VEOZA 45 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Veoza 45mg film-coated tablets

fezolinetant

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because itcontains important information for you.

• 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.

Contents of the pack

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

1. What is Veoza and what is it 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 estrogens, a female sex hormone, and a protein made by the brain called neurokinin B (NKB) that regulates the brain's temperature control center. As your body goes through menopause, estrogen levels decrease and this balance is disrupted, which can cause VMS. By blocking the binding of NKB in the temperature control center, Veoza reduces the number and intensity of hot flashes and night sweats.

2. What you need to know before you take Veoza

Do nottake 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 potent CYP1A2 inhibitors (e.g., contraceptives containing ethinylestradiol, mexiletine, enoxacin, fluvoxamine). These medicines may 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, a blood sample will be taken to check your liver function. This review should be repeated monthly for the first three months of treatment and then at regular intervals, if your doctor indicates.

Talk to your doctor or pharmacist before you start taking Veoza

• your doctor will ask for your complete medical history, including family history.
• if you have liver disease or liver problems.
• if you have kidney problems. Your doctor may not prescribe this medicine for you.
• if you have had or currently have breast cancer or other estrogen-related cancer. During treatment, your doctor may not prescribe this medicine for you.
• if you are being treated with hormone replacement therapy with estrogens (medicines used to treat estrogen deficiency symptoms). Your doctor may not prescribe this medicine for you.
• if you have a history of seizures. Your doctor may not prescribe this medicine for you.

Tell your doctor immediately if you experience any of the following signs and symptoms during treatment with Veoza:

• if you notice signs or symptoms of a liver problem.

You can find the list of associated symptoms in section 4. Possible side effects.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as this medicine is exclusively for postmenopausal women.

Other medicines and Veoza

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Some medicines may increase the risk of Veoza side effects by increasing the amount of Veoza in the blood. These medicines should not be taken during treatment with Veoza and are the following:

• Fluvoxamine (a medicine used to treat depression and anxiety)
• Enoxacin (a medicine used to treat infections)
• Mexiletine (a medicine used to treat muscle stiffness symptoms)
• Contraceptives containing ethinylestradiol (medicines used to prevent pregnancy)

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding, or if you think you may be pregnant. The use of this medicine is exclusively for postmenopausal women. If you become pregnant while taking this medicine, stop taking it immediately and talk to your doctor. Women of childbearing age should use effective non-hormonal contraceptives.

Driving and using machines

Veoza has no effect on the ability to drive or use machines.

3. How to take Veoza

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one 45 mg tablet taken orally once a day.

Instructions for correct use

• Take this medicine every day at the same time.
• Swallow the tablet whole with liquids. 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 should or if someone else has taken your tablets by mistake, contact your doctor or pharmacist immediately.

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

If you forget to take Veoza

If you forget to take your medicine, take the missed dose on the same day as soon as you remember, unless there are less than 12 hours left until your next scheduled dose. If there are less than 12 hours left until your next scheduled dose, do not take the missed dose. Return to your regular schedule the next day. Do not take a double dose to make up for a single missed dose.

If you forget several doses, talk to your doctor and follow their recommendations.

If you stop taking Veoza

Do not stop taking this medicine until your doctor tells you to. If you decide to stop taking this medicine before completing the prescribed treatment course, it is recommended that you first consult your doctor.

If you have any other questions about the use of this medicine, ask 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) can be serious.

Tell your doctor immediately if you experience any of the following side effects:

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

Common(may affect up to 1 in 10 people)

• diarrhea
• difficulty sleeping (insomnia)
• increase in levels of certain liver enzymes (ALT or AST), as shown by blood tests
• stomach pain (abdominal)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Veoza

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 is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

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), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose (E463a), microcrystalline cellulose (E460), magnesium stearate (E470b).

Film coating: hypromellose (E464), talc (E553b), macrogol (E1521), titanium dioxide (E171), red iron oxide (E172).

Appearance of Veoza and pack contents

Veoza 45 mg film-coated tablets are round, light red, film-coated, engraved with the company logo and "645" on the same side.

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

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

Not all pack sizes may be marketed.

Marketing authorization holder

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

You can request more information about this medicine from the local representative of the marketing authorization holder:

Date of last revision of this leaflet

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