Veoza 45 mg film-coated tablets

• 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.

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

• 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 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.
• if you are pregnant or think you may be pregnant.

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.
• 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.

Do not give this medicine to children and adolescents under 18 years of age, because this medicine is only for menopausal women.

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)

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.

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

• 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 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 a forgotten individual dose.

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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is 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 45 mg tablets are round, light red, film-coated tablets (tablets) debossed with the company logo and ‘645’ on the same side.

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

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

Not all pack sizes may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Free call from Northern Ireland: 0800 783 5018