently for children than adults and adolescents. Caution should be exercised when preparing Tamiflu oral suspension and when administering Tamiflu products to children.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
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Ask anything about Tamiflu 6 mg/ml Powder for Oral Suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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