SPC changes
Menorest patches
The summary of product
characteristics for Menorest (estradiol) patches from Novartis Pharmaceuticals
has been amended. The recommendation that the product should not be refrigerated
has been removed.
Altacite Plus suspension
Peckforton Pharmaceuticals has updated the summary
of product characteristics for Altacite Plus. The section on pharmacokinetic
properties now includes the statement: The active ingredients hydrotalcite
and activated dimethicone are not generally absorbed.
Enbrel injection
The new summary of product characteristics for Enbrel
(etanercept) injection from Wyeth Laboratories contains the following
changes.
The special warnings and precautions section now
includes the fact that serious sepsis has been reported with the use of
Enbrel. The section also states that there have been postmarketing reports
of central nervous system (CNS) demyelinating disorders in patients treated
with Enbrel. It therefore recommends that a careful risk/benefit evaluation
should be undertaken when prescribing Enbrel to patients with pre-existing
or recent onset of CNS demyelinating disease.
The following have been added to the undesirable
effects section: fever, pruritus, urticaria, seizures, angioedema and
CNS demyelinating events suggestive of multiple sclerosis or localised
demyelinating conditions such as optic neuritis.
The shelf life of Enbrel has been extended to three
years.
Zoton capsules and suspension
The summary of product characteristics for Zoton
capsules and suspension from Wyeth Laboratories has been amended. The
posology and method of administration section now states that, in acid-related
dyspepsia, Zoton can be taken in intermittent courses as required.
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