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
| 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
Brief description of the 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 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 for 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.
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.
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.
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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