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Formal drug interaction studies showed an increase in galantamine bioavailability of about 40during co-administration of paroxetinea potent CYP2D6 inhibitorand of 30and 12during co-treatment with ketoconazole and erythromycinboth CYP3A4 inhibitorsThereforeduring initiation of treatment with potent inhibitors of CYP2D6e.gquinidineparoxetine or fluoxetineor CYP3A4e.gketoconazole or ritonavirpatients may experience an increased incidence of cholinergic adverse reactionspredominantly nausea and vomitingUnder these circumstancesbased on tolerabilitya reduction of the galantamine maintenance dose can be consideredsee section 4.2

Multiple metabolic pathways and renal excretion are involved in the elimination of galantamineThe possibility of clinically relevant interactions is lowHoweverthe occurrence of significant interactions may be clinically relevant in individual cases.

Patients with Alzheimer’s disease lose weightTreatment with cholinesterase inhibitorsincluding galantaminehas been associated with weight loss in these patientsDuring therapypatient’s weight should be monitored.

The pharmacokinetics of galantamine in subjects with mild hepatic impairmentChild-Pugh score of 5-6were comparable to those in healthy subjectsIn patients with moderate hepatic impairmentChild-Pugh score of 7-9AUC and half-life of galantamine were increased by about 30see section 4.2

The initial maintenance dose is 16 mg/day8 mg twice a dayand patients should be maintained on 16 mg/day for at least 4 weeks.

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