Glycopyrronium Aspire Pharma 160 Mikrogramm/ml Lösung zum Einnehmen - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Glycopyrronium Aspire Pharma 160 Mikrogramm/ml Lösung zum Einnehmen

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)

Glycopyrronium Morningside 160 Mikrogramm/ml Lösung zum Einnehmen

Administrative Information:

Wirkstoff	Glycopyrroniumbromid (Ph.Eur.)
ATC-Code	A03AB02
Darreichungsform	Lösung zum Einnehmen
Art der Anwendung	zum Einnehmen
Inhaber der Zulassung	Morningside Healthcare (Malta) Limited 93, Mill Street QRM 3102 QORMI Malta
Zulassungsnummer	7008265.00.00
Datum der Zulassung	05.09.2023
Verkaufsabgrenzung	verschreibungspflichtig
Version und Datum des Risikomanagement-Plans	3.3 / 09.02.2023
Datum der Genehmigung des RMPs	05.09.2023

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 30. Oktober 2023 veröffentlicht.

PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN

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

Glycopyrronium Bromide’ summary of product characteristics (SmPC) and package leaflet (PL) give essential information to healthcare professionals and patients on how Glycopyrronium Bromide should be used.

Important new concerns or changes to the current ones will be included in updates of Glycopyrronium Bromide’ RMP.

I. The medicine and what it is used for

Glycopyrronium Bromide is authorised for symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders..

Glycopyrronium Bromide contain glycopyrronium bromide 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 Glycopyrronium Bromide, together with measures to minimise such risks and the proposed studies for learning more about Glycopyrronium Bromide’ 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 PL 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 the case of Glycopyrronium Bromide, these measures are supplemented with additional risk minimisation measures mentioned under relevant important risks, below.

In addition to these measures, information about adverse reactions is collected continuously and regularly analysed, including Periodic safety update report (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 Glycopyrronium Bromide is not yet available, it is listed under ‘missing information’ below.

II.A List of important risks and missing information

Important risks of Glycopyrronium Bromide 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 Glycopyrronium Bromide. 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 longterm use of the medicine).

List of important risks and missing information
Important identified risks	Off label treatment of children with mild to moderate sialorrhoea Anticholinergic effects – Urinary retention – Constipation – Risk of overheating – Pneumonia Overdose including unintentional overdose due to 10ml syringe Off label use in patients below the age of 3 years due to the higher susceptibility to adverse effects
Important potential risks	Cardiac disorders Dental caries Central nervous system [CNS] effects
Missing information	Safety in long term use, beyond 24 weeks

II.B Summary of important risks

Important identified risks

Off label treatment of children with mild to moderate sialorrhoea

Evidence for linking the risk to the medicine

There is no published evidence to support a positive risk benefit ratio for the treatment of children with mild to moderate sialorrhoea. Further, glycopyrronium may enhance the effect of topiramate and zonisaminde by reduction of sweating.

Risk factors and risk groups

Children with mild to moderate sialorrhoea.

Risk minimisation measures

Routine risk minimisation measures:

SmPC sections 4.4, 4.5, 4.8 and 5.1
PIL sections 2 and 4
Prescription only medicine

Additional risk minimisation measures:

– None proposed

Anticholinergic Effects
Evidence for linking the risk to the medicine	As per SmPC, anticholinergic effects such as urinary retention, constipation and overheating due to inhibition of sweating may be dose dependent and difficult to assess in a disabled child. Anticholinergics may delay the gastrointestinal absorption of other anticholinergics administered orally and also increase the risk of anticholinergic undesirable effects.
Risk factors and risk groups	Children and adolescents aged 3 years and older with chronic neurological disorders
Risk minimisation measures	Routine risk minimisation measures: SmPC sections 4.4, 4.5, 4.8 and 4.9 PIL sections 2 and 4 Prescription only medicine Additional risk minimisation measures: Educational materials in the form of: The carer and patient information pack containing – PIL – Reminder Card for the patient’s carer Physician educational material containing – SmPC – HCP checklist

Overdose including unintentional overdose due to 10ml syringe
Evidence for linking the risk to the medicine	SmPC of Glycopyrronium bromide mention that, there are chances of overdose, if this medicine is not used as per the prescribed information.
Risk factors and risk groups	Patients taking more than the prescribed dose of Glycopyrronium Bromide.
Risk minimisation measures	Routine risk minimisation measures: SmPC section 4.9 PIL section 3 Prescription only medicine Additional risk minimisation measures: Educational materials in the form of: The carer and patient information pack containing – PIL – Reminder Card for the patient’s carer Physician educational material containing – SmPC – HCP checklist

Important potential risks

Cardiac disorders

Evidence for linking the risk to the medicine

Published literature and SmPC mention that Glycopyrronium bromide produce increase in heart rate after its adminitration.

Further, Concomitant use of inhaled anaesthetics with glycopyrronium bromide may lead to potential change to normal heart rhythm.

Risk factors and risk groups

Increased heart rate itself is an independent predictor of cardiovascular mortality. However, it also positively associated with cardiovascular risk factors (hypertension, diabetes mellitus, hypertriglyceridemia, alcohol and habitual exercise) and clustering of these factors.

As per the SmPC, risk factors include:

Concomitant use of inhaled anaesthetics

Risk group includes:

Patients with cardiovascular disorders (including acute MI, hypotension, CAD and cardiac tachyarrhythmias)

Risk minimisation measures

Routine risk minimisation measures:

SmPC sections 4.4, 4.5, 4.8 and 5.1
PIL sections 2 and 4
Prescription only medicine

Additional risk minimisation measures:

Educational materials in the form of:

The carer and patient information pack containing

– PIL
– Reminder Card for the patient’s carer Physician educational material containing
– SmPC
– HCP checklist

Dental caries
Evidence for linking the risk to the medicine	SmPC and Published literature mention that, a possible consequence of reduced salivary flow is an increased risk of tooth decay.
Risk factors and risk groups	Dental caries is a multifactorial disease caused by host, agent, and environmental factors. Mutans streptococci is the primary etiologic agent of dental caries. Factors involved in the dental caries process include the tooth, bacteria in the form of a dental plaque, and a diet containing sugar. The quantity, quality, and frequency of sugar intake have a definitive influence on the incidence and prevalence of caries.
Risk minimisation measures	Routine risk minimisation measures: SmPC section 4.4 PIL section 2 Prescription only medicine Additional risk minimisation measures: Educational materials in the form of: The carer and patient information pack containing – PIL – Reminder Card for the patient’s carer Physician educational material containing – SmPC

– HCP checklist

CNS effects
Evidence for linking the risk to the medicine	As per the SmPC, increased CNS effects have been reported in clinical trials including: irritability; drowsiness; restlessness; overactivity; short attention span; frustration; mood changes; temper outbursts or explosive behaviour; excessive sensitivity; seriousness or sadness; frequent crying episodes; fearfulness. Published literature mention that, CNS effects including behavioural changes have been reported with glycopyrronium use, and their significance in children with neurological disorders is associated with uncertainty.
Risk factors and risk groups	Risk groups include : Patients with mental disorders Patients with compromised blood brain barrier (BBB) (ie patients with infection of devices implanted in brain to remove fluid from brain [shunt infection], children with fluid in brain [hydrocephalus]) Risk groups include : High dose Long-term treatment
Risk minimisation measures	Routine risk minimisation measures: SmPC sections 4.4 and 4.8 PIL sections 2 and 4 Prescription only medicine Additional risk minimisation measures: Educational materials in the form of: The carer and patient information pack containing – PIL – Reminder Card for the patient’s carer Physician educational material containing – SmPC – HCP checklist

Missing information

Safety in long term use, beyond 24 weeks

Risk minimisation measures

Routine risk minimisation measures:

SmPC sections 4.2, 4.4 and 4.8
PIL section 2
Prescription only medicine

Additional risk minimisation measures:

No risk minimisation measures

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 Glycopyrronium Bromide Tablets and Glycopyrronium Bromide Oral Solution.

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

There are no studies required for Glycopyrronium Bromide Tablets and Glycopyrronium Bromide Oral Solution.

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