Xofluza

Package leaflet: Information for the patient

Xofluza 20 mg film-coated tablets, 40 mg film-coated tablets

baloxavir marboxil
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Xofluza is and what it is used for
2. What you need to know before taking Xofluza
3. How to take Xofluza
4. Possible side effects
5. How to store Xofluza
6. Contents of the pack and other information

1. What Xofluza is and what it is used for

What Xofluza is
Xofluza contains baloxavir marboxil, a type of antiviral medicine called a "cap-dependent endonuclease inhibitor".
Xofluza is used for the treatment and prevention of influenza. This medicine stops the spread of the influenza virus in the body and helps reduce the time to alleviation of influenza symptoms.

What Xofluza is used for

• Xofluza is used to treat influenza in patients aged 3 weeks and older who have had influenza symptoms for less than 48 hours.
• Xofluza is used to prevent influenza in individuals aged 3 weeks and older who have been in close contact with people known or suspected to have influenza.

2. What you should know before taking Xofluza

Do not take Xofluza

• if you are allergic to baloxavir marboxil or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Xofluza.
Infants and children
Do not give this medicine to children under 3 weeks of age. The effects of Xofluza in this age group are unknown.
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, antacids, or oral supplements containing iron, zinc, selenium, calcium, or magnesium. These medicines may reduce the effect of Xofluza.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, as a precautionary measure it is preferable to avoid using Xofluza. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Xofluza will affect your ability to drive or operate machinery.
Xofluza contains lactose
Xofluza contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult him/her before taking this medicine.
Xofluza contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Xofluza

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
When to take Xofluza
For the treatment of influenza, take a single dose of Xofluza as soon as possible within 48 hours
of the onset of flu symptoms.
For the prevention of influenza, take a single dose of Xofluza as soon as possible within 48
hours after close contact with an infected person.
How much Xofluza to take
The dose of Xofluza depends on body weight. Your doctor or pharmacist will tell you how much
medicine to take.

Xofluza may be taken with or without food. Swallow all tablets with a glass of water.
If you take more Xofluza than you should
If you accidentally take more than the prescribed amount, consult your doctor or pharmacist.
If you forget to take Xofluza
If you forget to take part or all of the dose, take it as soon as possible.
For the treatment of influenza, Xofluza should be taken within 48 hours of the onset of flu symptoms.
For the prevention of influenza, Xofluza should be taken within 48 hours after close contact with a person known or suspected to have influenza.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Adults, adolescents and children
Seek immediate medical advice 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 breathing difficulties.

The frequency of these side effects cannot be determined from the available data.
Other possible side effects:
The following side effects are common (may affect up to 1 in 10 people):

• diarrhoea and vomiting.

The following side effect is uncommon (may affect up to 1 in 100 people):

• itchy rash.

Children (aged between 3 weeks and 12 years)
The following side effects are common (may affect up to 1 in 10 people):

• diarrhoea, rash, and vomiting.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xofluza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after 'EXP/Scad.'. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Store in the original packaging, protected from moisture.
Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Xofluza contains

• 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.
• The other ingredients are monohydrate lactose (see section 2 'Xofluza contains lactose'), croscarmellose sodium (E468) (see section 2 'Xofluza contains sodium'), povidone (K25), microcrystalline cellulose (E460), sodium stearyl fumarate in the tablet core, and hypromellose (E464), talc (E553b) and titanium dioxide (E171) in the film coating.

Description of the appearance of Xofluza and contents of the pack
The 20 mg Xofluza tablets are white to pale yellow, oblong-shaped, film-coated tablets, imprinted with “ 772” on one side and “20” on the other.

Xofluza 20 mg film-coated tablets are available in blisters containing 2 tablets.
The 40 mg Xofluza tablets are white to pale yellow, oblong-shaped, film-coated tablets, imprinted with “BXM40” on one side.
Xofluza 40 mg film-coated tablets are available in blisters containing 2 tablets.

Marketing Authorization Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Latvija
Luxembourg/Luxemburg Roche Latvija SIA
N.V. Roche S.A. Tel: +371 - 6 7039831
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11

България Lietuva
Рош България ЕООД UAB “Roche Lietuva”
Тел: +359 2 474 544 44 Tel.: +370 5 2546799

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel.: +420 - 2 20382111 Tel.: +36 - 1 279 4500

Danmark Nederland
Roche Pharmaceuticals A/S Roche Nederland B.V.
Tlf: +45 - 36 39 99 99 Tel: +31 (0) 348 438050

Deutschland Norge
Roche Pharma AG Roche Norge AS
Tel.: +49 (0) 7624 140 Tlf: +47 - 22 78 90 00

Eesti Österreich
Roche Eesti OÜ Roche Austria GmbH
Tel.: + 372 - 6 177 380 Tel.: +43 (0) 1 27739

Ελλάδα, Κύπρος Polska
Roche (Hellas) A.E. Roche Polska Sp.z o.o.
Ελλάδα Tel.: +48 - 22 345 18 88
Τηλ: +30 210 61 66 100

España Portogallo
Roche Farma S.A. Roche Farmacêutica Química, Lda
Tel.: +34 - 91 324 81 00 Tel.: +351 - 21 425 70 00

Francia România
Roche Roche România S.R.L.
Tél: +33 (0)1 47 61 40 00 Tel.: +40 21 206 47 01

Hrvatska Slovenija
Roche d.o.o. Roche farmacevtska družba d.o.o.
Tel.: + 385 1 47 22 333 Tel.: +386 - 1 360 26 00

Irlanda, Malta Slovenská republika
Roche Products (Ireland) Ltd. Roche Slovensko, s.r.o.
Ireland/L-Irlanda Tel.: +421 - 2 52638201
Tel.: +353 (0) 1 469 0700

Ísland Suomi/Finland
Roche Pharmaceuticals A/S Roche Oy
c/o Icepharma hf Puh/Tel: +358 (0) 10 554 500
Sími: +354 540 8000

Italia Sverige
Roche S.p.A. Roche AB
Tel.: +39 - 039 2471 Tel.: +46 (0) 8 726 1200

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/ .

Patient information leaflet

Xofluza 40 mg film-coated tablets, 80 mg film-coated tablets

baloxavir marboxil
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Xofluza is and what it is used for
2. What you need to know before taking Xofluza
3. How to take Xofluza
4. Possible side effects
5. How to store Xofluza
6. Contents of the pack and other information

1. What Xofluza is and what it is used for

What Xofluza is
Xofluza contains baloxavir marboxil, a type of antiviral medicine called a "cap-dependent endonuclease inhibitor".
Xofluza is used to treat and prevent influenza. This medicine stops the spread of the influenza virus in the body and helps reduce the time it takes for influenza symptoms to resolve.

What Xofluza is used for

• Xofluza is used to treat influenza in patients aged 3 weeks and older who have had influenza symptoms for less than 48 hours.
• Xofluza is used to prevent influenza in individuals aged 3 weeks and older who have been in close contact with people known or suspected to have influenza.

2. What you should know before taking Xofluza

Do not take Xofluza

• if you are allergic to baloxavir marboxil or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Xofluza.
Infants and children
Do not give this medicine to children under 3 weeks of age. The effects of Xofluza in this age group are unknown.
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, antacids, or oral supplements containing iron, zinc, selenium, calcium, or magnesium. These medicines may reduce the effect of Xofluza.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, as a precautionary measure, it is preferable to avoid using Xofluza. Consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that Xofluza will affect your ability to drive or use machines.
Xofluza contains lactose
Xofluza contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.
Xofluza contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Xofluza

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
When to take Xofluza
For the treatment of influenza, take a single dose of Xofluza as soon as possible within 48 hours
of the onset of influenza symptoms.
For the prevention of influenza, take a single dose of Xofluza as soon as possible within 48
hours after close contact with an infected person.
How much Xofluza to take
The dose of Xofluza depends on body weight. Your doctor or pharmacist will tell you how much
medicine to take.

Xofluza can be taken with or without food. Take all tablets with some water.
If you take more Xofluza than you should
If you accidentally take more than the prescribed amount, consult your doctor or pharmacist.
If you forget to take Xofluza
If you forget to take part or all of the dose, take it as soon as possible.
For the treatment of influenza, Xofluza should be taken within 48 hours of the onset of flu symptoms.
For the prevention of influenza, Xofluza should be taken within 48 hours after close contact with a person known or suspected to have influenza.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Adults, adolescents and children
Seek immediate medical advice 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 breathing difficulties.

The frequency of these side effects cannot be determined from the available data.
Other possible side effects:
The following side effects are common (may affect up to 1 in 10 people):

• diarrhoea and vomiting.

The following side effect is uncommon (may affect up to 1 in 100 people):

• itchy rash.

Children (aged between 3 weeks and 12 years)
The following side effects are common (may affect up to 1 in 10 children):

• diarrhoea, rash, and vomiting.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xofluza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after 'EXP/Scad.'. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Store in the original packaging, protected from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Xofluza contains

• The active substance is baloxavir marboxil.
• Each 40 mg film-coated tablet contains 40 mg of baloxavir marboxil. Each 80 mg film-coated tablet contains 80 mg of baloxavir marboxil.
• The other ingredients are monohydrate lactose (see section 2 ‘Xofluza contains lactose’), croscarmellose sodium (E468), see section 2 ‘Xofluza contains sodium’, povidone (K25), microcrystalline cellulose (E460), sodium stearyl fumarate in the tablet core, and hypromellose (E464), talc (E553b) and titanium dioxide (E171) in the coating film.

Description of the appearance of Xofluza and package contents
Xofluza 40 mg film-coated tablets are white to pale yellow, oblong-shaped, film-coated tablets,
imprinted with “BXM40” on one side.
Xofluza 40 mg film-coated tablets are available in blisters containing 1 tablet.
Xofluza 80 mg film-coated tablets are white to pale yellow, oblong-shaped, film-coated tablets,
imprinted with “BXM80” on one side.
Xofluza 80 mg film-coated tablets are available in blisters containing 1 tablet.

Marketing Authorization Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Latvija
Luxembourg/Luxemburg Roche Latvija SIA
N.V. Roche S.A. Tel: +371 - 6 7039831
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11

България Lietuva
Рош България ЕООД UAB “Roche Lietuva”
Тел: +359 2 818 44 44 Tel.: +370 5 2546799

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel.: +420 - 2 20382111 Tel.: +36 - 1 279 4500

Danmark Nederland
Roche Pharmaceuticals A/S Roche Nederland B.V.
Tlf: +45 - 36 39 99 99 Tel.: +31 (0) 348 438050

Deutschland Norge
Roche Pharma AG Roche Norge AS
Tel.: +49 (0) 7624 140 Tlf: +47 - 22 78 90 00

Eesti Österreich
Roche Eesti OÜ Roche Austria GmbH
Tel.: + 372 - 6 177 380 Tel.: +43 (0) 1 27739

Ελλάδα, Κύπρος Polska
Roche (Hellas) A.E. Roche Polska Sp.z o.o.
Ελλάδα Tel.: +48 - 22 345 18 88
Τηλ: +30 210 61 66 100

España Portogallo
Roche Farma S.A. Roche Farmacêutica Química, Lda
Tel.: +34 - 91 324 81 00 Tel.: +351 - 21 425 70 00

Francia România
Roche Roche România S.R.L.
Tél: +33 (0)1 47 61 40 00 Tel.: +40 21 206 47 01

Hrvatska Slovenija
Roche d.o.o. Roche farmacevtska družba d.o.o.
Tel.: + 385 1 47 22 333 Tel.: +386 - 1 360 26 00

Irlanda, Malta Slovenská republika
Ireland/L-Irlanda Roche Slovensko, s.r.o.
Roche Products (Ireland) Ltd. Tel.: +421 - 2 52638201
Tel.: +353 (0) 1 469 0700

Ísland Suomi/Finland
Roche Pharmaceuticals A/S Roche Oy
c/o Icepharma hf Puh/Tel: +358 (0) 10 554 500
Sími: +354 540 8000

Italia Sverige
Roche S.p.A. Roche AB
Tel.: +39 - 039 2471 Tel.: +46 (0) 8 726 1200

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/ .

Patient information leaflet

Xofluza 2 mg/mL oral suspension granules

baloxavir marboxil
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• The information in this leaflet is intended for you or for a person you are caring for, even though the term “you” is used only in reference to the patient.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Xofluza is and what it is used for
2. What you need to know before taking Xofluza
3. How to take Xofluza
4. Possible side effects
5. How to store Xofluza
6. Contents of the pack and other information

1. What Xofluza is and what it is used for

What Xofluza is
Xofluza contains baloxavir marboxil, an antiviral medicine called a "cap-dependent endonuclease inhibitor".
Xofluza is used for the treatment and prevention of influenza. This medicine blocks the spread of the influenza virus in the body and helps reduce the time needed for symptom resolution.
What Xofluza is used for

• Xofluza is used to treat influenza in patients aged 3 weeks and older who have had influenza symptoms for less than 48 hours.
• Xofluza is used to prevent influenza in individuals aged 3 weeks and older who have been in close contact with people known or suspected to have influenza.

2. What you need to know before taking Xofluza

Do not take Xofluza

• if you are allergic to baloxavir marboxil or to 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 infants
Do not give this medicine to children under 3 weeks of age. The effects of Xofluza in this age group are unknown.
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, antacids, or oral supplements containing iron, zinc, selenium, calcium, or magnesium. These medicines may reduce the effect of Xofluza.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, as a precautionary measure it is preferable to avoid using Xofluza. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Xofluza will affect your ability to drive or use machinery.
Xofluza contains sodium
This medicine contains 23.6 mg of sodium (a main component of table salt) in each 20 mL of oral suspension. This corresponds to 1.2% of the maximum daily intake recommended in the diet.
Xofluza contains maltitol
This medicine contains 700 mg of maltitol in each 20 mL of oral suspension. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Xofluza

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Avoid contact with the skin.
When to take Xofluza
For the treatment of influenza, take a single dose of Xofluza as soon as possible within 48 hours
of the onset of flu symptoms.
For the prevention of influenza, take a single dose of Xofluza as soon as possible within
48 hours after contact with an infected person.
How much Xofluza to take
The dose of Xofluza depends on body weight. Your doctor or pharmacist will tell you the amount
of medicine you should take.

Xofluza can be taken either with or without food (for example, on an empty stomach or after eating).
The granules for oral suspension and the oral suspension must not be mixed with food. Any mixing outside the recommended instructions is the responsibility of the healthcare provider or user.
Xofluza can be administered via a feeding tube. Follow the instructions provided by your doctor and/or pharmacist for administering Xofluza through a feeding tube.
If you take more Xofluza than you should
If you accidentally take more than the prescribed amount, consult your doctor or pharmacist for advice.
If you forget to take Xofluza
If you forget to take your dose, take it as soon as possible. If the suspension has already been reconstituted, take the dose within 10 hours after reconstitution.
For the treatment of influenza, Xofluza should be taken within 48 hours of the onset of flu symptoms.
For the prevention of influenza, Xofluza should be taken within 48 hours following close contact with a person known or suspected to have influenza.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adults, adolescents and children
Seek immediate medical advice 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 breathing difficulties.

The frequency of these side effects cannot be estimated from the available data.
Other possible side effects:
The following side effects are common (may affect up to 1 in 10 people):

• Diarrhoea and vomiting.

The following side effect is uncommon (may affect up to 1 in 100 people):

• Itchy rash.

Children (aged between 3 weeks and 12 years)
The following side effects are common (may affect up to 1 in 10 people):

• Diarrhoea, rash, and vomiting.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xofluza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle following "Exp.". The expiry date refers to the last day of that month.
Before reconstitution: keep the bottle tightly closed and protect from moisture.
After reconstitution: store at temperatures not exceeding 30 °C and use within 10 hours.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Xofluza contains

• The active substance is baloxavir marboxil.
• Each bottle of oral suspension granules contains 40 mg of baloxavir marboxil.
• The other ingredients are anhydrous colloidal silica (E551), hypromellose (E464), maltitol ([E965], see section 2 “Xofluza contains maltitol”), mannitol (E421), povidone (K25) (E1201), sodium chloride (see section 2 “Xofluza contains sodium”), strawberry flavour (including propylene glycol), sucralose (E955) and talc (E553b).

Description of the appearance of Xofluza and the contents of the pack

• Xofluza granules are white to slightly yellow in colour.
• Xofluza 2 mg/mL granules for oral suspension are supplied in an amber glass bottle with a white child-resistant tamper-evident screw cap. The bottle contains 40 mg of granules to be mixed with 20 mL of drinking water.
• Each carton contains 1 bottle, 1 press-in adapter for the bottle (to facilitate transferring the reconstituted Xofluza oral suspension into the syringe), 1 measuring spoon (to measure 20 mL of drinking water), 1 oral syringe of 3 mL and 1 oral syringe of 10 mL (to administer the correct dose of medicine by mouth). Each oral syringe is marked with graduations indicating millilitres (mL) (see images in the Instructions for Use).

For further details on how to prepare the oral suspension and how to measure, take or
administer the medicine, please read the Instructions for Use.
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
For further information about this medicinal product, contact the local representative of the
Marketing Authorisation Holder:
België/Belgique/Belgien Latvija
Luxembourg/Luxemburg Roche Latvija SIA
N.V. Roche S.A. Tel.: +371 - 6 7039831
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11
България Lietuva
Рош България ЕООД UAB “Roche Lietuva”
Тел: +359 2 818 44 44 Tel.: +370 5 2546799
Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel.: +420 - 2 20382111 Tel.: +36 - 1 279 4500
Danmark Nederland
Roche Pharmaceuticals A/S Roche Nederland B.V.
Tlf: +45 - 36 39 99 99 Tel.: +31 (0) 348 438050
Deutschland Norge
Roche Pharma AG Roche Norge AS
Tel.: +49 (0) 7624 140 Tlf: +47 - 22 78 90 00
Eesti Österreich
Roche Eesti OÜ Roche Austria GmbH
Tel.: + 372 - 6 177 380 Tel.: +43 (0) 1 27739
Ελλάδα, Κύπρος Polska
Roche (Hellas) A.E. Roche Polska Sp.z o.o.
Ελλάδα Tel.: +48 - 22 345 18 88
Τηλ: +30 210 61 66 100
España Portogallo
Roche Farma S.A. Roche Farmacêutica Química, Lda
Tel.: +34 - 91 324 81 00 Tel.: +351 - 21 425 70 00
Francia România
Roche Roche România S.R.L.
Tél: +33 (0)1 47 61 40 00 Tel.: +40 21 206 47 01
Hrvatska Slovenija
Roche d.o.o. Roche farmacevtska družba d.o.o.
Tel.: + 385 1 47 22 333 Tel.: +386 - 1 360 26 00
Irlanda, Malta Slovenská republika
Ireland/L-Irlanda Roche Slovensko, s.r.o.
Roche Products (Ireland) Ltd. Tel.: +421 - 2 52638201
Tel.: +353 (0) 1 469 0700
Ísland Suomi/Finland
Roche Pharmaceuticals A/S Roche Oy
c/o Icepharma hf Puh/Tel: +358 (0) 10 554 500
Sími: +354 540 8000
Italia Sverige
Roche S.p.A. Roche AB
Tel.: +39 - 039 2471 Tel.: +46 (0) 8 726 1200
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu/ .

Instructions for use (IFU)

Xofluza 2 mg/mL oral suspension granules

baloxavir marboxil

Read these Instructions for Use in full before mixing (reconstituting) and/or
administering Xofluza.
Ask your doctor and/or pharmacist to show you how to use Xofluza.
The information contained in these instructions is intended for you or for someone under your care, even though the term “you” is used only in reference to the patient.
Storage

• After reconstitution: Keep the bottle tightly closed and protect from moisture.
• After reconstitution: Store at temperatures not exceeding 30 °C and use within 10 hours.
• If Xofluza has been exposed to temperatures higher than recommended, it must be discarded (see step 15).
• Always keep Xofluza out of sight and reach of children.

Important information

• Wash your hands before and after using Xofluza.
• If the Xofluza suspension comes into contact with skin or surfaces, wash with soap and water.
• Before use, check the expiry date and whether the product is damaged.
• If you received Xofluza as a suspension, check the time of mixing and use it immediately or within 10 hours of mixing.
• Xofluza may be administered via a feeding tube. Follow your doctor’s or pharmacist’s instructions for administering Xofluza via a feeding tube. × Do not shake Xofluza.

Administration of Xofluza

• The dose of Xofluza depends on the patient’s body weight. Refer to the table in step 17 for the correct dose. If you still have doubts, consult your doctor or pharmacist.
• The oral suspension of Xofluza is taken as a single dose in a single administration. Administer Xofluza immediately after mixing. If immediate use is not possible, use within 10 hours after mixing.
• Any unused residue must be discarded after administration. × Do not reuse the oral suspension of Xofluza for another person.

PHASE 1: BEFORE YOU BEGIN
Check the medicine

1. Check whether Xofluza has already been mixed by the pharmacist.
2. Before use, check the expiry date and whether the product is damaged.

Storage conditions

• Oral suspension granules: × Store in the original container. Keep the bottle tightly closed and protect from moisture.
• Reconstituted oral suspension:

Use immediately after reconstitution with drinking water. If immediate use is not possible, the
reconstituted product may be stored for up to 10 hours (at temperatures not exceeding 30 °C).

• Always keep Xofluza out of sight and reach of children.

Check the contents of the package

1 bottle of Xofluza

1 dosing cup

1 bottle adapter

2 oral syringes: 3 mL and 10 mL
× Do not use if any of the supplied materials are missing or damaged.
PHASE 2: PREPARING XOFLUZA

3. If the medicine has been mixed by the pharmacist and the bottle contains a liquid, proceed to PHASE 3: ADMINISTRATION. Otherwise, continue reading.
4. Wash your hands before and after using Xofluza.

Redistribute the granules and open the bottle

5. Gently tap the bottom of the bottle on

a hard surface to redistribute the
Xofluza granules.

6. To open the bottle, press down and

unscrew the cap in the direction of the
arrow.

• Keep the cap, as you will need it later to rotate the suspension (see fig. 13).

Add 20 mL of drinking water to the granules
× Do not add water if the bottle already contains a suspension and the medicine has already been mixed
by the pharmacist.

7. Rinse the dosing cup (supplied) before use.
8. Pour 20 mL of drinking water at room

temperature into the dosing cup. Check
that the dosing cup contains exactly 20 mL.

9. Pour the water into the bottle.

× Do not use food or liquids other than drinking water to mix the Xofluza oral suspension.
Insert the bottle adapter

10. Hold the bottle on the table with one hand.
11. Insert the bottle adapter into the opening and push it down firmly.

• The bottle adapter must fit snugly around the rim of the bottle.

12. Screw the cap back tightly onto the bottle.

Do not shake the bottle.
Shaking causes foam formation and may
result in an incorrect dose being administered.

13. Hold the bottle by the cap and gently rotate it for 1 minute.
14. Store Xofluza at room temperature (at temperatures not exceeding 30 °C) and use it immediately after mixing. If immediate use is not possible, use within 10 hours after mixing.

PHASE 3: ADMINISTERING XOFLUZA

15. Ensure that Xofluza has been stored at room temperature (at temperatures not exceeding 30 °C) and was mixed within the last 10 hours. If not, do not use it and contact your doctor or pharmacist.

Do not shake the bottle.
Shaking causes foam formation and may
result in an incorrect dose being administered.

16. Hold the bottle by the cap and gently rotate it for 1 minute.

Choose the oral syringe

17. Use the dose volume prescribed by your doctor or pharmacist, or select the dose volume based on body weight (see table below). If you are unsure about the volume to use, contact your doctor/pharmacist. Patient body weight Oral suspension volume Up to 20 kg 1 mL per kg of body weight 20 kg up to < 80 kg 20 mL (from one bottle) 80 kg or more 40 mL (from two bottles)

For example : for a child weighing 12 kg, the dose is 12 mL of Xofluza oral suspension.

18. Choose the oral syringe based on the dose volume.

• If the dose exceeds 10 mL, you will need

to withdraw the medicine from the bottle
twice, using the larger syringe.

• If the second withdrawal is less than 3 mL, use the smaller syringe to withdraw from the bottle.

If you are unsure which oral syringe to use, contact your doctor or pharmacist.
For example : for a total dose of 12 mL, withdraw 10 mL with the larger syringe and
then 2 mL with the smaller syringe.
× Do not overfill syringes beyond the graduated scale. To administer multiple doses, use the same syringe twice or two syringes.
Open the bottle

19. To open the bottle, press down and unscrew the cap in the direction of the arrow.

• Keep the cap to close the bottle after use.

Insert the syringe

20. Push the plunger of the oral syringe

fully down to remove air.

21. Hold the bottle on the table and insert the tip of the syringe into the bottle adapter.

Withdraw the suspension

22. To fill the syringe, carefully invert the bottle and syringe.
23. While holding the syringe firmly inserted

into the bottle adapter, slowly pull back
the plunger to withdraw the required amount of suspension, until the top edge of the plunger aligns with the corresponding mark on the syringe scale.
Remove the syringe

24. Hold the plunger in place (to prevent it from moving) and turn the bottle and syringe upright on the table.
25. Remove the oral syringe

from the bottle adapter.
Check the volume inside the syringe

26. With the tip of the syringe pointing upwards,

check:

• That you have withdrawn the correct volume.
• That there are no large air bubbles.

Note: if you did not withdraw the correct volume or if large bubbles are present, reinsert the syringe into the bottle adapter, return the medicine to the bottle, and withdraw it again (starting from step 22).
× Do not overfill syringes beyond the graduated scale. To administer multiple doses, use the same syringe twice or two syringes.
PHASE 4: ADMINISTERING THE DOSE
Do not administer Xofluza directly into the throat or too quickly to avoid

choking.

27. Sit upright to avoid choking on the suspension.
28. Insert the oral syringe into the mouth with

the tip along one of the cheeks.

29. Slowly press the plunger all the way down. Ensure the medicine is swallowed.

Note: when the full dose requires multiple withdrawals, repeat the procedure starting from step 20.
PHASE 5: AFTER ADMINISTRATION

30. After administering the medicine, you may

drink some water.

31. Close the bottle containing any residual

Xofluza suspension and return it to a pharmacy or local collection point.
Dispose of the oral syringe(s) in accordance with local regulations.

32. Wash your hands.

× Do not dispose of any medicine via wastewater or household waste. All unused medicines and waste derived from such medicines must be disposed of in accordance with local regulations.
× Do not reuse the oral suspension of Xofluza for another person.

Patient Information Leaflet

Xofluza 10 mg granules in sachet, 30 mg granules in sachet, 40 mg granules in sachet

baloxavir marboxil
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• The information in this leaflet is intended for you or for a person you are caring for, even though the term "you" is used only in reference to the patient.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Xofluza is and what it is used for
2. What you need to know before taking Xofluza
3. How to take Xofluza
4. Possible side effects
5. How to store Xofluza
6. Contents of the pack and other information

1. What Xofluza is and what it is used for

What Xofluza is
Xofluza contains the active substance baloxavir marboxil, an antiviral medicine called a "cap-dependent endonuclease inhibitor".
Xofluza is used to treat and prevent influenza. This medicine blocks the spread of the influenza virus in the body and helps reduce the time needed for symptoms to resolve.

What Xofluza is used for
Xofluza is used in patients aged 3 weeks and older. It is used to:

• treat influenza in patients who have had influenza symptoms for less than 48 hours;
• prevent influenza in individuals who have been in close contact with people affected by influenza or are at risk of contracting influenza.

2. What you need to know before taking Xofluza

Do not take Xofluza

• if you are allergic to baloxavir marboxil or to 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 infants
Do not give this medicine to children under 3 weeks of age. The effects of Xofluza in this age group are unknown.
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,
• antacids,
• oral supplements containing iron, zinc, selenium, calcium, or magnesium.

These medicines may reduce the effect of Xofluza.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, as a precautionary measure it is preferable to avoid using Xofluza. Consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that Xofluza will affect your ability to drive or operate machinery.
Xofluza contains sodium
This medicine contains sodium (salt):

• Each 10 mg and 30 mg sachet of Xofluza granules contains less than 23 mg of sodium (the main component of table salt), i.e., is essentially “sodium-free”.
• Each 40 mg sachet of Xofluza granules contains 23.6 mg of sodium (the main component of table salt). This corresponds to 1.2% of the maximum daily intake recommended in the diet.

Xofluza contains maltitol
This medicine contains maltitol:

• Xofluza 10 mg granules in sachet contain 175 mg of maltitol
• Xofluza 30 mg granules in sachet contain 525 mg of maltitol
• Xofluza 40 mg granules in sachet contain 700 mg of maltitol

If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Xofluza

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Keep the granules (and the liquid after mixing) away from the skin.
When to take Xofluza
For the treatment of influenza, take a single dose of Xofluza as soon as possible within 48 hours
of the onset of flu symptoms.
For the prevention of influenza, take a single dose of Xofluza as soon as possible within
48 hours after contact with an infected person.
For information on how to take this medicine, read the section "Instructions for use".
How much Xofluza to take

Xofluza can be taken either with or without food (for example, on an empty stomach or after eating).
The granules or granules in water must not be mixed with food.
Any mixing outside of these recommendations is the responsibility of the healthcare provider or
the user.
Xofluza can be administered via a nasogastric tube. Follow the instructions provided by your doctor or pharmacist for administering Xofluza through a nasogastric tube.
If you take more Xofluza than you should
If you accidentally take more medicine than you should, consult your doctor or pharmacist.
If you forget to take Xofluza
If you forget to take your dose, take it as soon as possible.

• For treatment of influenza: take the dose within 48 hours of onset of influenza symptoms.
• For prevention of influenza: take the dose within 48 hours after close contact with a potentially infected person.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects in adults, adolescents and children
Serious side effects
Seek immediate medical advice if you experience any of the following serious side effects
because you may need urgent medical treatment as they could be signs of a severe allergic
reaction (anaphylaxis):

• swelling of the face or skin
• itchy rash
• low blood pressure
• breathing difficulties

The frequency of these side effects cannot be determined from the available data.
Other possible side effects:
Common (may affect up to 1 in 10 people):

• diarrhoea
• vomiting

Uncommon (may affect up to 1 in 100 people):

• itchy rash

Side effects in children aged 3 weeks to less than 12 years
Common (may affect up to 1 in 10 people):

• diarrhoea
• rash
• vomiting

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xofluza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet following "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Xofluza contains

• The active substance is baloxavir marboxil.
• Each sachet contains 10 mg, 30 mg or 40 mg of baloxavir marbox, respectively.
• The other ingredients are anhydrous colloidal silica (E551), hypromellose (E464), maltitol ([E965] [see section 2 “Xofluza contains maltitol”]), mannitol (E421), povidone (K25) (E1201), sodium chloride (see section 2 “Xofluza contains sodium”), strawberry flavour (including propylene glycol), sucralose (E955) and talc (E553b).

What Xofluza looks like and contents of the pack

• Xofluza granules are white to pale yellow in colour.
• Xofluza 10 mg, 30 mg or 40 mg granules are supplied in laminated foil sachets (polyethylene terephthalate/aluminum/polyethylene).
• Each carton contains 1 sachet (30 mg or 40 mg) or 2 sachets (10 mg).

For detailed instructions on how to prepare the granules for administration and how to take or give the medicine, please read the section “Instructions for use” below.

Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in your country:

België/Belgique/Belgien Latvija
Luxembourg/Luxemburg Roche Latvija SIA
N.V. Roche S.A. Tel: +371 - 6 7039831
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11

България Lietuva
Рош България ЕООД UAB “Roche Lietuva”
Тел: +359 2 818 44 44 Tel: +370 5 2546799

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 1 279 4500

Danmark Nederland
Roche Pharmaceuticals A/S Roche Nederland B.V.
Tlf: +45 - 36 39 99 99 Tel: +31 (0) 348 438050

Deutschland Norge
Roche Pharma AG Roche Norge AS
Tel: +49 (0) 7624 140 Tlf: +47 - 22 78 90 00

Eesti Österreich
Roche Eesti OÜ Roche Austria GmbH
Tel: + 372 - 6 177 380 Tel: +43 (0) 1 27739

Ελλάδα, Kύπρος Polska
Roche (Hellas) A.E. Roche Polska Sp.z o.o.
Ελλάδα Tel: +48 - 22 345 18 88
Τηλ: +30 210 61 66 100

España Portugal
Roche Farma S.A. Roche Farmacêutica Química, Lda
Tel: +34 - 91 324 81 00 Tel: +351 - 21 425 70 00

France România
Roche Roche România S.R.L.
Tél: +33 (0)1 47 61 40 00 Tel: +40 21 206 47 01

Hrvatska Slovenija
Roche d.o.o. Roche farmacevtska družba d.o.o.
Tel: + 385 1 47 22 333 Tel: +386 - 1 360 26 00

Ireland, Malta Slovenská republika
Roche Products (Ireland) Ltd. Roche Slovensko, s.r.o.
Ireland/L-Irlanda Tel: +421 - 2 52638201
Tel: +353 (0) 1 469 0700

Ísland Suomi/Finland
Roche Pharmaceuticals A/S Roche Oy
c/o Icepharma hf Puh/Tel: +358 (0) 10 554 500
Sími: +354 540 8000

Italia Sverige
Roche S.p.A. Roche AB
Tel: +39 - 039 2471 Tel: +46 (0) 8 726 1200

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu .

Instructions for Use (IFU)

Xofluza 10 mg granulate in sachet, 30 mg granulate in sachet, 40 mg granulate in sachet

baloxavir marboxil

Read these Instructions for Use and the previous Patient Information Leaflet completely
before preparing and taking or administering Xofluza.

• Ask your doctor and/or pharmacist to show you how to use Xofluza.
• The information contained in these instructions for use is intended for you or for a person you are caring for, even though the term “you” is used only in reference to the patient. Storage
• This medicine does not require any special storage conditions.
• Always keep Xofluza out of the sight and reach of children.

Important information you should know before preparing and taking/administering Xofluza

• Keep the granules (and the liquid after mixing) away from the skin.
• Wash your hands before and after using Xofluza.
• Before use, check the expiry date and whether the product is damaged. Do not use if expired or damaged.

Taking or administering Xofluza

• The dose of Xofluza varies depending on the patient's body weight. Please consult the table below. If you still have any doubts, consult your doctor or pharmacist.

• Xofluza is taken as a single dose in a single administration.
• You must mix Xofluza with 1 tablespoon (approximately 15–20 mL) of drinking water.
• Take Xofluza immediately after mixing.
• Xofluza may be administered via a nasogastric or orogastric tube. Follow your doctor's or pharmacist's instructions for administering Xofluza through a tube.

Preparation for Administration of Xofluza
Preparation and administration for patients with body weight < 9 kg must be performed by a healthcare professional.