elinzanetant: package leaflet

Lynkuet contains the active substance elinzanetant. It is a non-hormonal medicine.

It is used to treat moderate to severe vasomotor symptoms:
- associated with menopause
- caused by so-called adjuvant endocrine therapy for breast cancer.
These are anti-hormonal medicines (such as tamoxifen or anastrozole) that prevent cancer from coming back after anti-cancer treatment.

Vasomotor symptoms are sudden feelings of warmth or intense heat, mainly in the face, neck and chest and sweating during day or night, also called hot flashes or night sweats.

How Lynkuet works
The active substance in Lynkuet, elinzanetant, works by blocking the activity of certain nerve cells in the brain (so-called Kisspeptin/Neurokinin B/Dynorphin neurons) that are involved in regulating body temperature and sleep. By blocking these nerve cells, Lynkuet helps to control hot flashes and night sweats.

Do not take Lynkuet if
- you are allergic to elinzanetant or any of the other ingredients of this medicine (listed in section 6)
- you are pregnant or think you might be pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lynkuet, if
- you are taking certain medicines that keep the CYP3A4 liver enzyme from working properly.
These medicines may cause Lynkuet to stay longer in your body, which may increase the risk of side effects. Examples are medicines used to treat infections such as itraconazole, clarithromycin, ritonavir, cobicistat or to treat breast cancer such as ribociclib.
- you are taking hormone replacement therapy with oestrogens (medicines used to treat oeastrogen deficiency symptoms).
If you are unsure if you are taking such medicines, talk to your doctor.

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

Other medicines and Lynkuet
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, or Lynkuet may influence how these medicines work. These may include medicines to:
- treat fungal or bacterial infections such as itraconazole, clarithromycin, erythromycin, ciprofloxacin, fluconazole
- treat HIV infections such as ritonavir, cobicistat
- treat breast cancer such as ribociclib
- treat high blood pressure, chest pain and fast heartbeat such as verapamil
- prevent organ rejection after transplantation such as cyclosporine, tacrolimus
- treat long-term pain such as fentanyl

Lynkuet with food and drink
Do not eat grapefruit or drink grapefruit juice as long as you take this medicine. This is because grapefruit also keeps the CYP3A4 enzyme from working properly and may cause Lynkuet to stay longer in your body. This may increase the risk of side effects.

Pregnancy and breast-feeding
Do not take this medicine if you are pregnant, 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 are breast-feeding or plan to breast feed, ask your doctor for advice before taking this medicine.

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

Lynkuet contains sorbitol
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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should take one dose (2 capsules) of this medicine each day at bedtime.

Talk with your doctor, if
- you take this medicine together with other medicines
- you have kidney problems
Your doctor may reduce your daily dose to only 1 capsule each day at bedtime.

Swallow the capsule(s) whole with a glass of water. Do not cut, chew or crush the capsule(s) due to its oily formulation.

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

If you forget to take Lynkuet
If you missed a dose at bedtime, take the next dose as planned on the following day. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lynkuet
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In patients with moderate to severe vasomotor symptoms associated with menopause, the following side effects were seen:

Common (may affect up to 1 in 10 people)
- abdominal pain
- diarrhoea
- dizziness
- tiredness
- headache
- muscle spasms
- skin rash
- sleepiness

Uncommon (may affect up to 1 in 100 people)
- increase in levels of certain liver enzymes (ALT or AST)
- increased sensitivity of the skin to sun

In patients with moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy , the following side effects were seen:

Very common (may affect more than 1 in 10 people)
- tiredness

Common (may affect up to 1 in 10 people)
- depression, depressive mood
- diarrhoea
- increase in levels of certain liver enzymes (ALT)
- dizziness
- hair loss
- muscle spasms
- sleepiness
- spinning sensation

Uncommon (may affect up to 1 in 100 people)
- increase in levels of certain liver enzymes (AST)
- increased sensitivity of the skin to sun

Reporting of side effects
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

This medicine does not require any special temperature storage conditions. Store in the original blister in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton and on each blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Lynkuet contains
- 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, gelatin, glycerol monocaprylocaprate, glycerol mono-oleate (E 471), iron oxide red (E 172), iron oxide yellow (E 172), macrogol 400 (E 1521), medium-chain triglycerides, partially dehydrated liquid sorbitol (E 420) - glycerol (E 422) blend, phosphatidyl choline solution 53% in medium-chain triglycerides, polysorbate 80 (E 433), polyvinyl acetate phthalate, propylene glycol (E 1520), titanium dioxide (E 171).

See ‘Lynkuet contains sorbitol’ in section 2 for more information.

What Lynkuet looks like and contents of the pack
The soft capsules (capsules) are opaque red and oblong. They are marked with white printing of “EZN60”.
They are available in PVC/PCTFE-Aluminium/PET/paper blisters in cartons of 24 or 60 or as multipack with 180 (3 packs of 60) soft capsules. Each blister contains 6 × 2 capsules as unit dose.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Catalent Germany Eberbach GmbH
Gammelsbacher Str. 2
69412 Eberbach
Germany

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

België/Belgique/Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Lietuva
UAB Bayer
Tel. +37 05 23 36 868
България
Байер България ЕООД
Tел.: +359 (0)2 4247280
Luxembourg/Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Česká republika
Bayer s.r.o.
Tel: +420 266 101 111
Magyarország
Bayer-Hungária Kft.
Tel.: +36 1 487 4100
Danmark
Bayer A/S
Tlf: +45 45 23 50 00
Malta
Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05
Deutschland
Bayer Vital GmbH
Tel: +49 (0)214-30 513 48
Nederland
Bayer B.V.
Tel: +31-(0)23-799 1000
Eesti
Bayer OÜ
Tel: +372 655 8565
Norge
Bayer AS
Tlf: +47 23 13 05 00
Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30-210-61 87 500
Österreich
Bayer Austria Ges.m.b.H.
Tel: +43-(0)1-711 46-0
España
Bayer Hispania S.L.
Tel: +34-93-495 65 00
Polska
Bayer Sp. z o.o.
Tel: +48 22 572 35 00
France
Bayer HealthCare
Tél (N° vert): +33-(0)800 87 54 54
Portugal
Bayer Portugal, Lda.
Tel: +351 21 416 42 00
Hrvatska
Bayer d.o.o.
Tel: +385-(0)1-6599 900
România
SC Bayer SRL
Tel: +40 21 529 59 00
Ireland
Bayer Limited
Tel: +353 1 216 3300
Slovenija
Bayer d. o. o.
Tel: +386 (0)1 58 14 400
Ísland
Icepharma hf.
Sími: +354 540 8000
Slovenská republika
Bayer spol. s r.o.
Tel. +421 2 59 21 31 11
Italia
Bayer S.p.A.
Tel: +39 02 397 8 1
Suomi/Finland
Bayer Oy
Puh/Tel: +358- 20 785 21
Κύπρος
NOVAGEM Limited
Tηλ: +357 22 48 38 58
Sverige
Bayer AB
Tel: +46 (0) 8 580 223 00

Latvija
SIA Bayer
Tel: +371 67 84 55 63

This leaflet was last revised in

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