Class 4 Medicines Defect Information: Ibuprofen 200mg and 400mg tablets (Aspar Pharmaceuticals) various liveries
Class 4 Medicines Defect Information: Ibuprofen 200mg and 400mg tablets (Aspar Pharmaceuticals) various liveries
July 20, 2020
Class 4 Medicines Defect Information: Ibuprofen 200mg and 400mg tablets (Aspar Pharmaceuticals) various liveries
Drug alert number: EL (20)A/30
Date issued: 20 July 2020
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
Class 4 Medicines Defect Information: Ibuprofen 200mg and 400mg tablets (Aspar Pharmaceuticals) various liveries
Aspar Pharmaceuticals Limited have advised that the Patient Information Leaflets (PILs) within the ibuprofen packs below are missing some information identified from post-marketing experience that should be documented in Section 3 (How To Take The Tablets) and Section 4 (Possible Side Effects) of the PIL
| Product | Pack Size | PL Number |
| Aspar Ibuprofen 200mg Caplets (GSL) | 16 | PL 08977/0015 |
| Product | Pack Size | PL Number |
| Nisa Ibuprofen 200mg BP Tablets (GSL) | 16 | PL 08977/0016 |
| Lloyds Pharmacy Ibuprofen 200mg Tablets (GSL) | 16 | PL 08977/0016 |
| Lloyds Pharmacy Ibuprofen 200mg 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 Tablets (P) | 25,48 | PL 08977/0016 |
| Asda Ibuprofen 200mg Tablets (P) | 48 | PL 08977/0016 |
| Product | Pack Size | PL Number |
| Ibucalm 400mg Tablets (P) | 24,48,96 | PL 08977/0017 |
| Asda Ibuprofen 400mg Tablets (P) | 48,96 | PL 08977/001 |
| Careway Ibuprofen 400mg Tablets (P) | 24,48 | PL 08977/001 |
| Lloyds Pharmacy Ibuprofen 400mg Tablets (P) | 12,24,48,96 | PL 08977/001 |
The correct information is as follows:
Section 3 (How to take the tablets)
| 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. |
Section 4 (Possible side effects)
| 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). |
Aspar Pharmaceuticals Limited has taken corrective steps to update the PIL going forward.
Advice for healthcare professionals
If any of the above products are supplied and/or dispensed, please ensure that patients are aware of the missing information as highlighted above. It is important that any patients who notice the above symptoms should seek immediate medical advice.
As a general reminder, 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.
View full alert here
Further Information
For more information or medical information enquiries please contact:
Aspar Pharmaceuticals
Acrewood Way
Hatfield Road
St Albans AL4 0JY
Hertfordshire
Tel: 020 8205 9846
Posted in: Dispensing & Supply
