Other safety alerts
|
| |
| The United Kingdom: Class 4 Medicines Defect Information: Exeltis UK Limited, Gepretix 100mg Capsules |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that 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 (progesterone) 100mg capsules (batch number: LF32022A, LF32119A, LF32120A, LF33488A, LF33513A).
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’.
Healthcare professionals are recommended to reiterate the prescribed dosage to their patients and to ensure that patients follow the dispensing advice. The product quality of Gepretix 100mg capsules is not impacted by this issue, therefore the affected batches are not being recalled.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-exeltis-uk-limited-gepretix-100mg-capsules-el-24-a-slash-04
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Feb 2, 2024
Issued at HKT 14:00
|
| |
