SPC changes
Epilim
The summaries of product characteristics for Epilim, Epilim Intravenous
and Epilim Chrono (sodium valproate; sanofi-aventis) have been updated.
They now state that Epilim should only be discontinued under the supervision
of a specialist in a gradual manner. They also state that the National
Institute for Health and Clinical Excellence has advised that generic
switching of valproate preparations is not normally recommended. Very
rare cases of hyponatraemia and enuresis have been added to the undesirable
effects sections. See SPCs.
Naprosyn
The summaries of product characteristics for Naprosyn and Naprosyn EC
(naproxen; Roche) tablets have been updated to include history of peptic
ulceration as a contraindication. They also say that the use of naproxen
may impair fertility and is not recommended in women attempting to
conceive. The interactions sections now state that co-administration
with warfarin or heparin is not considered safe unless under direct
medical supervision. The adverse events sections have also been updated.
See SPCs.
Seroxat
The summary of product characteristics for Seroxat (paroxetine; GlaxoSmithKline)
has been updated. It now states that paroxetine should only be used
during pregnancy when strictly indicated. It says that prescribers
need to weigh the option of alternative treatments in women who are
pregnant or planning to become pregnant. Abrupt discontinuation during
pregnancy should be avoided and the SPC advises that a taper phase
regimen of decreasing the daily dose by 10mg at weekly intervals has
been used in clinical trials. It recommends that neonates should be
observed if maternal use of paroxetine continues into the later stages
of pregnancy, particularly the third trimester. See SPC.
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