Lyfnua 45 mg film-coated tablets

• 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.

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

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

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

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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

You may feel dizzy after taking Lyfnua. If this happens, do not drive or use tools or machines until you no longer feel dizzy.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

The recommended dose of Lyfnua is:

• one 45 mg tablet twice every day.

Your doctor may change how much and how often you take Lyfnua if:

• you have severe kidney failure and are not on dialysis.

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, talk to a doctor or pharmacist straight away.

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.

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

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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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).

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.

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