Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43
Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
DMRC reference number
DMRC-35799492
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal) S.A.
Medicine Details
Gemcitabine 2g/52.6ml concentrate for solution for infusion
Licence: PL: 15413/0093
Active ingredient: gemcitabine
SNOMED code: 17844811000001107
GTIN: 5391512 456702
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| CB0033 | 01/05/2026 | 1 | 05 August 2025 |
Background
Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
Gemcitabine 2g/52.6ml concentrate for solution for infusion is administered by Healthcare Professionals within a hospital setting, and most healthcare professionals will already be aware of these serious skin reactions.
The missing information is:
PIL Section 2
Talk to your doctor, nurse or hospital pharmacist before using gemcitabine: If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using gemcitabine.
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis (AGEP) have been reported in association with gemcitabine treatment. Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
PIL Section 4
You must contact your doctor immediately if you notice any of the following: A red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever (Acute Generalized Exanthematous Pustulosis (AGEP) (frequency not known).
Advice for Healthcare Professionals:
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing and dispensing this product, where possible.
Please see copies of the correct Patient Information Leaflet: GEMCITABINE PIL.
To request hard copies of the PIL, please contact customerserviceuk@hikma.com with your details, i.e. contact point, address, required number of leaflets.
Advice for Patients:
This medicine is administered under the supervision of a healthcare professional who will be aware of the missing information in the Patient Information Leaflet (PIL).
Please see copies of the correct Patient Information Leaflet: GEMCITABINE PIL.
Patients who experience adverse reaction or have any questions about their medicine should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card Scheme
Additional information:
For medical information queries please telephone +351 21 960 8410, or email portugaleupharmacovigilance@hikma.com.
For all stock control enquiries please telephone +44 020 7399 2760, or email customerserviceuk@hikma.com
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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