Patient Information Leaflet: Information for the Patient

Lyfnua 4545 mg Film-Coated Tablets

gefapixant

This medicine is subject to additional monitoring, which will speed up the detection of any new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

Lyfnua contains the active ingredient gefapixant.

Lyfnua is a medication used in adults for chronic cough (cough lasting more than 8 weeks) and:

• cough that does not disappear even after using other medications or
• the cause of the cough is unknown.

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

Do not take Lyfnua

• if you areallergicto gefapixant or any of the other components of this medication (listed in section6).

Warnings and precautions

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

• you areallergicto medications containing sulfonamida
• you havesleep apnea– in which your breathing stops and starts again while you are asleep
• you developan acute lung/respiratory tract infection (for example, pneumonia or bronchitis)
• you perceivea change in the taste of things, loss of tasteorreduced ability to taste, which continues even after stopping Lyfnua

Children and adolescents

Do not give this medication to children and adolescents under 18years of age. This is because it has not been studied in this age group.

Other medications and Lyfnua

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

Pregnancy and breastfeeding

The effects of Lyfnua on the fetus are unknown. Therefore, it is best to avoid the use of Lyfnua if you are pregnant.

If you are pregnant, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Studies in animals have shown that Lyfnua may pass into breast milk. It cannot be ruled out that there is a risk to your baby. You and your doctor must decide jointly whether to take Lyfnua or choose breastfeeding.

Driving and operating machines

You may feel dizzy after taking Lyfnua. If this occurs, do not drive or use tools or machines until you stop feeling dizzy.

Lyfnua contains sodium

This medication contains less than 1mmol of sodium (23mg) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 at which 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 too much Lyfnua

If you take too much Lyfnua, contact a doctor or pharmacist immediately.

If you miss a dose of 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 the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The possible adverse effects are:

Very frequent (may affect more than 1 in 10 people)

• Change in the taste of things (such as metallic, bitter, or salty taste)
• Reduced sense of taste
• Loss of taste

Frequent(may affect up to 1 in 10people)

• Sensation of nausea (nausea)
• Different taste of things than before
• Cough (worsening, increase)
• Dry mouth
• Upper respiratory tract infection (an infection in the upper respiratory tract, which includes the nose and throat)
• Diarrhea
• Pain in the mouth or throat
• Reduced appetite
• Feeling dizzy
• Pain in the upper abdominal area (stomach)
• Indigestion
• Unusual sensations in the mouth (for example, tingling or itching sensation)
• Loss of sensitivity in the mouth
• Increased saliva production
• Insomnia (difficulty sleeping)

Rare(may affect up to 1 in 100people)

• Stones in the bladder, urine, or kidney

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Lyfnua

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

The other components are colloidal anhydrous silica (E 551), crospovidone (E 1202), hypromellose (E 464), magnesium stearate (E 470b), mannitol (E 421), microcrystalline cellulose (E 460), and sodium stearyl fumarate. The tablets are coated with a film coating that contains the following components: hypromellose (E 464), titanium dioxide (E 171), triacetin (E 1518), and iron oxide red (E 172). The tablets are polished with carnauba wax (E 903).

Appearance of the product and contents of the pack

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

Lyfnua is available in white PVC/PE/PVdC blisters.

Lyfnua is available in packs of 28, 56, and 98 film-coated tablets in unperforated blisters (14 tablets per card) and multiple packs with 196 (2 packs of 98) film-coated tablets in unperforated blisters.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:{MM/AAAA}.

For detailed information about this medicinal product, please visit the website of the European Medicines Agency:http://www.ema.europa.eu