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Boots identifies error with PILs of Decongestant Tablets

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The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare professionals to ensure appropriate patient counselling takes place and patients are aware of the missing information on the patient information leaflet (PIL) of Decongestant Tablets and Decongestant with Pain Relief Tablets.

The advise came after Boots has identified an error with the printed PIL provided with batches of the tablets.

See below the details of the affected batches:

Decongestant Tablets PL 00014/0375

Batch Number Expiry Date Pack Size First Distributed
2008662A 30/09/23 12 Tablets 18/12/20
2008662C 30/09/23 12 Tablets 28/05/21
2109523A 30/09/24 12 Tablets 07/10/21
2109523B 30/09/24 12 Tablets 17/11/21
2111550A 30/11/24 12 Tablets 26/11/21

Active Pharmaceutical Ingredient: Pseudoephedrine hydrochloride

Decongestant with Pain Relief Tablets PL 00014/0594

Batch Number Expiry Date Pack Size First Distributed
2006973 30/06/23 12 Tablets 30/08/21
2110262 31/10/24 12 Tablets 14/12/21
2110264A 31/10/24 12 Tablets 13/12/21

Active Pharmaceutical Ingredient: Paracetamol, Pseudoephedrine hydrochloride

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)

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Current Issue December 2023

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