GovWire

MDR Number

MDR 197-08/21

Company name

Accord Healthcare Limited

Product description

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

Active Pharmaceutical Ingredient: Rosuvastatin calcium

Brief description of the problem

Further to a previous defect notification, EL (21)/A21 Accord Healthcare have informed us of an errorwith the patient information leaflets (PILs) that have been packaged in the above additional batches ofproducts. These were an older version of the PIL which did not include the most up to date safetyinformation.

Accord Healthcare have confirmed that this issue impacts 29086 packs across the three differentbatches mentioned. The MHRA have confirmed with Accord Healthcare that all other packs of theabove batches currently on hold at the manufacturer will not be distributed.

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 HIVor 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 beingrecalled. Healthcare professionals are advised to exercise caution when dispensing the product andwhere possible, provide an updated PIL. The updated PIL is 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

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

Further Information

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

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.

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Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg and 20 mg film-coated tablets EL (22)A/35