Lyfnua 45 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lyfnua 45 mg film-coated tablets

gefapixant

This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is provided at the end of section 4.

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Lyfnua is and what it is used for

Lyfnua contains the active substance gefapixant.

Lyfnua is a medicine used in adults for chronic cough (cough lasting longer than 8 weeks) when:

• the cough does not go away despite using other medicines, or
• the cause of the cough is unknown.

The active ingredient in Lyfnua, gefapixant, blocks the action of nerves that cause abnormal coughing.

2. What you need to know before starting Lyfnua

Do not take Lyfnua

• if you are allergic to gefapixant or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting and while taking Lyfnua if:

• you are allergic to medicines containing sulfonamides
• you have sleep apnea – a condition in which your breathing stops and starts again while you sleep
• you develop an acute lung/lower respiratory tract infection (e.g., pneumonia or bronchitis)
• you notice a change in how things taste, loss of taste, or reduced 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 need to take any other medicines.

Pregnancy and breastfeeding

It is unknown whether 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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Animal studies have shown that Lyfnua can pass into breast milk. A risk to your baby cannot be ruled out. You and your doctor should decide together 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 the dizziness stops.

Lyfnua contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially "sodium-free".

3. How to take Lyfnua

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

What dose to take

The recommended dose of Lyfnua is:

• one 45 mg tablet twice daily.

Adults with kidney problems

Your doctor may adjust the dose and frequency with which you take Lyfnua if:

• you have severe renal impairment and are not on dialysis.

How to take it

Swallow the tablet whole. Do not split, crush, or chew the tablet.

You may 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 missed doses.

If you have any further questions about the use of this medicine, 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)
• reduced ability to taste
• loss of taste

Common (may affect up to 1 in 10 people)

• feeling sick (nausea)
• altered taste of things compared to how they previously tasted
• cough (worsening, increase)
• dry mouth
• upper respiratory tract infection (an infection in the upper part of the respiratory tract, including the nose and throat)
• diarrhoea
• pain in the mouth or throat
• reduced appetite
• feeling dizzy
• pain in the upper part of the abdomen (stomach)
• indigestion
• unusual sensations in the mouth (e.g., tingling or itching)
• loss of sensitivity in the mouth
• increased saliva production
• insomnia (difficulty sleeping)
• headache

Uncommon (may affect up to 1 in 100 people)

• bladder stones, urinary stones, or kidney stones

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included 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 stated on the blister and the carton after "EXP". The expiry date is the last day of the month indicated.

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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Lyfnua

The active substance is gefapixant. Each film-coated tablet contains 45 mg of gefapixant (as citrate).

The other components are silica (colloidal anhydrous) (E 551), crospovidone (E 1202), hypromellose (E 464), magnesium stearate (E 470b), mannitol (E 421), microcrystalline cellulose (E 460), sodium stearyl fumarate, and sodium. The tablets are film-coated with a coating material containing the following components: 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 of the product and contents of the container

Lyfnua is a pink, round, convex tablet, engraved with "777" on one side and smooth on the other.

Lyfnua is available in white, opaque PVC/PE/PVdC blisters with peelable aluminum foil lids.

Lyfnua is available in packs of 28, 56, and 98 film-coated tablets in non-perforated blisters (14 tablets per plate), and multiple packs containing 196 tablets (2 packs of 98) of film-coated tablets in non-perforated blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu