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Pilocarpinhydrochlorid Bay Pharma 5 mg Filmtabletten - Zusammengefasste Informationen

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Zusammenfassung der Merkmale des Arzneimittels - Pilocarpinhydrochlorid Bay Pharma 5 mg Filmtabletten

Zusammenfassung des Risikomanagement-Plans gemäß § 34
Summary of risk management plan forSummary of risk management plan for

This is a summary of the risk management plan (RMP) for Pilocarpine Hydrochloride Milstein 5 mg Film-Coated Tablets. The RMP details important risks of Pilocarpine Hydrochloride Milstein 5 mg Film-Coated Tablets , how these risks can be minimised, and how more information will be obtained about Pilocarpine Hydrochloride Milstein 5 mg Film-Coated Tablets 's risks and uncertainties (missing information).

Pilocarpine Hydrochloride Milstein 5 mg Film-Coated Tablets ’s summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Pilocarpine Hydrochloride Milstein 5 mg Film-Coated Tablets should be used.

Important new concerns or changes to the current ones will be included in updates of Pilocarpine Hydrochloride Milstein 5 mg Film-Coated Tablets ’s RMP.

I.    The medicine and what it is used for

Pilocarpine Hydrochloride Milstein 5 mg Film-Coated Tablets is authorised for the alleviation of symptoms of salivary gland hypofunction in patients with severe xerostomia following irradiation for head and neck cancer, and for the treatment of symptoms of dry mouth and dry eyes in patients with Sjögren's syndrome (see SmPC for the full indication). It contains pilocarpine as the active substance and it is given by oral administration.