The Medicines and Health products Regulatory Agency (MHRA) has issued a class four medicines defect information notice for Ibuprofen 200mg and 400mg tablets of Aspar Pharmaceuticals.
The patient information leaflets (PILs) within the ibuprofen packs are missing some information which should be documented in section three and section four of the PIL, Aspar Pharmaceuticals Limited has said.
How to take the tablets (section three)
| Current information in the PIL | Correct information that should be included in the PIL |
|---|---|
| Seek medical attention IMMEDIATELY if you accidentally take too many tablets. | Seek medical attention IMMEDIATELY if you accidentally take too many tablets. If you have taken more than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken. The symptoms can include nausea, stomach pain, vomiting (may be blood-streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported. |
Possible side effects (section four)
| Current information in the PIL | Correct information that should be included in the PIL |
|---|---|
| (No appropriate wording related to DRESS syndrome) | A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells). |
Product Description
MDR number of the product is MDR 054-07/20 and ibuprofen is the active pharmaceutical ingredient.| Product | Pack Size | PL Number |
|---|---|---|
| Aspar Ibuprofen 200mg Caplets (GSL) | 16 | PL 08977/0015 |
| Product | Pack Size | PL Number |
|---|---|---|
| Nisa Ibuprofen Tablets BP 200mg (GSL) | 16 | PL 08977/0016 |
| Lloyds Pharmacy Ibuprofen 200mg Tablets (GSL) | 16 | PL 08977/0016 |
| Lloyds Pharmacy Ibuprofen200mg Tablets (P) | 24, 48, 16 | PL 08977/0016 |
| Lifestyle Ibuprofen Tablets BP 200mg (GSL) | 16 | PL 08977/0016 |
| Ibucalm 200mg Tablets (GSL) | 16 | PL 08977/0016 |
| Ibucalm 200mg Tablets (P) | 24, 48, 16 | PL 08977/0016 |
| Careway Ibuprofen 200mg Tablets (GSL) | 16 | PL 08977/0016 |
| Careway Ibuprofen 200mg Tablets (P) | 25, 48 | PL 08977/0016 |
| Asda Ibuprofen 200mg Tablets (P) | 48 | PL 08977/0016 |
| Product | Pack Size(s) | PL Number |
|---|---|---|
| Ibucalm 400mg Tablets (P) | 24, 48, 96 | PL 08977/0017 |
| Asda Ibuprofen 400mg Tablets (P) | 48, 96 | PL 08977/0017 |
| Careway Ibuprofen 400mg Tablets (P) | 24, 48 | PL 08977/0017 |
| Lloyds Pharmacy Ibuprofen 400mg Tablets (P) | 12, 24, 48, 96 | PL 08977/0017 |
Advice for healthcare professionals
Community pharmacists have been adviced that if any of the above products are supplied or dispensed, then they should ensure that patients are aware of the missing information as mentioned above.It is important that any patients who notice any symptoms following the use of the product should seek immediate medical advice.
The patients who experience side effects from taking any medicines should be encouraged to report a suspected problem or incident via the Yellow Card scheme and seek medical advice accordingly.
