Veoza

Package leaflet: Information for the user

Veoza 45 mg film-coated tablets

fezolinetant
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 all of this leaflet carefully before you start taking this medicine because 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contents of this leaflet
  1. What Veoza is and what it is used for
  2. What you need to know before taking Veoza
  3. How to take Veoza
  4. Possible side effects
  5. How to store Veoza
  6. Contents of the pack and other information

1. What Veoza is and what it is used for

Veoza contains the active substance fezolinetant. Veoza is a non-hormonal medicine used in postmenopausal 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 estrogen, a female sex hormone, and a protein produced by the brain called neurokinin B (NKB), which regulates the brain's temperature control centre. When the body enters menopause, estrogen levels decrease and this balance is disrupted, which can lead to VMS. By blocking NKB from binding to its receptor in the temperature control centre, Veoza reduces the frequency and intensity of hot flashes and night sweats.

2. What you need to know before taking Veoza

Do not take Veoza

• if you are allergic to fezolinetant or to any of the other ingredients of this medicine (listed in section 6).
• with medicines known as moderate or strong CYP1A2 inhibitors (e.g., contraceptives containing ethinylestradiol, mexiletine, enoxacin, fluvoxamine). These medicines can reduce the metabolism of Veoza in the body, leading to increased side effects. See “Other medicines and Veoza” below.
• if you are pregnant or suspect you may be pregnant.

Warnings and precautions
Before starting Veoza, a blood sample will be taken to check your liver function.
This test must be repeated monthly during the first three months of treatment and subsequently at regular intervals, as 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 currently have liver disease or liver problems.
• if you currently have kidney problems. Your doctor may decide not to prescribe this medicine.
• if you currently have or have previously had breast cancer or another estrogen-related cancer. Your doctor may decide not to prescribe this medicine during treatment.
• if you are currently undergoing hormone replacement therapy with estrogens (medicines used to treat symptoms of estrogen deficiency). Your doctor may decide not to prescribe this medicine.
• if you have a history of seizures. Your doctor may decide not to prescribe this medicine.

Immediately inform your doctor if any of the following signs or symptoms occur
during treatment with Veoza:

• if you notice any sign or symptom of liver problems.

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, as it is intended exclusively for postmenopausal women.
Other medicines and Veoza
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Some medicines can increase the risk of side effects from Veoza because they increase the amount of Veoza in the blood. These medicines must not be taken during treatment with 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)
• Contraceptives containing ethinylestradiol (medicines used to prevent pregnancy)
  Pregnancy and breastfeeding Do not take this medicine if you are pregnant, suspect you may be pregnant, or are breastfeeding. This medicine is intended exclusively for postmenopausal women. If you become pregnant while taking this medicine, stop taking it immediately and contact your doctor. Women of childbearing potential must use effective non-hormonal contraception. Driving and using machines Veoza does not affect the ability to drive vehicles or operate machinery.

3. How to take Veoza

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one 45 mg tablet taken orally once daily.

Instructions for correct use

• Take this medicine at approximately the same time each day.
• Swallow the tablet whole with liquid. Do not break, crush, or chew the tablet.
• Take it with or without food.

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

Symptoms of overdose may include headache, feeling unwell (nausea), or a tingling or prickling sensation (paresthesia).

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, provided that at least 12 hours remain before the next scheduled dose. If less than 12 hours remain before the next scheduled dose, do not take the missed dose. Resume your regular dosing schedule the next day. Do not take a double dose to make up for a single missed dose.
If you forget to take more than one dose, contact your doctor and follow their advice.

If you stop taking Veoza
Do not stop taking this medicine unless your doctor tells you to. If you decide to stop taking this medicine before completing the prescribed course of treatment, consult your doctor first.

If you have any doubts about how to use 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.
Some side effects (e.g. liver damage) may be serious.
If you notice any of the following side effects, tell your doctor immediately:

• fatigue, sensation of skin itching, yellowing of the skin and eyes, dark urine, pale stools, feeling unwell (nausea or vomiting), loss of appetite and/or stomach pain. These symptoms may be signs of liver damage (frequency not known because it cannot be estimated from the available data).

Common (may affect up to 1 in 10 people)

• diarrhoea
• difficulty sleeping (insomnia)
• increased 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, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Veoza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Veoza contains

• The active substance is fezolinetant. Each film-coated tablet contains 45 mg of fezolinetant.
• The other components are:
  Tablet core: mannitol (E421), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose (E463a), microcrystalline cellulose (E460), magnesium stearate (E470b).
  Film coating: hypromellose (E464), talc (E553b), macrogol (E1521), titanium dioxide (E171), iron oxide red (E172).

Description of the appearance of Veoza and contents of the pack
Veoza 45 mg tablets are film-coated, round, light red tablets, with the company logo and "645" imprinted on one side.

Veoza is available in boxes containing unit-dose blisters in PA/aluminum/PVC/aluminum.
Pack sizes: 10 × 1, 28 × 1, 30 × 1 and 100 × 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Astellas Pharma B.V. Branch Astellas Pharma d.o.o.
Tél/Tel: + 32 (0)2 5580710 Tel.: + 370 37 408 681

България Luxembourg/Luxemburg
Астелас Фарма ЕООД Astellas Pharma B.V. Branch
Teл.: + 359 2 862 53 72 Belgique/Belgien
Tél/Tel: + 32 (0)2 5580710

Česká republika Magyarország
Astellas Pharma s.r.o. Astellas Pharma Kft.
Tel: +420 221 401 500 Tel.: + 36 1 577 8200

Danmark Malta
Astellas Pharma a/s Astellas Pharmaceuticals AEBE
Tlf.: + 45 43 430355 Tel: + 30 210 8189900

Deutschland Nederland
Astellas Pharma GmbH Astellas Pharma B.V.
Tel: + 49 (0)89 454401 Tel: + 31 (0)71 5455745

Eesti Norge
Astellas Pharma d.o.o. Astellas Pharma
Tel: + 372 6 056 014 Tlf: + 47 66 76 46 00

Ελλάδα Österreich
Astellas Pharmaceuticals AEBE Astellas Pharma Ges.m.b.H.
Τηλ: + 30 210 8189900 Tel.: + 43 (0)1 8772668

España Polska
Astellas Pharma S.A. Astellas Pharma Sp.z.o.o.
Tel: + 34 91 4952700 Tel.: + 48 225451 111

France Portugal
Astellas Pharma S.A.S. Astellas Farma, Lda.
Tél: + 33 (0)1 55917500 Tel: + 351 21 4401300

Hrvatska România
Astellas d.o.o. S.C. Astellas Pharma SRL
Tel: + 385 1670 0102 Tel: + 40 (0)21 361 04 95

Ireland Slovenija
Astellas Pharma Co. Ltd. Astellas Pharma d.o.o.
Tel: + 353 (0)1 4671555 Tel: + 386 14011400

Ísland Slovenská republika
Vistor ehf Astellas Pharma s.r.o.
Sími: + 354 535 7000 Tel: + 421 2 4444 2157

Italia Suomi/Finland
Astellas Pharma S.p.A. Astellas Pharma
Tel: + 39 (0)2 921381 Puh/Tel: + 358 (0)9 85606000

Κύπρος Sverige
Ελλάδα Astellas Pharma AB
Astellas Pharmaceuticals AEBE Tel: + 46 (0)40-650 15 00
Τηλ: + 30 210 8189900

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

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE VARIATION OF THE
TERMS OF THE MARKETING AUTHORISATION(S)

Scientific conclusions
Taking into account the assessment by the Pharmacovigilance Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for fezolinetant, the scientific conclusions of the PRAC are as follows:
In view of the available data from clinical studies and the information provided in this PSUR, the PRAC recommended removing the information on the incidence rates of ALT/AST level increases calculated from aggregated clinical study data in section 4.8 of the Summary of Product Characteristics, due to the heterogeneity of the fezolinetant clinical studies and because it was determined that such information does not provide relevant added value for healthcare professionals. Consequently, the asterisk in the corresponding cell of the adverse reactions table has also been removed.

Having reviewed the PRAC recommendation, the Committee for Human Medicinal Products (CHMP) agrees with the general conclusions and the rationale of the recommendation.

Reasons for the variation of the terms of the marketing authorisation(s)
Based on the scientific conclusions for fezolinetant, the CHMP considers that the benefit-risk balance of the medicinal product containing fezolinetant remains unchanged, subject to the proposed changes to the product information.

The CHMP recommends the variation of the terms of the marketing authorisation(s).