Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten
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)
Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten
Administrative Information:
| Wirkstoffe | Cinnarizin Dimenhydrinat |
| ATC-Code | N07CA52 |
| Darreichungsform | Tablette |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Torrent Pharma (Malta) Limited Triq Hal Tarxien GDJ1907 GUDJA Malta |
| Zulassungsnummer | 7010972.00.00 |
| Datum der Zulassung | 26.05.2024 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 0.1 / 20.06.2023 |
| Datum der Genehmigung des RMPs | 26.05.2024 |
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 28. Juni 2024 veröffentlicht.
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RMP_CIDI-2023-vs 0.1 SUN
________________________________________________________________________ PHARMA
Part VI: SUMMARY OF THE RISK MANAGEMENT PLAN
Summary of risk management plan for Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate
(C innarizine/Dimenhydrinate)
This is a summary of the risk management plan (RMP) C innarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate. The RMP details important risks of Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate, how these risks can be minimised, and how more information will be obtained about Cinnarizine/ Dimenhydrinate 20mg/40mg Tablets’s risks and uncertainties (missing information).
Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate’s summary of product characteristics (SmPC) and package leaflet give essential information to healthcare professionals and patients on how Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate should be used.
Important new concerns or changes to the current ones will be included in updates of Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate’s RMP.
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I. The medicine and what it is used for
Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate are authorised in adults for the treatment of vertigo symptoms of various origins (see SmPC for the full indication). It contain Cinnarizine and Dimenhydrinate as the active substances and they are given by oral route of administration.
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II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks of Cinnarizine/Dimenhydrinate20mg/40mg Tablets, together with measures to minimise such risks and the proposed studies for learning more about Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate’s 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
RMP_CIDI-2023-vs 0.1
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, 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 Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate is not yet available, it is listed under ‘missing information’ below.
II.A List of important risks and missing information
Important risks of Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate 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 Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate. 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 |
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| Important potential risks |
obstruction, prostatic hypertrophy, hypertension, hyperthyroidism, severe coronary heart disease.
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| Missing information |
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II.B Summary of important risks
The safety information in the proposed product information is aligned to the reference medicinal product Arlevert2 (Hennig Arzneimittel GmbH & Co. KG).
II.C Post-authorisation development plan
II.C.l Studies which are conditions of the marketing authorisation
There are no studies which are conditions of the marketing authorisation or specific obligation of Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten, Cinnarizina/Dimenidrinato Torrent 20 mg/40 mg compresse, Cynaryzyny/ Dimenhydraminy Torrent 20 mg/40 mg tabletki and Livostin 20 mg/40 mg comprimate.
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