Label: information for the user

ZEPATIER 50mg/100mg film-coated tablets

elbasvir/grazoprevir

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

1.What ZEPATIER is and for what it is used

2. What you need to know before starting to take ZEPATIER

3. How to take ZEPATIER

4. Possible adverse effects

5. Storage of ZEPATIER

6. Contents of the package and additional information

What is ZEPATIER

ZEPATIER is an antiviral medication that contains the active ingredients elbasvir and grazoprevir.

What is ZEPATIER 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 ingredients in the medication act in combination to block two different proteins that the hepatitis C virus needs to grow and reproduce. This allows the infection to be eliminated definitively from the body.

ZEPATIER is sometimes taken with another medication, ribavirin.

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

Do not take ZEPATIER

• if you are allergic to elbasvir, grazoprevir, or any of the other ingredients in this medication (listed in section6)
• if you have moderate to severe liver problems
• if you are taking any of the following medications:
• • rifampicin, usually administered for tuberculosis
  • protease inhibitors for HIV such as atazanavir, darunavir, lopinavir, saquinavir, or tipranavir
  • efavirenz or etravirina for HIV
  • elvitegravir/cobicistat/emtricitabina/tenofovir disoproxil fumarato or elvitegravir/cobicistat/emtricitabina/tenofovir alafenamida for HIVfor HIV
  • ciclosporina to prevent organ transplant rejection or to treat severe inflammatory eye, kidney, joint, or skin diseases
  • bosentan for pulmonary arterial hypertension
  • carbamazepina or phenitoína, mainly used for epilepsy and seizures
  • modafinilo to help people who cannot stay awake
  • St. John's Wort (Hypericum perforatum,a medicinal herb) for depression or other conditions

If you are taking ZEPATIER with ribavirina, make sure to read the "Do not take" section of the ribavirina prospectus. If you are unsure about any information in the prospectus, contact your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting ZEPATIER if you:

• have or have had a hepatitis B virus infection, as your doctor may want to monitor you more closely
• have taken any medication for hepatitis C
• have liver problems other than hepatitis C
• have had a liver transplant
• have diabetes. After starting ZEPATIER, you may need to have your blood glucose levels closely monitored and/or adjust your diabetes medication. Some diabetic patients have experienced low blood sugar (hypoglycemia) after starting treatment with medications like ZEPATIER.
• have any other disease.

Blood tests

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

• determine if you should take ZEPATIER and for how long
• determine which other medications you should take with ZEPATIER and for how long
• detect any adverse effects
• check if your treatment has been effective and you are free of hepatitis C
• check how your liver is functioning - inform your doctor immediately if you experience 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 your stool color. If you develop any of these symptoms, your doctor may want to perform a blood test to check your liver function.

Children

ZEPATIER should not be used in children under 12 years of age.

Other medications and ZEPATIER

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This includes medicinal herbs and medications obtained without a prescription. Keep a list of your medications and show it to your doctor and pharmacist when you start a new medication.

There are some medications thatyou should not takewith ZEPATIER. See the list in "Do not take ZEPATIER if you are taking any of the following medications."

Inform your doctor or pharmacist if you are taking any of the following medications:

• ketoconazol oral for fungal infections
• tacrolimus to prevent organ transplant rejection
• dabigatran to prevent blood clots
• rosuvastatina, atorvastatina, fluvastatina, simvastatina, or lovastatina to reduce blood cholesterol
• sunitinib to treat certain types of cancer
• warfarina and other medications similar to 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 treatment for hepatitis C, and therefore, may affect other medications controlled by the liver. Your doctor may need to closely monitor these other medications you are taking and make adjustments during treatment with ZEPATIER.

Your doctor may need to change your medications or adjust the dosage of your medications.

If any of the above information affects you (or you are unsure), consult your doctor or pharmacist before taking ZEPATIER.

Pregnancy and contraception

The effects of ZEPATIER on pregnancy are unknown. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

ZEPATIER with ribavirina

• You should not become pregnant while taking ZEPATIER with ribavirina. Ribavirina can be very harmful to the fetus. This means that you and your partner must take special precautions during sexual intercourse if there is any possibility that you or your partner may become pregnant.
• You and your partner must use an effective contraceptive method during ZEPATIER treatment with ribavirina and for some time after completing treatment. Consult your doctor about the different contraceptive methods that are suitable for you.
• If you or your partner become pregnant while taking ZEPATIER with ribavirina or in the months following treatment, inform your doctor immediately.
• It is very important that you read the information on pregnancy and contraception in the ribavirina prospectus carefully. It is essential that both men and women read this information.

Breastfeeding

Consult your doctor before taking ZEPATIERif you are breastfeeding. It is unknown whether the two medications in ZEPATIERpass into breast milk.

If you are taking ZEPATIER with ribavirina, make sure to also read the sections on Pregnancy and Breastfeeding in the ribavirina prospectus.

Driving and operating machinery

Do not drive or operate machinery if you feel tired after taking your medication.

ZEPATIER contains lactose

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

ZEPATIER contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Consult your doctor or pharmacist before taking ZEPATIER if you have previously taken any medication for hepatitis C or if you have any other disease.

How much to take

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

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

If you take more ZEPATIERthan you should

If you take more ZEPATIER than you should, inform your doctor immediately. Bring the medication packaging with you so your doctor can see what you have taken.

If you forget to take ZEPATIER

It is essential not to forget to take any dose of this medication. If you miss a dose, check how long it has been since you should have taken ZEPATIER:

• If less than 16hours have passed since the time 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 more than 16hours have passed since the time 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 the missed doses.

Do not interrupt treatment with ZEPATIER

Do not interrupt treatment with this medication unless your doctor tells you to. It is very important that you complete the entire treatment cycle. This will allow the medication to treat your hepatitis C infection as effectively as possible.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them. With this medication, the following adverse effects may appear:

Inform your doctor or pharmacist if you notice any of the following adverse effects.

Very Frequent:may affect more than 1 in 10people

• feeling extremely tired (fatigue)
• headache

Frequent:may affect up to 1 in 10people

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

Rare:may affect up to 1 in 100people

• abnormalities in laboratory tests to check liver function

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist,even if it is a possible adverse effectthat does not appear in this prospectus. You can also report them directly through theAppendixV. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on thecontainer and the blister pack afterEXP. The expiration date is the last day of the month indicated.

This medication does not require special temperature conditions for its conservation.

Store in the original container until use to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need.This will help protect the environment.

Composition of ZEPATIER

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

• The other components are:

Core tablet:

Lauril sodium sulfate, vitamin E polyethylene glycol succinate, copovidone, hypromellose, microcrystalline cellulose, mannitol (E421), lactose monohydrate, croscarmellose sodium, 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 contents of the pack

The film-coated tablets are beige, oval-shaped, engraved with the inscription “770” on one face and smooth on the other. The tablet measures 21mm in length and 10mm in width.

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

For further information about this medicinal product, please consult the representative of the marketing authorization holder in your country:

Last update date of this leaflet{MM/AAAA}.

For detailed information about this medicinal product, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.