SPC changes
Accessing SPCs
The summaries of product characteristics and patient
information leaflets for medicines licensed in the UK are available online |
Decapeptyl
The wording of the indication of Decapeptyl (triptorelin; Ipsen) has
been clarified in the product’s summary of product characteristics.
It now reads: “Decapeptyl is indicated for the treatment of patients
with locally advanced, non-metastatic prostate cancer, as an alternative
to surgical castration and for the treatment of metastatic prostate cancer”.
Ergometrine
A warning about increased susceptibility to angina or myocardial infarction
in patients with coronary heart disease has been added to the summary
of product characteristics for Hameln Pharmaceuticals’s ergometrine
injection 0.05 per cent. Coronary arteriospasm with very rare reports
of myocardial infarction has been added to the undesirable effects
list.
Napratec
Severe heart failure is now listed as a contraindication to the use of
Napratec OP (naproxen and misoprostol; Pfizer) tablets in the product’s
summary of product characteristics. Hypertension and cardiac failure
are also now listed as adverse events.
Xalatan
Additional safety information about the use of Xalatan (latanoprost;
Pharmacia) eye drops has been added the medicine’s summary of
product characteristics. There have been updates to the wording relating
to the use of Xalatan in aphakic patients, in pseudophakic patients
with torn posterior lens capsule or anterior chamber lens and in patients
with known risk factors for cystoid macular oedema. Text has been added
relating to paradoxical elevations in intraocular pressure with concomitant
administration of two prostaglandin analogues.
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