Zylanza Special Precautions

Patients should be assessed before taking ZYLANZA.
Medicines of this type may cause unusual movements mainly of the face or tongue. Patients should be assessed if this happens after ZYLANZA has been given.
Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, immediate medical attention is necessary.
Weight gain has been seen in patients taking ZYLANZA. Weight should be checked regularly. A referral to a dietician or help with a diet plan should be considered if necessary.
High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYLANZA. Blood tests should be performed to check blood sugar and certain fat levels before initiating treatment with ZYLANZA and regularly during treatment.
The physician should know if patients or someone else in their family have a history of blood clots, as medicines like these have been associated with the formation of blood clots.
The physician should know as soon as possible if patients suffer from any of the following illnesses: Stroke or "mini" stroke (temporary symptoms of stroke); Parkinson's disease; Prostate problems; Paralytic ileus; Liver or kidney disease; Blood disorders; Heart disease; Diabetes; Seizures; Salt depletion as a result of prolonged severe diarrhoea and vomiting or usage of diuretics.
If patients suffer from dementia, they or their carer/relative should inform the physician if they have ever had a stroke or "mini" stroke.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with olanzapine exposure. DRESS consists of a combination of three or more of the following: cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, lymphadenopathy and one or more systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and pericarditis. Olanzapine should be discontinued if DRESS is suspected.
ZYLANZA contains aspartame: Patients who cannot take phenylalanine should note that ZYLANZA contains aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.
ZYLANZA contains lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine before consulting their physician.
Driving and using machines: There is a risk of feeling drowsy when being treated with ZYLANZA. If this happens, patients should not drive or operate any tools or machines.
Use in Pregnancy: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. ZYLANZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Children: ZYLANZA is not for patients who are under 18 years.
Use in the Elderly: The use of ZYLANZA in elderly patients with dementia is not recommended as it may have serious side effects.
As a routine precaution, blood pressure may be monitored if patients are over 65 years.