Lamotrigin Syri Pharma 5 mg/ml Suspension zum Einnehmen - 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)

Epobine 25mg/5ml Suspension zum Einnehmen

Administrative Information:

Wirkstoff	Lamotrigin
ATC-Code	N03AX09
Darreichungsform	Suspension zum Einnehmen
Art der Anwendung	zum Einnehmen
Inhaber der Zulassung	Syri Pharma Limited Floor 0, 1 WML, 1, Windmill Lane D02F206 DUBLIN 2 Irland
Zulassungsnummer	2206000.00.00
Datum der Zulassung	11.08.2023
Verkaufsabgrenzung	verschreibungspflichtig
Version und Datum des Risikomanagement-Plans	0.3 / 08.12.2021
Datum der Genehmigung des RMPs	11.08.2023

Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) des o. g. Arzneimittels 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 dieses Arzneimittel so sicher wie möglich angewendet wird.

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. Arzneimittel gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bundfinden können.

Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 25. September 2023 veröffen­tlicht.

• (1)

• (2)

Risk Management Plan

Lamotrigine Version 0.3

This is a summary of the risk management plan (RMP) for Lamotrigine 25mg/5ml Oral Suspension. The RMP details important risks of Lamotrigine 25mg/5ml Oral Suspension, how these risks can be minimized, and how more information will be obtained about Lamotrigine 25mg/5ml Oral Suspension’s risks and uncertainties (missing information).

Lamotrigine 25mg/5ml Oral Suspension’s sum­mary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Lamotrigine 25mg/5ml Oral Suspension should be used.

• I. The medicine and what it is used for

Lamotrigine 25mg/5ml Oral Suspension is intended for epilepsy for those 2 years of age or older and bipolar disorder for those 18 years of age or older. (see SmPC for the full indications). It contains Lamotrigine as the active substance and it is given by oral administration.

• II. Risks associated with the medicine and activities to minimize or further characterize the risks

Important risks of Lamotrigine 25mg/5ml Oral Suspension, together with measures to minimize such risks are outlined below:

Measures to minimise the risks identified for Lamotrigine 25mg/5ml Oral Suspension 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.

In addition to these measures, information about adverse reactions is collected continuously and regularly analysed, including PSUR assessment so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities. If important information that may affect the safe use of Lamotrigine 25mg/5ml Oral Suspension is not yet available, it is listed under ‘missing information’ below.”

• II.A List of important risks and missing information

Important risks of Lamotrigine 25mg/5ml Oral Suspension 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 Lamotrigine 25mg/5ml Oral Suspension. Potential risks are concerns for which an association with the use of this medicine is possible based on

Risk Management Plan Syri Pharma Limited

Lamotrigine Version 0.3

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);

Summary of safety concerns
Important identified risks	Hypersensitivity syndrome Severe skin reactions Clinical worsening and suicide risk Interaction with hormonal contraceptives Use in patients with renal impairment Hepatic impairment Rebound seizures after abrupt withdrawal Interaction with concomitant drugs Teratogenicity Use in breastfeeding Overdose
Important potential risks	Medication error leading to over or under dosage
Missing information	Use in children and adolescents under 18 years suffering from bipolar disorder Interaction studies for children population Development in children Effects on ability to drive and use machines

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

Lamotrigine 25mg/5ml Oral Suspension.

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

There are no studies required for Lamotrigine 25mg/5ml Oral Suspension and there is no post authorisation development plan.

Page 10 of 11