Patient Leaflet Updated 13-Sep-2023 | Roche Products Limited
Xofluza 20 mg & 40 mg film coated tablets
Xofluza 20 mg film-coated tablets
Xofluza 40 mg film-coated tablets
baloxavir marboxil
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Xofluza is and what it is used for
2. What you need to know before you take Xofluza
3. How to take Xofluza
4. Possible side effects
5. How to store Xofluza
6. Contents of the pack and other information
Xofluza contains baloxavir marboxil. This is a type of antiviral medicine called a ‘cap-dependent endonuclease inhibitor’.
Xofluza is used for treating and preventing influenza. This medicine stops the influenza virus from spreading in the body and helps shorten the time to recovery from symptoms.
Talk to your doctor or pharmacist before taking Xofluza.
Do not give this medicine to children below 1 year of age. This is because the effects of Xofluza in this age group are not known.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Xofluza with:
The medicines listed above may decrease the effect of Xofluza.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, as a precautionary measure it is preferable to avoid the use of Xofluza. Ask your doctor or pharmacist for advice before taking this medicine.
Xofluza is not likely to change your ability to drive and to use machines.
Xofluza contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
This medicine contains less than 23 mg of sodium per tablet, that is to say essentially ꞌsodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For treatment of influenza, take Xofluza as a single dose as soon as possible within 48 hours of your flu symptoms starting.
For prevention of influenza, take Xofluza as a single dose as soon as possible within 48 hours following exposure to an infected person.
Your dose of Xofluza depends on how much you weigh. Your doctor or pharmacist will tell you how much to take.
Your weight Xofluza dose
< 20 kg Refer to the Xofluza granules for oral suspension package leaflet
≥ 20 kg - < 80 kg Single dose of 40 mg taken as
- 2 x 20 mg tablets
80 kg or more Single dose of 80 mg taken as
- 2 x 40 mg tablets
Xofluza can be taken with or without food. Take all the tablets with some water.
If you accidentally take more of this medicine than you should, talk to your doctor or pharmacist for advice.
If you forget to take some or all of your dose, take it as soon as possible.
For the treatment of influenza, Xofluza should be taken within 48 hours of your flu symptoms starting.
For the prevention of influenza, Xofluza should be taken within 48 hours of close contact with someone who is known or suspected to have flu.
Like all medicines, it is possible for this medicine to cause side effects, although not everybody gets them.
Get medical help immediately if you get any of the following serious side effects:
The frequency of these side effects cannot be estimated from the available data.
The following side effect is uncommon (this can affect up to 1 in every 100 patients):
The following side effects are common (this can affect up to 1 in every 10 patients)
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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not need any special temperature storage conditions.
Store in the original package in order to protect from moisture.
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.
Xofluza 20 mg tablets are white to light yellow, oblong shaped film-coated tablets with “ 772” marked on one side and “20” on the other side.
Xofluza 20 mg film-coated tablets are available in blister packs of 2.
Xofluza 40 mg tablets are white to light yellow, oblong shaped film-coated tablets with “BXM40” marked on one side.
Xofluza 40 mg film-coated tablets are available in blister packs of 2.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in May 2023
gb-pil-xofluza-clean-230908-20mg-40mg-fct
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