PLEASE READ THE FOLLOWING INFORMATION BEFORE LOGGING ON TO ZTAS!
during pregnancy and risk of abnormal muscle movements and/or withdrawal symptoms in newborns.
Medicinal Products’ Pharmacovigilance Working Party (PhVWP)’, in June 2011.
updated PIL will be introduced in all newly-packaged Zaponex boxes and pots.
It could take a few months for this new stock to be delivered to your hospital or retail pharmacies.
on the public site and under ‘Information’ on the secured site) and can be printed from there.
The wording ‘drug’ / ‘drugs’ has been replaced by ‘substance’ / ‘substances’.
• The information in this section has been re-ordered, re-worded and partly extended.
• The following information has been added: “When a monitoring service is not used, evidence suggests a mortality rate from agranulocytosis of 0.3%. This is compared to a mortality rate from agranulocytosis when Zaponex is used in conjunction with the Zaponex Treatment Access System, of 0.01%.” • It is now mentioned clearly that “Monitoring must continue throughout treatment and for at least 4 • References  and  are added.
• In the boxed warning ‘should’ has been replaced by ‘must’.
• The subsection ‘Use in children’ has been changed to ‘Use in children and adolescents’.
section 4.4 ‘Special warnings and precautions for use’ under the subsection ‘Other precautions’.
in patients with risk factors for stroke.
family history of QT prolongation.
known to increase QTc interval.
with antipsychotics are at a small increased risk of death compared with those who are not treated.
the increased risk is not known.
Zaponex is not approved for the treatment of dementia-related behavioural disturbances.
with regard to the position of paroxetine.
‘Psychiatric disorders’, with respective frequencies ‘Common’ and ‘Uncommon’.
to read “Symptomatic treatment under continuous cardiac monitoring, surveillance of respiration, monitoring of electrolytes and acid-base balance. The use of epinephrine should be avoided in the treatment of hypertension because of the possibility of a ‘reverse epinephrine’ effect.
N.B.: In order to keep this message as concise as possible only the clinically relevant changes are described above. If you are interested to know all changes, please send an email to info@ztas.co.uk with a request for a marked copy of the SmPC, showing all changes.