Losartan Pharmaclan 100 mg Filmtabletten - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Summary of risk management plan for Losartan potassium 50 mg and 100 mg Film-coated Tablets

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.