Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lyfnua

Document Subject

Generated Narrative: MedicinalProductDefinition mpd5d0f8dae3251797998b53d83d0b35fa

identifier: http://ema.europa.eu/identifier/EU/1/21/1613/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Lyfnua 45 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-d5d0f8dae3251797998b53d83d0b35fa

identifier: http://ema.europa.eu/identifier/EU/1/21/1613/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - lyfnua

Attesters

What is in this leaflet

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

Lyfnua contains the active substance gefapixant. Lyfnua is a medicine used in adults for chronic cough (cough that lasts longer than 8 weeks) and:

• the cough does not go away even after using other medicines or
• the reason for the cough is unknown. The active substance in Lyfnua, gefapixant, blocks the action of nerves that trigger abnormal coughing.

Do not take Lyfnua

• if you are allergic to gefapixant or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before and while taking Lyfnua if you:

• are allergic to medicines containing sulphonamide

• have sleep apnoea where your breathing stops and starts while you sleep

• develop an acute infection of the lung / lower respiratory system (e.g., pneumonia or bronchitis)

• experience change in how things taste, loss of taste, or being less able to taste, that continues even after you stop taking Lyfnua Children and adolescents Do not give this medicine to children and adolescents below the age of 18 years. This is because it has not been studied in this age group. Other medicines and Lyfnua Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding It is not known if Lyfnua can harm your unborn baby. Therefore, it is better to avoid use of Lyfnua if you are pregnant. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Animal studies have shown that Lyfnua may pass into breast milk. A risk for your baby cannot be excluded. You and your doctor should decide together if you will take Lyfnua or breastfeed. Driving and using machines You may feel dizzy after taking Lyfnua. If this happens, do not drive or use tools or machines until you no longer feel dizzy. Lyfnua contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to 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 Lyfnua is:

• one 45 mg tablet twice every day. Adults with kidney problems Your doctor may change how much and how often you take Lyfnua if:

• you have severe kidney failure and are not on dialysis. How to take Swallow the tablet whole. Do not break, crush, or chew the tablet. You can take the tablet with or without food. If you take more Lyfnua than you should If you take too much Lyfnua, talk to a doctor or pharmacist straight away. If you forget to take Lyfnua If you miss a dose, skip that dose and take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose. 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 possible side effects are: Very common (may affect more than 1 in 10 people)

• change in how things taste (such as a: metallic, bitter, or salty taste)
• being less able to taste
• loss of taste Common (may affect up to 1 in 10 people)
• feeling sick (nausea)
• things tasting different than before
• cough (worsening, increase)
• dry mouth
• upper respiratory tract infection (an infection in the upper part of the airways including the nose and throat)
• diarrhoea
• pain in your mouth or throat
• feeling less hungry than usual
• feeling dizzy
• upper abdominal (belly) pain
• indigestion
• unusual feeling in mouth (e.g., tingling or prickling sensation)
• loss of feeling in the mouth
• increased saliva production
• insomnia (difficulty in sleeping) Uncommon (may affect up to 1 in 100 people)
• bladder, urinary or kidney stones 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 this medicine after the expiry date which is stated on the blister and the carton after EXP . The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering. 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 protect the environment.

What Lyfnua contains The active substance is gefapixant. Each film-coated tablet contains 45 mg gefapixant (as citrate). The other ingredients are silica (colloidal anhydrous) (E551), crospovidone (E1202), hypromellose (E464), magnesium stearate (E470b), mannitol (E421), microcrystalline cellulose (E460), sodium stearyl fumarate. The tablets are film-coated with a coating material containing the following ingredients: hypromellose (E464), titanium dioxide (E171), triacetin (E1518) and red ferric oxide (E172). The tablets are polished with carnauba wax (E903). What Lyfnua looks like and contents of the pack Lyfnua is a pink, round and convex tablet, debossed with 777 on one side and plain on the other side. Lyfnua is available in white PVC/PE/PVdC blisters. Lyfnua is available in packs containing 28, 56 and 98 film-coated tablets in non-perforated blisters (14 tablets per card), multipacks containing 196 (2 packs of 98) film coated tables in non-perforated blisters. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer 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 9999(+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@merck.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 web site: http://www.ema.europa.eu