SPC changes
Plavix
The summary of product characteristics for Plavix (clopidogrel) has been
amended. Section 4.4 now describes thrombotic thrombocytopenic purpura
as a “potentially fatal condition requiring prompt treatment”.
In Section 4.8, Stevens–Johnson Syndrome has been added to the “Undesirable
effects” list (under “Skin and subcutaneous tissue disorder”).
Section 4.9 has also been amended and now reads: “Overdose following
clopidogrel administration may lead to prolonged bleeding time and subsequent
bleeding complications. Appropriate therapy should be considered if bleedings
are observed.”
Ikorel
The summary of product characteristics for Ikorel (nicorandil) now includes
a new indication for a reduction in the risk of acute coronary syndromes
in patients with chronic stable angina and at least one of the following
risk factors: previous myocardial infarction; previous coronary artery
bypass graft; or coronary heart disease on angiography or a positive
exercise test, together with one of the following: left ventricular hypertrophy
on electrocardiogram, left ventricular dysfunction, age >65 years,
diabetes mellitus (type 1 or 2 excluding those on sulphonylureas), hypertension
or documented vascular disease.
The summary now also includes some details of the results of the IONA
(impact of nicorandil in angina) study in the list of pharmacodynamic
properties.
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