Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zepatier

Document Subject

Generated Narrative: MedicinalProductDefinition mp684a35c27d00abaf233bd95a3f24554a

identifier: http://ema.europa.eu/identifier/EU/1/16/1119/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: ZEPATIER 50 mg/100 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-684a35c27d00abaf233bd95a3f24554a

identifier: http://ema.europa.eu/identifier/EU/1/16/1119/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - zepatier

Attesters

What is in this leaflet

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. How to store ZEPATIER
6. Contents of the pack and other information

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 long-term 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 by blocking two different proteins that the hepatitis C virus needs to grow and reproduce. This allows the infection to be permanently removed from the body. ZEPATIER is sometimes taken with another medicine, ribavirin. It is very important that you also read the leaflets for the other medicines that you will be taking with ZEPATIER. If you have any questions about your medicines, please ask your doctor or pharmacist.

Do not take ZEPATIER if:

you are allergic to elbasvir, grazoprevir or any of the other ingredients of this medicine (listed in section 6)

you have certain moderate or severe liver problems

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 stop organ transplant rejection or to treat serious inflammatory illnesses of eyes, kidney, 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, please make sure that you read the "Do not take" section of the ribavirin package leaflet. If you are unsure of any information in the package leaflet, please contact your doctor or pharmacist. Warnings and precautions Talk to your doctor or pharmacist before taking ZEPATIER if you:

have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely

have ever taken any medicine for hepatitis C

have any liver problems other than hepatitis C

have had a liver transplant

have diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting ZEPATIER. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like ZEPATIER.

have any other medical conditions. Blood tests Your doctor will test your blood before, during and after your treatment with ZEPATIER. This is so your doctor can:

decide if you should take ZEPATIER and for how long

decide what other medicines you should take with ZEPATIER and for how long

check for side effects

check if your treatment has worked and you are free of hepatitis C

check how your liver is working - tell your doctor straight away if you have any of the following signs of liver problems: loss of appetite; feeling or being sick; feeling tired or weak; yellowing of your skin or eyes; colour changes in your stool. Your doctor may want to test your blood to check how your liver is working if you develop any of these symptoms. Children ZEPATIER is not for use in children younger than 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 get a new medicine. There are some medicines you must not take with ZEPATIER. See list under Do not take ZEPATIER if you are taking any of the following medicines. Tell your doctor or pharmacist if you take any of the following medicines:

oral 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 called vitamin K antagonists 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. Your liver function may improve with treatment of hepatitis C and therefore may affect other medications that are handled by the liver. Your doctor may need to closely monitor these other medicines you are taking and make adjustments during ZEPATIER therapy. Your doctor may have to change your medicines or change the dose of your medicines. If any of the above apply to you (or you are not sure), talk to 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 might 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 damaging to an unborn baby. This means you and your partner must take special precautions in sexual activity if there is any chance you or your partner could become pregnant.

You or your partner must use an effective method of contraception during treatment with ZEPATIER with ribavirin and for some time afterwards. Talk to your doctor about different contraception methods that are suitable for you.

If you or your partner becomes pregnant while taking ZEPATIER with ribavirin or in the months that follow, tell your doctor straight away.

It is very important that you read the information concerning pregnancy and contraception in the ribavirin package leaflet very carefully. It is important that both men and women read the information. Breast-feeding Talk to your doctor before taking ZEPATIER if you are breast-feeding. It is not known whether the two medicines in ZEPATIER pass into human breast milk. If you are taking ZEPATIER with ribavirin, make sure that you also read the Pregnancy and Breast-feeding sections of the package leaflet for this other medicine. Driving and using machines Do not drive or operate machines if you feel tired after taking your medicine. ZEPATIER contains lactose ZEPATIER contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine. ZEPATIER contains sodium This medicine contains 69.85 mg sodium (main component of cooking / table salt) in each tablet. This is equivalent to 3.5% of the recommended maximum daily dietary intake of sodium for an adult.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Talk to your doctor or pharmacist before taking ZEPATIER if you have ever taken any medicines for hepatitis C or if you have any other medical condition. How much to take The recommended dose is one tablet once a day with or without food. Your doctor will tell you how many weeks you should take ZEPATIER for. Swallow the tablet whole with or without food. Do not chew, crush or split the tablet. Tell your doctor or pharmacist if you have problems swallowing tablets. If you take more ZEPATIER than you should 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 forget to take ZEPATIER It is important not to miss a dose of this medicine. If you do miss a dose, work out how long it is since you should have taken ZEPATIER:

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. 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 course of treatment. This will give the medicine the best chance to treat your hepatitis C infection. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

feeling sick (nausea)

feeling weak or lack of energy (asthenia)

itching

diarrhoea

trouble sleeping (insomnia)

joint pain or painful, swollen joints

constipation

feeling dizzy

loss of appetite

feeling irritable

muscle aches

stomach pain

unusual hair loss or thinning

feeling nervous (anxiety)

depression

dry mouth

being sick (vomiting) Uncommon: may affect up to 1 in 100 people

abnormalities in laboratory tests of liver function Reporting of side effects If you get 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.

Keep this medicine out of the sight and reach of children. Do not use the medicine after the expiry date which is stated on the carton and blister packaging after EXP . The expiry date refers to the last day of that month. This medicine does not require any special temperature storage conditions. Store in the original package until use to protect 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.

What ZEPATIER contains

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

The other ingredients are:

Tablet core: Sodium laurilsulfate, vitamin E polyethylene glycol succinate, copovidone, hypromellose, microcrystalline cellulose, mannitol (E421), lactose monohydrate, croscarmellose sodium, sodium chloride, colloidal anhydrous silica, magnesium stearate.

Film-coating: Lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), carnauba wax. What ZEPATIER looks like and contents of the pack The film-coated tablets are beige, oval, debossed with 770 on one side and plain on the other. The tablet is 21 mm long and 10 mm wide. The tablets are packaged into a carton containing two cardboard cards, each cardboard card containing two 7-count aluminium blisters. Each carton contains a total of 28 tablets. Marketing Authorisation Holder Merck Sharp & Dohme B.V. Waarderweg 2031 BN Haarlem The Netherlands Manufacturer Organon Heist bv Industriepark 2220 Heist-op-den-Berg Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: BE/LU MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com LT UAB Merck Sharp & Dohme Tel.: +370 5 278 02 msd_lietuva@merck.com BG

.: +359 2 819 3info-msdbg@merck.com HU MSD Pharma Hungary Kft. Tel.: +361 888 53 hungary_msd@merck.com CZ Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 dpoc_czechslovak@merck.com MT Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com DK MSD Danmark ApS Tlf: +45 4482 4dkmail@merck.com NL Merck Sharp & Dohme B.V. Tel: 0800 99 99 000 (+31 23 5153153) medicalinfo.nl@merck.com DE MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) e-mail@msd.de NO MSD (Norge) AS Tlf: +47 32 20 73 msdnorge@msd.no EE Merck Sharp & Dohme O Tel.: +372 6144 msdeesti@merck.com AT Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 dpoc_austria@merck.com EL MSD . . . . . : + 30 210 98 97 dpoc_greece@merck.com PL MSD Polska Sp.z o.o. Tel.: +48 22 549 51 msdpolska@merck.com ES Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 msd_info@merck.com PT Merck Sharp & Dohme, Lda Tel: +351 21 446 5inform_pt@merck.com FR MSD France T l: + 33 (0) 1 80 46 40 RO Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 msdromania@merck.com HR Merck Sharp & Dohme d.o.o. Tel: + 385 1 66 11 croatia_info@merck.com SI Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204msd_slovenia@merck.com IE Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfo_ireland@merck.com SK Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282dpoc_czechslovak@merck.com IS Vistor hf. S mi: +354 535 7FI MSD Finland Oy Puh/Tel: +358 (0) 9 804 info@msd.fi IT MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) medicalinformation.it@msd.com SE Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700medicinskinfo@merck.com CY Merck Sharp & Dohme Cyprus Limited : 800 00 673 (+357 22866700) cyprus_info@merck.com UK (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfoNI@msd.com LV SIA Merck Sharp & Dohme Latvija Tel: +371 67364 msd_lv@merck.com This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.