LYFNUA 45 mg FILM-COATED TABLETS
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Introduction
Package Leaflet: Information for the Patient
Lyfnua 45mg film-coated tablets
gefapixant
This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking 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 or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Lyfnua and what is it used for
- What you need to know before you take Lyfnua
- How to take Lyfnua
- Possible side effects
- Storage of Lyfnua
- Contents of the pack and other information
1. What is Lyfnua and what is it used for
Lyfnua contains the active substance gefapixant.
Lyfnua is a medicine used in adults for chronic cough (cough that lasts for more 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 of Lyfnua, gefapixant, blocks the action of the nerves that cause abnormal coughing.
2. What you need to know before you take Lyfnua
Do not take Lyfnua
- if you are allergicto gefapixant or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Tell your doctor or pharmacist before you start taking and while you are taking Lyfnua if:
- you are allergicto medicines that contain sulfonamide
- you have sleep apnea- where your breathing stops and starts again while you sleep
- you develop an acute infection of the lung/lower respiratory system (e.g. pneumonia or bronchitis)
- you notice a change in the taste of things, loss of tasteor less ability to taste, which continues even after stopping Lyfnua.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age. 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 breastfeeding
It is not known if Lyfnua can harm the fetus. Therefore, it is best to avoid using 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 can pass into breast milk. A risk to the baby cannot be excluded. You and your doctor must decide whether to take Lyfnua or to 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 feel better.
Lyfnua contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take Lyfnua
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.
How much to take
The recommended dose of Lyfnua is:
- one 45 mg tablet twice a day.
Adults with kidney problems
Your doctor may change the amount and frequency you take Lyfnua if:
- you have severe kidney failure and are not on dialysis.
How to take it
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, contact a doctor or pharmacist immediately.
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 forgotten doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are:
Very common (may affect more than 1 in 10 people)
- change in the taste of things (such as metallic, bitter or salty taste)
- having less taste
- loss of taste
Common(may affect up to 1 in 10 people)
- feeling sick (nausea)
- taste different from what it used to be
- cough (worsening, increase)
- dry mouth
- upper respiratory tract infection (an infection in the upper part of the respiratory tract, which includes the nose and throat)
- diarrhea
- pain in the mouth or throat
- having less appetite than usual
- feeling dizzy
- pain in the upper abdomen (stomach)
- indigestion
- unusual sensations in the mouth (e.g. tingling or itching sensation)
- loss of sensation in the mouth
- increased saliva production
- insomnia (difficulty sleeping)
- headache
Uncommon(may affect up to 1 in 100 people)
- kidney stones, in the urine or in the kidney
Reporting of side effects
If you experience 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.
5. Storage of Lyfnua
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 carton after “EXP”. The expiry date refers to the last day of the month shown.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Lyfnua contains
The active substance is gefapixant. Each film-coated tablet contains 45 mg of gefapixant (as citrate).
The other ingredients are silica (colloidal anhydrous) (E 551), crospovidone (E 1202), hypromellose (E 464), magnesium stearate (E 470b), mannitol (E 421), microcrystalline cellulose (E 460), sodium fumarate and stearic acid. The film coating contains the following ingredients: hypromellose (E 464), titanium dioxide (E 171), triacetin (E 1518) and red iron oxide (E 172). The tablets are polished with carnauba wax (E 903).
Appearance and packaging
Lyfnua is a pink, round and convex tablet, engraved with “777” on one side and smooth on the other.
Lyfnua is available in white, opaque PVC/PE/PVdC blisters with a push-through lid, in pack sizes of 28, 56 and 98 film-coated tablets, and in multipacks containing 196 (2 packs of 98) film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
For further information on this medicine, contact the local representative of the marketing authorisation holder:
Belgium MSD Belgium Tel: +32(0)27766211 | Lithuania UAB Merck Sharp & Dohme Tel: +370 5 2780 247 |
| Luxembourg MSD Belgium Tel: +32(0)27766211 |
Czech Republic Merck Sharp & Dohme s.r.o. Tel: +420 233 010 111 | Hungary MSD Pharma Hungary Kft. Tel: +36 1 888 5300 |
Denmark MSD Danmark ApS Tel: +45 4482 4000 | Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) |
Germany MSD Sharp & Dohme GmbH Tel: +49 (0) 89 20 300 4500 | Netherlands Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) |
Estonia Merck Sharp & Dohme OÜ Tel: +372 614 4200 | Norway MSD (Norge) AS Tel: +47 32 20 73 00 |
Greece MSD Α.Φ.Ε.Ε. Tel: +30 210 98 97 300 | Austria Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 |
Spain Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 | Poland MSD Polska Sp. z o.o. Tel: +48 22 549 51 00 |
France MSD France Tel: +33 (0) 1 80 46 40 40 | Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700 |
Croatia Merck Sharp & Dohme d.o.o. Tel: +385 1 6611 333 | Romania Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00 |
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 | Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 520 4201 |
Iceland Vistor ehf. Tel: +354 535 7000 | Slovakia Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 |
Italy MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) | Finland MSD Finland Oy Tel: +358 (0)9 804 650 |
Cyprus Merck Sharp & Dohme Cyprus Limited Tel: 800 00 673 (+357 22866700) | Sweden Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 |
Latvia SIA Merck Sharp & Dohme Latvija Tel: +371 67025300 |
Date of last revision of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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