Zusammenfassung der Merkmale des Arzneimittels - Losartan Pharmaclan 100 mg Filmtabletten
Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the
Medicinal Products Act(2)
Losartan Pharmaclan 100 mg Filmtabletten
Administrative Information:
| Wirkstoff | Losartan-Kalium |
| ATC-Code | C09CA01 |
| Darreichungsform | Filmtablette |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Pharmaclan, s.r.o. Trtinova 260/1 196 00 PRAHA – CAKOVICE Tschechische Republik |
| Zulassungsnummer | 7006654.00.00 |
| Datum der Zulassung | 04.03.2024 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 0.2 / 16.02.2022 |
| Datum der Genehmigung des RMPs | 04.03.2024 |
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 29. April 2024 veröffentlicht.
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Part VI: Summary of the risk management plan
This is a summary of the risk management plan (RMP) for Losartan 50 mg/100 mg film-coated tablets. The RMP details important risks of Losartan 50 mg/100 mg film-coated tablets, how these risks can be minimised, and how more information will be obtained about Losartan 50 mg/100 mg film-coated tablets's risks and uncertainties (missing information).
Losartan 50 mg/100 mg film-coated tablets's summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Losartan 50 mg/100 mg film-coated tablets should be used.
I. The medicine and what it is used for
Losartan 50 mg/100 mg film-coated tablets is authorised for essential hypertension in adults and in children and adolescents 6 – 18 years of age. It is also indicated in treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment and treatment of chronic heart failure in adult patients when treatment with Angiotensin-converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication as well as for reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG (see SmPC for the full indication). It contains losartan as the active substance and it is given by oral route of administration.
II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks of Losartan 50 mg/100 mg film-coated tablets, together with measures to minimise such risks and the proposed studies for learning more about Losartan 50 mg/100 mg film-coated tablets '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 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 Losartan 50 mg/100 mg film-coated tablets is not yet available, it is listed under ‘missing informationʼ below.
II.A List of important risks and missing information
Important risks of Losartan 50 mg/100 mg film-coated tablets 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 Losartan 50 mg/100 mg film-coated tablets. 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 | None |
| Important potential risks | None |
| Missing information | None |
II.B Summary of important risks
The safety information in the proposed Product Information is aligned to the reference medicinal product.