InfoCons Consumer Protection informs you – Zepatier – Package Leaflet

Before anything else

Read all of this leaflet car efully before y ou start taking th is medicine b ecause it con tains impor tant inform ati on for you.  Keep t h is leaf let. You may need to read it again.  If you have any f ur ther questions, ask your doctor or ph armacis t.  This medicine has been pres cribe d for you o nly. Do not pas s it on to others.

It may harm them, even if their sign s of illnes s a re the same a s you rs.  If you get any s ide ef f ects, talk to your doctor or p harmaci st. This includes a ny p ossible side ef f ects not lis ted in this leaf let. Se e sec tion 4.

What is i n this l eaflet 1. What ZEPATIER is and what it is used f or 2. What you n eed to know bef o re yo u take ZEPATIER 3. How to take ZEPATIER 4.

Possible side ef f ects 5.

How to store ZEPAT IER 6. Content s of th e pack and other inf ormation

ℹ️ 1. What ZEPATIE R is an d what i t is used for

What ZEPATIER is

ZEPAT IER is an antivira l med icine that contains th e acti

ve substances elbas vir and grazoprevir.

What ZEPATIER is used for ZEPATIER is use d to treat long -term hepa titis C inf ection in adult s and children aged 12 years and older who weigh a t least 30 kilogr ams.

How ZEPA TIER works

Hepa titis C is a v irus that infects the liver. The a c tive substances in the medi cine wo rk toge ther by blocking two dif f erent pro teins that the hepatitis C virus needs to grow and reproduce . This allows the inf ect ion to be perman ently rem oved f rom the body.

ZEPATIER is som etimes taken with ano ther medicine , ribavirin.

It is very imp ortant that yo u also read the leaf lets f or the o ther medicines that you will be t aking wit h ZEPATI ER. If you have any questions abou t your m edicines , please ask your doctor or pharmacist.

⚠️ 2. What you need to knowbefore you ta

ke ZEPATIER Do not take ZEP ATIER if:  you are allergic to elbasvir, grazopre vir or any of the other ingredien ts of this medici ne (listed in section 6)  you have certain moderate or sever e liver problems  you are taking any o f the f ollowing m edicines: o rif ampi cin , usually given f or tuber culosis o HIV pr otease inhibitors such as atazanav ir, darunavir, lopinavir , saquina vir, or t ipranavi r o efaviren z or etravirine f or HIV o elvitegravir/cob icistat/emtricita bine/tenofovir disoprox il f um arate or elvitegravir /cobicistat/e m tricitabine/tenof ovir alafe namide f or HIV 47o ciclosporin to stop organ transpl ant rejection or to treat serious inf lamma tory illnesses of eyes, kidney, joints or skin o bosentan f o r pulmona ry arter ial hypertension o carbam azepin e or phenytoin, mainly used f or ep i lepsy and seizures o modaf ini l to he lp peop le who cannot stay awake o St. John’ s wort ( Hyperi cum perforatum , a herbal med icine) f or depress ion or other problems If you ar e taking ZEPATIER with ri bavirin, please make su re tha t you read the “Do no t take” secti on of the ribavirin package leaf let . If yo u are unsure of any inf ormation in the package l eaf let, please contact your doctor o r pharmaci st.

War nings and precau tions Talk to y our docto r or pha rmacist before taking ZEPATIE R if you:  have a cur rent or previ o us inf ection with the hepat itis B virus, since your doctor may want to moni tor you more c losely  have ever ta ken any m edicine f or hepati tis C  have any liver pro blems ot her than hepatitis C  have had a liver transplant  have diabetes. You may nee d closer moni t oring of your blood glucose levels and/or adjustment of your diabetes medic ation after st arting ZEPATIER. So me diabet ic patie nts have e xperienc ed low sugar lev els in the blood (hypogly caemia) after starting treatmen t with medicines like ZEPAT IER.  have any other medical cond itions.

Blood t ests Y our doctor will test your blood be f ore, during a nd af ter your treat ment with ZEPATIE R. This is so your doctor can:  decide if you shou ld take ZEPATIER and f or how long  decide what other medicines you s hould take wi th ZEPATIER and for how long  check f or sid e ef f ects  check if your treatment has worked an d you are f ree of h epatitis C  check how your l iver is working – tell your doctor strai ght away if you h ave any of the f ollowin g sign s of liver problems: loss of appet i te; f eeling or being sick; f eeling tired or weak; yellowing of your skin or eyes; colo ur changes in your sto ol. Your doctor m ay w ant to test yo ur blood to ch eck how yo ur liver is work ing if yo u deve lop any of these sympto ms.

Children

ZEPATIER is not f or use in child ren younger than 12 years of age.

Othe r medi cines and ZEPATIER Tell your d octor o r pharmaci st if you are taking, have re centl y taken or might t ake any other med icines. This includ es herb al medi cines and medicines o btained withou t a prescription. Keep a list of your medicine s and sh ow it to your doct or and pharm acist whe n you get a new medicine.

There are some medic ines yo u must not take with ZE PAT IER. See list under “Do not take ZEPATIE R if yo u are tak ing any of t he following m edicines.” Tell your d octor or pharmacist if you take any of the follow ing medicine s:  oral ket oconazole f or fungal infections  tacrolim us to prevent organ transplant rejec tion  dabigatran t o prevent blood clo ts  rosuvastati n, atorva statin, f luv astatin, simva statin, or lovastatin, f or lowe ring blood chol esterol  sunitinib to treat certain can cers 48 warfar in and other s imilar med icines called vi tamin K antag onist s used to thin the blood. Your doct or may need to incr ease th e f requ ency of y our blood te sts to check h ow well your blood can clot.

Your liver f unct ion may improve with treat ment of hepa titis C and theref ore may aff ect other medications that a re hand led b y the liver. Your doctor may need t o closely monitor t hese ot her medicines yo u are taking and make adju stments during ZEPATIER therapy.

Your doctor may have to chan ge your me dicines or change the d ose of your me dicines.

If any of the ab ove ap ply to you ( or you are not sur e), talk to your doctor or pharmacis t bef or e takin g ZEPATIE R.

Pregnanc y and contrace ption The ef f ects of ZEPATIER in pr egnancy are not kno wn. If you are pre gnant, thin k you migh t be pregnant or are planning to have a baby, ask your docto r for advice bef or e taki ng this med icine.

ZEPATIER with rib avirin  You must not become p regnant if you are taking ZEPATIER with ribav irin. Ribavirin can be very dam aging to a n unborn ba by. This m ea ns you and you r partner must take specia l precautions in sexual activity if there is any chan ce you or your part ner cou ld beco me pregna nt.  You or your partner m ust use an ef f ective me thod of contraception d uring tr eatment with ZEPAT IER with ri bavirin an d f or some time afterwards. Talk to your d octor about d if f erent contraception methods that are suitable for you.  If you or your partner become s pregnant while tak ing ZEPATIER with ribav irin or in the months t hat f oll ow, tell your doct or straight away.  It i s very importa nt that you read the inf or mation concer ning pregnancy and cont raception in the ribavirin package l eaf let very ca refully. It is import ant that both men and women read the inf ormat ion.

Breast -feeding Talk to your doctor bef ore tak ing ZEPATI ER if you are br east-f eeding. It is not kn own wh ether t he two medicines in ZEPATIER pass into h uman breast milk.

If you are tak ing ZEPAT IER with rib avirin, make s ure that you als o read the Preg nanc y and Breas t-f eedin g sectio ns of the package lea flet f or this other medici ne.

Driving and using mac hines Do not drive or operate machin es if you f eel ti red af ter taking yo ur medi cine.

ZEPATIER contains la ctose

ZEPATIE R contains lactose mono hydrate . If you have been told by your doctor tha t you have an intoler ance to so me sug ars, talk to your doc tor b ef ore taking this medic ine.

ZEPATI ER contains sodiu m

This medicine contains 69.85 mg sodiu m (main compon ent of cooking / table salt) in each table t. This is equival ent to 3.5% of the recomme nded maximum daily di et ary intake of sodium f or an adult .

💊 3. How to take ZEPATI ER

Always t ake th is medicine exact ly as your doctor or pharm acist h as told you. Check with your doctor or pha rmacis t if you are not sure. Talk to yo ur docto r or pha rmacist be f ore taking ZEPATIER if you have ever taken any medicines f or h epatitis C or if y ou ha ve any other medical condition .

49How muc h to take The re commend ed dose is one tabl et once a day with or w ithout f ood. Your doctor will tell you how many weeks y ou should take ZEPATIER f or.

Swallow the tabl et whole wi th or with out food. D o not chew, crush or spl it the tablet. Tell you r doctor or pharmac ist if you hav e problems swallowin g tablets.

If you take more ZEPA TIER than you should

If you take mo re ZEPAT IER than y ou should, talk to a do ctor straight away. Take the medici ne pa ck with you so tha t you can sh ow the docto r what you have take n.

If yo u forge t to ta ke ZEP ATIER It is im portant not to miss a d ose of this medicine. If you do miss a dose, w ork out how long i t is since you should have taken ZEPA TIER:  If it has been less than 16 hours sin ce yo u shoul d have taken your dose, take the missed do se as soon as possible. Then take your next dose at your usual time.  If it has been more than 16 hours since y ou should have taken your dose, d o not take the missed dose. Wait an d tak e your next dose a t you r usual time.  Do not take a d ouble dos e (two dos es toge ther) t o make up f or a f org otten dose.

Do not st op tak ing ZEPATIER Do not stop t aking this med icine un less your doctor tells you to.

It is very impor tant that y ou complet e the f ull course of tr eatme nt. Thi s will give the medicin e the bes t chance to treat your h epatitis C inf ection .

If you have any f ur ther q uestions on the use of thi s medi cine, as k your d octor or p harmacist.

❗ 4. Possi ble side effects

Like all medicines, this medic ine can caus e side ef f ec ts, al though not everyb ody gets them . The f ollowi ng side eff ects may happen with this medic ine:

Tell you r doctor or pharmacist if you notice any of the f ollowing side ef f ects.

Very common: may af f e ct more tha n 1 in 10 peopl e

 f eeling very ti red (f atigue )  headache

Common: may af f ect up to 1 in 10 peo ple

 f eeling sick (nausea)  f eeling weak o r lack o f ener gy (asthenia)  itching  diarrhoea  trouble sleepin g (insomni a)  joint pain or pain f u l, swollen joi nts  consti pation  f eeling dizzy  loss of appe tite  f eeling irritable  muscle aches  stomach pain  unusual ha ir loss or thinning  f eeling nervous (anxie ty)  depression  dry mouth 50 being sick (vom iting) Uncomm on: may af f ect up to 1 in 100 people  abno rmalities in l aboratory t ests of li ver f unctio n Reportin g of side ef fects If you get any si de ef f e cts, talk to your d octor o r pharmacist. This i ncludes any pos sible si de ef f ects not listed in this le aflet. You can also re port side ef f ects directly via th e national rep orting syst em listed in Appendix V. By repor ting s ide effects you c an help p rovide more in f ormatio n on the saf ety of this medicin e.

🌡️ 5. How to s tore ZEPATI ER

Keep t his m edicin e out of the sight and r each o f children.

Do not us e the medicin e af ter the ex piry date which is st ated on the ca rton and bliste r packaging af ter ‘EXP’. T he expiry dat e ref ers to the la st day of that month.

This medicine does not require any special temperature st orage condit ions.

Store in the ori ginal packag e until use to protec t f rom moisture.

Do not throw away any medicin es via wastewater or household w aste. Ask your pha rmac ist how to throw away medic in es you no long er use. The se measure s wil l help to protect the e nvironm ent.

📦 6. Contents of t he pack and other i nformat ion

What ZEPATI ER contains  The act ive su bstances are : elbasvir and grazo previr. Each film-coated table t contains 50 mg elbasvir and mg grazoprevi r.  The oth er ingredi ents are:

Tablet core :

Sodium la urilsu lf ate, vitamin E polyethyl ene glycol succin ate, co povidone, hypromellos e, micro crystalline cellul ose, m annitol (E421), lactose m onohydrate, croscar mellose sodium, sodium chloride , colloidal anhy drous silica, magnesi um st earate .

Film -coating:

Lactos e mono hydrat e, hypromel lose, titanium diox ide, tr iacetin , iron oxide ye llow (E172), iron oxide red (E172 ), iron oxide black (E172) , carnauba wax.

What ZEPAT IER lo oks like and contents of the pack The film-coate d tablets are b eige, oval, deboss ed with “770 ” on o ne side and pla in on the other. The tablet is 21 mm long an d 10 mm wide .

The ta blets ar e packaged into a carton cont aining two ca rdboard cards, ea ch cardbo a rd card containing two 7-count alumin ium blister s. Each ca rton contai ns a total o f 28 tablets .

Marketing Author isation Holder Merck S harp & Dohm e B.V.

Waard erweg 3 9 2031 BN Haar lem The Netherlands Manu facturer Organon Heist bv Industriep ark 30 2220 Heist -op-den-Berg Belgiu m 51For an y inf ormati on ab out this medicine, please cont act th e l ocal repres entative o f the Market ing Authorisation Holde r:

BE/LU MSD Belgium Tél/Tel: +32( 0)27766211 dp oc_belux@merc k.comLT UAB Mer ck Sharp & Dohme Tel.: +370 5 278 02 47 msd_lie tuva@merck. com BG Мерк Шарп и Доум България ЕОО Д Тел.: +359 2 819 3737 info-m sdbg@mer ck.comHU MSD Pharma Hung ary Kf t.

Tel.: +361 888 53 00 hungary [email protected] CZ Merck Sha rp & Dohme s.r.o.

Tel.: +420 233 010 111 [email protected] MT Merck Sharp & Do hme Cypru s Limi ted Tel:

8007 4433 (+35 6 99917558) malt a_inf o@merc k.com DK MSD Danm ark ApS Tlf : + 45 4482 4000 [email protected] omNL Merck S harp & Dohme B.V.

Tel: 0800 9 9 99 000 (+31 23 5153153) medicalinf [email protected] DE MSD S harp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) e-mail@ms d.deNO MSD (Norge) AS Tlf : +4 7 32 20 73 00 msdnorge @msd .no EE Merck Sharp & Dohme OÜ Tel.: +372 6144 200 msdeesti@m erck.comAT Merc k Sharp & Dohme Ges.m.b.H.

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Τηλ: + 30 210 98 97 300 dpoc_greece @me rck.comPL MSD Polska Sp.z o.o.

Tel.: +48 22 549 51 00 msdpolska@merck .com ES Merc k Sharp & Dohme d e España, S.A.

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Tel: + 385 1 66 11 333 croatia_inf [email protected] SI Merck Shar p & Dohme , inova tivna zdravila d.o.o.

Tel: + 386 1 5204201 msd_sl ovenia@merc k.com 52IE Merck Shar p & Dohme Ir eland ( Human Health) Limite d Tel: +353 (0)1 2998700 medinf [email protected] M erck Sharp & Dohme, s. r. o.

Tel.: +421 2 58282010 dpoc_czechslo vak@merck .com IS Vistor hf .

Sími: +354 535 7000 FI MSD Finl and Oy Puh/Tel : +358 (0) 9 804 650 inf [email protected] IT MS D Italia S.r.l.

Tel:

800 23 99 89 ( +39 0 6 361911 ) medicalinf ormati [email protected] Merck Sharp & Dohme (Swe den) AB Tel: + 46 77 5700488 medicinskin f o@mer ck.com CY Merc k Sharp & Dohme Cyprus Limited Τηλ:

800 00 673 ( +357 22866700) cyprus_inf [email protected] UK (Northe rn Ireland ) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: + 353 (0)1 2998700 medinf [email protected] LV SIA Merck Sharp & Dohme Latvija Tel: +371 67364 224 [email protected] This leafl et was last revised in {MM /YYYY}.

Detailed inf ormation on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Zepatier (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1119).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.