Label: information for the user

Maviret 100mg/40mg film-coated tablets

glecaprevir/pibrentasvir

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this label. See section4.

1.What Maviret is and for what it is used

2.What you need to know before starting to take Maviret

3.How to take Maviret

4.Possible adverse effects

5.Storage of Maviret

6.Contents of the package and additional information

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

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

Do not take Maviret:

• if you are allergic to glecaprevir, pibrentasvir, or any of the other components of this medication (listed in section6).
• if you have severe liver problems other than hepatitisC.
• if you are 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 take Maviret if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking Maviret.

Warnings and precautions

Consult your doctor if you are in any of the following cases, as you may need closer monitoring:

• you have liver problems other than hepatitisC

• you have or have had a hepatitis B virus infection
• you have diabetes. After starting Maviret, you may need a strict control of your blood glucose levels and/or adjust your antidiabetic medication. Some diabetic patients have experienced low blood sugar (hypoglycemia) after starting treatment with medications like Maviret.

Blood tests

Your doctor will perform blood tests before, during, and after treatment with Maviret. This will allow them to determine:

• whether you should take Maviret and for how long
• whether the treatment has been effective and you no longer have the hepatitis C virus.

Children

This medication should not be administered to children under 3 years of age or with a weight less than 12 kg. Maviret has not yet been studied in children under 3 years of age or with a weight less than 12 kg.

Other medications and Maviret

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

Inform your doctor or pharmacistbefore taking Maviret if you are taking any of the medications listed in the following table. Your doctor may need to change the dose of these medications.

*Your doctor may need to increase the frequency of your blood tests to verify the proper functioning of the blood clotting process.

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before taking Maviret.

Pregnancy and contraception

The effects of Maviret during pregnancy are unknown. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication, as it is not recommended to take Maviret during pregnancy. Birth control pills that contain etinilestradiol should not be used in combination with Maviret.

Breastfeeding

Consult your doctor before taking Maviret if you are breastfeeding.The two components of Maviret are unknown to pass into breast milk.

Driving and using machines

Maviret should not affect your ability to drive or use tools or machines.

Maviret contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Always follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will inform you for how long you will need to take Maviret.

Maviret tablets are intended for adults, children 12 years of age and older, or children weighing 45 kg or more. Maviret coated granules are intended for children 3 years to less than 12 years and weighing 12 kg to less than 45 kg.

Amount to take

The recommended dose for adults, children 12 years of age and older, or children weighing at least 45 kg is three Maviret 100 mg/40 mg tablets taken at once, once a day. The daily dose is the three tablets from a blister.

Form of taking the medication

• Take the tablets with food.
• The tablets should be swallowed whole.
• Do not chew, crush, or break them as this may affect the amount of Maviret in your blood..

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

• If you vomit when less than 3 hours have passed since taking Maviret, take another dose.
• If you vomit when more than 3 hours have passed since taking Maviret, do not take another dose until your next scheduled dose.

If you take more Maviret than you should

If you accidentally take a higher dose than recommended, consult your doctor or go immediately to the nearest hospital. Bring the packaging of this medication with you to show your doctor what you have taken.

If you forget to take Maviret

It is essential not to miss doses of this medication.

If you forget to take a dose, calculate how long it has been since you should have taken Maviret:

• If you remember in less than 18 hours after the time you usually take the Maviret dose, take it as soon as possible. Then, take the next dose at the usual time.
• If you remember in 18 hours or more after the time you usually take the Maviret dose, wait and take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

Very common:may affect more than 1 in 10 people

• feeling of extreme fatigue (fatigue)
• headache

Common:may affect up to 1 in 10 people

• urge to vomit (nausea)
• diarrhea
• feeling of weakness or lack of energy (asthenia)
• increase in a laboratory test of liver function (bilirubin)

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 you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. 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 after “CAD” and on the blister pack after “EXP.”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 containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Maviret

• The active ingredients are glecaprevir and pibrentasvir. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.
• The other excipients are:

• Tablet core: copovidone (type K 28), polyethylene glycol succinate of vitamin E, anhydrous colloidal silica, propylene glycol monocaprylate (type II), croscarmellose sodium, sodium stearate fumarate.
• Tablet coating: hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol 3350, red iron oxide (E172).

Maviret contains lactose and sodium. See section 2.

Appearance of the product and contents of the package

Maviret tablets are pink-coated, oval-shaped, biconvex tablets, 18.8 mm × 10.0 mm in size, and marked with “NXT” on one side.

Maviret tablets are packaged in blisters containing 3 tablets each. Maviret is available in packages of 84 tablets, with 4 boxes, each containing 21 tablets coated with a film.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Responsible for manufacturing

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

or

AbbVie Logistics B.V

Zuiderzeelaan 53

8017 JV Zwolle

Netherlands

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

Last review date of this leaflet: 05/2022

Other sources of information

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

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