Cenobamate: package leaflet

tube.

If you have any further questions, ask your doctor.

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 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.

If you stop taking Ontozry

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 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 immediately if you have any of the following serious side effects:
Rare side effects (may affect up to 1 in 1,000 people):
- a serious skin reaction which may include fever and other flu-like symptoms, a rash on the face, rash spreading to other areas of the body, and swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and of a type of white blood cell (eosinophilia).
Liver disorders
- If you develop a sudden illness particularly if it includes nausea, repeated vomiting, extreme tiredness, abdominal pain, drowsiness, weakness, loss of appetite, upper stomach pain, jaundice (yellowing of the skin or whites of the eyes), unusually dark urine, pale or clay-coloured stools, or bruising more easily than normal. These may be signs of severe liver disorders (see Section 2).

You may get the following other side effects with this medicine. Tell the doctor if you have any of the following:
Very common side effects (may affect more than 1 in 10 people):
- feeling sleepy (somnolence), sedated or very tired (fatigue)
- feeling dizzy
- spinning sensation (vertigo)
- having problems with coordination of movements, having problems walking or keeping your balance (ataxia, gait disturbance, abnormal coordination)
- headache

Common side effects (may affect up to 1 in 10 people):
- reduced memory, confusion
- excitability
- having difficulty in saying words or difficulty speaking
- rapid and uncontrollable movements of the eyes (nystagmus), blurred vision, double vision
- nausea (feeling sick), vomiting, constipation or diarrhoea
- dry mouth
- rash, itching
- swollen eyelids, swollen limbs
- blood tests showing increases in levels of certain liver enzymes

Uncommon side effects (may affect up to 1 in 100 people):
- allergic reactions
- thoughts of harming or killing yourself.

Reporting of side effects
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.
How to store 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 refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What Ontozry contains

- 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 (171)

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)

What Ontozry looks like and contents of the pack

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.

Marketing Authorisation Holder

Angelini Pharma S.p.A
Viale Amelia 70, 00181
Rome – Italy

Manufacturer

Aziende Chimiche Riunite Angelini Francesco ACRAF SPA
Via Vecchia del Pinocchio, 22 60131
Ancona (AN), Italy

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

België/Belgique/Belgien
Angelini Pharma S.p.A.
Tél/Tel: + 32 (0) 80 08 93 39
Lietuva
Angelini Pharma S.p.A.
Tel: + 39 06 78 0531
България
Анджелини Фарма България ЕООД
Teл.: +359 2 975 13 95 office@angelini.bg
Luxembourg/Luxemburg
Angelini Pharma S.p.A.
Tél/Tel: 80085530 lux.intake@angelinipharma.com
Česká republika
Angelini Pharma Česká republika s.r.o.
info@angelini.cz
Magyarország
Angelini Pharma Magyarország Kft.
office@angelini.hu
Danmark
Angelini Pharma Nordics nordic.medinfo@angelinipharma.com
Malta
Angelini Pharma S.p.A.
Tel: + 39 06 78 0531
Deutschland
Angelini Pharma Deutschland GmbH
Tel: 00800 42762727
Nederland
Angelini Pharma S.p.A.
Tel: + 31 (0) 80 00 20 10 77
Eesti
Angelini Pharma S.p.A.
Tel: + 39 06 78 0531
Norge
Angelini Pharma Nordics nordic.medinfo@angelinipharma.com
Ελλάδα
Angelini Pharma Hellas Μονοπρόσωπη ABEE
Tηλ: + 30 210 626 9200 info@angelinipharma.gr
Österreich
Angelini Pharma Österreich GmbH office@angelini.at
España
ANGELINI PHARMA ESPAÑA, S.L.
Tel: +34 932534505
Polska
Angelini Pharma Polska Sp. z o.o.
angelini@angelini.pl
France
Angelini Pharma France
Tél: +33 (0) 1 88 24 70 98 intake.frbene@angelinipharma.com
Portugal
Angelini Pharma Portugal, Unipessoal Lda farmacovigilancia@angelini.pt

Hrvatska
Angelini Pharma S.p.A.
Tel: + 39 06 78 0531
România
Angelini Pharmaceuticals România SRL office@angelini.ro
Ireland
Angelini Pharma UK & Ireland
Tel: +353 (0) 1584 4671
Slovenija
Angelini Pharma S.p.A.
Tel: + 39 06 78 0531
Ísland
Angelini Pharma Nordics nordic.medinfo@angelinipharma.com
Slovenská republika
Angelini Pharma Slovenská republika s.r.o.
office@angelini.sk
Italia
Angelini Pharma S.p.A.
Tel: + 39 071 809 809
Suomi/Finland
Angelini Pharma Nordics nordic.medinfo@angelinipharma.com
Κύπρος
Angelini Pharma Hellas Μονοπρόσωπη ABEE
Tηλ: + 30 210 626 9200 info@angelinipharma.gr
Sverige
Angelini Pharma Nordics nordic.medinfo@angelinipharma.com
Latvija
Angelini Pharma S.p.A.
Tel: + 39 06 78 0531

This leaflet was last revised in

Other sources of information

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

Annex IV
Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Scientific conclusions
Taking into account the PRAC Assessment Report on the PSUR(s) for cenobamate, the scientific conclusions of PRAC are as follows:
In view of available data on cenobamate-associated liver injury from clinical trial(s), the literature and spontaneous reports including in some cases a close temporal relationship, a positive de- challenge and in view of a plausible mechanism of action, the PRAC considers a causal relationship between cenobamate and liver injury is at least a reasonable possibility. The PRAC concluded that the product information of products containing cenobamate should be amended accordingly.
Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Grounds for the variation to the terms of the marketing authorisation(s)
On the basis of the scientific conclusions for cenobamate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing cenobamate is unchanged subject to the proposed changes to the product information The CHMP recommends that the terms of the marketing authorisation(s) should be varied.