Seroquel (Quetiapine) Tablets Abbreviated Prescribing Information

Please refer to the full Summary of Product Characteristics (SmPC) before prescribing

Indications: Schizophrenia; moderate to severe manic and major depressive episodes in bipolar disorder; prevention of recurrence of manic or depressed episodes in bipolar patients who have previously responded to quetiapine treatment. Available strengths: 25, 100, 200, 300mg (x60 tablets). Dosage: Schizophrenia: Should be given twice a day with the total daily dose of 50mg day 1, 100mg day 2, 200mg day 3, 300mg day 4. Day 4 onwards dose should be titrated to usual effective dose of 300-450mg/day; max dose 750mg daily. Moderate to severe manic episodes in bipolar disorder: Should be given twice a day with the total daily dose of 100mg day 1; 200mg day 2; 300mg day 3, 400mg day 4; further dose adjustments up to 800mg/day by day 6 in increments no greater than 200mg/day. Usual effective dose of 400-800mg/day.  Major depressive episodes in bipolar disorder: Should be given twice a day with the total daily dose of 50mg day 1; 100mg day 2; 200mg day 3, 300mg day 4; recommended daily dose is 300mg. Individual patients may benefit from a 600mg dose. Doses greater than 300mg/day should be initiated by physicians experienced in treating bipolar disorder. Preventing recurrence in bipolar disorder: Continue on the same total daily dose between 300-800mg administered twice daily. The lowest effective dose should be used for maintenance. Administration: Can be administered with or without food and should be given twice a day.  Contraindications: Patients with hypersensitivity to active substance or excipients; concomitant use of cytochrome P450 CYP3A4 inhibitors (e.g., HIV protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin, nefazodone). Special warnings and precautions for use: Elderly – use with caution. Rate of titration may need to be slower and daily dose lower. Efficacy and safety not evaluated in bipolar patients over 65 with depressive episodes. Not recommended for use in children and adolescents <18 years old due to lack of data. No dose adjustment necessary in renal impairment. Use with caution if known hepatic impairment – start on 25mg/day and increase by increments of 25-50mg/day to effective dose, depending on response and tolerability. Closely supervise and monitor patients, especially those at high risk, for worsening, suicidal behaviour/thoughts and unusual changes in behaviour, particularly in early treatment and after dose changes; assess metabolic parameters at initiation of and regularly throughout treatment; observe for signs and symptoms of hyperglycaemia; diabetic patients and those at risk for diabetes mellitus should be monitored regularly for worsening glucose control; consider dose reduction/ discontinuation if symptoms of tardive dyskinesia – symptoms can worsen or even arise after treatment discontinuation; discontinue if neuroleptic malignant syndrome develops and treat appropriately; if akathisia develops, increasing dose may be detrimental; if somnolence occurs, onset usually within first 3 days of treatment; orthostatic hypotension has been reported, usually during titration – can increase risk of falls, especially in elderly; caution in those with cardiovascular disease, risk factors for VTE, cerebrovascular disease, other conditions predisposing to hypotension, elderly patients with Parkinson’s disease/parkinsonism, patients receiving concomitant CNS depressants and those at risk for sleep apnoea (e.g. overweight/male), history of seizures, risk factors for neutropenia, concomitant use of medications with anti-cholinergic (muscarinic) effects, diagnosis or history of urinary retention, prostatic hypertrophy, intestinal obstruction, increased intraocular pressure/narrow angle glaucoma, family history of QT prolongation, risk factors for stroke, risk of aspiration pneumonia, history of alcohol or drug abuse. Caution when used with medicines known to cause electrolyte imbalance or increase QT interval, or with neuroleptics, especially in elderly, those with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia, hypomagnesaemia, or in combination with other centrally acting medicines or alcohol. In patients with suspected cardiomyopathy or myocarditis discontinuation of quetiapine should be considered. Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP), erythema multiforme (EM) 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. Undesirable 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): dizziness, somnolence, headache, dry mouth and withdrawal (discontinuation) symptoms, decreased haemoglobin, elevations in serum triglycerides, elevations in total cholesterol (predominantly LDL), decreases in HDL cholesterol, weight gain and extrapyramidal 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, cardiomyopathy, myocarditis, stroke, rhabdomyolysis, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS), cutaneous vasculitis, drug withdrawal syndrome neonatal. Marketing Authorisation Number: PL 50827/0002-5. Basic NHSPrice: £48.60 for 25mg, £135.72 for 100mg, £135.72 for 200mg, £204.00 for 300mg. Marketing Authorisation Holder: Luye Pharma Ltd, Surrey Technology Centre, 40 Occam Road, Guildford, Surrey, UK. GU2 7YG. Legal category: POM. Date of Preparation: December 2022. 

Adverse events should be reported

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Adverse events should also be reported to Luye Pharma Ltd. at safety@luyepharma.co.uk.