Class 4 Medicines Defect Information: Boots Company Plc, Decongestant Tablets and Decongestant with Pain Relief Tablets, EL (22)A/12

Class 4 Medicines Defect Information: Boots Company Plc, Decongestant Tablets and Decongestant with Pain Relief Tablets, EL (22)A/12

Class 4 Medicines Defect Information: Boots Company Plc, Decongestant Tablets and Decongestant with Pain Relief Tablets, EL (22)A/12

Boots have identified an error with the printed patient information leaflet provided with batches of the Decongestant Tablets and Decongestant with Pain Relief Tablets.

MDR Number: MDR 176-02/22

Company name: Boots Company Plc.

Product description: Decongestant Tablets PL 00014/0375

Details of the affected batch:

Product description:

Details of the affected batch:

Brief description of problem:

Boots have identified an error with the printed patient information leaflet provided with batches of the above-mentioned products.

Please see missing information from the PIL(s) (in bold):

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 EL (22)A/12 Page 2 of 2 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)

Advice to Healthcare Professionals:

Healthcare professionals should ensure that appropriate patient counselling takes place and patients are aware of the missing information.

Please provide a replacement PIL printed from eMC.com with each sale of the product. Web links provided below.

• Decongestant Tablets, PL 00014/0375
  • https://www.medicines.org.uk/emc/product/8292/pil
• Decongestant with Pain Relief Tablets, PL 00014/0594:
  • https://www.medicines.org.uk/emc/product/1566/pil

This issue only impacts Boots Stores, however other healthcare professionals should be aware of the missing information and provide patient support/advice as necessary. Boots Company Plc have confirmed that all stock currently in their warehouse has been suppressed from sale and will not be sent to store or sold onwards. All suspected side effects should also be reported via the Yellow Card Scheme.

Company contacts for further information:

For medical information and stock control queries please contact: UKRegulatory@boots.co.uk

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.            

Full recall