Boots identifies error with PILs of Decongestant Tablets

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

Active Pharmaceutical Ingredient: Pseudoephedrine hydrochloride

Decongestant with Pain Relief Tablets PL 00014/0594

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)