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Biquelle XL (Quetiapine) Tablets Prescribing Information (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 and 400mg x60 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. 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. 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 the lowest effective dose. 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. 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: Elderly – use with caution. Rate of titration may need to be slower and daily dose lower. Start on 50mg/day. Efficacy and safety not evaluated in bipolar patients over 65 with depressive episodes. Not recommended for use in children and adolescents <18 years old. No dosage adjustment necessary in renal impairment. Use with caution if known hepatic impairment – start on 50mg/day. Monitor patients for risk of suicidal thoughts, particularly in early treatment and following dose changes; assess metabolic parameters and weight at initiation of and throughout treatment; observe for hyperglycaemia; diabetic patients should have glucose control monitored regularly; consider dose reduction or discontinuation if symptoms of tardive dyskinesia; discontinue if neuroleptic malignant syndrome; if develop akathisia, increasing dose may be detrimental; caution in cardiovascular disease, risk factors for VTE, cerebrovascular disease, other conditions predisposing to hypotension, 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 factor for stroke, suspected cardiomyopathy or myocarditis, risk of aspiration pneumonia, congenital long QT syndrome, use with medicinal products known to cause electrolyte imbalance or increase QT interval, congestive heart failure, heart hypertrophy, hypokalaemia, hypomagnesaemia, history of alcohol or drug abuse, in combination with other centrally acting medicinal products, alcohol, or with neuroleptics in the elderly. Discontinue if neutrophil count <1.0×109/L – monitor neutrophil count and for signs of infection. 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. Monitor if severe somnolence and consider discontinuation. Advise not to drive or 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. If receiving a hepatic enzyme inducer, initiation of quetiapine should only occur if benefits outweigh risks of removing hepatic enzyme inducer. Concomitant use with strong hepatic enzyme inducer could affect efficacy. Consult SmPC for dose reduction/titration or discontinuation. Advise gradual withdrawal over 1-2 weeks. Only use during pregnancy if benefits outweigh risks; use during lactation not recommended. 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 triglyceride levels, 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 and pyrexia. Serious uncommon/rare/very rare/not known: 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, rhabdomyolysis, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), 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). MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK. Legal category: POM. Date last reviewed: August 2018. Version Number: 1010269093 v 6.0.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148 1010269333 v 2.0 August 2018