MAVIRET 100 mg/40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Maviret 100mg/40mg film-coated tablets

glecaprevir/pibrentasvir

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.

Contents of the pack

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

1. What is Maviret and what is it used for

Maviret is an antiviral medicine used to treat adults and children (from 3 years of age) with long-term (chronic) hepatitis C infection. This is an infectious disease that affects the liver and is 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. This eliminates the infection from the body.

2. What you need to know before you take 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 the following medicines:
• • atazanavir (for HIV infection)
  • atorvastatin or simvastatin (to lower blood cholesterol)
  • carbamazepine, phenobarbital, phenytoin, primidone (usually 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), (herbal medicine used for mild depression).

Do not take Maviret if you are in any of the above situations. If in doubt, consult your doctor or pharmacist before taking Maviret.

Warnings and precautions

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

• you have liver problems other than hepatitis C

• you have had or currently have a hepatitis B virus infection
• you have diabetes. After starting Maviret, you may need close monitoring of your blood glucose levels and/or adjustment of your diabetic medication. After starting treatment with medicines like Maviret, some diabetic patients have experienced low blood sugar levels (hypoglycaemia).

Blood tests

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

• if you should take Maviret and for how long
• if the treatment has worked and you no longer have 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 in children under 3 years of age or weighing less than 12 kg has not been studied yet.

Other medicines and Maviret

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

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

• Your doctor may increase the frequency of your blood tests to check the proper functioning of your 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 not known. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine, as it is not recommended to take Maviret during pregnancy. Contraceptive medicines containing ethinylestradiol must not be used in combination with Maviret.

Breast-feeding

Ask your doctor or pharmacist for advice before taking Maviret if you are breast-feeding. It is not known if the active substances in Maviret pass into breast milk.

Driving and using machines

Maviret is unlikely to affect your ability to drive or use tools or machines.

Maviret contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Maviret

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long you need to take Maviret.

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

How much to take

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

How to take the medicine

• Take the tablets with food.
• Swallow the tablets 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 medicine in your blood may be affected. In this case, the effectiveness of Maviret may be lower.

• If you vomit when it has been less than 3hourssince you took Maviret, take another dose.
• If you vomit when it has been more than 3hourssince you took 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 to the nearest hospital immediately. Take the medicine pack with you to show the doctor what you have taken.

If you forget to take Maviret

It is important not to miss any doses of this medicine.

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

• If it has been less than 18hourssince you should have taken your Maviret dose, take it as soon as possible. Then take your next dose at the usual time.
• If it has been 18hours or moresince you should have taken your Maviret dose, wait and take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or pharmacist if you notice any of the following side 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 laboratory test of liver function (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 side effects

If you get any side effects, talk to your doctor or pharmacist. 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 the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side 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 which is stated on the carton after “EXP” and on the blister after “EXP”. The expiry date refers to the last day of the month shown.

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 no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Maviret contains

• 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 succinate, colloidal anhydrous silica, propylene glycol monocaprylate (type II), sodium croscarmellose, sodium stearyl fumarate.
• Tablet coating: hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol 3350, red iron oxide (E172).

Maviret contains lactose and sodium. See section 2.

Appearance and packaging

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

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

Marketing Authorisation 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

Netherlands

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet: 05/2022

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

To request a copy of this leaflet in large print, contact the local representative of the Marketing Authorisation Holder.