Veoza

• Reduces hot flashes and night sweats
• Non-hormonal medicine
• Tablets for oral use
• For menopausal women only
• Do not use while pregnant or breastfeeding

The doctor may ask you to upload additional documents and accompanying results in order to assess your health. Specifically, the alanine transaminase (ALT) test, aspartate aminotransferase (AST) test and bilirubin test (liver function test).

Veoza is a medicine used in menopausal women to reduce symptoms associated with menopause, such as hot flashes or night sweats. Menopause is the period in a woman's life that occurs a few years before and after her last period.

Hot flashes and night sweats are accompanied by a sudden rise in body temperature and excessive sweating. Also, the skin of the neck and face may turn red, as if blushing. Before menopause, there is a balance between oestrogens, a female sex hormone, and a protein made by the brain that regulates the brain’s temperature control centre. During menopause, oestrogen levels decline and this balance is disrupted, which can lead to these symptoms.

The active ingredient fezolinetant acts on the temperature control centre in the brain. By doing so, Veoza reduces the number and intensity of hot flashes and night sweats.

Veoza is a non-hormonal medicine.

Take this medicine at about the same time each day. Swallow the tablet whole with liquids. Do not break, crush or chew the tablet. Veoza can be taken with or without food.

Dosage

Dosage should be determined by a doctor.

The general recommended dose is:

• One 45mg tablet once a day, by mouth.

Veoza is not suitable for use in children and only intended for use in menopausal women. If you have any further questions on the use of this medicine, contact your doctor or pharmacist.

Alcohol/driving

This medicine does not interact with alcohol.

Veoza has no significant influence on the ability to drive and use machines.

Taken too much/forgot to take/stop taking Veoza

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 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 the forgotten one. If you miss several doses, tell your doctor and follow the advice given to you.

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.

Do not take Veoza if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Veoza contains').
• You use 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.
• You are pregnant or think you may be pregnant.

When should this medicine be used with caution?

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. Your doctor may want to monitor your liver enzymes periodically.
• You have kidney problems. Your doctor may not prescribe this medicine to you.
• If you currently have or previously had breast cancer or another oestrogenrelated 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.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby. 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.

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).

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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 pain (abdominal pain).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

The active substance is fezolinetant. Each film-coated tablet contains 45 mg of fezolinetant.

Read the package leaflet before use.