Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Loperamid Tenshi 2 mg Lyophilisat 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)
Loperamid Tenshi 2 mg Lyophilisat zum Einnehmen
Administrative Information:
| Wirkstoff | Loperamidhydrochlorid |
| ATC-Code | A07DA03 |
| Darreichungsform | Schmelztablette |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Tenshi Kaizen B.V. Kingsfordweg 151 1043 GR AMSTERDAM Niederlande |
| Zulassungsnummer | 2204830.00.00 |
| Datum der Zulassung | 26.11.2021 |
| Verkaufsabgrenzung | apothekenpflichtig |
| Version und Datum des Risikomanagement-Plans | 1.1 / 11.02.2021 |
| Datum der Genehmigung des RMPs | 26.11.2021 |
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 03. Dezember 2021 veröffentlicht.
-
(1)
-
(2)
-
III.2 Additional pharmacovigilance activities
Additional pharmacovigilance requirements are not considered necessary and routine pharmacovigilance activities are considered sufficient to monitor the benefit-risk profile of the product and detect any safety concerns.
-
III.3 Summary Table of additional Pharmacovigilance activities
Part VI: Summary of the risk management plan
Summary of risk management plan for Loperamide 2 mg oral lyophilisate (loperamide):
This is a summary of the risk management plan (RMP) for Loperamide 2 mg oral lyophilisate. The RMP details important risks of Loperamide 2 mg oral lyophilisate, how these risks can be minimised, and how more information will be obtained about Loperamide 2 mg oral lyophilisateʼs risks and uncertainties (missing information).
Loperamide 2 mg oral lyophilisateʼs summary of product characteristics (SmPC1) and its package leaflet2 give essential information to healthcare professionals and patients on how Loperamide 2 mg oral lyophilisate should be used.
Important new concerns or changes to the current ones will be included in updates of Loperamide 2 mg oral lyophilisate's RMP.
-
I. The medicine and what it is used for
Loperamide 2 mg oral lyophilisate is one of a group of medicines called „anti-diarrhoeals“ which are used to treat diarrhoea by slowing down an overactive bowel (see SmPC1 for the full indication). This allows water and salts that are usually lost in diarrhoea to be absorbed by the body. It contains loperamide 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 Loperamide 2 mg oral lyophilisate, together with measures to minimise such 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 leaflet2 and SmPC1 addressed to patients and healthcare professionals;
- Important advice on the medicineʼs packaging;
- The authorised pack size — the amount of medicine in a pack is chosen so to ensure that the medicine is used correctly;
- The medicineʼs 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, 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 Loperamide 2 mg oral lyophilisate is not yet available, it is listed under ^missing informationʼ below.
-
II.A List of important risks and missing information
Important risks of Loperamide 2 mg oral lyophilisate 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 Loperamide 2 mg oral lyophilisate. 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).
| Summary of safety concerns | |
| Important identified risks |
|
| Important potential risks |
|
| Missing information |
|
-
II.B Summary ofimportant risks
The safety information for the other important safety concerns 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 which is a specific obligation of Loperamide 2 mg oral lyophilisate.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for Loperamide 2 mg oral lyophilisate.
Page 910