Lacosamid Jubilant 50 mg Filmtabletten - Zusammengefasste Informationen

Zusammenfassung des Risikomanagement-Plans gemäß § 34Zusammenfassung des Risikomanagement-Plans gemäß § 34

Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the

Medicinal Products Act(2)

Lacosamid Jubilant 50 mg Filmtabletten

Lacosamid Jubilant 100 mg Filmtabletten

Lacosamid Jubilant 150 mg Filmtabletten

Lacosamid Jubilant 200 mg Filmtabletten

Administrative Information:

Wirkstoff	Lacosamid
ATC-Code	N03AX18
Darreichungsform	Filmtablette
Art der Anwendung	zum Einnehmen
Inhaber der Zulassung	Jubilant Pharmaceuticals NV Axxes Business Park, Guldensporenpark 22, Blok C 9820 MERELBEKE Belgien
Zulassungsnummern	2204005.00.00 2204006.00.00 2204007.00.00 2204008.00.00
Datum der Zulassung	11.02.2022
Verkaufsabgrenzung	verschreibungspflichtig
Version und Datum des Risikomanagement-Plans	1.1 / 30.08.2019
Datum der Genehmigung des RMPs	11.02.2022

Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) der o. g. Arzneimittel ist eine Zusammenfassung der wesentlichen Inhalte des RMP. Der RMP beschreibt die zu ergreifenden Maßnahmen zur Arzneimittelsicher­heit, die Aktivitäten im Risikomanagement und in der Risikoanalyse um sicherzustellen, dass diese Arzneimittel so sicher wie möglich angewendet werden.

Weitere Informationen zu RMP-Zusammenfassungen finden Sie(nur auf Englisch verfügbar).

Diese RMP-Zusammenfassung sollte in Verbindung mit der Zusammenfassung des öffentlichen Bewertungsberichts und der Produktinformation zu o. g. Arzneimitteln gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bundfinden können.

Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 03. März 2022 veröffen­tlicht.

(1)

(2)

Part VI: Summary of the risk management plan

This is a summary of the risk management plan (RMP) for Lacosamide Jubilant. The RMP details important risks of Lacosamide Jubilant, how these risks can be minimised, and how more information will be obtained about Lacosamide risks and uncertainties (missing information).

Lacosamide Jubilant summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Lacosamide Jubilant 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets should be used.

I.    The medicine and what it is used for

Lacosamide Jubilant 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets is authorised for treatment of treatment of partial-onset seizures with or without secondary generalisation (see SmPC for the full indication). It contains Lacosamide as the active substance and it is given by oral route.

II.    Risks associated with the medicine and activities to minimise or further characterise the risksII. Risks associated with the medicine and activities to minimise or further characterise the risks

Important risks of Lacosamide Jubilant, together with measures to minimise such risks for learning more about Lacosamide Jubilant risks, are outlined below.

Measures to minimise the risks identified for medicinal products can be:

Specific information, such as warnings, precautions, and advice on correct use, in the package leaflet and SmPC addressed to patients and healthcare professionals; Important advice on the medicine’s pac­kaging; The authorised pack size — the amount of medicine in a pack is chosen so to ensure that the medicine is used correctly; The medicine’s legal status — the way a medicine is supplied to the patient (e.g. with or without prescription) can help to minimise its risks.

Together, these measures constitute routine risk minimisation measures.

II.A List of important risks and missing information

Important risks of Lacosamide Jubilant are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely administered. Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of Lacosamide Jubilant. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected (e.g. on the long-term use of the medicine);

List of important risks and missing information

Important identified risks	Cardiac AEs that may be potentially associated with PR interval prolongation and sodium channel modulation Suicidality as an antiepileptic product Dizziness
Important potential risks	Potential for hepatotoxicity Potential for worsening of seizures Potential for abuse as a CNS-active product Potential for off-label use of a loading dose in acute conditions such as status epilepticus
Missing information	Use in pregnant or lactating women Paediatric patients

II.B Summary of important risks

The safety information in the proposed Product Information is aligned to the reference medicinal product.