Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Tadalafil Holsten 20 mg Filmtabletten
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)
Tadalafil Holsten 5 mg Filmtabletten
Tadalafil Holsten 10 mg Filmtabletten
Tadalafil Holsten 20 mg Filmtabletten
Administrative Information:
| Wirkstoff | Tadalafil |
| ATC-Code | G04BE08 |
| Darreichungsform | Filmtablette |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Holsten Pharma GmbH Hahnstraße 31–35 60528 Frankfurt am Main Deutschland |
| Zulassungsnummern | 7016336.00.00 7016337.00.00 7016338.00.00 |
| Datum der Zulassung | 17.08.2024 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 4.2 / 07.09.2022 |
| Datum der Genehmigung des RMPs | 17.08.2024 |
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 11. September 2024 veröffentlicht.
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PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN
Summary of risk management plan for Tadalafil Rivopharm film-coated tablets (tadalafil)*
*in AT-RMS: Tadalafil Rivopharm 2,5 mg Filmtabletten, Tadalafil Rivopharm 5 mg Filmtabletten, Tadalafil Rivopharm 10 mg Filmtabletten, Tadalafil Rivopharm 20 mg Filmtabletten
This is a summary of the risk management plan (RMP) for Tadalafil Rivopharm 2,5 mg, 5 mg, 10 mg, 20 mg Filmtabletten (herein referred to as Tadalafil Rivopharm). The RMP details important risks of Tadalafil Rivopharm, how these risks can be minimised, and how more information will be obtained about Tadalafil Rivopharm’s risks and uncertainties (missing information).
Tadalafil Rivopharm’s summary of product characteristics (SmPC) and its package leaflet (PL) give essential information to healthcare professionals and patients on how Tadalafil Rivopharm should be used.
Important new concerns or changes to the current ones will be included in updates of Tadalafil Rivopharm’s RMP.
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I. The medicine and what it is used for
Tadalafil Rivopharm 2,5 mg, 5 mg, 10 mg, 20 mg Filmtabletten are authorised for the treatment of erectile dysfunction in adult males. Tadalafil Rivopharm 5 mg Filmtabletten are also authorised for the treatment of the signs and symptoms of benign prostatic hyperplasia in adult males (see SmPC for the full indication).
Tadalafil Rivopharm contains tadalafil as the active substance and it is given by oral route.
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II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks of Tadalafil Rivopharm, together with measures to minimise such risks and the proposed studies for learning more about Tadalafil Rivopharm’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 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.
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II.A List of important risks and missing information
Important risks of Tadalafil Rivopharm 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 Tadalafil Rivopharm. 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 |
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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.
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 Tadalafil Rivopharm.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for Tadalafil Rivopharm.
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