Losartan-Kalium und Hydrochlorothiazid Ipca 50 mg/12,5 mg Filmtabletten - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

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)

Losartan- Kalium und Hydrochlorothiazid 50 mg/12.5 mg Filmtabletten

Losartan-Kalium und Hydrochlorothiazid Ipca 100 mg/12,5 mg Filmtabletten
Losartan-Kalium und Hydrochlorothiazid Ipca 100 mg/25 mg Filmtabletten

Administrative Information:

Wirkstoffe	Losartan-Kalium Hydrochlorothiazid
ATC-Code	C09DA01
Darreichungsform	Filmtablette
Art der Anwendung	zum Einnehmen
Inhaber der Zulassung	IPCA, Produtos Farmacêuticos Unipessoal Lda Rua José Nogueira Vaz, n° 8B 2625–099 PÓVOA DE SANTA IRIA Portugal
Zulassungsnummern	7006143.00.00 7006144.00.00 7006145.00.00
Datum der Zulassung	12.04.2024
Verkaufsabgrenzung	verschreibungspflichtig
Version und Datum des Risikomanagement-Plans	0.1 / 06.07.2021
Datum der Genehmigung des RMPs	12.04.2024

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 29. Mai 2024 veröffen­tlicht.

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PART VI: Summary of the risk management plan

Summary of risk management plan (RMP) for Losartan Potassium and hydrochlorothiazide 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets (Losartan Potassium and hydrochlorothi­azide)

This is a summary of the RMP for Losartan Potassium and hydrochlorothiazide 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets (herein after referred to as Losartan and hydrochlorothi­azide). The RMP details important risks of Losartan and Hydrochlorothi­azide, how these risks can be minimised, and how more information will be obtained about Losartan and Hydrochlorothi­azide’s risks and uncertainties (missing information).

Losartan and Hydrochlorothiazide SmPC and PL give essential information to healthcare professionals and patients on how Losartan and Hydrochlorothiazide should be used.

Important new concerns or changes to the current ones will be included in updates of Losartan Potassium and Hydrochlorothi­azide’s RMP.

• I. The medicine and what it is used for

Losartan and Hydrochlorothiazide is indicated in adults for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on Losartan potassium or hydrochlorothi­azide alone.

It contains Losartan Potassium and Hydrochlorothiazide as the active substance and it is given by the oral route.

• II. Risks associated with the medicine and activities to minimise or further characterise the risks

Important risks of Losartan and Hydrochlorothi­azide, together with measures to minimise such risks and the proposed studies for learning more about Losartan and Hydrochlorothiazide risks are outlined below.

Measures to minimize the risks identified for the medicinal products can be:

• Specific information, such as warnings, precautions, and advice on correct use, in the package insert 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 analyzed so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.

• II.A List of important risks and missing information

Important risks of Losartan and Hydrochlorothiazide 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 and Hydrochlorothi­azide. 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).

Table 2: List of important risks and missing information

List of important risks and missing information
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.

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 for Losartan and Hydrochlorothi­azide.

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

There are no studies required for Losartan and Hydrochlorothi­azide.

CONFIDENTIAL

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