Glecaprevir/Pibrentasvir 50 mg/20 mg coated granules in sachet

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your child’s doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
• If your child gets any side effects, talk to their doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Glecaprevir/Pibrentasvir is and what it is used for
2. What you need to know before your child takes Glecaprevir/Pibrentasvir
3. How to take Glecaprevir/Pibrentasvir
4. Possible side effects
5. How to store Glecaprevir/Pibrentasvir
6. Contents of the pack and other information
7. Instructions for use

• 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 Glecaprevir/Pibrentasvir to your child if any of the above apply. If you are not sure, talk to your child’s doctor or pharmacist before giving Glecaprevir/Pibrentasvir.

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

• 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 Glecaprevir/Pibrentasvir. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Glecaprevir/Pibrentasvir.

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

• Your child should take Glecaprevir/Pibrentasvir and for how long
• The treatment has worked and your child is free of the hepatitis C virus.

Do not give this medicine to children under 3 years of age or weighing less than 12 kg. The use of Glecaprevir/Pibrentasvir in children under 3 years of age or weighing less than 12 kg has not yet been studied.

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 Glecaprevir/Pibrentasvir, if they are taking any of the medicines in 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 Glecaprevir/Pibrentasvir

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 Glecaprevir/Pibrentasvir.

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

This medicine contains 4 mg propylene glycol in each sachet.

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

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 Glecaprevir/Pibrentasvir tablets.

• Give Glecaprevir/Pibrentasvir 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 Glecaprevir/Pibrentasvir granules through a feeding tube.

If your child is sick (vomits) after taking Glecaprevir/Pibrentasvir it may affect the amount of Glecaprevir/Pibrentasvir in their blood. This may make Glecaprevir/Pibrentasvir work less well.

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

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.

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 Glecaprevir/Pibrentasvir:

• If you notice within 18 hours of the time your child usually takes Glecaprevir/Pibrentasvir, 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 Glecaprevir/Pibrentasvir, wait and give the next dose at the usual time. Do not give a double dose to make up for a forgotten dose.

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 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

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

• 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)

Glecaprevir/Pibrentasvir contains lactose, propylene glycol and sodium. See section 2.

Glecaprevir/Pibrentasvir coated granules are supplied in polyester/aluminium/polyethylene film sachets in cartons. Each carton contains 28 sachets. Each sachet contains pink and yellow granules.

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

Food Amount (approximate)

About 1-2 teaspoons (5-10 mL) of recommended food listed in step 2

For children weighing 45 kg or more, talk to your child’s doctor about giving Glecaprevir/Pibrentasvir tablets.

Do not give more than 5 sachets.

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, Glecaprevir/Pibrentasvir 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 Glecaprevir/Pibrentasvir.

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.

Place the following on a clean surface:

• Box with sachets in it
• Soft food
• Bowl to use for mixing
• Teaspoon
• Scissors

• 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.

• 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.

• 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.

• 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.

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.

• 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.

• 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 Glecaprevir/Pibrentasvir” for further information.

Check to make sure there are enough sachets for your child’s next dose of Glecaprevir/Pibrentasvir.

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