fezolinetant: package leaflet

Veoza contains the active substance fezolinetant. Veoza is a non-hormonal medicine used in menopausal women to reduce moderate-to-severe vasomotor symptoms (VMS) associated with menopause. VMS are also known as hot flashes or night sweats.

Before menopause, there is a balance between oestrogens, a female sex hormone, and a protein made by the brain known as neurokinin B (NKB) that regulates your brain’s temperature control centre. As your body goes through menopause, oestrogen levels decline and this balance is disrupted, which can lead to VMS. By blocking NKB binding in your temperature control centre, Veoza reduces the number and intensity of hot flashes and night sweats.

Do not take Veoza
- if you are allergic to fezolinetant or any of the other ingredients of this medicine (listed in section 6).
- with medicines known as moderate or strong CYP1A2 inhibitors (e.g., ethinyl oestradiol containing contraceptives, mexiletine, enoxacin, fluvoxamine). These medicines can reduce the breakdown of Veoza in the body, leading to more side effects. See ‘Other medicines and Veoza’ below.
- if you are pregnant or think you may be pregnant.

Warnings and precautions
Before you start taking Veoza you will have a blood sample taken to check your liver function. This check should be repeated monthly during the first three months of treatment and at regular intervals afterwards if required by your doctor.

Talk to your doctor or pharmacist before taking Veoza
- your doctor may ask for your full medical history, including family history.
- if you have ongoing liver disease or liver problems.
- if you have kidney problems. Your doctor may not prescribe this medicine to you.
- if you currently have or previously had breast cancer or another oestrogen-related cancer.
During treatment, your doctor may not prescribe this medicine to you.
- if you are taking hormone replacement therapy with oestrogens (medicines used to treat oestrogen deficiency symptoms). Your doctor may not prescribe this medicine to you.
- if you have a history of seizures. Your doctor may not prescribe this medicine to you.

Tell your doctor immediately if you get any of the following signs and symptoms during treatment with Veoza:
- if you notice any sign or symptom of a liver problem.

The list of associated symptoms is provided in section 4. Possible side effects.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because this medicine is only for menopausal women.
Other medicines and Veoza
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines without a prescription.
Certain medicines may increase the risk of side effects of Veoza by increasing the amount of Veoza in the blood. These medicines must not be taken while you are taking Veoza, and include:
- Fluvoxamine (a medicine used to treat depression and anxiety)
- Enoxacin (a medicine used to treat infections)
- Mexiletine (a medicine used to treat symptoms of muscle stiffness)
- Ethinyl oestradiol containing contraceptives (medicines used to prevent pregnancy) Pregnancy and breast-feeding Do not take this medicine if you are pregnant or breast-feeding, or if you think you might be pregnant.
This medicine is for use only by menopausal women. If you become pregnant while taking this medicine, stop taking it immediately and talk to your doctor. Women of childbearing potential should use effective non-hormonal contraception.
Driving and using machines
Veoza has no effect on the ability to drive or use machines.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one 45 mg tablet taken by mouth once daily.
Instructions for proper use
- Take this medicine at about the same time each day.
- Swallow the tablet whole with liquids. Do not break, crush, or chew the tablet.
- Take with or without food.

If you take more Veoza than you should
If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor or pharmacist straight away.

Symptoms of overdose may include headache, feeling sick (nausea), or a tingling or prickling sensation (paraesthesia).
If you forget to take Veoza
If you forget to take your medicine, take the missed dose as soon as you remember on the same day, and at least 12 hours before the next scheduled dose. If there is less than 12 hours before the next scheduled dose, do not take the missed dose. Return to your regular schedule the following day. Do not take a double dose to make up for a forgotten individual dose.

If you miss several doses, tell your doctor and follow the advice given to you.
If you stop taking Veoza
Do not stop taking this medicine unless your doctor tells you to do so. If you decide to stop taking this medicine before finishing the prescribed course of treatment, you should 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.
Some side effects (e.g. liver injury) could be serious.

If you experience any of the following side 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 (frequency not known, since it cannot be estimated from the available data).

Common (may affect up to 1 in 10 people)
- diarrhoea
- difficulty sleeping (insomnia)
- increase in levels of certain liver enzymes (ALT or AST), as shown in blood tests
- stomach (abdominal) pain
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.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 to protect the environment.

What Veoza contains
- The active substance is fezolinetant. Each film-coated tablet contains 45 mg of fezolinetant.
- The other ingredients are:
Tablet core: mannitol (E421), hydroxypropyl cellulose (E463), low-substituted hydroxypropyl cellulose (E463a), microcrystalline cellulose (E460), magnesium stearate (E470b).
Film-coating: hypromellose (E464), talc (E553b), macrogol (E1521), titanium dioxide (E171), iron oxide red (E172).
What Veoza looks like and contents of the pack
Veoza 45 mg tablets are round, light red, film-coated tablets (tablets) debossed with the company logo and ‘645’ on the same side.

Veoza is available in PA/Aluminium/PVC/Aluminium unit dose blisters in cartons.

Pack sizes: 10 × 1, 28 × 1, 30 × 1, and 100 × 1 film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands

Manufacturer
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
The Netherlands

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

België/Belgique/Belgien
Astellas Pharma B.V. Branch
Tél/Tel: + 32 (0)2 5580710

Lietuva
Astellas Pharma d.o.o.
Tel: + 370 37 408 681

България
Астелас Фарма ЕООД
Teл.: + 359 2 862 53 72

Luxembourg/Luxemburg
Astellas Pharma B.V. Branch
Belgique/Belgien
Tél/Tel: + 32 (0)2 5580710

Česká republika
Astellas Pharma s.r.o.
Tel: +420 221 401 500

Magyarország
Astellas Pharma Kft.
Tel.: + 36 1 577 8200

Danmark
Astellas Pharma a/s
Tlf.: + 45 43 430355

Malta
Vivian Corporation Ltd.
Tel: +356 22588600

Deutschland
Astellas Pharma GmbH
Tel: + 49 (0)89 454401

Nederland
Astellas Pharma B.V.
Tel: + 31 (0)71 5455745

Eesti
Astellas Pharma d.o.o.
Tel: + 372 6 056 014

Norge
Astellas Pharma
Tlf: + 47 66 76 46 00

Ελλάδα
Astellas Pharmaceuticals AEBE
Τηλ: + 30 210 8189900

Österreich
Astellas Pharma Ges.m.b.H.
Tel: + 43 (0)1 8772668

España
Astellas Pharma S.A.
Tel: + 34 91 4952700

Polska
Astellas Pharma Sp.z.o.o.
Tel.: + 48 225451 111
France
Astellas Pharma S.A.S.
Tél: + 33 (0)1 55917500

Portugal
Astellas Farma, Lda.
Tel: + 351 21 4401300

Hrvatska
Astellas d.o.o.
Tel: + 385 1670 0102

România
S.C. Astellas Pharma SRL
Tel: + 40 (0)21 361 04 95

Ireland
Astellas Pharma Co. Ltd.
Tel: + 353 (0)1 4671555

Slovenija
Astellas Pharma d.o.o.
Tel: + 386 14011400

Ísland
Vistor ehf
Sími: + 354 535 7000

Slovenská republika
Astellas Pharma s.r.o.
Tel: + 421 2 4444 2157

Italia
Astellas Pharma S.p.A.
Tel: + 39 (0)2 921381

Suomi/Finland
Astellas Pharma
Puh/Tel: + 358 (0)9 85606000

Κύπρος
Novagem Ltd
Τηλ: +357 22 483858

Sverige
Astellas Pharma AB
Tel: + 46 (0)40-650 15 00

Latvija
Astellas Pharma d.o.o.
Tel: + 371 67 619365

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.