SPC changes
Losec
The summary of product characteristics for Losec (omeprazole; AstraZeneca)
has been updated. It now states that Losec can be used during pregnancy.
It also states that omeprazole is excreted in breast milk but is not
likely to influence the child when therapeutic doses are used. The SPC
for capsules and MUPs now also states that in children aged one year
and over with severe ulcerating reflux oesophagitis, Losec is recommended
for healing and symptom relief at the following doses: 10–20kg,
10mg once daily, >20kg, 20mg once daily (increased to 20mg and 40mg,
respectively, for four to 12 weeks if needed). The undesirable effects
section has also been updated to include use in children. Treatment should
be initiated by a paediatrician. See SPC.
Vfend
Vfend (voriconazole; Pfizer) is now additionally indicated for the treatment
of candidaemia in non-neutropenic patients. The summary of product
characteristics also states that there is an interaction between Vfend
and methadone which may require a methadone dose reduction. Insomnia,
encephalopathy, somnolence during infusion and tinnitus have been added
as rare undesirable effects. Supraventricular tachycardia and prolongation
of the QT interval is now listed as an uncommon rather than a rare
adverse effect. The pharmacodynamic properties section has also been
updated. See SPC.
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