Finasterid Careforsons 1 mg Filmtabletten - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Summary of risk management plan for Finasteride 1mg film-coated tablets (finasteride)

This is a summary of the risk management plan (RMP) for Finasteride 1mg film-coated tablets (finasteride). The RMP details important risks of Finasteride, how these risks can be minimised, and how more information will be obtained about Finasteride’s risks and uncertainties (missing information).

Finasteride's sum­mary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Finasteride should be used.

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

• I. The medicine and what it is used for

Finasteride is authorised for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss (see SmPC for the full indication). It contains finasteride as the active substance, and it is given orally.

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

Important risks of Finasteride, together with measures to minimise such risks and the proposed studies for learning more about Finasteride'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.

• II.A List of important risks and missing information

Important risks of Finasteride 1mg 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 Finasteride 1mg 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);

• II.B Summary of important risks