Lacosamid Ascend 150 mg Filmtabletten - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Zusammenfassung 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 Ascend 100 mg Filmtabletten

Lacosamid Ascend 150 mg Filmtabletten
Lacosamid Ascend 200 mg Filmtabletten

Administrative Information:

Wirkstoff	Lacosamid
ATC-Code	N03AX18
Darreichungsform	Filmtablette
Art der Anwendung	zum Einnehmen
Inhaber der Zulassung	Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41 60439 Frankfurt am Main Deutschland
Zulassungsnummern	7005964.00.00 7005965.00.00 7005966.00.00
Datum der Zulassung	29.10.2022
Verkaufsabgrenzung	verschreibungspflichtig
Version und Datum des Risikomanagement-Plans	0.2 / 10.01.2022
Datum der Genehmigung des RMPs	29.10.2022

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 16. November 2022 veröffen­tlicht.

• (1)

• (2)

PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN

Summary of risk management plan for Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup

This is a summary of the risk management plan (RMP) for Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup. The RMP details important risks of Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup, how these risks can be minimised, and how more information will be obtained about Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup’s risks and uncertainties (missing information).

Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup’s summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup should be used.

• I. The medicine and what it is used for

Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup are authorised as monotherapy and adjunctive therapy in the treatment of partial-onset seizures (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 risks

Important risks of Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup, together with measures to minimize such risks, are outlined below.

Measures to minimise the risks identified for Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup:

• Specific information, including 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 will constitute routine risk minimisation measures.

In addition to these measures, information about adverse reactions is collected continuously and regularly analysed, so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.

The important information that may affect the safe use of Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup is not yet available, it is listed under ‘missing information’ below.

• II.A List of important risks and missing information:

Important risks of Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely taken. 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 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup. 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);

Important identified risks	Cardiac AEs that may be potentially associated with PR interval prolongation or sodium channel modulation
Important potential risk	None
Missing information	Pregnant or lactating women Impact on long-term growth, long-term neurodevelopment, and on puberty in pediatric population aged 4 to < 16 years

• II.B Summary of important risks

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

II.C Post-authorisation development plan

II.C.1 Studies which are conditions of the marketing authorisation

There are no studies which are conditions of the marketing authorisation or specific obligation of Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup.

II.C.2 Other studies in post-authorisation development plan

There are no studies required for Lacosamide 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets and Lacosamide 10 mg/ml syrup.

Ascend GmbH

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