Active ingredient
- glecaprevir
- pibrentasvir
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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: EU/1/17/1213/001.
Maviret
Package leaflet: Information for the user
Maviret 100 mg/40 mg film-coated tablets
glecaprevir/pibrentasvir
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Maviret is and what it is used for
2. What you need to know before you take Maviret
3. How to take Maviret
4. Possible side effects
5. How to store Maviret
6. Contents of the pack and other information
1. What Maviret is and what it is used for
Maviret is an antiviral medicine used to treat adults and adolescents (12 to less than 18 years old) with long-term (‘chronic’) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus). It 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 from the body.
2. What you need to know before you take Maviret
Do not take Maviret if:
Do not take Maviret if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Maviret.
Warnings and precautions
Talk to your doctor if you have the following because your doctor may want to check you more closely:
Blood tests
Your doctor will test your blood before, during and after your treatment with Maviret. This is so that your doctor can decide if:
Children
Do not give this medicine to children under 12 years of age. The use of Maviret in children under 12 years of age has not yet been studied.
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 pharmacist before taking Maviret, 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 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 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 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 the use of Maviret in pregnancy is not recommended. Contraceptive medicines that contain ethinylestradiol must not be used in combination with Maviret.
Breast-feeding
Talk to your doctor before taking Maviret if you are breast-feeding. It is not known whether the two medicines in Maviret pass into breast milk.
Driving and using machines
Maviret should not affect your ability to drive or use any tools or machines.
Maviret contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
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 for.
How much to take
The recommended dose for adults and adolescents (12 to <18 years old) is three tablets of Maviret 100mg/40mg taken together, once a day.
Three tablets in one blister is the daily dose.
How to take
If you are sick (vomit) after taking Maviret it may affect the amount of Maviret in your blood. This may make Maviret work less well.
If you take more Maviret than you should
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.
If you forget to take Maviret
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 Maviret:
If you have any further questions on the use of this medicine, 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
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
swelling of the face, lips, tongue, throat, abdomen, arms or legs
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 (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
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 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.
6. Contents of the pack and other information
What Maviret contains
What Maviret looks like and contents of the pack
Maviret 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’.
Maviret tablets are packed into foil blisters, each containing 3 tablets. Maviret is available in a pack of 84 tablets as 4 cartons, each containing 21 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 04/2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://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.
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, UK
+44 (0)1628 561 092
+44 (0)1628 561 092