February 2nd 2024

By Ailsa Colquhoun

Gepretix 100mg capsules alert

Exeltis UK Limited has issued an alert relating to five batches of Gepretix 100mg capsules (progesterone).

The affected batches are not being recalled:  

The alert relates to inconsistency in the patient information leaflet (PIL):

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’.

Dispensary teams are recommended to reiterate the prescribed dosage to patients. The batch distributed on 30 January 2024 will be accompanied by an explanatory note. All future batches of the product will contain the corrected PIL.

For medical information enquiries please contact Uk.medinfo@exeltis.com or telephone 01494411775.

For stock control enquiries please contact uk.office@exeltis.com