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08-Jun-2019 19:45

Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.With regard to the chance of suicide, in particular at the beginning of treatment, onlythe smallest amount of Zispin film-coated tablets should be given to the patient consistent with good patient management, in order to reduce the risk of overdose.It should be taken preferably as a single night-time dose before going to bed.Zispin may also be given in two divided doses (once in the morning and once at night-time, the higher dose should be taken at night).Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatraemia.Interaction with serotonergic active substances: serotonin syndrome may occur when selective serotonin reuptake inhibitors (SSRIs) are used concomitantly with other serotonergic active substances (see section 4.5).

Close supervision of patients and in particular those at high risk should accompany therapy with antidepressants especially in early treatment and following dose changes.Treatment should be discontinued in any patient who develops seizures, or where there is an increase in seizure frequency.