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Product news (20 December 2008)

SPC changes: Epanutin; Harmogen; Strattera / Discontinued products: Eskamel cream / Supply issues: Lomotil

SPC changes


The summaries of product characteristics for Epanutin (phenytoin; Pfizer) have been updated to include a warning that suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents.

Patients taking Epanutin should be monitored for signs of suicidal ideation and behaviours, and appropriate treatment should be considered.

Patients and carers of patients should be advised to seek medical advice if signs of suicidal ideation or behaviour emerge.


The shelf life of Harmogen tablets (estropipate USP; Pfizer) is now three years according to its updated summary of product characteristics.


The summary of product characteristics for Strattera (atomoxetine; Lilly UK) now states that sudden death has been reported in children and adolescents with structural cardiac abnormalities who have taken Strattera at standard doses. Strattera should be used with caution and in consultation with a cardiac specialist in children and adolescents with these abnormalities.

The updated SPC states that Strattera can cause psychotic or manic symptoms in children and adolescents without a prior history of psychotic illness or mania. If these symptoms occur, discontinuation should be considered.

The SPC also states that the possibility that Strattera will cause exacerbation of pre-existing pschotic or manic symptoms cannot be excluded.

Patients should be closely monitored for the appearance or worsening of aggressive behaviour, hostility or emotional lability.

Headache and somnolence are now listed as very common (=1/10) undesirable effects in children and adolescents.

Insomnia is listed as a common (=1/100 to <1/10) undesirable effect in adults.


Discontinued Products

Eskamel Cream

Eskamel cream 25mg has been discontinued by Goldshield. Medical information on 020 8588 9449.

Stock related information on 020 8588 9273.


Supply Issues


Lomotil (co-phenotrope) tablets will be unavailable from Goldshield from mid December 2008. The product should be available again in March 2009.

Further information from Goldshield medical information on 020 8588 9449. Stock related information on 020 8588 9273.

Citation: The Pharmaceutical Journal URI: 10043855

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