ZEPATIER 50mg/100mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

ZEPATIER 50mg/100mg film-coated tablets

elbasvir/grazoprevir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the pack

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. Storage of 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 chronic hepatitis C infection in adults and children aged 12 years and older who weigh at least 30 kilograms.

How ZEPATIER works

Hepatitis C is a virus that infects the liver. The active substances in the medicine work together to block two different proteins that the hepatitis C virus needs to grow and reproduce. This allows the infection to be eliminated from the body.

ZEPATIER is sometimes taken with another medicine, ribavirin.

It is very important that you also read the package leaflets of the other medicines that you will take with ZEPATIER. If you have any questions about your medicines, ask your doctor or pharmacist.

2. What you need to know before you take ZEPATIER

Do not take ZEPATIER

• if you are allergic to elbasvir, grazoprevir or any of the other ingredients of this medicine (listed in section 6)
• if you have 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 organ rejection or to treat severe inflammatory diseases of the eyes, kidneys, joints or skin
  • bosentan for pulmonary arterial hypertension
  • carbamazepine or phenytoin, mainly used for epilepsy and seizures
  • modafinil to help people who cannot stay awake
  • St. John's Wort (Hypericum perforatum, a herbal medicine) for depression or other problems

If you are taking ZEPATIER with ribavirin, make sure you also read the "Do not take" section of the ribavirin package leaflet. If you are not sure about any information that appears in the package leaflet, contact your doctor or pharmacist.

Warnings and precautions

Tell your doctor or pharmacist before you start taking ZEPATIER if you:

• have had a hepatitis B infection in the past, as your doctor may want to monitor you more closely
• have ever taken any medicine for hepatitis C
• have liver problems other than hepatitis C
• have had a liver transplant
• have diabetes. After starting ZEPATIER, you may need close monitoring of your blood glucose levels and/or adjustment of your anti-diabetic medication. After starting treatment with medicines like ZEPATIER, some diabetic patients have experienced low blood sugar levels (hypoglycaemia).
• have any other illness.

Blood tests

Your doctor will perform blood tests before, during and after your treatment with ZEPATIER. This is to:

• decide if you should take ZEPATIER and for how long
• decide which other medicines you should take with ZEPATIER and for how long
• detect side effects
• check if your treatment has worked and you are free of hepatitis C
• check how your liver is working - immediately tell your doctor if you have any of the following signs of liver problems: loss of appetite; feeling sick; feeling tired or weak; yellowing of your skin or eyes; changes in the colour of your stools. If you develop any of these symptoms, your doctor may want to perform a blood test to check your liver function.

Children

ZEPATIER must not be used 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 herbal medicines and medicines obtained without a prescription. Keep a list of your medicines and show it to your doctor and pharmacist when you take a new medicine.

There are some medicines that you must not takewith ZEPATIER. See the list in "Do not take ZEPATIER if you are taking any of the following medicines."

Tell your doctor or pharmacist if you are taking any of the following medicines:

• oral ketoconazole for fungal infections
• tacrolimus to prevent organ rejection
• dabigatran to prevent blood clots
• rosuvastatin, atorvastatin, fluvastatin, simvastatin or lovastatin to lower blood cholesterol
• sunitinib to treat certain types of cancer
• warfarin and other similar medicines called vitamin K antagonists, used to thin the blood. Your doctor may increase the number of blood tests to check how your blood clots.

Your liver function may improve with hepatitis C treatment, and therefore may affect other medicines controlled by the liver. Your doctor may need to closely monitor these other medicines that you are taking and make adjustments during treatment with ZEPATIER.

Your doctor may need to change your medicines or change the dose of your medicines.

If any of the above applies to you (or you are not sure), consult 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 may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

ZEPATIER with ribavirin

• You must not become pregnant if you are taking ZEPATIER with ribavirin. Ribavirin can be very harmful to the unborn baby. This means that you and your partner must take special precautions during sex if there is any chance that you or your partner may become pregnant.
• You or your partner must use an effective method of contraception during treatment with ZEPATIER and ribavirin and for some time after finishing treatment. Ask your doctor about the different types of contraception that are suitable for you.
• If you or your partner become pregnant while taking ZEPATIER with ribavirin or in the months following treatment, immediately tell your doctor.
• It is very important that you carefully read the information about pregnancy and contraception in the package leaflet of ribavirin. It is important that both men and women read this information.

Breast-feeding

Ask your doctor for advice before taking ZEPATIER if you are breast-feeding. It is not known if the active substances in ZEPATIER pass into breast milk.

If you are taking ZEPATIER with ribavirin, make sure you also read the sections on Pregnancy and Breast-feeding in the package leaflet of this other medicine.

Driving and using machines

Do not drive or use machines if you feel tired after taking your medicine.

ZEPATIERcontainslactose

ZEPATIER contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

ZEPATIER contains sodium

This medicine contains 69.85 mg of sodium (a major component of cooking/table salt) in each tablet. This is equivalent to 3.5% of the maximum recommended daily intake of sodium for an adult.

3. How to take ZEPATIER

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Ask your doctor or pharmacist before you take ZEPATIER if you have previously taken any medicine for hepatitis C or if you have any other illness.

How much to take

The recommended dose is one tablet once a daywith or without food.Your doctor will tell you how many weeks you should take ZEPATIER.

Swallow the tablet whole with or without food. Do not chew, crush or break the tablet. Tell your doctor or pharmacist if you have problems swallowing tablets.

If you take more ZEPATIERthan you should

If you take more ZEPATIER than you should, immediately tell your doctor. Take the medicine package with you to show the doctor what you have taken.

If you forget to take ZEPATIER

It is important that you do not miss any dose of this medicine. If you miss a dose, check how long it is since you should have taken ZEPATIER:

• If it has been less than 16 hours since you should have taken your usual dose, take the missed dose 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 your usual dose, do not take the missed dose. Wait and take the next dose at the usual time.
• Do not take a double dose (two doses together) to make up for missed doses.

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 treatment course. This will allow the medicine to treat your hepatitis C infection in the best way possible.

If you have any other questions about 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

• feeling very tired (fatigue)
• headache

Common:may affect up to 1 in 10 people

• nausea
• feeling weak or lacking energy (asthenia)
• itching
• diarrhoea
• difficulty sleeping (insomnia)
• joint pain or painful, swollen joints
• constipation
• feeling dizzy
• loss of appetite
• feeling irritable
• muscle pain
• stomach pain
• uncommon hair loss or thinning
• feeling anxious (anxiety)
• depression
• dry mouth
• vomiting

Uncommon:may affect up to 1 in 100 people

• abnormalities in laboratory tests to check liver function

Reporting of side effects

If you experience 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 listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ZEPATIER

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. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

ZEPATIER Composition

• The active ingredients are:elbasvir and grazoprevir. Each film-coated tablet contains 50 mg of elbasvir and 100 mg of grazoprevir.

• The other components are:

Core of the tablet:

Sodium lauryl sulfate, vitamin E polyethylene glycol succinate, copovidone, hypromellose, microcrystalline cellulose, mannitol (E421), lactose monohydrate, sodium croscarmellose, sodium chloride, anhydrous colloidal silica, magnesium stearate

Film coating:

Lactose monohydrate, hypromellose, titanium dioxide, triacetin, yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172), carnauba wax

Appearance of the Product and Package Contents

The film-coated tablets are beige, oval, engraved with "770" on one side and smooth on the other. The tablet measures 21 mm in length and 10 mm in width.

The tablets are packaged in a box containing two cardboard cards, each with two aluminum blisters of 7 tablets. Each box contains a total of 28 tablets.

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet{MM/YYYY}.

Detailed information on this medication is available on the European Medicines Agency website: https://www.ema.europa.eu.