Class 4 Medicines Defect Notification: Olmesartan medoxomil 10mg film-coated tablets, Jubilant Pharmaceuticals NV, EL(25)A/37
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
DMRC Number: DMRC-34866997
Company name:Jubilant Pharmaceuticals NV
Product description:
Olmesartan medoxomil 10mg film-coated tablets
PL: 19156/0097
Active Ingredient: olmesartan medoxomil
SNOMED code: 4623911000001104
Details of the affected batch:
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| MR124001A | 03/2026 | 28 tab/pack | 02/10/2024 |
| MR124002A | 03/2026 | 28 tab/pack | 30/09/2024 |
Olmesartan medoxomil 20mg film-coated tablets
PL: 19156/0098
Active Ingredient: olmesartan medoxomil
SNOMED code: 4624211000001106
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| MR224001A | 04/2026 | 28 tab/pack | 02/10/2024 |
Brief description of problem:
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL. These packs contain a PIL which was revised in September 2021. The latest approved PIL is dated January 2024.
The out-of-date PIL included in the affected batches is missing important updated safety information. The latest PIL is available on the MHRA website; the missing information relates to the following text that has been added into the PIL:
4. Possible side effects
“Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started therapy with Olmesartan medoxomil film-coated tablets longer time ago, contact your doctor immediately who will evaluate your symptoms and decide on how to continue your blood pressure medication.”
Advice to Healthcare Professionals:
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing this product. When products from batches included in the table are supplied or dispensed, please ensure that patients are aware of the missing information. Please inform the patients that the latest PIL for olmesartan medoxomil film-coated tablets is available. Alternatively, hard copies of the correct PIL will be provided by the Marketing Authorisation Holder upon request, so that any of the affected packs remaining in the dispensary can be supplemented with the correct PIL.
Jubilant can provide printed copy of an updated PIL to HCP’s via safety.uk@lambda-cro.com, or telephone 0800 0668348.
Advice to Patients:
Patients should continue to take medicines from the impacted batch as prescribed by your healthcare professional. This does not affect the quality of the product. There is updated safety information in the latest patient information leaflet (PIL) which accompanies the medicine. The latest version of the PIL is available:
The current PIL is missing some information which is presented below:
4. Possible side effects
“Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started therapy with Olmesartan medoxomil film-coated tablets longer time ago, contact your doctor immediately who will evaluate your symptoms and decide on how to continue your blood pressure medication.”
Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Company contacts for further information:
For medical information enquiries please email safety.uk@lambda-cro.com, or telephone 0800 0668348.
For stock control enquiries please email JPUK.Customerservice@jubl.com, or telephone 01233 552293