Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Boots Company Plc, Decongestant Tablets and Decongestant with Pain Relief Tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Boots Company Plc has identified an error with the printed patient information leaflet (PIL) provided with certain batches of the following products:
- Decongestant Tablets (pseudoephedrine hydrochloride) (batch number: 2008662A, 2008662C, 2109523A, 2109523B, 2111550A)
- Decongestant with Pain Relief Tablets (paracetamol, pseudoephedrine hydrochloride) (batch number: 2006973, 2110262, 2110264A)
Please see missing information from the PIL(s):
Section ‘Do not take’:
- if you are pregnant or breastfeeding
Section ‘Talk to your pharmacist or doctor if you experience’:
- Sudden abdominal pain or rectal bleeding may occur with this medicine, due to inflammation of the colon (ischaemic colitis). If you develop these gastro-intestinal symptoms, stop taking this medicine and contact your doctor or seek medical attention immediately. See ‘Possible side effects’ section.
- Reduction of blood flow to your optic nerve may occur with pseudoephedrine. If you develop sudden loss of vision, stop taking this medicine and contact your doctor or seek medical attention immediately. See ‘Possible side effects’ section.
Section ‘Possible side effects’:
If you get any of these serious side effects, stop taking the tablets. See a doctor at once: Frequency not known:
- Inflammation of the colon due to insufficient blood supply (ischaemic colitis).
- Reduced blood flow to the optic nerve, loss of vision (Ischaemic optic neuropathy)
Healthcare professionals should ensure that appropriate patient counselling takes place and patients are aware of the missing information.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-boots-company-plc-decongestant-tablets-and-decongestant-with-pain-relief-tablets-el-22-a-slash-12
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Mar 11, 2022
Issued at HKT 15:30
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