LYNKUET

Patient Information Leaflet

Lynkuet 60 mg soft capsules

elinzanetant
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Lynkuet is and what it is used for

Lynkuet contains the active substance elinzanetant. Lynkuet 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 the recurrence of cancer after anti-tumour treatment.

Vasomotor symptoms are sudden feelings of heat (sometimes intense) that occur
mainly in the face, neck and chest, and episodes of sweating during the day or night.
They are also known as hot flushes or night sweats.
How Lynkuet works
The active substance in Lynkuet, elinzanetant, works by blocking the activity of certain nerve cells
in the brain called kisspeptin/neurokinin B/dynorphin neurons, which are involved in the
regulation of body temperature and sleep. By blocking these nerve cells, Lynkuet helps control hot flushes and night sweats.

2. What you need to know before taking Lynkuet

Do not take Lynkuet if

• you are allergic to elinzanetant or to any of the other ingredients of this medicine (listed in section 6);
• you are pregnant or suspect you may be pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lynkuet if

• you are taking certain medicines that inhibit the proper function of the liver enzyme CYP3A4. These medicines may prolong the presence of Lynkuet in your body, which could increase the risk of side effects. Examples include medicines used to treat infections, such as itraconazole, clarithromycin, ritonavir, cobicistat, or those used to treat breast cancer, such as ribociclib.
• you are undergoing estrogen hormone replacement therapy (medicines used to treat symptoms of estrogen deficiency). If you are unsure whether you are taking such medicines, consult your doctor.

Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Other medicines and Lynkuet
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those available with or without a prescription, or over-the-counter medicines such as vitamins, dietary supplements, or herbal remedies.
Some medicines may affect how Lynkuet works, or Lynkuet may affect how these medicines work. These include medicines used 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 rapid heartbeat, such as verapamil;
• prevent organ rejection after transplantation, such as cyclosporine, tacrolimus;
• treat long-term pain, such as fentanyl.

Lynkuet with food and drinks
Do not eat grapefruit or drink grapefruit juice during treatment with this medicine.
This is because grapefruit also inhibits the proper function of the CYP3A4 enzyme and may prolong the presence of Lynkuet in your body, increasing the risk of side effects.
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or suspect you may be pregnant.
If you are a woman of childbearing potential, you or your partner must use an effective contraceptive method to avoid pregnancy during treatment with this medicine. Consult your doctor about the most suitable contraceptive method for you.
If you become pregnant while taking this medicine, stop treatment immediately and contact your doctor.
If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine.
Driving and using machines
If you experience fatigue or drowsiness during treatment with this medicine, exercise particular caution when driving or operating machinery.
Lynkuet contains sorbitol
This medicine contains 71 mg of sorbitol per capsule. Sorbitol is a source of fructose.
Sorbitol may alter the effectiveness of other medicines taken orally at the same time.

3. How to take Lynkuet

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
You must take one dose (2 capsules) of this medicine every day at bedtime.
Contact your doctor if:

• you are taking this medicine together with other medicines
• you have kidney problems. Your doctor may reduce your daily dose to one single capsule to be taken every day at bedtime.

Swallow the capsule(s) whole with a glass of water. Do not cut, chew or crush the capsule(s) due to their oily formulation.
If you take more Lynkuet than you should
Taking an excessive amount of Lynkuet may increase the frequency or severity of side effects. If you have taken too much medicine, contact your doctor or pharmacist.
If you forget to take Lynkuet
If you forget to take a dose at bedtime, take the next dose as scheduled the following day. Do not take a double dose to make up for the missed dose.
If you stop taking Lynkuet
Do not stop treatment with Lynkuet unless your doctor tells you to. If you wish to stop treatment with this medicine before the end of the prescribed period, consult your doctor first.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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 have been observed:

Common (may affect up to 1 in 10 people)

• abdominal pain
• diarrhoea
• dizziness
• fatigue
• headache
• muscle spasms
• rash
• somnolence

Uncommon (may affect up to 1 in 100 people)

• increased levels of certain liver enzymes (ALT or AST)
• increased skin sensitivity to sunlight

In patients with moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy, the following side effects have been observed:

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

• fatigue

Common (may affect up to 1 in 10 people)

• depression, depressed mood
• diarrhoea
• increased levels of certain liver enzymes (ALT)
• dizziness
• hair loss
• muscle spasms
• somnolence
• sensation of spinning (vertigo)

Uncommon (may affect up to 1 in 100 people)

• increased levels of certain liver enzymes (AST)
• increased skin sensitivity to sunlight

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lynkuet

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Store in the original blister pack to protect the medicine from moisture.
Do not use this medicine after the expiry date which is stated on the carton after "Exp." and on the individual blister packs after "EXP." The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lynkuet contains

• The active substance is elinzanetant. Each soft capsule contains 60 mg of elinzanetant.
• The other components are all-rac-α-tocopherol (E 307), caprylic/capric macrogol glycerides, gelatin, glycerol monocaprylocaprate, glycerol mono-oleate (E 471), red iron oxide (E 172), yellow iron oxide (E 172), macrogol 400 (E 1521), medium-chain triglycerides, mixture of partially dehydrated sorbitol liquid (E 420) – glycerol (E 422), 53% phosphatidylcholine solution in medium-chain triglycerides, polysorbate 80 (E 433), polyvinyl acetate phthalate, propylene glycol (E 1520), titanium dioxide (E 171).

For further information, see “Lynkuet contains sorbitol” in section 2.
Description of the appearance of Lynkuet and contents of the pack
The soft capsules (capsules) are oblong, opaque red, with the inscription “EZN60” printed in white.
They are available in PVC/PCTFE-aluminium/PET/paper blisters, in boxes containing 24 or 60 soft capsules, or in multiple packs of 180 soft capsules (3 packs of 60). Each blister contains 6 × 2 capsules as a unit dose.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Bayer AG
51368 Leverkusen
Germany
Manufacturer
Catalent Germany Eberbach GmbH
Gammelsbacher Str. 2
69412 Eberbach
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Bayer SA-NV UAB Bayer
Tél/Tel: +32-(0)2-535 63 11 Tel. +37 05 23 36 868
България Luxembourg/Luxemburg
Байер България ЕООД Bayer SA-NV
Tел.: +359 (0)2 4247280 Tél/Tel: +32-(0)2-535 63 11
Česká republika Magyarország
Bayer s.r.o. Bayer-Hungária Kft.
Tel: +420 266 101 111 Tel.: +36 1 487 4100
Danmark Malta
Bayer A/S Alfred Gera and Sons Ltd.
Tlf: +45 45 23 50 00 Tel: +35 621 44 62 05
Deutschland Nederland
Bayer Vital GmbH Bayer B.V.
Tel: +49 (0)214-30 513 48 Tel: +31-(0)23-799 1000
Eesti Norge
Bayer OÜ Bayer AS
Tel: +372 655 8565 Tlf: +47 23 13 05 00
Ελλάδα Österreich
Bayer Ελλάς ΑΒΕΕ Bayer Austria Ges.m.b.H.
Τηλ: +30-210-61 87 500 Tel: +43-(0)1-711 46-0
España Polska
Bayer Hispania S.L. Bayer Sp. z o.o.
Tel: +34-93-495 65 00 Tel: +48 22 572 35 00
France Portugal
Bayer HealthCare Bayer Portugal, Lda.
Tél (N° vert): +33-(0)800 87 54 54 Tel: +351 21 416 42 00
Hrvatska România
Bayer d.o.o. SC Bayer SRL
Tel: +385-(0)1-6599 900 Tel: +40 21 529 59 00
Ireland Slovenija
Bayer Limited Bayer d. o. o.
Tel: +353 1 216 3300 Tel: +386 (0)1 58 14 400
Ísland Slovenská republika
Icepharma hf. Bayer spol. s r.o.
Sími: +354 540 8000 Tel. +421 2 59 21 31 11
Italia Suomi/Finland
Bayer S.p.A. Bayer Oy
Tel: +39 02 397 8 1 Puh/Tel: +358- 20 785 21
Κύπρος Sverige
NOVAGEM Limited Bayer AB
Tηλ: +357 22 48 38 58 Tel: +46 (0) 8 580 223 00
Latvija
SIA Bayer
Tel: +371 67 84 55 63
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.