50 mg/100 mg film-coated tablets
elbasvir/grazoprevir
What ZEPATIER is and what it is used for
What ZEPATIER is
ZEPATIER is a medicine for the treatment of a viral infection 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 and children aged 12 years and over who weigh at least 30 kg.
How ZEPATIER works
Hepatitis C is a virus that infects the liver. The active substances in the medicine work together by blocking two important proteins that the hepatitis C virus needs to grow and multiply. In this way, the infection can be permanently removed from the body.
ZEPATIER is sometimes taken together with another medicine, ribavirin.
It is very important that you also read the package leaflet for the other medicines that you take with ZEPATIER. If you have questions about your medicines, contact your doctor or pharmacist.
What you need to know before you take ZEPATIER
Do not take ZEPATIER:
- if you are allergic to elbasvir or grazoprevir or any of the other ingredients of this medicine (listed in section 6)
- if you have certain moderate or severe liver problems
- if you are taking any of the following medicines:
- rifampicin, usually given for tuberculosis
- HIV – protease inhibitors such as atazanavir, darunavir, lopinavir, saquinavir, or tipranavir
- efavirenz or etravirine for HIV
- elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for HIV
- ciclosporin to prevent rejection of organ transplants or to treat severe inflammatory diseases of the eyes, kidney, joints, or skin
- bosentan for pulmonary arterial hypertension (lung disease)
- carbamazepine or phenytoin, mainly used for epileptic seizures
- modafinil to keep you awake
- St. John’s wort ( Hypericum perforatum, a (traditional) herbal medicine) for mild depression or mild anxiety
If you take ZEPATIER together with ribavirin, be sure to read the “Do not take” section of the ribavirin package insert. If you are unsure about any information in the leaflet, contact your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking ZEPATIER:
- if you have or have previously had an infection with the hepatitis B virus, the doctor may then want to monitor you more closely
- if you have ever taken any medicine for hepatitis C
- if you have any liver problems other than hepatitis C
- if you have had a liver transplant
- if you have diabetes. Your blood sugar levels may need to be monitored more closely and/or your diabetes medications may need to be adjusted after you start taking ZEPATIER. In some diabetic patients, blood sugar levels have fallen (hypoglycemia) after treatment with medicines such as ZEPATIER has been started.
- if you have any other health problems.
Blood samples
The doctor will check your blood before, during, and after your treatment with ZEPATIER. The doctor does this to be able to:
- decide whether to take ZEPATIER and for how long
- decide which other medicines to take with ZEPATIER and for how long
- check side effects ar
- check if the treatment has been effective and you are free of hepatitis C
- check how your liver is working – tell your doctor immediately if you get any of the following signs of liver problems: loss of appetite, nausea or vomiting, tiredness or weakness, yellowing of the skin or the whites of the eyes, or change in the color of the stool. If you develop any of these problems, your doctor may want to do blood tests to check how your liver is working.
Children
ZEPATIER is not intended for use in children under 12 years of age.
Other medicines and ZEPATIER
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes (traditional) herbal and herbal medicines as well as over-the-counter medicines. Make a list of your medicines and show it to the doctor or pharmacist when you get a new medicine.
There are certain medicines that you must not take with ZEPATIER. See the list under “Do not take ZEPATIER if you are taking any of the following medicines”.
Inform the doctor or pharmacist if you are taking any of the following medicines:
- ketoconazole tablets for fungal infections
- tacrolimus to prevent rejection of organ transplants
- dabigatran to prevent blood clots
- rosuvastatin, atorvastatin, fluvastatin, simvastatin, or lovastatin to lower blood cholesterol levels
- sunitinib to treat certain cancers
- warfarin and other similar medicines called vitamin K antagonists to thin the blood. Your doctor may need to test your blood more often to check your blood’s clotting ability.
Your liver function may improve during hepatitis C treatment and may then affect other medicines that are broken down by the liver. Your doctor may therefore need to check other medicines you are taking and make changes during treatment with ZEPATIER.
The doctor may need to change your medication or the dose of one of your medicines.
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking ZEPATIER.
Pregnancy and contraception
It is not known how ZEPATIER can affect a pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
ZEPATIER with ribavirin
- You must not become pregnant if you take ZEPATIER with ribavirin. Ribavirin can be very harmful to the fetus. This means that you and your partner must take special precautions during intercourse if it is possible that you or your partner could become pregnant.
- You or your partner must use an effective method of contraception during treatment with ZEPATIER together with ribavirin and for some time after treatment has stopped. Talk to your doctor about different birth control methods that are right for you.
- If you or your partner become pregnant during treatment with ZEPATIER in combination with ribavirin or the following months, tell the doctor immediately.
- You must read the information about pregnancy and contraceptive methods in the package insert for ribavirin very carefully. Both men and women must read the information.
Breast-feeding
Talk to your doctor before taking ZEPATIER if you are breastfeeding. It is not known whether the two drugs in ZEPATIER pass into breast milk.
If you are taking ZEPATIER together with ribavirin, be sure to read the “Pregnancy and breastfeeding” section of the leaflet for this medicine.
Driving ability and use of machinery
Do not drive a car or other vehicle or use machinery if you feel tired after taking the medicine.
ZEPATIER contains lactose
ZEPATIER contains lactose monohydrate. If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
ZEPATIER contains sodium
This medicine contains 69.85 mg of sodium (the main ingredient in common/table salt) per tablet. This corresponds to 3.5% of the maximum recommended daily intake of sodium for adults.
How to take ZEPATIER
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure. Talk to your doctor or pharmacist before taking ZEPATIER if you have ever taken any medicine for hepatitis C or if you have any other health problems.
How much to take
The recommended dose is one tablet once daily with or without food. The doctor will tell you how many weeks you will take ZEPATIER.
Swallow the tablet whole with or without food. The tablet must not be chewed, crushed, or split. Tell your doctor or pharmacist if you have trouble swallowing tablets.
If you take too much ZEPATIER
Contact your doctor immediately if you have taken too much ZEPATIER. Bring the medicine package with you so you can show what you have taken.
If you forget to take ZEPATIER
You mustn’t miss a dose of this medicine. If you forget a dose, calculate how much time has passed since you should have taken ZEPATIER:
- If it has been less than 16 hours since you should have taken dose one, take the missed dose one as soon as possible. Then take the next dose at the usual time.
- If it has been more than 16 hours since you should have taken dose one, do not take the missed dose one. Wait and take the next dose at the usual time.
- Do not take a double dose (two doses at the same time) to compensate for a missed dose.
Do not stop taking ZEPATIER
Do not stop taking this medicine unless your doctor tells you to. You must complete the entire treatment. This gives the medicine the best conditions to treat your hepatitis C infection.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur when using 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 users
- feeling tired (fatigue)
- headache.
Common: may affect up to 1 in 10 users
- nausea
- weakness or lack of energy ( asthenia )
- itching
- diarrhea
- difficulty sleeping (insomnia)
- joint pain or aching, swollen joints
- constipation
- dizziness
- loss of appetite
- irritability
- muscle pain
- stomach ache
- abnormal hair loss or thinning of the hair
- nervousness (anxiety)
- Depression
- dry mouth
- vomiting.
Uncommon: may affect up to 1 in 100 users
- abnormal response to liver function tests
How to store ZEPATIER
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister pack after EXP.
The expiration date is the last day of the specified month.
No special temperature instructions.
Store in the original packaging. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are elbasvir and grazoprevir. One film-coated tablet contains 50 mg elbasvir and 100 mg grazoprevir.
- Other ingredients are
Tablet core:
Sodium lauryl sulfate, vitamin E polyethylene glycol succinate, crospovidone, hypromellose, microcrystalline cellulose, mannitol (E421), lactose monohydrate, croscarmellose sodium, sodium chloride, colloidal anhydrous silicon dioxide, magnesium stearate.
Film coating:
Lactose monohydrate, hypromellose, titanium dioxide, triacetin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), carnauba wax.
Appearance and package sizes of the medicine
The film-coated tablets are beige, oval, and debossed with “770” on one side and plain on the other. The tablets are 21 mm long and 10 mm wide.
The tablets are packed in an outer carton containing two folding packs, where each folding pack contains 2 x 7 aluminum blister cards. Each box contains a total of 28 tablets.
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