Class 4 Medicines Defect Information:Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets

Class 4 Medicines Defect Information: Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets (EL (21)A/21)

MDR Number: MDR 197-08/21

Company name: Accord Healthcare Limited

Date issued: 10 September 2021

The Medicines and Health products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Information:

Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets (EL (21)A/21)

Accord Healthcare have informed the MHRA of an error with the patient information leaflets (PILs) that have been packaged in the below listed batches of products. These were an older version of the PIL which did not include the most up to date safety information.

Rosuvastatin 5 mg film-coated tablets PL 20075/0402

Rosuvastatin 10 mg film-coated tablets PL 20075/0403

Rosuvastatin 20 mg film-coated tablets PL 20075/0404

Rosuvastatin 40 mg film-coated tablets PL 20075/0405

The information missing from the PILs are as below:

Section 2 Other medicines and Rosuvastatin tablets:

Tell your doctor if you are taking any of the following:

Regorafenib (used to treat cancer), any of the following drugs used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (please see Warnings and precautions): atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Section 4 Possible side effects:

Stop taking Rosuvastatin tablets and talk to your doctor immediately

• If you experience muscle rupture
• If you have lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

Rosuvastatin tablets may cause the following possible side effects:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps). If you think you are having an allergic reaction, then stop taking Rosuvastatin tablets and seek medical help immediately
• Muscle damage in adults – as a precaution, stop taking Rosuvastatin tablets and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected
• Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

Advice for 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 the product and where possible, provide an updated PIL. The updated PILs are available via the MHRA website:

Rosuvastatin 5 mg film-coated tablets-PIL

Rosuvastatin10 mg film-coated tablets-PIL

Rosuvastatin 20 mg film-coated tablets-PIL

Rosuvastatin 40 mg film-coated tablets-PIL

Accord Healthcare Limited have confirmed that all future batches will contain the updated PIL and that upon request they will be send hard copies by post of the updated PIL to wholesalers and pharmacies, so that any remaining stock in the dispensary can be supplemented with the updated PIL information.

Further Information

Full Medicines Notification can be viewed here

For more information or medical information queries please contact: Accord Medical Information Department on 01271 385257, email medinfo@accord-healthcare.com.

For stock control queries, please contact: Accord Customer Services Team on 0800 373573

For updated PIL requests please contact contact@accord-healthcare.com or phone: 01271 385200