Ontozry 100 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 Ontozry is and what it is used for
2. What you need to know before you take Ontozry
3. How to take Ontozry
4. Possible side effects
5. How to store Ontozry
6. Contents of the pack and other information

• if you are allergic to cenobamate or any of the other ingredients of this medicine (listed in section 6).
• you were born with heart problems, with changes in the electrical activity of the heart, related to a rare condition called familial short-QT syndrome.

Talk to your doctor or pharmacist before taking Ontozry or during treatment if:

• you have thoughts of harming or killing yourself. A few people being treated with anti-epileptic medicines such as Ontozry have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, contact your doctor immediately.
• you have a serious skin reaction which may include high temperature and other flu-like symptoms, rash on the face, rash spreading to other parts of the body, swollen glands (enlarged lymph nodes); and blood tests showing increased levels of liver enzymes and of a type of white blood cell (eosinophilia).

Ontozry is not recommended in children and adolescents under 18 years, as it was not investigated in this group.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Ontozry with certain other medicines may affect how the other medicines work or how Ontozry works. Do not start or stop other medicines without talking to your doctor or pharmacist.

Tell your doctor if you are taking any of the following medicines, as your dose may need to be adjusted:

• medicines used to help you fall asleep such as barbiturates and benzodiazepines.
• other medicines to treat epilepsy, such as clobazam, phenytoin and phenobarbital, lamotrigine.
• birth control medicines (oral contraceptives) as these may be less effective when combined with Ontozry. Your doctor may prescribe alternative methods for preventing pregnancy while you take this medicine and up to 4 weeks after you stop taking this medicine.
• medicines, which are known to be transformed in the body by specific groups of enzymes such as midazolam (a medicine used to stop prolonged, acute (sudden) convulsive seizures, for sedation and sleep problem), bupropion (a medicine used to help stop smoking), omeprazole (a medicine used to treat heartburn or stomach ulcer), baricitinib (a medicine used to treat painful inflammation of the joints or skin eczema), cefaclor (an antibiotic), empagliflozin (a medicine used to treat high blood glucose in diabetes), penicillin G (an antibiotic), ritobegron (a medicine used to treat overactive bladder), sitagliptin (a medicine used to control high blood glucose in diabetes).

Do not take this medicine with alcohol. Ontozry can increase the effects of alcohol such as feeling tired or sleepy and you should not drink alcohol with this medicine.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before you take this medicine.

Only take Ontozry during pregnancy if you and your doctor decide that it is absolutely necessary. You must use effective contraception during use of cenobamate and until 4 weeks after you stop taking this medicine. Ask your doctor for advice regarding effective measures of birth control.

You should stop breast-feeding while taking Ontozry.

• You may feel sleepy, dizzy or tired, and your vision may be reduced while taking Ontozry.
• These effects are more likely at the start of the treatment or after your dose is increased.
• Do not drive, cycle or use any tools or machines if your reaction are slowed down and until you know how the medicine affects you.

If you have been told by your doctor that you have an intolerance to some sugars, speak with your doctor before taking this medicine.

You will start Ontozry with a daily dose of one 12.5 mg tablet for the first 2 weeks, followed by one 25 mg tablet once a day for the next 2 weeks. Then your dose will be gradually adjusted every 2 weeks until you reach the dose that works best. Your doctor will work out the right daily dose for you and may need to adjust it over time.

The recommended daily dose is between 200 mg and 400 mg once daily.

Take the recommended dose once a day at around the same time. You can take Ontozry at any time either during the day or in the evening, with food or between meals.

Swallow the tablets whole with a glass of water. Do not break the tablets in half because the tablets are not suitable for splitting into two equal halves.

Talk to your doctor. You may feel dizzy, tired and sleepy.

Take the forgotten dose as soon as you remember, if fewer than 12 hours have passed since you should have taken it. If more than 12 hours have passed, skip the forgotten dose and take the next dose at your regular time. Do not take a double dose to make up for a forgotten dose.

Do not reduce the dose or stop taking Ontozry without checking with your doctor. Your doctor will explain how to stop taking Ontozry by reducing the dose gradually.

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:

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 cenobamate.
  One Ontozry 12.5 mg tablet contains 12.5 mg cenobamate.
  One Ontozry 25 mg film-coated tablet contains 25 mg cenobamate.
  One 50 mg film-coated tablet contains 50 mg cenobamate.
  One 100 mg film-coated tablet contains 100 mg cenobamate.
  One 150 mg film-coated tablet contains 150 mg cenobamate.
  One 200 mg film-coated tablet contains 200 mg cenobamate.
• The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, sodium starch glycolate, silica colloidal anhydrous (E551), magnesium stearate (E470b)
  25 mg and 100 mg film-coated tablets: indigo carmine aluminium lake (E132), iron oxide red (E172), iron oxide yellow (E172), -macrogol, partially hydrolysed poly(vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171)
  50 mg film-coated tablets: iron oxide yellow (E172), macrogol, partially hydrolysed poly(vinyl alcohol) (E1203), talc, titanium dioxide (E171)
  150 mg and 200 mg film-coated tablets: iron oxide red (E172), iron oxide yellow (E172), macrogol, partially hydrolysed poly(vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171)

Ontozry 12.5 mg are uncoated round white to off-white tablets with AV on one side and ‘12’ on the other side.

Ontozry 25 mg are round brown film-coated tablets with AV on one side and ‘25’ on the other side.

Ontozry 50 mg are round yellow film-coated tablets with AV on one side and ‘50’ on the other side.

Ontozry 100 mg are round brown film-coated tablets with AV on one side and ‘100’ on the other side.

Ontozry 150 mg are round light orange film-coated tablets with AV on one side and ‘150’ on the other side.

Ontozry 200 mg are oval light orange film-coated tablets with AV on one side and ‘200’ on the other side.

Ontozry Treatment Initiation pack contains 14 tablets of 12.5 mg and 14 film-coated tablets of 25 mg.

Ontozry 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets are available in packs of 14, 28 or 84.

Not all pack sizes may be marketed.