Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Fampridin Rontis 10 mg Retardtabletten
Summary of risk management plan for Fampridine Rontis 10 mg prolonged-release tablets
This is a summary of the risk management plan (RMP) for fampridine. The RMP details important risks of fampridine, how these risks can be minimised, and how more information will be obtained about fampridine's risks and uncertainties (missing information).
Fampridine's summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how fampridine should be used.
Important new concerns or changes to the current ones will be included in updates of fampridine's RMP.
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I. The medicine and what it is used for
Fampridine is authorised for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4–7) (see SmPC for the full indication). It contains fampridine, as the active substance, and it is given by oral route of administration of 10 mg prolonged-release tablets.
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II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks of fampridine, together with measures to minimise such risks and the proposed studies for learning more about fampridine'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.
If important information that may affect the safe use of fampridine is not yet available, it is listed under ‘missing information’ below.
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II.A List of important risks and missing information
Important risks of fampridine are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely administered. 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 fampridine. 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 |
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| Important potential risks |
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| Missing information |
o Pregnancy exposure o Elderly population >65 years of age o Paediatric and adolescent patients o Patients with impaired renal function
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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 fampridine.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for fampridine.
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