Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - prevymis

Document Subject

Generated Narrative: MedicinalProductDefinition mpd4e8178d3a905eabdd581f1645891fb4

identifier: http://ema.europa.eu/identifier/EU/1/17/1245/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: PREVYMIS 240 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-d4e8178d3a905eabdd581f1645891fb4

identifier: http://ema.europa.eu/identifier/EU/1/17/1245/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - prevymis

Attesters

What is in this leaflet

1. What PREVYMIS is and what it is used for
2. What you need to know before you take PREVYMIS
3. How to take PREVYMIS
4. Possible side effects
5. How to store PREVYMIS
6. Contents of the pack and other information

PREVYMIS is an antiviral prescription medicine that contains the active substance letermovir. PREVYMIS is a medicine for adults who have recently had a stem cell (bone marrow) transplant or a kidney transplant. The medicine helps stop you from getting ill from CMV ( cytomegalovirus ). CMV is a virus. For most people, CMV does not hurt them. However, if your immune system is weak after you get a stem cell transplant or a kidney transplant, you may be at high risk of becoming ill from CMV.

Do not take PREVYMIS if:

• you are allergic to letermovir or any of the other ingredients of this medicine (listed in section 6).
• you take either of these medicines:* pimozide - used for Tourette s syndrome* ergot alkaloids (such as ergotamine and dihydroergotamine) - used for migraine headaches.
• you take the following herbal product:* St. John s wort (Hypericum perforatum) Do not take PREVYMIS if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before taking PREVYMIS. If you are taking PREVYMIS with cyclosporine, do not take the following medicines:* dabigatran - used for blood clots* atorvastatin, simvastatin, rosuvastatin, pitavastatin for high cholesterol Warnings and precautions If you are also taking a medicine for high cholesterol (see list of medicines in section Other medicines and PREVYMIS below) you must tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever. Your medicine or dose may then need to be changed. See the package leaflet for your other medicine for further information. Additional blood tests may be needed to monitor the following medicines:
• Cyclosporine, tacrolimus, sirolimus
• Voriconazole Children and adolescents PREVYMIS is not for use in children and adolescents under 18 years old. This is because PREVYMIS has not been tested in this age group. Other medicines and PREVYMIS Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because PREVYMIS may affect the way other medicines work, and other medicines may affect how PREVYMIS works. Your doctor or pharmacist will tell you if it is safe to take PREVYMIS with other medicines. There are some medicines you must not take with PREVYMIS (see list under Do not take PREVYMIS if: ). There are some additional medicines you must not take with PREVYMIS and cyclosporine (see list under If you are taking PREVYMIS with cyclosporine, do not take the following medicines: ). Also tell your doctor if you are taking any of the following medicines. This is because your doctor may have to change your medicines or change the dose of your medicines:
• alfentanil - for severe pain
• fentanyl - for severe pain
• quinidine - for abnormal heart rhythms
• cyclosporine, tacrolimus, sirolimus - used to prevent transplant rejection
• voriconazole - for fungal infections
• statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin - for high cholesterol
• glyburide, repaglinide - for high blood sugar
• carbamazepine, phenobarbital, phenytoin - for fits or seizures
• dabigatran, warfarin - used to thin the blood or for blood clots
• midazolam used as a sedative
• amiodarone - used to correct irregular heartbeats
• oral contraceptive steroids-for birth control
• omeprazole, pantoprazole for stomach ulcers and other stomach problems
• nafcillin - for bacterial infections
• rifabutin, rifampicin - for mycobacterial infections
• thioridazine - for psychiatric disorders
• bosentan - for high blood pressure in the vessels in the lungs
• efavirenz, etravirine, nevirapine, lopinavir, ritonavir - for HIV
• modafinil - for wakefulness You can ask your doctor or pharmacist for a list of medicines that may interact with PREVYMIS. Pregnancy 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. PREVYMIS is not recommended in pregnancy. This is because it has not been studied in pregnancy and it is not known if PREVYMIS will harm your baby while you are pregnant. Breast-feeding If you are breast-feeding or are planning to breast-feed, tell your doctor before taking this medicine. Breast-feeding is not recommended while taking PREVYMIS. This is because it is not known if PREVYMIS gets in your breast milk and will be passed to your baby. Driving and using machines PREVYMIS may have minor influence on your ability to drive and use machines (see section 4. Possible side effects below). Some patients have reported fatigue (feeling very tired) or vertigo (feeling like you are spinning) during treatment with PREVYMIS. If you experience any of these effects, do not drive or use machines until the effect wears off. PREVYMIS contains lactose PREVYMIS contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. PREVYMIS contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that isto say essentially sodium- free .

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much to take The recommended dose of PREVYMIS is one 480 mg tablet once a day. If you also take cyclosporine, your doctor will decrease the dose of PREVYMIS to one 240 mg tablet once a day.

• Take PREVYMIS at the same time every day.
• Take it with or without food. How to take
• Swallow the tablet whole with some water. Do not break, crush, or chew the tablet. If you take more PREVYMIS than you should If you take more PREVYMIS than you should, call your doctor straight away. If you forget to take PREVYMIS It is very important that you do not miss or skip doses of PREVYMIS.
• If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Take your next dose at the usual time.
• Do not take two doses of PREVYMIS at the same time to make up for a missed dose.
• If you are not sure what to do, call your doctor or pharmacist. Do not stop taking PREVYMIS Do not stop taking PREVYMIS without talking to your doctor first. Do not run out of PREVYMIS. This will give the medicine the best chance to keep you from becoming ill from CMV after you get a stem cell transplant or a kidney transplant.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Common: may affect up to 1 in 10 people

• diarrhoea
• feeling sick (nausea)
• being sick (vomiting) Uncommon: may affect up to 1 in 100 people
• allergic reaction (hypersensitivity) the signs may include wheezing, difficulty breathing, rashes or hives, itchiness, swelling
• loss of appetite
• changes in taste
• headache
• feeling like you are spinning (vertigo)
• stomach ache
• abnormalities in laboratory tests of liver function (i.e. raised levels of liver enzymes)
• muscle spasms
• high blood creatinine - shown in blood tests
• feeling very tired (fatigue)
• swelling of hands or feet Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. 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 this medicine after the expiry date which is stated on the carton and blister card 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 in order 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 PREVYMIS contains The active substance is letermovir. Each film-coated tablet contains 240 mg letermovir or 480 mg letermovir. The other ingredients are: Tablet core Microcrystalline cellulose (E460), croscarmellose sodium (E468), povidone (E1201), colloidal anhydrous silica (E551), magnesium stearate (E470b). Film-coating Lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), iron oxide yellow (E172), iron oxide red (only for 480 mg tablets) (E172), carnauba wax (E903). See section 2 PREVYMIS contains lactose and PREVYMIS contains sodium . What PREVYMIS looks like and contents of the pack PREVYMIS 240 mg film-coated tablet ( tablet ) is a yellow oval tablet, debossed with 591 on one side and corporate logo on the other side. The tablet is 16.5 mm long and 8.5 mm wide. PREVYMIS 480 mg film-coated tablet ( tablet ) is a pink oval, bi-convex tablet, debossed with 595 on one side and corporate logo on the other side. The tablet is 21.2 mm long and 10.3 mm wide. The 28x1 tablets are packaged into a carton containing Polyamide/Aluminium/PVC Aluminium perforated unit dose blister cards (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 Merck Sharp & Dohme B.V. Waarderweg 2031 BN Haarlem The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com Lietuva UAB Merck Sharp & Dohme Tel. + 370 5 278 02 msd_lietuva@merck.com

.: +359 2 819 3info-msdbg@merck.com Luxembourg/Luxemburg MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com esk republika Merck Sharp & Dohme s.r.o. Tel: +420 233 010 dpoc_czechslovak@merck.com Magyarorsz g MSD Pharma Hungary Kft. Tel.: +36 1 888 5hungary_msd@merck.com Danmark MSD Danmark ApS Tlf: + 45 4482 4dkmail@merck.com Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) e-mail@msd.de Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com Eesti Merck Sharp & Dohme O Tel.: +372 6144 msdeesti@merck.com Norge MSD (Norge) AS Tlf: +47 32 20 73 msdnorge@msd.no

MSD . . . . . : +30 210 98 97 dpoc_greece@merck.com sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 dpoc_austria@merck.com Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 msd_info@merck.com Polska MSD Polska Sp. z o.o. Tel: +48 22 549 51 msdpolska@merck.com France MSD France T l: + 33 (0) 1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465inform_pt@merck.com Hrvatska: Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 croatia_info@merck.com
Rom nia Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 msdromania@merck.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfo_ireland@msd.com Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 msd.slovenia@merck.com sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282dpoc_czechslovak@merck.com Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) medicalinformation.it@msd.com Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 info@msd.fi

Merck Sharp & Dohme Cyprus Limited .: 800 00 673 (+357 22866700) cyprus_info@merck.com Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700medicinskinfo@merck.com Latvija SIA Merck Sharp & Dohme Latvija Tel: + 371 67364msd_lv@merck.com United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfoNI@msd.com This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .

Package leaflet: Information for the patient PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion letermovir Read all of this leaflet carefully before you are given 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, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.