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

 



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