20.07.2020

Ibuprofen - Aspar Pharmaceuticals Limited

Threat

Aspar Pharmaceuticals Limited has informed us 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.

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Source of the alert

Producers/Retail chains/Distributors

The risk concerns products
Recommendations for consumers
Section 3 (How to take the tablets)


Current information in the PIL:

Seek medical attention IMMEDIATELY if you accidentally take too many tablets.


Correct information that should be included in the PIL:

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:

(No appropriate wording related to DRESS syndrome)

Correct information that should be included in the PIL:

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.


For more information or medical information queries, please contact:

Aspar Pharmaceuticals

Acrewood Way

Hatfield Road

St Albans AL4 0JY

Hertfordshire

Tel: 020 8205 9846

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.

NHS England and NHS Improvement Regional Offices are asked to forward this alert to community pharmacy contractors.

Alert details

Country of origin

-

Country for notification

United Kingdom

Category

Pharmaceuticals

Source of the alert

Producers/Retail chains/Distributors - Information posted directly by producers or commercial networks.

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