Maviret 50 mg/20 mg granulos recubiertos en sobre

Package Leaflet: Information for the User

Maviret 50mg/20mg Coated Granules in a Blister

glecaprevir/pibrentasvir

Read this leaflet carefully before your child starts taking this medicine because it contains important information for your child.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your child's doctor or pharmacist.
• This medicine has been prescribed only for your child. Do not give it to other people even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any side effects, consult your child's doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1.What Maviret is and what it is used for

2.What you need to know before your child starts taking Maviret

3.How to take Maviret

4.Possible side effects

5.Storage of Maviret

6.Contents of the pack and additional information

7.Instructions for use

Maviret is an antiviral medication used to treat children 3 years of age and older with chronic hepatitis C. It is an infectious disease that affects the liver, caused by the hepatitis C virus. Maviret contains active ingredients glecaprevir and pibrentasvir.

Maviret acts by preventing the hepatitis C virus from multiplying and infecting new cells. In this way, the infection is eliminated from the body.

Do not give Maviret if:

• your child is allergic to glecaprevir, pibrentasvir, or any of the other components of this medication (listed in section6).
• your child has severe liver problems other than hepatitisC.
• your child is taking the following medications:
• • atazanavir (for HIV infection)
  • atorvastatina or simvastatina (to reduce blood cholesterol)
  • carbamazepina, fenobarbital, fenitoína, primidona (usually used for epilepsy)
  • dabigatrán etexilato (to prevent blood clots)
  • medicines that contain etinilestradiol (such as birth control pills, including vaginal rings, transdermal patches, and tablets)
  • rifampicina (for infections)
  • St. John's Wort (hypericum perforatum),(a plant-based medicine used for mild depression).

Do not give Maviret to your child if they are in any of the above situations. If in doubt, consult your child's doctor or pharmacist before administering Maviret.

Warnings and precautions

Consult your child's doctor if they are in any of the following cases, as the doctor may want to monitor your child more closely:

• have liver problems other than hepatitisC
• have or have had a hepatitis B virus infection
• have diabetes. After starting Maviret, your child may need a strict control of their blood glucose concentration and/or adjust their antidiabetic treatment. After starting treatment with medications such as Maviret, some diabetic patients have presented low blood sugar (hypoglycemia).

Blood tests

Your child's doctor will perform blood tests before, during, and after treatment with Maviret. This way, the doctor can determine the following:

• if your child should take Maviret and for how long
• if the treatment has worked and your child no longer has the hepatitis C virus.

Children under 3 years

This medication should not be administered to children under 3years or weighing less than 12kg. Maviret has not yet been studied in children under 3 years or weighing less than 12kg.

Other medications and Maviret

Inform your child's doctor or pharmacist if they are taking, have taken recently, or may need to take any other medication.

Inform your child's doctor or pharmacistbefore administering Maviret, if your child is taking any of the medications in the following table. The doctor may need to change the dose of these medications.

*The doctor may increase the frequency of your child's blood tests to verify the proper functioning of their blood clotting process.

If your child is in any of the above situations (or is unsure), consult your child's doctor or pharmacist before administering Maviret.

Maviret contains lactose

If your doctor has indicated that your child has a certain sugar intolerance, consult with them before administering this medication.

Maviret contains propylene glycol

This medication contains 4mg of propylene glycol in each sachet.

Maviret contains sodium

This medication contains less than 1mmol of sodium (23mg) per sachet; this is “sodium-free”.

Always follow exactly the administration instructions of this medication indicated by your child's doctor or pharmacist. In case of doubt, consult your child's doctor or pharmacist. Maviret coated granules are indicated for children from 3 to less than 12 years of age and weighing from 12 kg to less than 45 kg.Maviret tablets are indicated for adults, children 12 years of age and older, or children weighing 45 kg or more.

Your child's doctor will tell you for how long your child needs to take Maviret.

Amount to take

The recommended dose for children from 3 to less than 12 years of age is based on their body weight as indicated in the table that follows below.

In the case of children weighing 45 kg or more, consult your child's doctor about the possibility of administering Maviret in tablets.

How to take Maviret

• Administer Maviret once a day just before or after taking a snack or main meal.
• Mix all the granules from the packet with a small amount of the recommended food and swallow. The granules should not be crushed or chewed (see usage instructions to consult the list of recommended foods).
• Do not administer Maviret granules through a feeding tube.

If your child vomits after taking Maviret, the amount of this medication present in the blood may be affected. In this case, the effectiveness of Maviret may be reduced.

• If your child vomits withinless than 3hoursafter taking Maviret, administer another dose.
• If your child vomits withinmore than 3hoursafter taking Maviret, it is not necessary to administer another dose until the next one is due.

If you take more Maviret than you should

If you accidentally take a higher dose than recommended, consult your child's doctor or go immediately to the nearest hospital. Bring the packaging of this medication with you so that the doctor can see what your child has taken.

If you forget to administer Maviret

It is essential not to miss any doses of this medication.

If your child misses a dose, calculate how long it has been since they should have taken Maviret:

• If you rememberwithin less than 18hoursafter the time when your child usually takes the Maviret dose, administer it as soon as possible. Then, administer the next dose at the usual time.
• Ifyou rememberwithin 18hours or moreafter the time when your child usually takes the Maviret dose, wait and administer the next dose at the usual time. Do not administer a double dose (two doses very close together).

If you have any other doubts about the use of this medication, ask your child's doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Inform your child's doctor or pharmacist if you notice any of the following adverse effects:

Very common:may affect more than 1 in 10 people

• feeling extremely tired (fatigue)
• headache

Common:may affect up to 1 in 10 people

• nausea (gag reflex)
• diarrhea
• feeling weak or lacking energy (asthenia)
• increased liver function test (bilirubin) in a laboratory test

Rare:may affect up to 1 in 100 people

• swelling of the face, lips, tongue, throat, abdomen, arms, or legs

Unknown frequency:cannot be estimated from available data

• itching

Reporting Adverse Effects

If your child experiences any type of adverse effect, consult with your child's doctor or pharmacist.This includes any possible adverse effect not listed in this prospectus.You can also report them directly through the national notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the carton after “CAD”.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Maviret

• The active ingredients are glecaprevir and pibrentasvir. Each pack contains 50 mg of glecaprevir and 20 mg of pibrentasvir.
• The other excipients are:
• Copovidone, tocofersolan, propylene glycol monocaprylate, colloidal silicon dioxide, croscarmellose sodium (only in the glecaprevir granules), stearate sodium, hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol, iron oxide red (E172), iron oxide yellow (E172)

Maviret contains lactose, propylene glycol, and sodium. See section 2.

Appearance of Maviret and contents of the pack

The coated granules of Maviret are supplied in blister packs with a polyester/aluminium/polyethylene film, which come in cartons. Each carton contains 28 blister packs. Each blister pack contains pink and yellow granules.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

AbbVie S.r.l.

S.R. 148 Pontina km 52 SNC

04011 Campoverde di Aprilia (LT)

Italy

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet 05/2022

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

To request a copy of this leaflet in large print, please contact the local representative of the marketing authorization holder.

7. Instructions for use

Read the entire section 7 before using the granules in blister packs of Maviret.