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Publication #8050
Reference
Drug alert 04/2024
Name
Drug alert class 4 – 04 2024 – Class 4 medicines defect information – caution in use – Exeltis UK Ltd Gepretix 100mg capsules
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS
SCOTLAND
DRUGS
SAFETY
RISKS
PHARMACEUTICAL INDUSTRY
MEDICINES RECALL
Description
Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules. The PIL contains the following inconsistency: • Section 3 states: ‘The recommended dose is 200 mg daily at bedtime, for twelve days in the last half of each therapeutic cycle (beginning on Day 15 of the cycle and ending on Day 26). Alternatively, 100 mg can be given at bedtime from Day 1 to Day 25 of each therapeutic cycle.’ • However, in the ‘How much to take’ subsection below, the PIL states: ‘Take one capsule at bedtime on days 15 to 26 of your 28 day cycle.’ This section should state 'Take two capsules at bedtime on days 15 to 26 of your 28- day cycle'.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2024-02-01 00:00:00
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