Active ingredient
- elbasvir
- grazoprevir
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/1/16/1119/001.
ZEPATIER 50 mg/100 mg film coated tablets
Package leaflet: Information for the user
ZEPATIER® 50 mg/100 mg film-coated tablets
elbasvir/grazoprevir
▼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 ZEPATIER is and what it is used for
2. What you need to know before you take ZEPATIER
3. How to take ZEPATIER
4. Possible side effects
5. How to store ZEPATIER
6. Contents of the pack and other information
1. What ZEPATIER is and what it is used for
What ZEPATIER is
ZEPATIER is an antiviral medicine that contains the active substances elbasvir and grazoprevir.
What ZEPATIER is used for
ZEPATIER is used to treat long-term hepatitis C infection in adults aged 18 years and older.
How ZEPATIER works
Hepatitis C is a virus that infects the liver. The active substances in the medicine work together by blocking two different proteins that the hepatitis C virus needs to grow and reproduce. This allows the infection to be permanently removed from the body.
ZEPATIER is sometimes taken with another medicine, ribavirin.
It is very important that you also read the leaflets for the other medicines that you will be taking with ZEPATIER. If you have any questions about your medicines, please ask your doctor or pharmacist.
2. What you need to know before you take ZEPATIER
Do not take ZEPATIER if:
If you are taking ZEPATIER with ribavirin, please make sure that you read the "Do not take" section of the ribavirin package leaflet. If you are unsure of any information in the package leaflet, please contact your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking ZEPATIER if you:
Blood tests
Your doctor will test your blood before, during and after your treatment with ZEPATIER. This is so your doctor can:
Children and adolescents
ZEPATIER is not for use in children and adolescents under 18 years of age. This is because ZEPATIER has not been tested in this age group.
Other medicines and ZEPATIER
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
There are some medicines you must not take with ZEPATIER. See list under “Do not take ZEPATIER if you are taking any of the following medicines.”
Tell your doctor or pharmacist if you take any of the following medicines:
Your liver function may improve with treatment of hepatitis C and therefore may affect other medications that are handled by the liver. Your doctor may need to closely monitor these other medicines you are taking and make adjustments during ZEPATIER therapy.
Your doctor may have to change your medicines or change the dose of your medicines.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking ZEPATIER.
Pregnancy and contraception
The effects of ZEPATIER in pregnancy are not known. If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
ZEPATIER with ribavirin
Breast-feeding
Talk to your doctor before taking ZEPATIER if you are breast-feeding. It is not known whether the two medicines in ZEPATIER pass into human breast milk.
If you are taking ZEPATIER with ribavirin, make sure that you also read the Pregnancy and Breast-feeding sections of the package leaflet for this other medicine.
Driving and using machines
Do not drive or operate machines if you feel tired after taking your medicine.
ZEPATIER contains lactose
ZEPATIER contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
ZEPATIER contains sodium
This medicine contains 69.85 mg sodium (main component of cooking / table salt) in each tablet. This is equivalent to 3.5% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to take ZEPATIER
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Talk to your doctor or pharmacist before taking ZEPATIER if you have ever taken any medicines for hepatitis C or if you have any other medical condition.
How much to take
The recommended dose is one tablet once a day with or without food. Your doctor will tell you how many weeks you should take ZEPATIER for.
Swallow the tablet whole with or without food. Do not chew, crush or split the tablet. Tell your doctor or pharmacist if you have problems swallowing tablets.
If you take more ZEPATIER than you should
If you take more ZEPATIER than you should, talk to a doctor straight away. Take the medicine pack with you so that you can show the doctor what you have taken.
If you forget to take ZEPATIER
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 taken ZEPATIER:
Do not stop taking ZEPATIER
Do not stop taking this medicine unless your doctor tells you to. It is very important that you complete the full course of treatment. This will give the medicine the best chance to treat your hepatitis C infection.
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. The following side effects may happen with this medicine:
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
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store ZEPATIER
Keep this medicine out of the sight and reach of children.
Do not use the medicine after the expiry date which is stated on the carton and blister packaging after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions.
Store in the original package until use to protect from moisture.
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 to protect the environment.
6. Contents of the pack and other information
What ZEPATIER contains
What ZEPATIER looks like and contents of the pack
The film-coated tablets are beige, oval, debossed with “770” on one side and plain on the other. The tablet is 21 mm long and 10 mm wide.
The tablets are packaged into a carton containing two cardboard cards, each cardboard card containing two 7-count aluminium blisters. Each carton contains a total of 28 tablets.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in May 2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
© Merck Sharp & Dohme Limited, 2020. All rights reserved.
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