Prospect: information for the user

Veoza 45mg film-coated tablets

fezolinetant

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part ofsection4 includesinformation on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, becauseit contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

Veoza contains the active ingredient fezolinetant. Veoza is a non-hormonal medication 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 made by the brain called neurokinin B (NKB) that regulates the brain's temperature control center. As the body goes through menopause, estrogen levels decrease and this balance is disrupted, which can cause VMS. By blocking NKB binding in the temperature control center, Veoza reduces the frequency and intensity of hot flashes and night sweats.

Do not take Veoza

• if you are allergic to fezolinetant or any of the other components of this medication (listed in section6).
• with medications known as moderate or potent inhibitors of CYP1A2 (e.g., contraceptives containing ethinylestradiol, mexiletine, enoxacine, fluvoxamine). These medications may reduce the degradation of Veoza in the body, leading to more adverse effects. See “Other medications and Veoza” below.
• if you are pregnant or think you may be pregnant.

Warnings and precautions

Before starting to take 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 subsequently at regular intervals if your doctor advises.

Consult your doctor or pharmacist before starting to take Veoza

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

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

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

You can find the list of symptoms associated in section4. Possible adverse effects.

Children and adolescents

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

Other medications and Veoza

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

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

• Fluvoxamine (a medication used to treat depression and anxiety)
• Enoxacine (a medication used to treat infections)
• Mexiletine (a medication used to treat muscle stiffness symptoms)
• Contraceptives containing ethinylestradiol (medications used to prevent pregnancy)

Pregnancy and breastfeeding

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

Driving and operating machinery

Veozahas no effect on the ability to drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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 medication 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

Ifyou have taken more tablets than indicated or if someone has taken them accidentally, contact your doctor or pharmacist immediately.

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

If You Forget to Take Veoza

If you forget to take your medication, take the missed dose as soon as you remember,unless there are less than 12 hours left until the next scheduled dose. If there are less than 12 hours left until the 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 missed dose.

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

If You Interrupt Treatment with Veoza

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Some adverse effects (e.g., liver damage) can be severe.

Inform your doctor immediately if you experience any of the following adverse effects:

-fatigue, itching on the skin, yellow discoloration 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 unknown, since it cannot be estimated from available data).

Frequent(may affect 1 in 10people)

-diarrhea

-difficulty sleeping (insomnia)

-increased levels of certain liver enzymes (ALT or AST), as shown by blood tests

-stomach pain (abdominal)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for preservation.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Veoza

• The active ingredient is fezolinetant. Each film-coated tablet contains 45mg of fezolinetant.
• The other components are:

Core of the tablet: mannitol (E421), hydroxypropylcellulose (E463), hydroxypropylcellulose of low substitution (E463a), microcrystalline cellulose (E460), magnesium stearate (E470b).

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

Appearance of Veoza and packaging content

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

Veoza is available in single-dose blisters of PA/Aluminum/PVC/Aluminum in boxes.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Astellas Pharma Europe B.V.

Sylviusweg62

2333BELeiden

Netherlands

Responsible for manufacturing

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet

The detailed information about this medication is available on the website of the European Medicines Agency:https://www.ema.europa.eu.