(Please refer to the full 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; add-on treatment of major depressive episodes in patients with major depressive disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. Available strengths: 50, 150, 200, 300, 400mg (x60 tablets) and 600mg (x30 tablets). Dosage: Schizophrenia, moderate to severe manic episodes in bipolar disorder: Administer at least one hour before meal. 300mg day 1, 600mg day 2; recommended daily dose 600mg; max dose 800mg daily. Adjust dose within the effective dose range of 400mg to 800mg per day, depending on clinical response and tolerability. No dosage adjustment necessary for maintenance therapy in schizophrenia. Major depressive episodes in bipolar disorder: Administer at bedtime. 50mg day 1; 100mg day 2; 200mg day 3, 300mg day 4. Recommended daily dose 300mg; Doses over 300mg at experienced physician’s discretion. Preventing recurrence in bipolar disorder: Continue on the same dose between 300-800mg at bedtime. Use the lowest effective dose for maintenance therapy. For add-on treatment of major depressive episodes in MDD: Administer prior to bedtime. 50mg (day 1 & 2), 150mg (day 3 & 4), dose may be increased to 300mg/day on individual patient evaluation. Maintain at lowest effective dose. Elderly: use with caution, especially during initial dosing period. Start on 50mg/day and increase in 50mg/day increments to an effective dose. In elderly patients with major depressive episodes in MDD, 50mg/day day 1-3, 100mg/day day 4, 150mg/day day 8. Use the lowest effective dose. Based on individual patient, if dose increase to 300mg/day is required, this should not be before day 22. Efficacy and safety not evaluated in bipolar patients over 65 with depressive episodes. Paediatric Population: Biquelle XL is not recommended in children and adolescents below 18 years. Hepatic impairment: use with caution in patients with known hepatic impairment, especially during initial dosing period. Start on 50mg/day and increase in increments of 50mg/day to an effective dose. Renal impairment: No dose adjustment necessary. Administration: Once daily without food. Swallow tablets whole – do not split, chew, or crush. Patients on quetiapine immediate-release tablets may be switched to quetiapine prolonged-release tablets at equivalent total daily dosage taken once daily. Individual dose adjustments may be necessary. Contraindications: Patients with hypersensitivity to active substance or excipients; concomitant use of cytochrome P450 CYP 3A4 inhibitors (e.g., HIV protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin, nefazodone). Special warnings and precautions for use:. Long-term efficacy and safety in MDD patients has been evaluated as monotherapy but not as add-on therapy. Not recommended for use in children and adolescents <18 years old due to lack of data. 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. Consider potential risk of suicide-related events after abrupt cessation of quetiapine treatment. Assess metabolic parameters at initiation of and regularly throughout treatment – monitor and manage any weight gain and any lipid changes; 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 appear– symptoms can worsen or even arise after treatment discontinuation; discontinue if neuroleptic malignant syndrome develops and treat appropriately; if akathisia develops (most likely in first weeks of treatment), increasing dose may be detrimental; if somnolence occurs, onset usually within first 3 days of treatment (may need to consider treatment discontinuation); 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 related conditions, 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. Concomitant administration with other serotonergic agents e.g. MAO inhibitors, SSRIs, SNRIs or tricyclic antidepressants may result in serotonin syndrome which can be potentially life-threatening. If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome suspected, consider dose reduction or discontinuation. Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson 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. Patients with intestinal obstruction/ileus should be managed with close monitoring and urgent care. 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. Interactions: Use with caution in combination with centrally acting medicines or alcohol. Use with caution in combination with serotonergic medicines e.g. MAO inhibitors, SSRIs, SNRIs, tricyclic antidepressants due to increased risk of serotonin syndrome. Concomitant use with CYP3A4 inhibitors contraindicated. Do not consume grapefruit juice. Use caution if patients are taking medicines with anti-cholinergic (muscarinic) effects. False positive results reported in enzyme immunoassays for methadone and tricyclic antidepressants. Recommend confirmation of questionable immunoassay screening results by an appropriate chromatographic technique. Hepatic enzyme inducers e.g. carbamazepine, phenytoin lead to increased clearance of quetiapine. 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. A higher incidence of extrapyramidal events were observed with lithium and quetiapine vs placebo and quetiapine in a randomised 6 week study. Caution if used concomitantly with medicines known to cause electrolyte imbalances or increase the QT interval. Not approved for dementia-related psychosis. Advise gradual withdrawal over 1-2 weeks to avoid acute withdrawal symptoms. Pregnancy: Only use in pregnancy if benefits justify potential risks. If exposed to antipsychotics in third trimester, monitor newborns carefully for adverse events. Breastfeeding: Decide whether to discontinue breast-feeding or discontinue quetiapine taking into account benefit of breastfeeding for the child and benefit of therapy for the woman. Ability to drive and use machines: Advise patients not to drive or operate machinery until individual susceptibility to effects on mental alertness is known. 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: Neutropenia, thrombocytopenia, anaemia, decreased platelet count, hypersensitivity, hypothyroidism, hyponatraemia, diabetes mellitus, exacerbation of pre-existing diabetes mellitus, seizure, tardive dyskinesia, QT prolongation, bradycardia, dysphagia, raised serum aspartate aminotransferase, urinary retention; Serious rare: agranulocytosis, metabolic syndrome, venous thromboembolism, pancreatitis, intestinal obstruction/ileus, jaundice, hepatitis, priapism, neuroleptic malignant syndrome, raised blood creatine phosphokinase; Serious very rare: anaphylactic reaction, inappropriate ADH secretion, angioedema, Stevens Johnson Syndrome, rhabdomyolysis; Serious frequency unknown: cardiomyopathy, myocarditis, stroke, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), cutaneous vasculitis, neonatal drug withdrawal syndrome. 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: February 2025. Version Number: 1010269093 v 14.0
XLW1010311L3_FEB2025
