其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Aspar Pharmaceuticals Limited, Ibuprofen 200mg and 400mg tablets packaged in various liveries (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Aspar Pharmaceuticals Limited has informed MHRA that the Patient Information Leaflets (PIL) within the following ibuprofen packs 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. The affected products are:
- Aspar Ibuprofen 200mg Caplets (GSL)
- Nisa Ibuprofen Tablets BP 200mg (GSL)
- Lloyds Pharmacy Ibuprofen 200mg Tablets (GSL)
- Lloyds Pharmacy Ibuprofen 200mg Tablets (P)
- Lifestyle Ibuprofen Tablets BP 200mg (GSL)
- Ibucalm 200mg Tablets (GSL)
- Ibucalm 200mg Tablets (P)
- Careway Ibuprofen 200mg Tablets (GSL)
- Careway Ibuprofen 200mg Tablets (P)
- Asda Ibuprofen 200mg Tablets (P)
- Ibucalm 400mg Tablets (P)
- Asda Ibuprofen 400mg Tablets (P)
- Careway Ibuprofen 400mg Tablets (P)
- Lloyds Pharmacy Ibuprofen 400mg Tablets (P)
Correct information that should be included in the PIL:
- Section 3: 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: 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.
Healthcare professionals are advised that, 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-aspar-pharmaceuticals-limited-ibuprofen-200mg-and-400mg-tablets-packaged-in-various-liveries-el-20-a-30
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Tuesday, Jul 21, 2020
Issued at HKT 15:00
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