InfoCons Consumer Protection informs you – Xofluza – Package Leaflet

Before anything else

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

ℹ️ 1. What Xofluza is and what it is used for

What Xofluza is Xofluza contains the active substance baloxavir marboxil. This is a type of antiviral medicine called a ‘cap-dependent endonuclease inhibitor’.

Xofluza is used for treating and preventing flu (influenza). This medicine stops the flu virus from spreading in the body. This helps shorten the time to recovery from symptoms.

What Xofluza is used for

Xofluza is used in patients aged 3 weeks and above. It is used to:  treat flu in patients who have had flu symptoms for less than 48 hours.  prevent flu in individuals who have been in close contact with someone who has flu or is likely to have flu.

⚠️ 2. 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.

105Infants and Children Do not give this medicine to children below 3 weeks of age. This is because the effects of Xofluza in this age group are 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  antacids  oral supplements containing iron, zinc, selenium, calcium, or magnesium.

The medicines listed above may decrease the effect of Xofluza.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, as a precaution avoid the use of Xofluza. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Xofluza is not likely to change your ability to drive and to use machines.

Xofluza contains sodium

This medicine contains sodium (salt)

 10 mg and 30 mg Xofluza granules in sachets each contain less than 23 mg of sodium (main component of cooking/table salt), making it essentially ´sodium-free´.  40 mg Xofluza granules in sachet contain 23.6 mg of sodium (main component of cooking/table salt).

This is equivalent to 1.2 % of the recommended maximum daily dietary intake of sodium .

Xofluza contains maltitol

This medicine contains maltitol

 10 mg Xofluza granules in sachet contain 175 mg of maltitol  30 mg Xofluza granules in sachet contain 525 mg of maltitol  40 mg Xofluza granules in sachet contain 700 mg of maltitol If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

💊 3. How to take Xofluza

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Keep the granules (and the liquid after mixing) away from your skin.

When to take Xofluza To treat flu, take Xofluza as a single dose as soon as possible. This should be within 48 hours of your flu symptoms starting.

106To prevent flu, take Xofluza as a single dose as soon as possible. This should be within 48 hours of being in close contact with an infected person.

See the ‘Instructions for Use’ section for how to take this medicine.

How much Xofluza to take The dose of Xofluza depends on how much you weigh. Your doctor or pharmacist will tell you how much to take.

Patient’s body weight Xofluza dose Under 9 kg  2 mg/kga From 9 kg to under 15 kg 20 mg (two 10 mg sachets) From 15 kg to under 20 kg 30 mg From 20 kg to under 80 kg 40 mg From 80 kg and above 80 mg (two 40 mg sachets) aPreparation and administration of this dose must be done by the healthcare professional.

Xofluza can be taken with or without food (i.e. either on an empty stomach or after eating). Do not mix granules or granules in water with food. Any mixing outside the recommendations is the responsibility of the healthcare professional or the user.

Xofluza may be given through a feeding tube. Follow your doctor or pharmacist’s instructions for giving Xofluza through a feeding tube.

If you take more Xofluza than you should

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 the dose, take it as soon as possible.  To treat flu – take within 48 hours of your flu symptoms starting.  To prevent flu – take within 48 hours of close contact with a possibly infected person.

❗ 4. Possible side effects

Like all medicines, it is possible for this medicine to cause side effects, although not everybody gets them.

Side effects in adults, adolescents and children Serious side effect Get medical help immediately if you get any of the following serious side effects –you may need urgent medical treatment as they could be signs of a severe allergic reaction (anaphylaxis):  swelling of the face or skin 107 itchy rashes  low blood pressure  difficulty breathing.

The frequency of these side effects cannot be estimated 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 from 3 weeks to under 12 years old Common may affect up to 1 in 10 people:  diarrhoea  rash  vomiting

Reporting of side effects

If you get any side effects, talk to the doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 which is stated on the carton and sachet after ‘EXP’.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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. Contents of the pack and other information

What Xofluza contains

 The active substance is baloxavir marboxil.  Each sachet contains 10 mg, 30 mg or 40 mg baloxavir marboxil.  The other ingredients are silica, colloidal anhydrous (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).

108What Xofluza looks like and contents of the pack  Xofluza granules are white to light yellow.  Xofluza 10 mg, 30 mg or 40 mg granules are provided in laminated foil ( polyethylene terephthalate/aluminium/polyethylene) sachets.  Each carton contains 1 (30 mg or 40 mg) or 2 (10 mg) sachets.

For details on how to prepare the granules for administration and take or give the medicine, read the ‘Instructions for Use’ section 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien, Luxembourg/Luxemburg N.V. Roche S.A.

België/Belgique/Belgien Tél/Tel: +32 (0) 2 525 82 11Latvija Roche Latvija SIA Tel: +371 – 6 7039831 България Рош България ЕООД Тел: +359 2 474 54 44Lietuva UAB “Roche Lietuva” Tel: +370 5 2546799 Česká republika Roche s. r. o.

Tel: +420 – 2 20382111Magyarország Roche (Magyarország) Kft.

Tel: +36 – 1 279 4500 Danmark Roche Pharmaceuticals A/S Tlf: +45 – 36 39 99 99Nederland Roche Nederland B.V.

Tel: +31 (0) 348 438050 Deutschland Roche Pharma AG Tel: +49 (0) 7624 140Norge Roche Norge AS Tlf: +47 – 22 78 90 00 Eesti Roche Eesti OÜ Tel: + 372 – 6 177 380Österreich Roche Austria GmbH Tel: +43 (0) 1 27739 109Ελλάδα , Κύπρος Roche (Hellas) A.E.

Ελλάδα Τηλ: +30 210 61 66 100Polska Roche Polska Sp.z o.o.

Tel: +48 – 22 345 18 88 España Roche Farma S.A.

Tel: +34 – 91 324 81 00Portugal Roche Farmacêutica Química, Lda Tel: +351 – 21 425 70 00 France Roche Tél: +33 (0)1 47 61 40 00România Roche România S.R.L.

Tel: +40 21 206 47 01 Hrvatska Roche d.o.o.

Tel: + 385 1 47 22 333Slovenija Roche farmacevtska družba d.o.o.

Tel: +386 – 1 360 26 00 Ireland, Malta Roche Products (Ireland) Ltd.

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

Tel: +421 – 2 52638201 Ísland Roche Pharmaceuticals A/S c/o Icepharma hf Sími: +354 540 8000 Italia Roche S.p.A.

Tel: +39 – 039 2471Suomi/Finland Roche Oy Puh/Tel: +358 (0) 10 554 500 Sverige Roche AB Tel: +46 (0) 8 726 1200

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the Euro.pean Medicines Agency web site: https://www.ema.europa.eu .

110Instructions for Use (IFU) Xofluza 10 mg granules in sachet Xofluza 30 mg granules in sachet Xofluza 40 mg granules in sachet baloxavir marboxil Read these entire Instructions for Use and the leaflet information above before preparing and taking or giving Xofluza. Ask your doctor or pharmacist to show you how to use Xofluza. The information in this IFU is for you or someone you care for, but in the IFU we just say ‘you’.

Storage   This medicine does not require any special storage conditions.   Always keep Xofluza out of sight and reach of children.

Important Information you need to know before preparing and taking / giving Xofluza   Keep the granules (and the liquid after mixing) away from your skin.  Wash your hands before and after using Xofluza.  Check the expiration date and the product for damage before use. Do not use if expired or damaged.

Taking or giving Xofluza  The dose of Xofluza differs depending on the weight of the patient. Refer to the table below. If you are still not sure, ask your doctor or pharmacist.

Patient’s body weight Xofluza dose Under 9 kg  2 mg/kga From 9 kg to under 15 kg 20 mg (two 10 mg sachets) From 15 kg tounder 20 kg 30 mg From 20 kg to under 80 kg 40 mg From 80 kg and above 80 mg (two 40 mg sachets) aPreparation and administration of this dose must be done by the healthcare professional.  Xofluza is taken as a single one-time dose.  You must mix Xofluza with about 1 tablespoon (approximately 15-20 mL) of drinking water.  Take Xofluza immediately after mixing.  You can give Xofluza through a feeding tube. Follow your doctor or pharmacist’s instructions for giving Xofluza through a feeding tube.

111Preparing to administer Xofluza Preparation and administration for patients who weigh <9 kg must be done by the healthcare professional.

Step 1: Wash your hands.

Step 2: Check your dose (refer to Table above). Count the number of sachets you need for your dose. For a 20 mg dose, use 2 of the 10 mg sachets. Take both sachets together as instructed below For an 80 mg dose, use 2 of the 40 mg sachets. Take the sachets separately . Follow steps 3 to 9 to take the first sachet, then repeat steps 3 to 9 to take the second sachet.

Step 3. Get your materials together.

You will need: The number of sachets for your dose A tablespoon A small clean cup containing a tablespoon (15-20 mL) of drinking water .

Step 4. Tap the sachet(s) to ensure the granules are on one side of the sachet(s). Open the sachet(s) by hand or with scissors. Take care not to cut the granules with the scissors.

Step 5. Add the granules to the cup containing about 15-20 mL of drinking water.

Tap the sachet to ensure all the granules have been removed.

112Step 6. Gently swirl the cup for 1 minute, or until the granules have fully dispersed.

Step 7. Drink immediately.

Step 8. Refill the cup with about 15-20 mL of drinking water. Swirl to get any remaining granules. Drink immediately.

Step 9. Repeat Step 8 one more time if there are still remaining granules in the cup.

Step 10. Wash your hands and all items used to give Xofluza.

Step 11. Throw away the empty sachet(s) in accordance with local requirements.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Xofluza (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/20/1500).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.