INFORMATION ABOUT USING ZEPATIER 50 mg/100 mg Film-Coated Tablets (Elbasvir and Grazoprevir) For distribution to users

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1 INFORMATION ABOUT USING ZEPATIER 50 mg/100 mg Film-Coated Tablets (Elbasvir and Grazoprevir) For distribution to users

3 CONTENTS INTRODUCTION... 5 GENERAL INFORMATION ABOUT HEPATITIS C INFECTION... 6 WHAT IS ZEPATIER AND WHAT IS IT USED FOR?... 8 HOW DOES THE MEDICINE WORK?... 9 WHAT YOU NEED TO KNOW BEFORE TAKING ZEPATIER TAKING ZEPATIER WITH OTHER MEDICINES PREGNANCY, BREASTFEEDING AND FERTILITY OTHER IMPORTANT THINGS TO KNOW BEFORE USING THIS MEDICINE HOW TO TAKE THE MEDICINE AND WHAT YOU SHOULD KNOW HOW TO STORE THE MEDICINE POSSIBLE SIDE EFFECTS HEALTH TIPS GETTING AND GIVING SUPPORT LIFE AFTER TREATMENT NOTES

4 The information in this brochure cannot and is not meant to replace personal information and advice from your doctor. Please read the ZEPATIER package leaflet before starting to take the medicine. 4

5 INTRODUCTION Dear Patient, Your doctor has given you this brochure. You have been diagnosed with a chronic infection with hepatitis C virus genotype 1 or 4. This brochure is a guide to treatment and tells you more about using ZEPATIER. Specifically, this brochure describes how the medicine works and what you should expect during treatment. It also tells you things you should know about the possible side effects of the treatment and provides useful lifestyle tips on dealing with hepatitis C infection. There are blank pages at the end of the brochure which you can use to make your own personal notes about your treatment. Hepatitis C can be cured* and the chances of beating hepatitis are better now than ever before. The main message is: own your treatment! Embrace the challenges. Seize the initiative. Discuss things with your doctor. Take an active part in battling the virus. These are important prerequisites for successful treatment. Another thing to remember: you are not alone. Your doctor is there to answer any questions you may have. We wish you strength, perseverance and the best of luck on the path ahead. Best regards MSD Hepatology Team * Cured means that the hepatitis C virus and its genetic material are no longer detected in the blood 12 weeks after completing treatment. 5

6 GENERAL INFORMATION ABOUT HEPATITIS C INFECTION Hepatitis C infection is a serious liver disease caused by the hepatitis C virus (HCV). The condition can seriously impair the function of the liver as the main organ of detoxification in our bodies. The hepatitis C virus is one of at least five different virus types (hepatitis A, B, C, D and E) that can cause inflammation of the liver (hepatitis) in humans. When hepatitis C viruses enter the blood, they spread throughout the body in the bloodstream. Hepatitis C viruses have a special attraction for certain cells in our bodies, especially the cells in the liver. This is where the virus multiplies and other processes take place that ultimately cause inflammation of the liver (hepatitis) and major changes to liver tissue. Unlike bacteria, viruses are not independent organisms. Like all viruses, the hepatitis C virus needs the cells of a host (a person, in this case) in order to multiply. 6

Infection with hepatitis C virus may be very subtle and often goes unnoticed. The first symptoms often do not occur until the disease is very far advanced and has become chronic.

7 Infection with hepatitis C virus may be very subtle and often goes unnoticed. The first symptoms often do not occur until the disease is very far advanced and has become chronic. There is no vaccine yet to protect against HCV infection. But hepatitis C can be cured* and the chances of beating hepatitis C are better now than ever before. * Cured means that the hepatitis C virus and its genetic material are no longer detected in the blood 12 weeks after completing treatment. 7

8 WHAT IS ZEPATIER AND WHAT IS IT USED FOR? ZEPATIER is an antiviral medicine containing the active substances elbasvir and grazoprevir. It is used to treat chronic hepatitis C in adults aged 18 years and older. What are the aims of treating hepatitis C infection? The main goal of treatment is to cure the hepatitis C infection. You can consider yourself cured if the virus and its genetic material are no longer detected in your blood 12 weeks after completing treatment. Your doctor will test your blood before, during and after treatment with ZEPATIER. This is done for several reasons (see package leaflet), including to check whether you are responding to treatment and no longer have hepatitis C infection. 8

9 HOW DOES THE MEDICINE WORK? Hepatitis C is caused by a virus that affects the liver. The active substances in this medicine (elbasvir and grazoprevir) work together by blocking two proteins that the hepatitis C virus needs to grow and reproduce. This allows the virus to be removed permanently from the body. ZEPATIER is sometimes taken with another medicine that contains an active substance called ribavirin. If you are using ribavirin, it is important that you also read the package leaflet for ribavirin. ZEPATIER ZEPATIER contains two different active substances. The medicine combats the hepatitis C virus by stopping it from multiplying. 9

WHAT YOU NEED TO KNOW BEFORE TAKING ZEPATIER?

Do not take ZEPATIER if you are allergic to elbasvir, grazoprevir or any of the other ingredients of this medicine, as

if you are taking certain medicines that should not be taken with ZEPATIER.

10 WHAT YOU NEED TO KNOW BEFORE TAKING ZEPATIER? Before starting treatment, your doctor will check whether ZEPATIER is suitable for you. Do not take ZEPATIER if you are allergic to elbasvir, grazoprevir or any of the other ingredients of this medicine, as listed in the ZEPATIER package leaflet. if you have moderate or severe liver problems. if you are taking certain medicines that should not be taken with ZEPATIER. For a list of these medicines, please consult the ZEPATIER package leaflet. If you are taking ZEPATIER with ribavirin, please read the Do not take section of the ribavirin package leaflet. If you are unsure about any of the information given in the package leaflet, ask your doctor or pharmacist for advice. 10

Please talk to your doctor or pharmacist before taking the medicine if You have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely

11 Please talk to your doctor or pharmacist before taking the medicine if You have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely in this case. You have ever taken any other medicine for hepatitis C. You have any liver problems other than hepatitis C. You have had a liver transplant. You have any other medical conditions. 11

TAKING ZEPATIER WITH OTHER MEDICINES Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and over-the-counter drugs.

12 TAKING ZEPATIER WITH OTHER MEDICINES Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and over-the-counter drugs. Keep a list of your medicines and show it or your medication plan to your doctor and pharmacist when you get a new medicine. There are some medicines you must not take with ZEPATIER. Please read the ZEPATIER package leaflet carefully for more information. Tell your doctor or pharmacist if you take any of the following medicines: ketoconazole for fungal infections tacrolimus to prevent organ transplant rejection dabigatran to prevent blood clots rosuvastatin, atorvastatin, fluvastatin, simvastatin or lovastatin for lowering blood cholesterol sunitinib to treat certain cancers warfarin and other similar medicines known as vitamin K antagonists that are used to thin the blood. Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot 12

13 Your doctor may have to change your medicines or change the dose of your medicines and review your medication plan. If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine. 13

14 PREGNANCY, BREASTFEEDING AND FERTILITY 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. Breastfeeding If you are breastfeeding, talk to your doctor before taking ZEPATIER. It is not known whether the two active substances in this medicine pass into the breast milk. You must not become pregnant if you are taking ZEPATIER with ribavirin. Ribavirin can be very harmful to an unborn baby. It is very important that both men and women read the ZEPATIER with ribavirin section in the ZEPATIER package leaflet carefully and also the sections on pregnancy and breastfeeding in the ribavirin package leaflet. 14

15 OTHER IMPORTANT THINGS TO KNOW BEFORE USING THIS MEDICINE Driving and operating machinery Do not drive or operate machinery if you feel tired after taking your medicine. ZEPATIER contains lactose and sodium ZEPATIER contains lactose monohydrate. If you are lactose intolerant or if your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine. ZEPATIER contains sodium. If you are on a low sodium diet, talk to your doctor before taking this medicine. 15

if you have any other medical condition.

16 HOW TO TAKE THE MEDICINE AND WHAT YOU SHOULD KNOW Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure, or if you have ever taken any medicines for hepatitis C, or if you have any other medical condition. One tablet once a day The recommended dose is one tablet once a day with or without food (including liquid). Your doctor will tell you how many weeks you should take the medicine for. one tablet, once a day 16

17 And remember: You can take ZEPATIER with or without food (including liquid). Take the film-coated tablets whole. Do not chew, crush or split the tablets. Tell your doctor or pharmacist if you have problems swallowing tablets. 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 do miss a ZEPATIER dose: If it has been less than 16 hours since you should have taken your dose, take the missed dose as soon as possible. Then take your next dose at your usual time. If it has been more than 16 hours since you should have taken your dose, do not take the missed dose. Wait and take your next dose at your usual time. Do not take a double dose (two doses together) to make up for a forgotten dose. It is important not to miss a dose of this medicine (you should also read the tips on page 18!). 17

18 HOW TO TAKE THE MEDICINE AND WHAT YOU SHOULD KNOW (CONTINUED) Important: Help to make a success of your treatment 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: Do not stop taking ZEPATIER unless your doctor tells you to. Make taking your medicine part of your daily routine. Set the alarm on your phone or other electronic devices. Stick this reminder on your refrigerator, medicine cabinet or bathroom mirror: 18

19 HOW TO STORE THE MEDICINE 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 packaging after use by or EXP. The expiry date refers to the last day of the stated month. This medicine does not require any special temperature storage conditions. Store this medicine in the original package until use to protect the contents 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. 19

20 POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. For information about risks and side effects, read the package leaflet and ask your doctor or pharmacist. More information is available at What if I get side effects? If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the ZEPATIER package leaflet. By reporting side effects, you can help to provide more information about the safety of this medicine. 20

21 If you have questions about ZEPATIER, contact our Tel.: Fax:

and as a filter organ for toxins from the blood. Your liver needs protection during and after treatment.

22 HEALTH TIPS Lead a healthy lifestyle Your liver performs a large number of essential tasks for your body. It regulates your fat and sugar metabolism and your mineral and vitamin balance and acts as a storage organ for nutrients and as a filter organ for toxins from the blood. Your liver needs protection during and after treatment. To help your liver to perform these important tasks, you should lead a healthy lifestyle. Remember that every small step you take brings you closer to your goal. 22

Follow a healthy diet that gives your body all the nutrients it needs: carbohydrates (e.g., cereals, vegetables, potatoes, salads and fruit), proteins (e.g., dairy products, fish), fats (less is more, e.

23 Follow a healthy diet that gives your body all the nutrients it needs: carbohydrates (e.g., cereals, vegetables, potatoes, salads and fruit), proteins (e.g., dairy products, fish), fats (less is more, e.g. vegetable oils), vitamins and minerals Drink plenty of fluids. You should drink at least two liters a day (unless you have a buildup of fluid in your abdomen (ascites)). Physical activity is recommended for people with chronic hepatitis. This includes people with compensated liver disease, i.e., patients who do not have advanced cirrhosis. A balanced diet and mild physical activity have positive effects in any liver condition and can improve your wellbeing. Ask your doctor about the right kind of exercise for you and how often you should exercise. Avoid alcohol. Alcohol can damage your liver and cause scarring. 23

24 GETTING AND GIVING SUPPORT You have probably been through a lot of emotional ups and downs since being diagnosed with hepatitis C. Here are some tips that may help you to cope better with certain feelings: Allow yourself to feel your emotions about the disease Surround yourself with people who support you. Connect with a self-help group, go for counseling or talk to a friend or loved one Keep busy and active. It will lift your mood and help you to beat stress Try to recognize and avoid things that get you down certain people, places or events Inform yourself about your disease. Knowing more about your condition can help you to feel better about it Talk to your doctors. They can advise and support you during your treatment 24

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26 GETTING AND GIVING SUPPORT Tell others about your hepatitis C infection The period leading up to your treatment can be a good time to tell the people close to you about your condition. How well your family and friends are informed about your hepatitis C can influence how they treat you. People who do not know how hepatitis C is transmitted may think they could easily catch it from you. Here are a couple of aspects you can mention to them: The damage caused by hepatitis C is very gradual and the symptoms may take decades to become noticeable Hepatitis C is not spread by hugging, kissing or touching hands Hepatitis C can be cured* and the chances of beating hepatitis are better now than ever before * Cured means that the hepatitis C virus and its genetic material are no longer detected in the blood 12 weeks after completing treatment. 26

Build up a support network If you have hepatitis C infection, there is no right or wrong way to deal with your feelings. Some people may decide to cope with the disease on their own.

One person can give you emotional support, while another can follow a diet or exercise plan with you. Think about where your needs lie and who is the best person for the particular role.

27 Build up a support network If you have hepatitis C infection, there is no right or wrong way to deal with your feelings. Some people may decide to cope with the disease on their own. Others may prefer to build up a support network to have people they can turn to. Every member of your support network can meet a specific need or take up a certain role in your life. One person can give you emotional support, while another can follow a diet or exercise plan with you. Think about where your needs lie and who is the best person for the particular role. The members of your support network may be drawn from every area of your life. Start by talking to the people close to you family members, friends, colleagues and neighbors. You can also try to extend your support network beyond this inner circle. 27

28 GETTING AND GIVING SUPPORT Extend your network It can sometimes be helpful to reach out to people outside your immediate support network. It may be an enriching experience to talk to others with hepatitis C infection, hear and share people s hepatitis C stories and experiences, and support others recovering from their own disease. 28

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30 LIFE AFTER TREATMENT Have I been cured of hepatitis C? You have completed your hepatitis C treatment. You will not know if you are cured until your doctor does a blood test after completion of your treatment. You are considered cured if the hepatitis C virus is no longer detected in your blood 12 weeks after you finish treatment. After being cured, can I become reinfected? You should always remember that you can become reinfected with the hepatitis C virus, although the risk of reinfection may be low. Your risk is higher if you inject drugs or are HIV positive. 30

items such as razors, toothbrushes or nail scissors with others Get any tattoos or

31 To protect against reinfection, you should take the following precautions: Do not share needles or blood glucose monitoring devices with others Do not share personal hygiene items such as razors, toothbrushes or nail scissors with others Get any tattoos or piercings from a reputable facility where they use sterile instruments Avoid unprotected sex 31

This means: Maintain a healthy weight If you have diabetes, monitor your blood glucose levels regularly Keep your

32 LIFE AFTER TREATMENT Take care of your liver Now that the hepatitis C virus has been removed from your body, you should make sure your liver stays in good shape. This means: Maintain a healthy weight If you have diabetes, monitor your blood glucose levels regularly Keep your cholesterol and blood lipid levels inside the range recommended by doctors Talk to your doctor about whether you can drink alcohol If your liver is heavily scarred, follow your doctor s recommendations very closely. 32

Let the people around you know that you re cured As soon as you complete your treatment and hear from your doctor that you are cured, you should tell your family and friends.

33 Let the people around you know that you re cured As soon as you complete your treatment and hear from your doctor that you are cured, you should tell your family and friends. There are no right or wrong ways of doing this, but you might want to explain to the people closest to you what cured means in this case. Tell them that you are considered cured if the hepatitis C virus is no longer detected in your blood 12 weeks after you finish treatment. 33

34 WRITE DOWN YOUR QUESTIONS FOR YOUR DOCTOR HERE: 34

36 If you have questions about ZEPATIER, contact our Tel.: Fax: All the individuals pictured in this brochure are fictional patients. INFC /17 MSD SHARP & DOHME GMBH Lindenplatz Haar

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION. ZEPATIER 50 mg of elbasvir and 100 mg of grazoprevir

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION ZEPATIER 50 mg of elbasvir and 100 mg of grazoprevir Read this carefully before you start taking ZEPATIER and each time