Regarding amendments to the instructions for medical use of medicinal products containing Ibuprofen
Dear applicants!
Having reviewed the available evidence in EudraVigilance and the literature data on the risk of acute generalized exanthematous pustulosis with the use of ibuprofen, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC) agreed that registration certificate holders of medicinal products containing ibuprofen should submit variations to the instructions for medical use within 2 months.
For medicinal products containing ibuprofen, for monotherapy or combinations of ibuprofen, except combinations with pseudoephedrine.
In the section of the instructions for medical use “Special precautions for use”
Severe skin reactions.
Rare serious skin reactions that can be fatal have been reported, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of nonsteroidal anti-inflammatory drugs (see section “Adverse reactions”).
There is a high risk of these reactions at the start of therapy. The onset of the reaction occurs in most cases within the first month of treatment. A case of acute generalized exanthematous pustulosis following the use of medicinal products containing ibuprofen has also been reported.
Ibuprofen should be discontinued at the first signs and symptoms of skin lesions, such as skin rash, mucosal lesions, or any other signs of hypersensitivity.
In the “Adverse reactions” section of the instructions for medical use
Skin and subcutaneous tissue disorders.
Unknown: Acute generalized exanthematous pustulosis
List of medicinal products containing Ibuprofen and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 19.09.2019)
Linkhttps://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-2-5-september-prac-meeting_en.pdf
