Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - xofluza

Document Subject

Generated Narrative: MedicinalProductDefinition mp49f2652f369e152b2094223d335e67b9

identifier: http://ema.europa.eu/identifier/EU/1/20/1500/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Xofluza 20 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-49f2652f369e152b2094223d335e67b9

identifier: http://ema.europa.eu/identifier/EU/1/20/1500/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - xofluza

Attesters

What is in this leaflet

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

What Xofluza is

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.

What Xofluza is used for

• Xofluza is used to treat influenza in patients aged 1 year and above who have had influenza symptoms for less than 48 hours.
• Xofluza is used to prevent influenza in individuals aged 1 year and above who have been in close contact with someone who is known or suspected to have influenza.

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. Infants and Children

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.

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

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 precautionary measure it is preferable to 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 lactose

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.

Xofluza contains sodium

This medicine contains less than 23 mg of sodium per tablet, that is to say essentially sodium-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.

When to take Xofluza

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.

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 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 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 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.

Adults, adolescents and children

Get medical help immediately if you get any of the following serious side effects:

• Severe allergic reaction (anaphylaxis), with signs such as swelling of the face or skin, itchy rashes, low blood pressure and difficulty breathing

The frequency of these side effects cannot be estimated from the available data.

Other possible side effects: The following side effect is uncommon (this can affect up to 1 in every 100 patients):

• Itchy rash

Children (1 to <12 years) The following side effects are common (this can affect up to 1 in every 10 patients)

• Diarrhoea, rash and vomiting

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

What Xofluza contains

• The active substance is baloxavir marboxil.
• Each 20 mg film-coated tablet contains 20 mg baloxavir marboxil. Each 40 mg film-coated tablet contains 40 mg baloxavir marboxil.
• The other ingredients are lactose monohydrate (see Section 2 Xofluza contains lactose ), croscarmellose sodium ((E468) (see Section 2 Xofluza contains sodium )), povidone (K25) (E1201), microcrystalline cellulose (E460), sodium stearyl fumarate in the tablet core, and hypromellose (E464), talc (E553b) and titanium dioxide (E171) in the film-coating.

What Xofluza looks like and contents of the pack

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. 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:

Belgi /Belgique/Belgien N.V. Roche S.A. T l/Tel: +32 (0) 2 525 82 Lietuva UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 818 44 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)

esk republika Roche s. r. o. Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft. Tel: +36 1 279 4Danmark Roche Pharmaceuticals A/S Tlf: +45 - 36 39 99 Malta (See Ireland)

Deutschland Roche Pharma AG Tel: +49 (0) 7624 Nederland Roche Nederland B.V. Tel: +31 (0) 348 438Eesti Roche Eesti O
Tel: + 372 - 6 177 Norge Roche Norge AS Tlf: +47 - 22 78 90
Roche (Hellas) A.E.
: +30 210 61 66 sterreich Roche Austria GmbH Tel: +43 (0) 1 27Espa a Roche Farma S.A. Tel: +34 - 91 324 81 Polska Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 France Roche T l: +33 (0)1 47 61 40 Portugal Roche Farmac utica Qu mica, Lda Tel: +351 - 21 425 70 Hrvatska Roche d.o.o. Tel: + 385 1 47 22 Rom nia Roche Rom nia S.R.L. Tel: +40 21 206 47 Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0Slovenija Roche farmacevtska dru ba d.o.o. Tel: +386 - 1 360 26 sland
Roche Pharmaceuticals A/S c/o Icepharma hf S mi: +354 540 8Slovensk republika
Roche Slovensko, s.r.o. Tel: +421 - 2 52638Italia Roche S.p.A. Tel: +39 - 039 2Suomi/Finland Roche Oy
Puh/Tel: +358 (0) 10 554 K
. . & . : +357 - 22 76 62 Sverige Roche AB Tel: +46 (0) 8 726 1Latvija Roche Latvija SIA Tel: +371 - 6 7039United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: