ONTOZRY 12.5 mg TABLETS + ONTOZRY 25 mg FILM-COATED TABLETS

2. What you need to know before you take Ontozry

Do not take Ontozry

• if you are allergic to cenobamate or any of the other ingredients of this medicine

(listed in section 6).

• if you were born with heart problems, with changes in the electrical activity of the heart,

related to a rare disease called short QT syndrome.

Warnings and precautions

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

• You have thoughts of harming yourself or of killing yourself. Some people treated with antiepileptic medicines, such as Ontozry, have had thoughts of harming themselves or of killing themselves. If at any time you have these thoughts, contact your doctor immediately.
• You experience a severe skin reaction, which can occur with fever and other symptoms similar to those of the flu, rash on the face, rash that spreads to other areas of the body, swollen glands (enlarged lymph nodes); and elevated levels of liver enzymes and a type of white blood cell (eosinophilia) in blood tests.

Children and adolescents

The use of Ontozry in children and adolescents under 18 years of age is not recommended, as it has not been investigated in this group.

Other medicines and Ontozry

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

Taking Ontozry with other medicines can affect the way these medicines work or the way Ontozry works. Do not start using or stop using other medicines without consulting your doctor or pharmacist first.

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

• Medicines to help you fall asleep, such as barbiturates or benzodiazepines.
• Other medicines to treat epilepsy, such as clobazam, phenytoin, and phenobarbital, lamotrigine.
• Contraceptives (oral contraceptives), as they may be less effective when combined with Ontozry. Your doctor may prescribe alternative methods to prevent pregnancy while taking this medicine and up to 4 weeks after stopping treatment with this medicine.
• Medicines that are broken down in the body by specific groups of enzymes, such as midazolam (a medicine used to stop seizures, for sedation, and for sleep disorders), bupropion (a medicine used to try to quit smoking), omeprazole (a medicine used to treat heartburn or stomach ulcers), baricitinib (a medicine used to treat painful and swollen joints or eczema), cefaclor (an antibiotic), empagliflozin (a medicine used to treat high blood sugar in diabetes), benzylpenicillin (an antibiotic), ritobegrone (a medicine used to treat overactive bladder), sitagliptin (a medicine used to control high blood sugar in diabetes).

Using Ontozry with alcohol

Do not take this medicine with alcohol. Ontozry may increase the effects of alcohol, such as drowsiness or sleepiness, and therefore, you should not drink alcohol if you take Ontozry.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. During pregnancy, take Ontozry only if you and your doctor decide that it is absolutely necessary. You should use effective contraceptive methods while taking cenobamate and up to 4 weeks after stopping treatment with this medicine. Ask your doctor to advise you on effective contraceptive methods.

You must stop breastfeeding while taking Ontozry.

Driving and using machines

• You may experience drowsiness, dizziness, fatigue, and may experience decreased visual ability while taking Ontozry.
• These effects are more likely at the start of treatment or after a dose increase.
• Do not drive vehicles, ride bicycles, or use tools or machines if your reaction ability is reduced and until you know how the medicine affects you.

Ontozry contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Ontozry

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

You will take Ontozry with other medicines to treat epilepsy.

The recommended dose is

You will start treatment with Ontozry by taking one 12.5 mg tablet per day for the first 2 weeks and then one 25 mg tablet per day for the next 2 weeks. After that, the dose will be gradually adjusted every 2 weeks until you reach the optimal dose for you. Your doctor will calculate the daily dose suitable for you, which may need to be adjusted over time.

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

Method of administration

Take the recommended dose once a day, approximately at the same time. You can take Ontozry at any time of day or night, with or without food.

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

If you take more Ontozry than you should

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

If you forget to take Ontozry

Take the missed dose as soon as you remember, if it is less than 12 hours since you were supposed to take it. If it is more than 12 hours, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Ontozry

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

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

4. Possible side effects

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

Tell your doctor immediatelyif you experience any of the following serious side effects: Rare side effects(may affect up to 1 in 1000 people):

• Severe skin reaction that can occur with fever and other symptoms similar to those of the flu, rash on the face, rash that spreads to other areas of the body or swollen glands (enlarged lymph nodes). Elevated levels of liver enzymes and a type of white blood cell (eosinophilia) in blood tests.

Additionally, this medicine can cause the following side effects. Tell your doctor if you experience any of the following:

Very common side effects(may affect more than 1 in 10 people):

• drowsiness (somnolence), sedation, or great fatigue (exhaustion)
• feeling of dizziness
• feeling that everything is spinning (vertigo)
• problems with coordinating movements, problems with walking or maintaining balance (ataxia, gait disturbance, and coordination abnormality)
• headache

Common side effects(may affect up to 1 in 10 people):

• decreased memory, confusion
• excitability
• problems with pronouncing words or difficulty speaking
• rapid, involuntary eye movements (nystagmus), blurred vision, double vision
• nausea (dizziness), vomiting, constipation, or diarrhea
• dry mouth
• rash, itching
• swelling of the eyelids, swelling of the limbs
• elevated levels of certain liver enzymes in blood tests

Uncommon side effects(may affect up to 1 in 100 people):

• allergic reactions

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ontozry

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ontozry

• The active substance is cenobamate.

One Ontozry 12.5 mg tablet contains 12.5 mg of cenobamate.

One Ontozry 25 mg film-coated tablet contains 25 mg of cenobamate. One 50 mg film-coated tablet contains 50 mg of cenobamate. One 100 mg film-coated tablet contains 100 mg of cenobamate. One 150 mg film-coated tablet contains 150 mg of cenobamate. One 200 mg film-coated tablet contains 200 mg of cenobamate.

• The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, sodium starch glycolate, anhydrous colloidal silica (E551), and magnesium stearate (E470b).

25 mg and 100 mg film-coated tablets: carmine indigo lake (E132), red iron oxide (E172), yellow iron oxide (E172), macrogol, partially hydrolyzed polyvinyl alcohol (E1203), talc (E553b), and titanium dioxide (E171)

50 mg film-coated tablets: yellow iron oxide (E172), macrogol, partially hydrolyzed polyvinyl alcohol (E1203), talc (E553b), and titanium dioxide (E171)

150 mg and 200 mg film-coated tablets: red iron oxide (E172), yellow iron oxide (E172), macrogol, partially hydrolyzed polyvinyl alcohol (E1203), talc (E553b), and titanium dioxide (E171)

Appearance and packaging

Ontozry 12.5 mg are white to off-white, round, uncoated tablets marked with “AV” on one side and “12” on the other.

Ontozry 25 mg are brown, round, film-coated tablets marked with “AV” on one side and “25” on the other.

Ontozry 50 mg are yellow, round, film-coated tablets marked with “AV” on one side and “50” on the other.

Ontozry 100 mg are brown, round, film-coated tablets marked with “AV” on one side and “100” on the other.

Ontozry 150 mg are light orange, round, film-coated tablets marked with “AV” on one side and “150” on the other.

Ontozry 200 mg are light orange, oval, film-coated tablets marked with “AV” on one side and “200” on the other.

The starter pack of Ontozry contains 14 tablets of 12.5 mg and 14 tablets of 25 mg film-coated.

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Angelini Pharma S.p.A

Viale Amelia 70, 00181

Rome - Italy

Manufacturer

Swiss Caps GmbH

Grassingerstrasse 9

83043 Bad Aibling

Germany

Aziende Chimiche Riunite Angelini Francesco ACRAF SPA

Via Vecchia del Pinocchio, 22 60100

Ancona (AN), Italy

Date of last revision of this leaflet: …….

Other sources of information

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