Pilocarpinhydrochlorid Bay Pharma 5 mg Filmtabletten - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Summary 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.

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

Important risks of Pilocarpine Hydrochloride Milstein 5 mg Film-Coated Tablets , together with measures to minimise such risks and the proposed studies for learning more about Pilocarpine Hydrochloride Milstein 5 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 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 Pilocarpine Hydrochloride Milstein 5 mg 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 Pilocarpine Hydrochloride Milstein 5 mg 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).

List of important risks and missing information
Important identified risks	None
Important potential risks	None
Missing information	None

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 of Pilocarpine Hydrochloride Milstein 5 mg Film-Coated Tablets.

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

There are no studies required for Pilocarpine Hydrochloride Milstein 5 mg Film-Coated Tablets.

EU Risk Management Plan (RMP) for Pilocarpine Hydrochloride Milstein 5 mg Film-Coated

Tablets (pilocarpine)

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