Bilastin Urquima 10 mg Schmelztabletten - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Summary of risk management plan for Bilastine 10 mg orodispersible tablets (bilastine)

This is a summary of the risk management plan (RMP) for Bilastine <invented name> 10 mg orodispersible tablets. The RMP details important risks of Bilastine, how these risks can be minimised, and how more information will be obtained about Bilastine's risks and uncertainties (missing information).

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

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

• I. The medicine and what it is used for

Bilastine <invented name> 10 mg orodispersible tablets is authorised for the symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria. Bilastine <invented name> 10 mg orodispersible tablets is indicated in adults and adolescents (12 years of age and over). It contains bilastine 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 Bilastine, together with measures to minimise such risks and the proposed studies for learning more about Bilastine'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.