The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 41042/0030.
Glecaprevir/Pibrentasvir 100 mg/40 mg film-coated tablets
Glecaprevir/Pibrentasvir 100 mg/40 mg film-coated tablets
1. What Glecaprevir/Pibrentasvir is and what it is used for
2. What you need to know before you take 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
Glecaprevir/Pibrentasvir is an antiviral medicine used to treat adults and children 3 years and older with long-term (‘chronic’) hepatitis C. This is an infectious disease that affects the liver, caused by the hepatitis C virus. Glecaprevir/Pibrentasvir contains the active substances glecaprevir and pibrentasvir.
Glecaprevir/Pibrentasvir works by stopping the hepatitis C virus from multiplying and infecting new cells. This allows the infection to be eliminated from the body.
Do not take Glecaprevir/Pibrentasvir if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Glecaprevir/Pibrentasvir .
Talk to your doctor if you have the following because your doctor may want to check you more closely:
Your doctor will test your blood before, during and after your treatment with Glecaprevir/Pibrentasvir . This is so that your doctor can decide if:
Do not give this medicine to children under 3 years of age or weighing less than 12kg. The use of Glecaprevir/Pibrentasvir in children under 3 years of age or weighing less than 12kg has not yet been studied.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist before taking Glecaprevir/Pibrentasvir , if you are taking any of the medicines in the table below. The doctor may need to change your dose of these medicines.
Medicines you must tell your doctor about before taking 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 doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Glecaprevir/Pibrentasvir .
The effects of Glecaprevir/Pibrentasvir 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 the use of Glecaprevir/Pibrentasvir in pregnancy is not recommended. Contraceptive medicines that contain ethinylestradiol must not be used in combination with Glecaprevir/Pibrentasvir .
Talk to your doctor before taking Glecaprevir/Pibrentasvir if you are breast-feeding. It is not known whether the two medicines in Glecaprevir/Pibrentasvir pass into breast milk.
Glecaprevir/Pibrentasvir should not affect your ability to drive or use any tools or machines.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
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 Glecaprevir/Pibrentasvir for. Glecaprevir/Pibrentasvir tablets are intended for adults, children 12 years and older, or children weighing 45kg or more. Glecaprevir/Pibrentasvir coated granules are intended for children aged 3 years to less than 12 years and weighing 12kg to less than 45kg.
The recommended dose for adults, children aged 12 years and older, or children weighing at least 45kg is three tablets of Glecaprevir/Pibrentasvir 100mg/40mg taken together, once a day.
Three tablets in one blister is the daily dose.
If you are sick (vomit) after taking Glecaprevir/Pibrentasvir it may affect the amount of Glecaprevir/Pibrentasvir in your blood. This may make Glecaprevir/Pibrentasvir work less well.
If you accidentally take more than the recommended dose, contact your doctor or go to the nearest hospital straight away. Take the medicine pack with you so that you can show the doctor what you have taken.
It is important not to miss a dose of this medicine.
If you do miss a dose, work out how long it is since you should have last taken Glecaprevir/Pibrentasvir:
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Not known: cannot be estimated from the available data
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
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 blister after ‘EXP’.
This medicine does not require any special storage.
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.
Glecaprevir/Pibrentasvir tablets are pink, oblong, curved on both sides (biconvex), film-coated tablets with dimensions of 18.8 mm x 10.0 mm and debossed on one side with ‘NXT’.
Glecaprevir/Pibrentasvir tablets are packed into foil blisters, each containing 3 tablets. Glecaprevir/Pibrentasvir is available in a pack of 84 tablets as 4 cartons, each containing 21 film-coated tablets.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 02/2023
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.