Veoza Film-coated Tablets (45mg) (ON HOLD)

What Veoza is and what it is used for?

Veoza contains fezolinetant as its active ingredient. It is a non-hormonal medication designed for menopausal women to alleviate moderate-to-severe vasomotor symptoms (VMS) related to menopause, commonly referred to as hot flashes or night sweats.

Prior to menopause, there is a balance between oestrogen, a female hormone, and neurokinin B (NKB), a protein produced by the brain that regulates the body's temperature control centre.

During menopause, oestrogen levels decrease, disrupting this balance and potentially leading to VMS.

Veoza works by obstructing the binding of NKB in the temperature control centre of the brain, thereby decreasing the frequency and intensity of hot flashes and night sweats.

What are Vasomotor Symptoms?

Vasomotor symptoms are a common aspect of menopause and can be quite bothersome for many women. These symptoms are primarily associated with the body's regulation of blood vessels and include hot flashes and night sweats.

• Hot Flashes: Hot flashes are the most well-known vasomotor symptom of menopause. They involve sudden feelings of heat, usually felt in the face, neck, and chest. The skin may become flushed or red, and sweating may occur. Hot flashes can be mild or intense and can last from a few seconds to several minutes. They can occur sporadically throughout the day and night, disrupting sleep and daily activities.
• Night Sweats: Night sweats are similar to hot flashes but occur specifically during sleep. They can lead to waking up drenched in sweat, which can disrupt sleep patterns and cause discomfort.

Vasomotor symptoms are believed to be caused by hormonal changes, particularly fluctuations in oestrogen levels, that occur during menopause. The exact mechanism is not fully understood, but it's thought that oestrogen plays a role in regulating body temperature, and its decline during menopause may disrupt this process, leading to hot flashes and night sweats.

These symptoms can vary in frequency and severity from woman to woman. Some women may experience mild symptoms that are easily manageable, while others may find them to be more severe and disruptive to their quality of life. Treatment options for vasomotor symptoms include hormone replacement therapy (HRT), non-hormonal medications, lifestyle changes, and alternative therapies like acupuncture or herbal remedies. It's important for women experiencing these symptoms to discuss their options with a healthcare provider to find the most appropriate treatment for their individual situation.

What are the benefits of Veoza vs traditional HRT treatments?

Why choose Veoza or traditional HRT treatments?

For some people, HRT is an unsuitable treatment. This could be for a variety of reasons, for example women with a history of certain cancers, blood clots, or liver disease may not be eligible.

Veoza can offer a suitable alternative for these women who still seek relief from vasomotor symptoms. It is important to note that Veoza comes with its own risks and side effects, so it is always important to speak to your doctor or pharmacist before you start taking either treatment.

Benefits of Veoza over HRT

As Veoza is non-hormonal it avoids potential side effects related to hormonal fluctuations. Furthermore as Veoza focuses on the root cause of hot flashes and night sweats without affecting other bodily functions, it has the potential to elicit fewer side effects, and the side effects which it does cause have so far been observed to be milder than those associated with traditional HRT.

Veoza warnings

If you have any questions after reading the patient information leaflet contained within the packet, 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.

Do not take Veoza:

• If you are allergic to fezolinetant or any of the other ingredients of this medicine
• With 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.

Talk to your doctor or pharmacist before taking Veoza:

• If 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
• If you have kidney problems. Your doctor may not prescribe this medicine to you
• If you currently have or previously had breast cancer or another oestrogen related 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

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.

Pregnancy and breast-feeding: Do not take this medicine if you are pregnant or breast-feeding, or if you think you might be pregnant. 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.

Driving and using machines: Veoza has no effect on the ability to drive or use machines.

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

How to take Veoza

Always take this medicine exactly as your doctor or pharmacist has told you. The recommended dose is one 45 mg tablet taken by mouth once daily.

Instructions for proper use:

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

If you take more Veoza than you should: 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).

What should you do if you forget to take your dose: 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 a forgotten individual dose. If you miss several doses, tell your doctor and follow the advice given to you.

If you stop taking Veoza: 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. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Veoza ingredients

Veoza contains the active substance fezolinetant. Each film-coated tablet contains 45 mg of fezolinetant.

The other ingredients are:

Tablet core: mannitol (E421), hydroxypropyl cellulose (E463), low substituted hydroxypropyl cellulose (E463a), microcrystalline cellulose (E460), magnesium stearate (E470b).

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

Veoza side effects

Possible side effects: 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 (abdominal) pain