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ZEPATIER 50mg/100mg FILM-COATED TABLETS

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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use ZEPATIER 50mg/100mg FILM-COATED TABLETS

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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.

Marketing Authorization Holder

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

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

BE/LU

MSD Belgium

Tel/Tel: +32(0)27766211

[email protected]

LT

UAB Merck Sharp & Dohme

Tel. +370 5 2780 247

[email protected]

Text in a foreign language with contact information of a Bulgarian pharmaceutical company including phone and email

HU

MSD Pharma Hungary Kft.

Tel.: +36 1 888 5300

[email protected]

CZ

Merck Sharp & Dohme s.r.o.

Tel: +420 233 010 111

[email protected]

MT

Merck Sharp & Dohme Cyprus Limited

Tel: 8007 4433 (+356 99917558)

[email protected]

DK

MSD Danmark ApS

Tlf.: +45 4482 4000

[email protected]

NL

Merck Sharp & Dohme B.V.

Tel: 0800 9999000 (+31 23 5153153)

[email protected]

DE

MSD Sharp & Dohme GmbH

Tel.: +49 (0) 89 20 300 4500

[email protected]

NO

MSD (Norge) AS

Tlf: +47 32 20 73 00

[email protected]

EE

Merck Sharp & Dohme OÜ

Tel: +372 614 4200

[email protected]

AT

Merck Sharp & Dohme Ges.m.b.H.

Tel: +43 (0) 1 26 044

[email protected]

EL

MSD Α.Φ.Ε.Ε.

Τηλ: +30 210 98 97 300

[email protected]

PL

MSD Polska Sp. z o.o.

Tel.: +48 22 549 51 00

[email protected]

ES

Merck Sharp & Dohme de España, S.A.

Tel: +34 91 321 06 00

[email protected]

PT

Merck Sharp & Dohme, Lda

Tel: +351 21 4465700

[email protected]

FR

MSD France

Tél: +33 (0) 1 80 46 40 40

RO

Merck Sharp & Dohme Romania S.R.L.

Tel: +40 21 529 29 00

[email protected]

HR

Merck Sharp & Dohme d.o.o.

Tel: + 385 1 6611 333

[email protected]

SI

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 520 4201

[email protected]

IE

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700

[email protected]

SK

Merck Sharp & Dohme, s. r. o.

Tel: +421 2 58282010

[email protected]

IS

Vistor ehf.

Sími: + 354 535 7000

FI

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650

[email protected]

IT

MSD Italia S.r.l.

Tel: 800 23 99 89 (+39 06 361911)

[email protected]

SE

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

[email protected]

CY

Merck Sharp & Dohme Cyprus Limited

Τηλ.: 800 00 673 (+357 22866700)

[email protected]

LV

SIA Merck Sharp & Dohme Latvija

Tel.: + 371 67025300

[email protected]

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.

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Discuss questions about ZEPATIER 50mg/100mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

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Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.

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Томаш Гжеловський

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

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Frequently Asked Questions

Is a prescription required for ZEPATIER 50mg/100mg FILM-COATED TABLETS?
ZEPATIER 50mg/100mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ZEPATIER 50mg/100mg FILM-COATED TABLETS?
The active ingredient in ZEPATIER 50mg/100mg FILM-COATED TABLETS is elbasvir and grazoprevir. This information helps identify medicines with the same composition but different brand names.
Who manufactures ZEPATIER 50mg/100mg FILM-COATED TABLETS?
ZEPATIER 50mg/100mg FILM-COATED TABLETS is manufactured by Merck Sharp & Dohme B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ZEPATIER 50mg/100mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ZEPATIER 50mg/100mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ZEPATIER 50mg/100mg FILM-COATED TABLETS?
Other medicines with the same active substance (elbasvir and grazoprevir) include EPCLUSA 150 mg/37.5 mg COATED GRANULES IN SACHET, EPCLUSA 200 mg/50 mg COATED GRANULES IN SACHET, EPCLUSA 400 MG/100 MG FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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