Maviret 100 mg/40 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Maviret 100mg/40mg film-coated tablets

glecaprevir/pibrentasvir

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

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Maviret is and what it is used for

Maviret is an antiviral medicine used to treat adults and children (aged 3 years and older) with long-term (“chronic”) hepatitis C. This is an infectious disease affecting the liver and caused by the hepatitis C virus. Maviret contains the active substances glecaprevir and pibrentasvir.

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

2. What you need to know before starting Maviret

Do not take Maviret:

• if you are allergic to glecaprevir, pibrentasvir, or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver problems other than hepatitis C.
• if you are taking any of the following medicines:
  • atazanavir (for HIV infection)
  • atorvastatin or simvastatin (to lower blood cholesterol)
  • carbamazepine, phenobarbital, phenytoin, primidone (commonly used for epilepsy)
  • dabigatran etexilate (to prevent blood clots)
  • medicines containing ethinylestradiol (such as contraceptive medicines, including vaginal rings, transdermal patches, and tablets)
  • rifampicin (for infections)
  • St. John’s wort (Hypericum perforatum), (a herbal medicine used for mild depression).

Do not take Maviret if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Maviret.

Warnings and precautions

Talk to your doctor if any of the following apply to you, as you may need closer monitoring:

• you have liver problems other than hepatitis C
• you currently have or have previously had hepatitis B virus infection
• you have diabetes. After starting Maviret, you may require strict monitoring of your blood glucose levels and/or adjustment of your antidiabetic medication. After starting treatment with medicines like Maviret, some diabetic patients have experienced low blood sugar levels (hypoglycaemia).

Blood tests

Your doctor will carry out blood tests before, during, and after treatment with Maviret. These tests will help determine:

• whether you should take Maviret and for how long
• whether the treatment has been effective and whether you have cleared the hepatitis C virus.

Children

This medicine must not be given to children under 3 years of age or weighing less than 12 kg. The use of Maviret has not yet been studied in children under 3 years of age or weighing less than 12 kg.

Other medicines and Maviret

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor or pharmacist before taking Maviret if you are taking any of the medicines listed in the table below. Your doctor may need to adjust the dose of these medicines.

• Your doctor may increase the frequency of your blood tests to check that your blood clotting process is working properly.

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 might be pregnant, or plan to become pregnant, consult your doctor before using this medicine, as taking Maviret during pregnancy is not recommended. Hormonal contraceptives containing ethinylestradiol must not be used in combination with Maviret.

Breastfeeding

Consult your doctor before taking Maviret if you are breastfeeding. It is unknown whether the two components of Maviret pass into breast milk.

Driving and using machines

Maviret should not affect your ability to drive or operate tools or machinery.

Maviret contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Maviret

Always follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Your doctor will tell you how long you need to take Maviret.

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

Dose to be taken

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

How to take the medicine

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

If you vomit after taking Maviret, the amount of this medicine in your blood may be affected. In such a case, the effectiveness of Maviret could be reduced.

• If you vomit less than 3 hours after taking Maviret, take another dose.
• If you vomit more than 3 hours after taking Maviret, you do not need to take another dose until your next scheduled dose.

If you take more Maviret than you should

If you accidentally take more than the recommended dose, contact your doctor or go immediately to the nearest hospital. Keep the medicine’s packaging handy so you can show your doctor what you have taken.

If you forget to take Maviret

It is important not to miss doses of this medicine.

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

• If you remember within 18 hours of your usual dosing time, take the missed dose as soon as possible. Then take your next dose at the usual time.
• If you remember 18 hours or more after your usual dosing time, wait and take your next dose at the usual time. Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Very common: may affect more than 1 in 10 people

• feeling very tired (fatigue)
• headache

Common: may affect up to 1 in 10 people

• feeling sick (nausea)
• diarrhoea
• feeling weak or lacking energy (asthenia)
• increase in a liver function laboratory test (bilirubin)

Uncommon: may affect up to 1 in 100 people

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

Frequency not known: cannot be estimated from the available data

• itching

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Maviret

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

Do not use this medicine after the expiry date stated on the carton after “EXP” and on the blister after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Maviret

• The active substances are glecaprevir and pibrentasvir. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.

• The other ingredients are:

• Tablet core: copovidone (type K 28), vitamin E polyethylene glycol succinate, colloidal anhydrous silica, propylene glycol monocaprylate (type II), sodium croscarmellose, sodium stearyl fumarate.

• Film-coating of the tablet: hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol 3350, iron oxide red (E172).

Maviret contains lactose and sodium. See section 2.

Appearance of the product and contents of the pack

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

Maviret tablets are packed in blisters containing 3 tablets each. Maviret is available in packs of 84 tablets, with 4 boxes, each containing 21 film-coated tablets.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

or

AbbVie Logistics B.V

Zuiderzeelaan 53

8017 JV Zwolle

The Netherlands

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

Date of the most recent review of this leaflet: 05/2022

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: 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.