Veoza 45 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Veoza 45mg film-coated tablets

fezolinetant

This medicine is subject to additional monitoring, which will allow for quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the 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 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 estrogens, a female sex hormone, and a protein produced by the brain called neurokinin B (NKB), which regulates the brain's temperature control center. As your body goes through menopause, estrogen levels decrease and this balance is disrupted, which may trigger VMS. By blocking the binding of NKB to the temperature control center, 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 breakdown of Veoza in your body, leading to more side effects. See "Other medicines and Veoza" below.
• if you are pregnant or think you might be pregnant.

Warnings and precautions

Before starting Veoza, a blood sample will be taken to monitor your liver function. This check should be repeated monthly during the first three months of treatment and then at regular intervals, as directed by your doctor.

Talk to your doctor or pharmacist before taking Veoza if:

• your doctor needs your complete medical history, including family history.
• you have liver disease or liver problems.
• you have kidney problems. Your doctor may decide not to prescribe this medicine.
• you have had or currently have breast cancer or another estrogen-related cancer. Your doctor may decide not to prescribe this medicine during treatment.
• you are undergoing estrogen hormone replacement therapy (medicines used to treat symptoms of estrogen deficiency). Your doctor may decide not to prescribe this medicine.
• you have a history of seizures. Your doctor may decide not to prescribe this medicine.

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 liver problems.

A list of associated symptoms can be found in section 4. Possible side effects.

Children and adolescents

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

Other medicines and Veoza

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

Some medicines may increase the risk of side effects from Veoza by increasing 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 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 might be pregnant. This medicine is intended exclusively for menopausal women. If you become pregnant while taking this medicine, stop taking it immediately and consult your doctor. Women of childbearing potential must use effective non-hormonal contraception.

Driving and using machines

Veoza has no effect on the ability to drive or operate machinery.

3. How to take Veoza

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Instructions for correct use

• Take this medicine every day at about the same time.
• Swallow the tablet whole with liquid. Do not break, crush, or chew the tablet.
• You may take it with or without food.

If you take more Veoza than you should

If you have taken more tablets than prescribed or if someone else has taken them accidentally, contact your doctor or pharmacist immediately.

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

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 remaining until your next scheduled dose. If there are less than 12 hours until your next scheduled dose, do not take the missed dose. Resume your regular dosing schedule the following day. Do not take a double dose to make up for a missed single dose.

If you miss several doses, consult your doctor and follow their advice.

If you stop taking Veoza

Do not stop taking this medicine unless instructed by your doctor. If you decide to stop taking this medicine before completing the prescribed course of treatment, it is recommended to consult your doctor first.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Some adverse effects (e.g. liver damage) may be serious.

Immediately tell your doctor if you experience any of the following adverse effects:

• tiredness, 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, as it cannot be estimated from the available data).

Frequent (may affect up to 1 in 10 people)

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Veoza

• 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).

Appearance of Veoza and contents of the pack

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

Veoza is available in unit-dose blisters of PA/Aluminium/PVC/Aluminium in carton packs.

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

Only some 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:

Date of the most recent review of this summary

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

Annex IV

Scientific Conclusions and Reasons for the Modification of the Marketing Authorisation(s) Conditions

Scientific Conclusions

Taking into account the findings of the Pharmacovigilance Risk Assessment Committee (PRAC) Assessment Report on the Periodic Safety Update Reports (PSURs) for fezolinetant, the PRAC's scientific conclusions are as follows:

In view of the available data from clinical trials and the information provided in this PSUSA (single assessment of periodic safety update reports), the PRAC recommended the removal of the information on the incidence rates of ALT/AST elevations calculated from pooled clinical trial data in section 4.8 of the Summary of Product Characteristics, due to the heterogeneity of the fezolinetant clinical trials and because it was determined that this information does not provide additional relevant value for healthcare professionals. Consequently, the asterisk in the corresponding cell in the adverse reactions table will also be removed.

After reviewing the PRAC recommendation, the CHMP agrees with the general conclusions and reasoning of the PRAC.

Reasons for the Modification of the Marketing Authorisation(s) Conditions

In accordance with the scientific conclusions for fezolinetant, the CHMP considers that the benefit-risk balance of the medicinal product(s) containing fezolinetant remains unchanged under the proposed modifications to the product information.

The CHMP recommends that the terms of the marketing authorisation(s) be amended.