Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Etrivex 500 micrograms/g Shampoo, EL (22)A/51

Galderma (U.K.) Limited has informed the MHRA that the patient information leaflet (PIL) packaged in specific batches of Etrivex Shampoo is missing safety information

MDR Number: MDR 108-11/22

Company name: Galderma (U.K.) Limited

Product description: Etrivex 500 micrograms/g Shampoo, PL 10590/0052

Details of the affected batch:

Brief description of problem:

Galderma (U.K.) Limited has informed the MHRA that the patient information leaflet (PIL) packaged in specific batches of Etrivex Shampoo is missing the following safety information (in bold):

Section 2: What you need to know before you use Etrivex 500 micrograms/g shampoo

Warnings and precautions

Take special care with Etrivex 500 micrograms/g Shampoo

• When using Etrivex shampoo, it must only be used on the scalp, do not use it as a regular shampoo or on other areas of the body and do not use Etrivex shampoo as a shower gel, body wash or bath foam.
• When treating the scalp with Etrivex shampoo you must not cover the area being treated, for example: a shower cap must not be used as it may make the active substance pass through the skin and affect the other parts of the body.
• When using Etrivex shampoo, avoid contact with the face, eyelids, axillae (armpits), erosive skin (chapped skin) surface and genital regions. Rinse off immediately with water if any product runs from the scalp.
• If you get Etrivex shampoo in your eye(s), wash the affected eye thoroughly with water. If any irritation persists, please seek advice from your doctor.
• If you do not notice an improvement of your scalp psoriasis, please see your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Section 4: Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Etrivex shampoo may cause the following side effects

Not known (frequency cannot be estimated from the available data)

- Blurred vision

Advice to Healthcare Professionals:

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing specific batches of the product. Where possible, provide an updated copy of the PIL to the patient and remind the patient to read the leaflet in its entirety before using the medicine. This is available via the link below:

Etrivex 500 micrograms/g Shampoo - Patient Information Leaflet (PIL)

Galderma (U.K.) Limited has confirmed that all future batches will contain the correct PIL. Upon request, Galderma (U.K.) Limited will post hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information.

Advice to Patients:

Patients should be aware that the Patient Information Leaflet (PIL) in the above batches of Etrivex 500 micrograms/g Shampoo does not contain the most up-to-date safety information on side effects.

If you experience blurred vision and visual disturbances, you should contact your doctor immediately. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For more information, medical information queries or replacement PIL enquiries, please contact: medinfo.uk@galderma.com

For stock control queries, please contact: sales.uk@galderma.com

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