syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) which can be life threatening or fatal have been reported very rarely with quetiapine treatment. SCARs commonly present as a combination of: extensive cutaneous rash or exfoliative dermatitis, fever, lymphadenopathy, and possible eosinophilia. If signs and symptoms suggestive of these severe skin reactions appear, withdraw quetiapine immediately and consider alternative treatment. Constipation and intestinal obstruction have been reported, including fatalities in those at higher risk for obstruction including those taking multiple medicines that decrease intestinal motility and may not report constipation symptoms. Pancreatitis has been reported. Severe neutropenia has been reported, mostly within months of initiation. Discontinue if neutrophil count <1.0×109/L – monitor neutrophil count and for signs of infection. Consider neutropenia if infection or fever, especially if no predisposing factor. Advise to immediately report signs/symptoms of agranulocytosis/infection, promptly check white blood cell and absolute neutrophil count. Contains lactose; do not use if rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption. Do not consume grapefruit juice. Advise not to drive/operate machinery until individual susceptibility to quetiapine affecting a patient’s mental alertness is known. False positive results reported in enzyme immunoassays for methadone and tricyclic antidepressants. Recommend confirmation of questionable immunoassay screening results by an appropriate chromatographic technique. Concomitant use with strong hepatic enzyme inducer could affect efficacy. If receiving a hepatic enzyme inducer, only initiate quetiapine if benefits outweigh risks of removing enzyme inducer. Any change in inducer must be gradual and if required, should be replaced with a non-inducer (e.g. sodium valproate). Data in combination with divalproex or lithium in manic episodes limited Not approved for dementia-related psychosis. Advise gradual withdrawal over 1-2 weeks to avoid acute withdrawal symptoms. Only use in pregnancy if benefits justify potential risks. If exposed to antipsychotics in third trimester, monitor newborns carefully for adverse events; lactation – decide whether to discontinue breast-feeding or discontinue quetiapine. Side effects: For full list of side effects consult SmPC. ‘Very Common’, ‘Common’ and ‘Serious’ side effects included in this prescribing information. Very common (≥1/10): decreased haemoglobin, elevations in serum triglycerides, elevations in total cholesterol (predominantly LDL), decreases in HDL cholesterol, weight gain, dizziness, somnolence, headache, extrapyramidal symptoms, dry mouth and withdrawal (discontinuation) symptoms. Common (≥1/100 to <1/10): leucopenia, decreased neutrophil count, eosinophils increased, hyperprolactinemia, decreases in total T4, decreases in free T4, decreases in total T3, increases in TSH, increased appetite, increased blood glucose to hyperglycaemic levels, abnormal dreams and nightmares, suicidal ideation and suicidal behaviour, dysarthria, tachycardia, palpitations, blurred vision, orthostatic hypotension, dyspnoea, constipation, dyspepsia, vomiting, elevations in serum alanine aminotransferase, elevations in gamma-GT levels, mild asthenia, peripheral oedema, irritability, pyrexia. Serious uncommon/rare/very rare/not known frequency: neutropenia, thrombocytopenia, anaemia, hypersensitivity (including allergic skin reactions), hyponatraemia, Diabetes Mellitus, exacerbation of pre- existing diabetes, seizure, tardive dyskinesia, syncope, QT prolongation, elevations in serum aspartate aminotransferase, bradycardia, agranulocytosis, metabolic syndrome, venous thromboembolism, pancreatitis, intestinal obstruction/ileus, hepatitis, priapism, neuroleptic malignant syndrome, hypothermia, elevations in blood creatine phosphokinase, anaphylactic reaction, inappropriate antidiuretic hormone secretion, angioedema, Stevens-Johnson syndrome, cardiopathy, myocarditis, stroke, rhabdomyolysis, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), cutaneous vasculitis, drug withdrawal syndrome neonatal.. MA number: PL 35533/0051-55. Cost: £29.45 for 50mg, £49.45 for 150mg, £49.45 for 200mg, £74.45 for 300mg, £98.95 for 400mg (x60 pack), £70.73 for 600mg (x30 pack). MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK. Legal category: POM. Date last reviewed: May 2021. Version Number: 1010269093 v 11.0.