Leaflet: information for the patient

Ontozry 12.5 mg tablets

Ontozry 25 mg film-coated tablets

Ontozry 50 mg film-coated tablets

Ontozry 100 mg film-coated tablets

Ontozry 150 mg film-coated tablets

Ontozry 200 mg film-coated tablets

cenobamate

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully before starting to take this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist,even if they are adverse effects that do not appear in this leaflet. See section 4.

1.What is Ontozry and what it is used for

2.What you need to know before starting to take Ontozry

3.How to take Ontozry

4.Possible adverse effects

5.Storage of Ontozry

6.Contents of the pack and additional information

Ontozry contains the active ingredient cenobamate. It belongs to a group of medications called “antiepileptics”. These medications are used to treat epilepsy, a condition that causes seizures or epileptic attacks due to abnormal activity in the brain.

Ontozry is used in combination with other antiepileptic medications in adult patients with epilepsy in whom sufficient control has not been achieved despite having received treatment with at least 2 antiepileptic medications, to treat a type of epilepsy that is characterized by focal seizure onset, with or without secondary generalization. Focal seizures are those caused by abnormal brain activity that begins in one part of the brain located on one side, and secondary generalization means that this abnormal activity spreads to both sides of the brain. This medication can only be used in adults.

Do not take Ontozry

-if you are allergic to cenobamate or any of the other components of this medication

(listed in section 6).

-if you were born with heart problems, with changes in heart electrical activity,

related to a rare disease called familial short QT syndrome.

Warnings and precautions

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

-You have thoughts of harming yourself or taking your life. Some people treated with antiepileptic medications, such as Ontozry, have had thoughts of harming themselves or taking their life. If you ever have thoughts of this type, contact your doctor immediately.

-You experience a severe skin reaction, which may be accompanied by fever and other symptoms similar to the flu, facial rash, rash that spreads to other parts of the body, swollen lymph nodes; and elevated 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 is not recommended, as it has not been investigated in this group.

Other medications and Ontozry

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking Ontozry with other medications may affect the functioning of these medications or the functioning of Ontozry. Do not start using or stop using other medications without consulting your doctor or pharmacist first.

Inform your doctor if you are using any of the following medications, as it may be necessary to adjust your dose:

-Sleeping aids, such as barbiturates or benzodiazepines.

-Other medications for treating epilepsy, such as clobazam, phenytoin, and phenobarbital, lamotrigine.

-Birth control medications (oral contraceptives), as they may be less effective when combined with Ontozry. Your doctor may prescribe alternative methods for preventing pregnancy while taking this medication and for up to 4 weeks after stopping treatment with this medication.

-Medications that are metabolized in the body by specific groups of enzymes, such as midazolam (a medication used to stop seizures [epileptic], acute and prolonged, for sedation, and for sleep disorders), bupropion (a medication used to try to quit smoking), omeprazole (a medication used to treat heartburn or stomach ulcers), baricitinib (a medication used to treat inflammatory joint pain or eczema), cefaclor (an antibiotic), empagliflozina (a medication used to treat elevated blood sugar in diabetes, benzylenicillin (an antibiotic), ritobegrón (a medication used to treat overactive bladder), sitagliptina (a medication used to control elevated blood sugar in diabetes).

Use of Ontozry with alcohol

Do not take this medication with alcohol. Ontozry may potentiate the effects of alcohol, such as fatigue or drowsiness, and therefore should not be consumed while taking Ontozry.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. During pregnancy, take Ontozry only if you and your doctor decide it is absolutely necessary. You will need to use effective birth control methods while taking cenobamate and for up to 4 weeks after stopping treatment with this medication. Ask your doctor for advice on effective birth control methods.

You should stop breastfeeding while taking Ontozry.

Driving and operating machinery

-You may experience drowsiness, dizziness, fatigue, and may experience a decrease in visual ability while taking Ontozry.

-These effects are more likely to occur at the beginning of treatment or after an increase in dose.

-You should not drive vehicles, cycle, or use tools or machines if your reaction time has been reduced and until you know how the medication affects you.

Ontozry contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You will take Ontozry along with other medications 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 two weeks, and then one 25 mg tablet once a day for the next two weeks. Your dose will then be adjusted gradually every two weeks until you reach the optimal dose for you. Your doctor will calculate the daily dose that is right for you, which may need to be adjusted over time.

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

Administration Form

You should take the recommended dose once a day at approximately the same time. You can take Ontozry at any time of day or night, with food or between meals.

You should 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

Consult your doctor. You may feel dizzy, tired, and drowsy.

If you forget to take Ontozry

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

If you interrupt treatment with Ontozry

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

-Severe skin reaction that may be accompanied by fever and other symptoms similar to the flu, facial rash, rash that spreads to other parts of the body, or inflammation of the lymph nodes (enlargement of lymph nodes). Elevated levels of liver enzymes and a type of white blood cell (eosinophilia) in blood tests.

In addition, this medicine may cause the following side effects. Inform your doctor if you experience any of the following:

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

-drowsiness, sedation, or extreme fatigue (exhaustion)

-sensation of dizziness

-sensation of spinning (vertigo)

-problems with coordinating movements, problems with walking or maintaining balance (ataxia, gait disturbance, and abnormal coordination)

-headache

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

-memory impairment, confusion

-excitability

-difficulty 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 extremities

-elevation of certain liver enzymes in blood tests

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

-allergic reactions

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ontozry

-The active ingredient is cenobamate.

A 12.5 mg Ontozry tablet contains 12.5 mg of cenobamate.

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

-The other components 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: indigo carmine lake (E132), iron oxide red (E172), iron oxide yellow (E172), macrogol, partially hydrolyzed polyvinyl alcohol (E1203), talc (E553b), and titanium dioxide (E171)

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

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

Appearance of the product and contents of the package

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

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

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

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

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

Ontozry 200 mg are oval-shaped, film-coated tablets, light orange in color, 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 film-coated tablets of 25 mg.

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

Only some package sizes may be marketed.

Marketing authorization holder

Angelini Pharma S.p.A

Viale Amelia 70, 00181

Roma - Italy

Responsible for manufacturing

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

Last review date of this leaflet:…….

Other sources of information

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