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Patients with this genotype have a several-fold higher exposure to atomoxetine when compared to patients with a functional enzyme. Poor metabolisers are therefore at higher risk of adverse events see section 4. For patients with a known poor metaboliser genotype, a lower starting dose and slower up titration of the dose may be considered.

Paediatric population under six years of age Atomoxetine should not be used in combination with monoamine oxidase inhibitors MAOI. Atomoxetine should not be used within a minimum of 2 weeks after discontinuing therapy with MAOI. Treatment with MAOI should not be initiated within 2 weeks after discontinuing atomoxetine.

Atomoxetine should not be used in patients with narrow-angle glaucoma, as in clinical trials the use of atomoxetine was associated with an increased incidence of mydriasis. Atomoxetine should not be used in patients with severe cardiovascular or cerebrovascular disorders see section 4. Severe cerebrovascular disorders may include cerebral aneurysm or stroke. Atomoxetine should not be used in patients with pheochromocytoma or a history of pheochromocytoma see section 4.

Sudden death and pre-existing cardiac abnormalities Although some serious structural cardiac abnormalities alone carry an increased risk of sudden death, atomoxetine should only be used with caution in patients with known serious structural cardiac abnormalities and in consultation with a cardiac specialist. Atomoxetine can affect heart rate and blood pressure. Long-term sustained changes in blood pressure may potentially contribute to clinical consequences such as myocardial hypertrophy. As a result of these findings, patients who are being considered for treatment with atomoxetine should have a careful history and physical exam to assess for the presence of cardiac disease, and should receive further specialist cardiac evaluation if initial findings suggest such history or disease.

Atomoxetine should be used with caution in patients whose underlying medical conditions could be worsened by increases in blood pressure and heart rate, such as patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease. Patients who develop symptoms such as palpitations, exertional chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of cardiac disease during atomoxetine treatment should undergo a prompt specialist cardiac evaluation. In addition, atomoxetine should be used with caution in patients with congenital or acquired long QT or a family history of QT prolongation see sections 4.

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