Maviret 50 mg/20 mg granules in sachet

Spain
Brand name Maviret 50 mg/20 mg granules in sachet
Form granules, coated in sachets
Active substance / Dosage
GLECAPREVIR · 50 mg
PIBRENTASVIR · 20 mg
Prescription type Hospital Diagnosis
ATC code
J05A J05AP J05AP57
Registration number 1171213002
Manufacturer Abbvie Deutschland Gmbh & Co. Kg
Maviret 50 mg/20 mg granules in sachet granules, coated in sachets

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Maviret 50mg/20mg granules in sachet

glecaprevir/pibrentasvir

Read the entire 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 questions, 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 type of adverse reaction, consult your doctor or pharmacist. This includes any possible adverse reaction 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 your child takes Maviret
  3. How to take Maviret
  4. Possible side effects
  5. How to store Maviret
  6. Contents of the pack and other information
  7. Instructions for use

1. What Maviret is and what it is used for

Maviret is an antiviral medicine used to treat children aged 3 years and older with long-term ("chronic") hepatitis C. This is an infectious disease affecting the liver, 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 your child starts taking Maviret

Do not give Maviret if:

  • your child is allergic to glecaprevir, pibrentasvir, or any of the other ingredients of this medicine (listed in section 6).
  • your child has severe liver problems other than hepatitis C.
  • your child is 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) (a herbal remedy used for mild depression).

Do not give Maviret to your child if any of the above apply. If you are unsure, consult your child’s doctor or pharmacist before administering Maviret.

Warnings and precautions

Talk to your child’s doctor if any of the following apply, as the doctor may want to monitor your child more closely:

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

Blood tests

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

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

Children under 3 years of age

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 child’s doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines.

Tell your child’s doctor or pharmacist before administering Maviret if your child is taking any of the medicines listed in the table below. The doctor may need to adjust the dose of these medicines.

Medicines you must inform your child's doctor about before administering Maviret

Medicine

Purpose of the medicine

ciclosporin, tacrolimus

to reduce the activity of the immune system

darunavir, efavirenz, lopinavir, ritonavir

for HIV infection

digoxin

for heart problems

fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin

to reduce blood cholesterol

warfarin and other similar medicines*

to prevent blood clots

*Your child's doctor may increase the frequency of blood tests to check that your child's blood clotting process is working properly.

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

Maviret contains lactose

If your doctor has informed you that your child has an intolerance to certain sugars, consult with your doctor before administering this medicine.

Maviret contains propylene glycol

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

Maviret contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; this is considered "sodium-free".

3. How to take Maviret

Always follow exactly the instructions for use of this medicine given by your child's doctor or pharmacist. If you are unsure, consult your child's doctor or pharmacist. Maviret granules with coating is intended for children aged 3 to less than 12 years and weighing 12 kg to less than 45 kg. Maviret tablets are intended for adults, children aged 12 years and older, or children weighing 45 kg or more.

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

Dose to be taken

The recommended dose for children aged 3 to less than 12 years is based on body weight, as shown in the table below.

Child's weight (kg)

Number of sachets once daily

From 12 to less than 20 kg

3 sachets

From 20 to less than 30 kg

4 sachets

From 30 to less than 45 kg

5 sachets

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 daily just before or just after a snack or main meal.
  • Mix all the granules from the sachet with a small amount of the recommended food and swallow. The granules must not be crushed or chewed (see the instructions for use for 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 medicine in the blood may be affected. In such a case, the effectiveness of Maviret may be reduced.

  • If vomiting occurs less than 3 hours after taking Maviret, administer another dose.
  • If vomiting occurs more than 3 hours after taking Maviret, do not administer another dose; wait until the next scheduled dose.

If you take more Maviret than you should

If you accidentally take more than the recommended dose, contact your child's doctor or go immediately to the nearest hospital. Keep the medicine package available so you can show the doctor what your child has taken.

If you forget to administer Maviret

It is important not to miss doses of this medicine.

If your child misses a dose, determine how long it has been since the time when the dose should have been taken:

  • If you remember within less than 18 hours after the usual time for taking Maviret, administer the missed dose as soon as possible. Then give the next dose at the regular time.
  • If you remember 18 hours or more after the usual time for taking Maviret, wait and administer the next dose at the regular time. Do not give a double dose (two doses close together).

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

4. Possible adverse effects

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

Tell 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 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 your child experiences any type of adverse effect, consult your child's doctor or pharmacist. This includes any possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. 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 and sachet after "EXP". The expiry date is 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 sachet contains 50 mg of glecaprevir and 20 mg of pibrentasvir.
  • The other excipients are:
  • Copovidone, tocophersolan, propylene glycol monocaprylate, colloidal silicon dioxide, sodium croscarmellose (only in the glecaprevir granules), sodium stearyl fumarate, 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

Maviret coated granules are supplied in sachets with polyester/aluminum/polyethylene film, which are packed in cartons. Each carton contains 28 sachets. Each sachet 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

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

Belgium/Belgium/Belgium

AbbVie SA

Tel/Tel: +32 10 477811

Lithuania

AbbVie UAB

Tel.: +370 5 205 3023

Bulgaria

AbbVie EAD

Tel.: +359 2 90 30 430

Luxembourg/Luxembourg

AbbVie SA

Belgium/Belgium

Tel/Tel: +32 10 477811

Czech Republic

AbbVie s.r.o.

Tel.: +420 233 098 111

Hungary

AbbVie Kft.

Tel.: +36 1 455 8600

Denmark

AbbVie A/S

Tlf: +45 72 30-20-28

Malta

V.J.Salomone Pharma Limited

Tel.: +356 22983201

Germany

AbbVie Deutschland GmbH & Co. KG

Tel.: 00800 222843 33 (toll-free)

Tel.: +49 (0) 611 / 1720-0

Netherlands

AbbVie B.V.

Tel.: +31 (0)88 322 2843

Estonia

AbbVie OÜ

Tel.: +372 623 1011

Norway

AbbVie AS

Tlf: +47 67 81 80 00

Greece

AbbVie PHARMACEUTICALS S.A.

Tel: +30 214 4165 555

Austria

AbbVie GmbH

Tel.: +43 1 20589-0

Spain

AbbVie Spain, S.L.U.

Tel.: +34 91 384 09 10

Poland

AbbVie Polska Sp. z o.o.

Tel.: +48 22 372 78 00

France

AbbVie

Tél: +33 (0)1 45 60 13 00

Portugal

AbbVie, Lda.

Tel.: +351 (0)21 1908400

Croatia

AbbVie d.o.o.

Tel.: +385 (0)1 5625 501

Romania

AbbVie S.R.L.

Tel.: +40 21 529 30 35

Ireland

AbbVie Limited

Tel.: +353 (0)1 4287900

Slovenia

AbbVie Biofarmacevtska družba d.o.o.

Tel.: +386 (1)32 08 060

Iceland

Vistor hf.

Tel: +354 535 7000

Slovakia

AbbVie s.r.o.

Tel.: +421 2 5050 0777

Italy

AbbVie S.r.l.

Tel.: +39 06 928921

Finland

AbbVie Oy

Tel/Tel: +358 (0)10 2411 200

Cyprus

Lifepharma (Z.A.M.) Ltd

Tel: +357 22 34 74 40

Sweden

AbbVie AB

Tel.: +46 (0)8 684 44 600

Latvia

AbbVie SIA

Tel.: +371 67605000

United Kingdom (Northern Ireland)

AbbVie Deutschland GmbH & Co. KG

Tel.: +44 (0)1628 561090

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

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.euopa.eu.

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

  1. Instructions for use

Read section 7 completely before using Maviret granules in sachets.

Step 1. Take the number of sachets your child's doctor has recommended

Child's weight (kg)

Number of sachets once daily

Amount of food (approximate)

From 12 to less than 20 kg

3 sachets

Approximately 1–2 teaspoons (5–10 ml) of one of the recommended foods listed in step 2

From 20 to less than 30 kg

4 sachets

From 30 to less than 45 kg

5 sachets

For children weighing 45 kg or more, consult your child's doctor about the possibility of administering Maviret in tablet form.

Do not administer more than 5 sachets.

Step 2. Choose an appropriate food to mix with Maviret granules

A hand holds a metal spoon containing a creamy substance with intense pink color and circular streaks

The food should be spoonable and not drip from the spoon. It must be soft, low in water content, and swallowable without chewing.

Examples of recommended foods:

  • Greek yoghurt
  • Cream/soft cheese
  • Peanut butter
  • Hazelnut chocolate spread
  • Thick jam
  • Other foods that are spoonable and do not drip

Important: In addition to the food used to mix with the granules, Maviret must be taken at the same time as, or immediately after, a main meal or snack. The food used to mix the granules does not replace the required main meal or snack that must be taken with Maviret.

A hand holds a spoon with red liquid dripping from it, overlaid with a large red prohibition sign with a cross

Do not use foods that drip from the spoon, as the medicine may dissolve too quickly, taste bitter, and become less effective. Do not use any food to which your child is allergic.

Examples of foods you should not use:

• Liquids or watery foods

• Apple sauce

• Heated or frozen foods or liquids

• Bread or other foods requiring chewing

• Yoghurt that is not Greek

• Baby food

• Foods that drip from the spoon

To obtain further information about suitable foods, consult your child's doctor or pharmacist.

Open box with vials, a bottle containing red liquid, a white bowl, and a teaspoon next to a pair of scissors on a white surface

Step 3. Prepare the necessary materials

On a clean surface, place the following:

  • Pouches box
  • Soft food
  • Mixing bowl
  • Teaspoon
  • Scissors

Two hands prepare a medication by pouring pink liquid from a teaspoon into a small white bowl

Step 4. Measure the amount of food

  • Place a small amount (1–2 teaspoons or 5–10 mL) of soft food into the mixing bowl.
  • The granules inside the sachets are very small; placing the food first helps ensure proper mixing.

A hand holds a vertical white sachet with a dark strip and the text Maviret, while a green arrow indicates to open it

Step 5. Prepare the sachet

  • Locate the dotted line on the sachet to identify the top.
  • Hold the sachet upright and tap the top gently. Continue tapping until all granules have fallen to the bottom.
  • Thoroughly check the top of the sachet to ensure all granules are in the bottom section.

A hand holds a paper strip labeled Maviret, with a scissors symbol indicating to cut along a horizontal dashed line

Step 6. Cut the top of the sachet

  • Hold the sachet in the middle, pressing above the area where the granules are located inside.
  • Use scissors to completely cut off the top of the sachet.

Caution: The granules are very small and may easily spill out.

A hand pours granular contents from a white sachet into a small bowl containing pink liquid

Step 7. Empty the sachet

  • Ensure the sachet is fully open.
  • Carefully empty the sachet, allowing all granules (pink and yellow) to fall into the bowl with food.
  • Tap the sachet gently to release all granules.
  • Repeat this step for each sachet required for your child's daily dose.

A hand holds between thumb and index finger a small cylindrical container with a dark cap for the medication

Step 8. Check the sachet

Look inside each sachet to ensure no granules remain inside.

Do not leave any granules in the sachet, as the medicine may be less effective if the full dose is not taken.

A hand holds a spoon and dips it into a bowl containing a thick, deep red substance

Step 9. Mix

  • Use the teaspoon to gently stir and incorporate the granules into the food.
  • Do not crush the granules. Crushing may result in a bitter taste.
  • Do not store the mixture; administer it to your child immediately.

If not administered within 5 minutes, the mixture may taste bitter.

If not administered within 15 minutes, the medicine may become less effective. Discard the mixture and prepare a new one.

Black-and-white illustration of a person with an open mouth receiving liquid from a spoon placed into the mouth

Step 10. Administer the medicine

  • Take a small amount of the mixture with the teaspoon.
  • Ensure your child swallows the mixture without chewing.
  • Repeat until your child has taken the entire mixture.
  • If granules remain, add more food and mix. Then complete the dose.
  • Ensure your child takes the full dose of medicine.

? If your child misses a dose, refer to section 3 “How to take Maviret” for further information.

Calendar icon with a green checkmark above an open box containing several white Maviret medication packages

Step 11. Confirm the next day’s dose

Check that you have enough sachets for your child's next Maviret dose.

To refill or renew the prescription, contact your child's doctor or pharmacist.