20 mg and 40 mg film-coated tablets
baloxavir marboxil
What Xofluza is and what it is used for
What Xofluza is
Xofluza contains baloxavir marboxil. It is a type of antiviral medicine called “cap-dependent endonuclease inhibitors”.
Xofluza is used to treat and prevent influenza. This medicine prevents the flu virus from spreading in the body and helps shorten the time to recover from symptoms.
What Xofluza is used for
- Xofluza is used to treat flu in patients aged 12 and over who have had flu symptoms for less than 48 hours.
- Xofluza is used to prevent influenza in individuals 12 years of age and older who have been in close contact with someone who has or is suspected of having influenza.
What you need to know before you take Xofluza
Do not take Xofluza:
- if you are allergic to baloxavir marboxil or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Xofluza.
Children and young people
Do not give this medicine to children under 12 years of age. This is because the effect of Xofluza on this age group is not known.
Other medicines and Xofluza
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Xofluza with:
- Laxatives, medicines against acid reflux (antacids), or dietary supplements taken orally (by mouth) that contain iron, zinc, selenium, calcium, or magnesium.
The products listed above may reduce the effectiveness of Xofluza.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, as a precaution you should avoid using Xofluza. Consult a doctor or pharmacist before using this medicine.
Driving ability and use of machinery
Xofluza is unlikely to affect your ability to drive or use machines.
Xofluza contains lactose
Xofluza contains lactose (a type of sugar). If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Xofluza contains sodium
This medicine contains less than 23 mg of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Xofluza
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
How to take Xofluza
For the treatment of influenza, take Xofluza as a single dose as soon as possible, within 48 hours after the onset of flu symptoms.
To prevent influenza, take Xofluza as a single dose as soon as possible, within 48 hours of meeting an infected person.
How much Xofluza to take
Your dose of Xofluza depends on how much you weigh. Your doctor or pharmacist will tell you how much to take.
| Your weight | Xofluza dosage |
|---|---|
| Up to 80 kg | A single dose of 40 mg taken as 2 x 20 mg tablets |
| 80 kg or more | A single dose of 80 mg taken as 2 x 40 mg tablets |
Xofluza can be taken with or without food. Swallow the tablets with water.
If you have taken too much Xofluza
If you accidentally take more of this medicine than you should, talk to your doctor or pharmacist for advice.
If you forget to take Xofluza
If you forget to take part of dose one or all of dose one, take it as soon as possible.
For the treatment of influenza, Xofluza must be taken within 48 hours of the onset of flu symptoms.
To prevent influenza, Xofluza should be taken within 48 hours of close contact with someone who has or is suspected of having influenza
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical attention if you experience any of the following serious side effects:
- Severe allergic reaction ( anaphylaxis ), with signs such as swelling of the face or skin, itchy rash, low blood pressure, and difficulty breathing.
The frequency of these side effects cannot be calculated based on available data.
Other possible side effects:
The following side effect is less common (may affect up to 1 in 100 patients):
- Itchy rash.
How to store Xofluza
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the blister card and carton after the Issue. dat. or EXP. The expiration date is the last day of the specified month.
No special temperature instructions.
Store in the original packaging. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is baloxavir marboxil.
- Each 20 mg film-coated tablet contains 20 mg of baloxavir marboxil. Each 40 mg film-coated tablet contains 40 mg of baloxavir marboxil.
- Other ingredients are lactose monohydrate, croscarmellose sodium (E468), povidone, microcrystalline cellulose (E460), sodium stearyl fumarate in the tablet core, and hypromellose, talc (E553b) and titanium dioxide (E171) in the film coating.
Appearance and package sizes of the medicine
Xofluza 20 mg tablets are white to light yellow, oblong film-coated tablets marked with “ 772” on one side and “20” on the other side.
Xofluza 20 mg film-coated tablets are available in blister packs of 2 tablets.
Xofluza 40 mg tablets are white to light yellow, oblong film-coated tablets marked with “BXM40” on one side.
Xofluza 40 mg film-coated tablets are available in blister packs of 2 tablets.
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| Finland/FinlandRoche Oy Tel: +358 (0) 10 554 500 |