Eslicarbazepin Jubilant 800 mg Tabletten - 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)

Eslicarbazepin Jubilant 200 mg Tabletten

Eslicarbazepin Jubilant 400 mg Tabletten

Eslicarbazepin Jubilant 600 mg Tabletten

Eslicarbazepin Jubilant 800 mg Tabletten

Administrative Information:

Wirkstoff	Eslicarbazepi­nacetat
ATC-Code	N03AF04
Darreichungsform	Tablette
Art der Anwendung	zum Einnehmen
Inhaber der Zulassung	Jubilant Pharmaceuticals NV Axxes Business Park, Guldensporenpark 22, Blok C 9820 MERELBEKE Belgien
Zulassungsnummern	2203572.00.00 2203573.00.00 2203574.00.00 2203575.00.00
Datum der Zulassung	05.11.2021
Verkaufsabgrenzung	verschreibungspflichtig
Version und Datum des Risikomanagement-Plans	1.0 / 08.10.2018
Datum der Genehmigung des RMPs	05.11.2021

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. Dezember 2021 veröffen­tlicht.

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Part VI: Summary of the risk management plan

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

Eslicarbazepine Jubilant summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Eslicarbazepine Jubilant 200 mg, 400 mg, 600 mg and 800 mg tablets should be used.

I.    The medicine and what it is used for

Eslicarbazepine Jubilant 200 mg, 400 mg, 600 mg and 800 mg tablets is authorised for treatment of treatment of partial-onset seizures (see SmPC for the full indication). It contains eslicarbazepine acetate 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 Eslicarbazepine Jubilant, together with measures to minimise such risks for learning more about Eslicarbazepine 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.

IUBIIANT

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II.A List of important risks and missing information

Important risks of Eslicarbazepine 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 Eslicarbazepine 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	Hyponatremia Cutaneous adverse reactions
Important potential risks	Thyroid function changes International Normalised Ratio (INR) and activated Partial Thromboplastin Time (aPTT) increase Cardiovascular/ce­rebrovascular ischemia Potential for suicidality as anti-epileptic drug Bone disorders
Missing information	Exposure during pregnancy Pediatric population (< 2 years of age) Elderly population Long term effects on brain development, learning, intelligence, growth, endocrine function, puberty and childbearing potential in children

II.B Summary of important risks

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