LYFNUA 45 mg FILM-COATED TABLETS

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

1. What is Lyfnua and what is it used for
2. What you need to know before you take Lyfnua
3. How to take Lyfnua
4. Possible side effects
5. Storage of Lyfnua
6. 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:

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