MHRA Class 4 Medicines Defect Information: Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml)
Class 4 Medicines Defect Information: Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) Galderma (U.K.) Limited
Drug alert number: EL (23)A/31
Date issued: 29 August 2023
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) Galderma (U.K.) Limited.
Company name: Galderma (U.K.) Limited
Product name: Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml), PL 10590/0042
SNOMED Code: 757311000001109
|Batch Number||Expiry Date||Pack Size||First Distributed|
|2212421||05/2025||1 x 5ml||19 August 2022|
Active Pharmaceutical Ingredient: 5% w/v amorolfine in the form of hydrochloride
Brief description of the problem
Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply chain due to a warehousing error at their UK pre-wholesaler. Although Loceryl is a registered medicine in both Ireland and the UK, there are differences between these products in the product labelling and Patient Information Leaflet (PIL) packaged with the medicine.
Details of the key packaging differences for Ireland (under Irish product authorisation number PA 22743/009/001; *SKU number 023299) versus the UK product (PL 10590/0042; SKU number 023271), which the company and MHRA have risk assessed as having minimal safety implications for the patient, are described below.
- The bottle label should state the requirement to protect the product from heat.
PIL Section 2 (‘What you need to know before you use Loceryl’)
- The instruction, in the event of a serious allergic reaction (a reaction which is described above the warnings and precautions section), to ‘stop applying the product, immediately remove the product with a nail varnish remover or the cleaning swabs provided with the package’ is missing.
- ‘Tongue or throat swelling’ is missing from the serious allergic reaction symptoms above the warnings and precautions section.
- The statement “One gram of Loceryl contains 552 mg of alcohol (ethanol), which is equivalent to 55.2 % w/w. It may cause a burning a sensation on damaged skin. Ethanol is a flammable substance and should not be used near an open flame, a lit cigarette or some devices (e.g. hair dryers).” is missing from the ‘Important information about some of the ingredients’ section. However, the ‘Possible side effects’ section of the PIL (section 4) does forewarn that a burning sensation may occur in the area around the nail (with a frequency of very rare) and the patient is instructed (in PIL section 5 – ‘How to store Loceryl’) to keep the pack away from heat.
PIL Section 4 (‘Possible side effects’)
- ‘Systemic allergic reaction (a serious allergic reaction that can be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash)’ wording is missing from the ‘Unknown frequency of occurrence’ section.
- The contact details provided in the leaflet for reporting side effects/adverse events relate to the Irish authority (HPRA) rather than the UK authority (MHRA).
- The carton, bottle label and PIL display the Marketing Authorisation Holder (MAH) name and address and Marketing Authorisation (MA) number as registered in Ireland rather than those registered in the UK.
Advice for healthcare professionals
Healthcare professionals are advised to exercise caution when dispensing the above batch of Loceryl 5% w/v Medicated Nail Lacquer (as packaged in the Irish livery). Where possible, please provide the current UK-approved copy of the PIL to the patient and remind the patient to read the leaflet in its entirety before using the medicine. Please reiterate to patients that this product contains ethanol, which is a flammable substance, and should not be used near an open flame, a lit cigarette or some devices (for example, hair dryers).
The Marketing Authorisation Holder can supply copies of the correct PIL on request; a copy of the UK PIL is available via the following link: Loceryl 5% w/v Medicated Nail Lacquer – Patient Information Leaflet (PIL) – (emc) (medicines.org.uk)
Advice for patients
There is missing information from the Patient Information Leaflet that accompanies certain packs of batch 2212421 of Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) – i.e. the Irish packs inadvertently distributed in the UK. The missing information has been detailed in this notification.
You can ask your pharmacist for a copy of the correct leaflet or you can download it directly. Please ensure that you read the information on the packaging and in the leaflet carefully before using the product.
If you experience symptoms of a systemic allergic reaction while using the medicated nail lacquer (swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash) then you should stop applying the product and immediately remove it with a nail varnish remover or the cleaning swabs provided with the package. Always seek medical advice if you have an allergic reaction.
Loceryl medicated nail lacquer also contains ethanol. Ethanol is a flammable substance and should not be used near an open flame, a lit cigarette or some devices (for example, hair dryers).
Loceryl is a Prescription Only Medicine (POM), (medicines that have to be prescribed by a doctor or other authorised health professional), and should be used as directed. If you have any questions, please consult your GP or pharmacist. Any suspected adverse reactions or side effects should be reported to the MHRA’s Yellow Card scheme.
View full alert here.
If you require more information, have further medical information enquiries (including replacement PIL enquiries) then please e-mail: email@example.com. For stock control queries, please contact: firstname.lastname@example.org