GovWire

DMRC reference number

DMRC 32407021

Company name

Sandoz Ltd.

Rosuvastatin 20mg Tablets, PL 04416/1425

SNOMED Code

35036111000001106

Rosuvastatin 40mg Tablets, PL 04416/1426

SNOMED Code:

35036311000001108

Active Pharmaceutical Ingredient: rosuvastatin calcium

Brief description of the problem

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Rosuvastatin 20mg and 40mg Tablets. The summary of the missing safety information is tabulated in Annex 1.

Advice for healthcare professionals

There is no risk to product quality or impact to safety of the medicines listed in this notification because of this missing information, full details in Annex Table 1.

• The information missing in Sections 4.1 and 4.2 of the SmPC pertains to the use of rosuvastatin in children aged 6 years with Homozygous familial hypercholesterolaemia, which is an approved condition. The reference SmPC has updates to include additional details about this approved use.
• The updated text in the lactation section now includes information that rosuvastatin is found in breast milk and may be harmful to infants. This aligns with the current Sandoz SmPC, which already advise against using rosuvastatin during pregnancy and lactation in Sections 4.6 and 4.3. The information on fertility was already present but has now been separated into its own heading to comply with changes in the SmPC template.
• The updated text regarding fusidic acid clarifies that there have been no studies conducted on the interaction between rosuvastatin and fusidic acid. However, the interaction was already described in the Sandoz SmPC in Section 4.5 Interaction with other medicinal products and other forms of interaction.
• The updated information in the reference SmPC from clinical trials shows that roxadustat, teriflunomide, capmatinib, fostamatinib, febuxostat, and tafamidis can increase rosuvastatin area under the curve (AUC) levels by 1.9 to 2.9 times. However, the current Sandoz SmPC already states in Section 5.2 and 4.5 that the elimination half-life of rosuvastatin does not increase with higher doses, and caution should be taken if the rosuvastatin dose exceeds 20 mg.
• The PIL is missing information related to telling your doctor if you are taking any of the following medication: roxadustat, teriflunomide, capmatinib, fostamatinib, febuxostat, and tafamidis.

Considering the above omissions, the majority of the safety information is already covered in other sections of the Sandoz SmPC and PIL.

Healthcare professionals are advised to review the content of this notification, as it provides information that is missing from the current SmPC and PIL on the existing clinical concepts (as detailed above) and take this into account when prescribing.

If the medicines listed in this notification are supplied or dispensed, ensure that patients are aware of the information missing from the PIL on interaction with other medicines see table 2 of Annex 1. Advise patients that if they are taking any of the medications listed in table 2 of Annex 1 they should discuss this with their prescribing healthcare professional before they start taking the medication.

Due to supply considerations, batches listed as not yet distributed will not be repackaged with the updated PIL prior to distribution. The specified Not yet distributed batches are scheduled to be distributed shortly to avoid any supply considerations. Sandoz Ltd. has confirmed that all future batches (not listed in this notification) of the product will contain the updated PIL.

Advice for patients

Patients do not need to take any action. The information in Annex Table 2 is missing from the Patient Information Leaflet. The missing information, summarised in this notification, does not change or affect the quality of the product. Therefore, you can safely continue your treatment. However, should you experience any adverse effects/side effects with the prescribed medication please contact your healthcare professional.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRAYellow Card scheme.

Further Information

For medical information queries, please contact: sandozgb@EU.propharmagroup.com, Telephone: +44 1276 698 101.

For stock control queries, please contact: sales.sandoz-gb@sandoz.com, Telephone: +44 1276 698607.

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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 4 Medicines Defect Information: Sandoz Ltd., Rosuvastatin 20mg, 40mg Tablets, EL(24)A/45