Lynkuet 60 mg soft capsules

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

Oestrogens are hormones made by a woman’s ovaries. The ovaries normally stop making oestrogens when a woman is in menopause. Before menopause, a balance exists between oestrogen and certain substances acting on so-called Kisspeptin/Neurokinin B/Dynorphin neurons in the brain. These neurons help regulate body temperature and sleep. During menopause or use of adjuvant endocrine therapy, when oestrogen levels decrease, this balance is disrupted making these neurons more active than usual. This can cause hot flushes and sleep problems. By lowering the activity of these neurons Lynkuet helps to improve these vasomotor symptoms.

• are allergic to elinzanetant or any of the other ingredients of this medicine (listed in section 6)
• have ongoing severe liver problems
• are taking other medicines known as strong inhibitors of the CYP3A4 enzyme (such as cobicistat, clarithromycin, itraconazole, ritonavir). These medicines may cause Lynkuet to stay longer in your body, which may increase the risk of side effects.
• know or think that you might be pregnant.

Before you start taking Lynkuet, your doctor may ask for your full medical history, including family history and you may have a blood sample taken to check your liver function.

If you experience any of the following effects, tell your doctor immediately: - tiredness, itching skin, yellowing of the skin and eyes, dark urine, light-coloured stools, feeling sick (nausea or vomiting), loss of appetite, and/or stomach ache. These symptoms may be signs of liver injury.

Talk to your doctor or pharmacist before taking Lynkuet, if you:

• had a seizure or have any condition that may increase your risk of having a seizure
• are taking other medicines known as moderate inhibitors of the CYP3A4 enzyme (such as erythromycin, ciprofloxacin, fluconazole, verapamil). These medicines may cause Lynkuet to stay longer in your body, which may increase the risk of side effects.
• are taking other medicines known as moderate to strong inducers of the CYP3A4 enzyme (such as rifampicin, carbamazepine, phenobarbital, St. John´s Wort). These medicines may lower the levels of Lynkuet in your body.
• are taking hormone replacement therapy with oestrogens (medicines used to treat oestrogen deficiency symptoms, not including topical vaginal oestrogen medicines). Your doctor may not prescribe this medicine to you.

This medicine is not for use in children and adolescents under 18 years.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained with or without prescription, or over-the-counter medicines such as vitamins, dietary supplements or herbal medicines.

Certain medicines may influence how Lynkuet works. If you are on a moderate CYP3A4 inhibitor, then let your doctor know as they may need to prescribe you a lower dose of Lynkuet. Moderate CYP3A4 inhibitors may include medicines to:

• treat fungal or bacterial infections such as ciprofloxacin, erythromycin, fluconazole
• treat chest pains and high blood pressure such as verapamil

Lynkuet may influence how certain medicines work. These may include medicines to:

• prevent organ rejection after transplantation such as cyclosporine, tacrolimus
• treat long-term pain such as fentanyl

Do not eat grapefruit or drink grapefruit juice as long as you take this medicine.

This is because grapefruit is also known to be an inhibitor of the CYP3A4 enzyme and may cause Lynkuet to stay longer in your body. This may increase the risk of side effects.

You should not take this medicine if you are pregnant or breast-feeding, or if you think you might be pregnant.

If you could get pregnant, you or your partner should use an effective birth control method to prevent pregnancy while you are taking this medicine. Ask your doctor about the best method of birth control for you.

If you get pregnant while taking this medicine, stop taking it and talk to your doctor.

If you feel tired, dizzy or sleepy while you are taking this medicine take extra care when driving or using machines.

This medicine contains 71 mg sorbitol in each capsule. Sorbitol is a source of fructose. Sorbitol may change how well other oral medicines work when you take them at the same time.

• Swallow the capsules whole with a glass of water. Do not cut, chew or crush the capsule due to its liquid formulation.
• Take Lynkuet orally once daily at bedtime with or without food.
• Do not take it with grapefruit juice or grapefruit. See “Lynkuet with food and drink” in section 2 for more information.

Taking too much Lynkuet may make side effects more likely or more severe. Talk to your doctor or pharmacist if you think you have taken too much of this medicine.

If you miss a dose, take the next dose as planned on the following day at bedtime. Do not take more than 2 capsules on the same day to make up for a forgotten dose.

Do not stop taking Lynkuet unless your doctor tells you to do so. If you want to stop taking this medicine before finishing treatment, talk to your doctor first.

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 elinzanetant. Each soft capsule contains 60 mg of elinzanetant.
• The other ingredients are all-rac-α-tocopherol (E 307), caprylocaproyl macrogolglycerides, concentrated ammonia solution, gelatine, glycerol monocaprylate, glycerol monooleate, iron oxide red (E 172), iron oxide yellow (E 172), isopropyl alcohol, macrogol 400 (E 1521), polysorbate 80 (E 433), polyvinyl acetate phthalate, propylene glycol (E 1520), purified water, SDA 35A alcohol, sorbitol special-glycerin (E 420), titanium dioxide (E 171).

The soft capsules (capsules) are opaque red, oblong, and approximately 24 mm long and 11 mm in diameter. They are marked with a white printing of “EZN60” on one side.

Lynkuet is available in cartons with foil blisters containing

• 24 (2 × 12) soft capsules
• 60 (5 × 12) soft capsules
• 180 (15 × 12) soft capsules

Not all pack sizes may be marketed.

For any information about this medicine, please contact the Marketing Authorisation Holder: