Ontozry

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

cenobamate

Available from:

Angelini Pharma S.p.A

ATC code:

N03AX

INN (International Name):

cenobamate

Therapeutic group:

Antiepileptics,

Therapeutic area:

Epilepsy

Therapeutic indications:

Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2021-03-26

Patient Information leaflet

41
B. PACKAGE LEAFLET
42
PACKAGE 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. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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.
WHAT IS IN THIS LEAFLET
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
1.
WHAT ONTOZRY IS AND WHAT IT IS USED FOR
Ontozry contains the active substance cenobamate. It belongs to a
group of medicines called ‘anti-
epileptics’. These medicines are used to treat epilepsy, a condition
where someone has seizures or fits
because of abnormal activity in the brain.
Ontozry is used in combination with other antiepileptic medicines in
adult patients with epilepsy who
have not been adequately controlled despite a history of treatment
with at least 2 anti-epileptic
products, to treat a type of epilepsy that has focal-onset seizures
with or without secondary
generalisation. Focal-onset seizures are those caused by abnormal
brain activity starting in a part of the
brain on one side, and secondary generalisation means that that the
ab

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
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
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ontozry 12.5 mg tablets
Each tablet contains 12.5 mg cenobamate.
Ontozry 25 mg film-coated tablets
Each film-coated tablet contains 25 mg cenobamate.
Ontozry 50 mg film-coated tablets
Each film-coated tablet contains 50 mg cenobamate.
Ontozry 100 mg film-coated tablets
Each film-coated tablet contains 100 mg cenobamate.
Ontozry 150 mg film-coated tablets
Each film-coated tablet contains 150 mg cenobamate.
Ontozry 200 mg film-coated tablets
Each film-coated tablet contains 200 mg cenobamate.
Excipient with known effect
Each 12.5 mg tablet contains 39.7 mg lactose monohydrate.
Each 25 mg film-coated tablet contains 79.3 mg lactose monohydrate.
Each 50 mg film-coated tablet contains 158.7 mg lactose monohydrate.
Each 100 mg film-coated tablet contains 108.7 mg lactose monohydrate.
Each 150 mg film-coated tablet contains 163 mg lactose monohydrate.
Each 200 mg film-coated tablet contains 217.4 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ontozry 12.5 mg tablet
3
Tablet
Ontozry 25 mg, 50 mg, 100 mg, 150 mg and 200 mg film-coated tablet
Film-coated tablet
Ontozry 12.5 mg tablet
Uncoated round white to off-white tablet with AV on one side and
‘12’ on the other side
Ontozry 25 mg film-coated tablet
Film-coated round brown tablet with AV on one side and ‘25’ on the
other side
Ontozry 50 mg film-coated tablet
Film-coated round yellow tablet with AV on one side and ‘50’ on
the other side
Ontozry