InfoCons Consumer Protection informs you – Maviret – Package Leaflet

Before anything else

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, t alk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 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 recently acquired (‘acute’) or long-term (‘chronic’) hepatitis C. This is an infectious disease that affects the liver, caused by the hepatitis C virus. Maviret contains the active substances glecaprevir and pibrentasvir.

Maviret works by stopping the hepatitis C virus from multiplying and infecting new cells. This allows the infection to be eliminated f rom the body.

⚠️ 2. What you need to know before your child takes 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 from hepatitis C.
• your child is taking the following medicines:
• atazanavir (for HIV infection)
• atorvastatin or simvastatin (to lower blood cholesterol)
• carbamazepine, phenobarbital, phenytoin, primidone (normally used for epilepsy)
• dabigatran etexilate (to prevent blood clots)
• ethinyl oestradiol-containing medicines (such as contraception medicines, including vaginal rings, transdermal patches and tablets)
• rifampicin (for infections)
• St. John’s wort (Hypericum perforatum ) (herbal remedy used for mild depression) .

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

Warnings and precautions

Talk to your child’s doctor if they have the following because the doctor may want to check your child more closely:

75 • liver problems other than hepatitis C

• current or previous infection with the hepatitis B virus
• diabetes. Your child may need closer monitoring of their blood glucose levels and/or adjustment of diabetes treatment after starting Maviret. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment wit h medicines like Maviret.

Blood tests Your child’s doctor will test their blood before, during and after treatment with Maviret. This is so that the doctor can decide if:

• Your child should take Maviret and for how long
• The treatment has worked and your c hild is free of the hepatitis C virus.

Children under 3 years old Do not give this medicine 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 yet been studied.

Other medicines and Maviret

Tell your child’s doctor or pharmacist if they are taking, have recently taken or might take any other medicines.

Tell your child’s doctor or pharmacist before giving Maviret, if they are taking any of the medicines i n the table below. The doctor may need to change the dose of these medicines.

Medicines you must tell your child’s doctor about before giving Maviret Medicine Purpose of the medicine ciclosporin, tacrolimus to suppress the immune system darunavir, efavirenz, lopinavir, ritonavir for HIV infection digoxin for heart problems fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol warfarin and other similar medicines* to prevent blood clots *Your child’s doctor may need to increase the frequency of blood tests to check how well your child’s blood can clot.

If any of the above apply to your child (or you are not sure), talk to your child’s doctor or pharmacist before giving Maviret.

Maviret contains lactose

If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicine.

Maviret contains propylene glycol

This medicine contains 4 mg propylene glycol in each sachet.

Maviret contains sodiu m

This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium free’.

💊 3. How to take Maviret

Always give this medicine exactly as your child’s doctor or pharmacist has told you. Check with your child’s doctor or pharmacist if you are not sure. Maviret coated granules are intended for children aged 76 3 years to less than 12 years and weighing 12 kg to less than 45 kg. Maviret tablets are intended for adults, children 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 for.

How much to take The recommended dose for children 3 to less than 12 years old is based on their body weight as shown in the table below.

Weight of child (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 For children weighing 45 kg or more, talk to your child’s doctor about giving Maviret tablets.

How to take Maviret

• Give Maviret once a day just before or after a snack or meal.
• Mix all the granules in the sachet with a small amount of recommended food and swallow . The granules should not be crushed or chewed (see Instructions for use for list of recommended food).
• Do not give Maviret granules through a feeding tube.

If your child is sick (vomits) after taking Maviret it may affect the amount of Maviret in their blood.

This may make Maviret work less well.

• If they vomit less than 3 hours after taking Maviret, give another dose.
• If they vomit more than 3 hours after taking Maviret, you do not need to give another dose until the next dose is due.

If they take more Maviret than they should If they accidentally take more than the recommended dose, contact your child’s doctor or go to the nearest hospital straight away. Take the medicine pack with you so that you can show the doctor what your child has taken.

If you forget to give Maviret It is important not to miss a dose of this medicine.

If your child does miss a dose, work out how long it is since they should have last taken Maviret:

• If you notice within 18 hours of the time your child usually takes Maviret, give the dose as soon as possible. Then give the next dose at the usual time.
• If you notice 18 hours or more after the time your child usually takes Maviret, wait and give the next dose at the usual time. Do not give a double dose to make up for a forgotten dose .

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

❗ 4. Possible side effects

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

Tell your child’s 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) 77 • diarrhoea
• feeling weak or lack of 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

Not known: frequency cannot be estimated from the available data

• itching

Reporting of side effects

If your child gets any side effects, talk to your child’s 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store 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 and sachet after EXP. The expiry date refers to the last day of th at month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Maviret contains

• The active substances are glecaprevir and pibrentasvir. Each sachet contains 50 mg of glecaprevir and 20 mg of pibrentasvir.
• The other ingredients are: Copovidone, tocofersolan, propylene glycol monocaprylate, colloidal silicon dioxide, croscarmellose sodium (in the glecaprevir granules only), 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.

What Maviret looks like and contents of the pack

Maviret coated granules are supplied in polyester/aluminium/polyethylene film sachets in cartons.

Each carton contains 28 sachets. Each sachet contains pink and yellow granules.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Germany 78 Manufacturer AbbVie S.r.l.

S.R. 148 Pontina km 52 SNC 04011 Campoverde di Aprilia (LT) Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien AbbVie SA Tél/Tel: +32 10 477811 Lietuva AbbVie UAB Tel: +370 5 205 3023 България АбВи ЕООД Тел.: +359 2 90 30 430 Luxembourg/Luxemburg AbbVie SA Belgique/Belgien Tél/Tel: +32 10 477811 Česká republika AbbVie s.r.o.

Tel: +420 233 098 111 Magyarország AbbVie Kft.

Tel.: +36 1 455 8600 Danmark AbbVie A/S Tlf.: +45 72 30-20-28 Malta V.J.Salomone Pharma Limited Tel: +356 21220174 Deutschland AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (gebührenfrei) Tel: +49 (0) 611 / 1720-0 Nederland AbbVie B.V.

Tel: +31 (0)88 322 2843 Eesti AbbVie OÜ Tel: +372 623 1011 Norge AbbVie AS Tlf: +47 67 81 80 00 Ελλάδα AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.

Τηλ: +30 214 4165 555 Österreich AbbVie GmbH Tel: +43 1 20589-0 España AbbVie Spain, S.L.U.

Tel: +34 91 384 09 10 Polska AbbVie 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 Hrvatska AbbVie d.o.o.

Tel: +385 (0)1 5625 501 România AbbVie S.R.L.

Tel: +40 21 529 30 35 Ireland AbbVie Limited Tel: +353 (0)1 4287900 Slovenija AbbVie Biofarmacevtska družba d.o.o.

Tel: +386 (1)32 08 060 79 Ísland Vistor Sími: +354 535 7000 Slovenská republika AbbVie s.r.o.

Tel: +421 2 5050 0777 Italia AbbVie S.r.l.

Tel: +39 06 928921 Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411 200 Κύπρος Lifepharma (Z.A.M.) Ltd Τηλ: +357 22 34 74 40 Sverige AbbVie AB Tel: +46 (0)8 684 44 600 Latvija AbbVie SIA Tel: +371 67605000

This leaflet was last revised in

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

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7. Instructions for use Please read all of section 7 before using Maviret granules in sachets.

Step 1. Get the number of sachets as advised by your child’s doctor Weight of child (kg) Number of sachets once daily Food Amount (approximate) From 12 to less than 20 kg 3 sachets About 1-2 teaspoons (5-10 mL) of recommended food 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, talk to your child’s doctor about giving Maviret tablets.

Do not give more than 5 sachets.

Step 2. Choose suitable food to mix with Maviret granules Suitable food should stick to the spoon. It must be soft, low in water content and can be swallowed without chewing.

Example of recommended foods: ✓ Greek yogurt ✓ Cream/soft cheese ✓ Peanut butter ✓ Chocolate hazelnut spread ✓ Thick jam ✓ Other food that sticks to the spoon Note: in addition to the food used to mix the granules, Maviret should also be taken at the same time or straight after a meal or snack. The food used to mix the granules does not replace the meal or snack to take with Maviret.

80 Do not use food if it drips off a spoon as the medicine may dissolve quickly, taste bitter, and become less effective. Do not use food that your child is allergic to.

Example of foods not to use: ✘ Liquids or watery food ✘ Apple sauce ✘ Food or liquid that is heated or frozen ✘ Bread or other food that requires chewing ✘ Non-Greek yogurt ✘ Baby food ✘ Food that drips off the spoon For more information about suitable foods, contact your child’s doctor or pharmacist.

Step 3. Gather materials Place the following on a clean surface:

• Box with sachets in it
• Soft food
• Bowl to use for mixing
• Teaspoon
• Scissors Step 4. Measure food
• Place a small amount (1 -2 teaspoons or 5-10 mL) of soft food into a bowl.
• The granules inside the sachets are very small, so placing food in the bowl first will help contain them.

Step 5. Prepare sachet

• Look for the dotted line on the sachet to find the top end.
• Hold the sachet upright and tap the top of the sachet. Keep tapping until all the granules inside fall to the bottom.
• Feel top area of sachet thoroughly to make sure all granules are at the bottom.

Step 6. Cut top of sachet

• Pinch the sachet in the centre, above the granules inside.
• Use scissors to cut the top of the sachet completely off.

Be Careful: Granules are very small and can fall out easily.

81 Step 7. Pour sachet

• Make sure the sachet is fully open.
• Carefully pour all granules (pink and yellow) out of the sachet into the bowl of food.
• Tap sachet to get all the granules out.
• Repeat for each sachet for your child’s daily dose.

Step 8. Check sachet Look inside each sachet to make sure there are no granules left inside.

Do not leave any granules behind as the medicine will not work as well if the full dose is not taken.

Step 9. Mix

• Use the teaspoon to gently stir the granules into the food.
• Do not crush the granules. If the granules are crushed, they will taste bitter.
• Do not store the mixture, give it to your child immediately.

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

If not given within 15 minutes, the medicine may be less effective. Throw away and start again.

Step 10. Give the medicine

• Scoop a small amount of mixture onto the teaspoon.
• Make sure your child swallows the mixture without chewing.
• Repeat until your child has taken all the mixture.
• If any granules are left, add more food and mix. Then finish the dose.
• Make sure your child takes the full dose of the medicine.

⚠ If your child misses a dose, see Section 3 “How to take Maviret” for further information.

Step 11. Confirm dose for tomorrow Check to make sure there are enough sachets for your child’s next dose of Maviret.

For replacement sachets or to refill your prescription contact your child’s doctor or pharmacist.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Maviret (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/17/1213).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.