Losarta-Kalium IPCA 50 mg Filmtabletten - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

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PART VI: Summary of the risk management plan

Summary of RMP for Losartan Potassium 25 mg, 50 mg and 100 mg tablets (Losartan Potassium)

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

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

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

• I. The medicine and what it is used for

Losartan is indicated for the following treatment:

• For treatment of essential hypertension in adults and in children and adolescents 6 – 18 years of age
• 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
• Treatment of chronic heart failure in adult patients when treatment with Angiotensincon­verting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart failure
• Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG

It contains Losartan potassium as the active substance and it is given by the oral route of administration.

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

Important risks of Losartan, together with measures to minimise such 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.

If important information that may affect the safe use of Losartan is not yet available, it is listed under ‘missing information’ below.

II.A List of important risks and missing information

Important risks of Losartan 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. 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	Renal dysfunction as a consequence of dual RAAS blockade Foetotoxicity when used during 2nd and 3rd trimester of pregnancy Hyperkalaemia
Important Potential Risks	Teratogenicity during the 1st trimester of pregnancy
Missing Information	Exposure during breast feeding Treatment of proteinuria in children under 1 year of age Treatment of hypertension in children under 6 months of age

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.

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

There are no studies required for Losartan.

CONFIDENTIAL

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