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Quetiapine Film-coated Tablets  symptoms (EPS) compared to placebo in patients treated for major  exacerbation of diabetes occasionally associated with ketoacidosis or  malabsorption should not take this medicine. Quetiapine contains
              depressive episodes in bipolar disorder. The use of quetiapine has  coma has been reported rarely, including some fatal cases. In some  less than 1 mmol sodium (23 mg) per tablet, that is to say essentially
              been associated with the development of akathisia, characterised by  cases, a prior increase in body weight has been reported which may  ‘sodium-free’. Effects on ability to drive and use machines: Given its
              a subjectively unpleasant or distressing restlessness and need to  be a predisposing factor. Appropriate clinical monitoring is advisable  primary central nervous system effects, quetiapine may interfere
 50mg & 400mg x 60  move often accompanied by an inability to sit or stand still. This is  in accordance with utilised antipsychotic guidelines. Patients treated  with activities requiring mental alertness. Therefore, patients should
              most likely to occur within the first few weeks of treatment. In  with any antipsychotic agent including quetiapine, should be  be advised not to drive or operate machinery, until individual
              patients who develop these symptoms, increasing the dose may be  observed for signs  and symptoms of hyperglycaemia (such  as  susceptibility to this is known.
              detrimental.  Tardive  dyskinesia: If signs and symptoms of tardive  polydipsia, polyuria, polyphagia and weakness), and patients with
 25mg x 60    dyskinesia appear, dose reduction or discontinuation of quetiapine  diabetes mellitus or with risk factors for diabetes mellitus should be   Pregnancy & Lactation: Pregnancy: First trimester: The moderate
 100mg x 60   should be considered. The symptoms of tardive dyskinesia can worsen  monitored regularly for worsening of glucose control. Weight should   amount of published data from exposed pregnancies do not suggest
 150mg x 60   or even arise after discontinuation of treatment. Somnolence and  be monitored regularly. Lipids: Increases in triglycerides, LDL and total   an increased risk of malformations due to treatment. However,
 200mg x 60   dizziness: Quetiapine treatment has been associated with somnolence  cholesterol, and decreases in HDL cholesterol have been observed.   based on all available data, a definite conclusion cannot be drawn.
 300mg x 60   and related symptoms, such as sedation. In patients with bipolar  Lipid changes should be managed as clinically appropriate.  QT  Therefore, quetiapine should only be used during pregnancy if the
 Already available    depression, onset is usually within the first 3 days of treatment and  Prolongation: In use in accordance with the SmPC, quetiapine was not  benefits justify the potential risks. Third trimester: Neonates exposed
 in the Accord    predominantly of mild to moderate intensity. Patients experiencing  associated with a persistent increase in absolute QT intervals. QT  to antipsychotics (including quetiapine) during the third trimester of
 portfolio    somnolence of severe intensity may require more frequent contact for  prolongation was reported with quetiapine at the therapeutic doses  pregnancy are at risk of adverse reactions including extrapyramidal
              a minimum of 2 weeks from onset of somnolence, or until symptoms  and in overdose. As with other antipsychotics, caution should be  and/or withdrawal symptoms that may vary in severity and duration
              improve and treatment discontinuation may need to be considered.  exercised when quetiapine is prescribed in patients with  following delivery. There have been reports of agitation, hypertonia,
              Orthostatic hypotension: Quetiapine treatment has been associated  cardiovascular disease or family history of QT prolongation. Also,  hypotonia, tremor, somnolence, respiratory distress, or feeding
              with  orthostatic  hypotension and  related  dizziness  which,  like  caution should be exercised when quetiapine is prescribed either with  disorder. Consequently, newborns should be monitored carefully.
              somnolence has onset usually during the initial dose-titration period.  medicines known to increase QT interval, or with concomitant  Breast-feeding: Based on very limited data from published reports on
              This could increase the occurrence of accidental injury (fall), especially  neuroleptics, especially in the elderly, in patients with congenital  quetiapine excretion into human breast milk, excretion of quetiapine
              in the elderly population. Therefore, patients should be advised to  long QT syndrome, congestive heart failure, heart hypertrophy,  at therapeutic doses appears to be inconsistent. Due to lack of robust
 Product Presentation  exercise caution until they are familiar with the potential effects of  hypokalaemia or hypomagnesaemia.  Cardiomyopathy and  data, a decision must be made whether to discontinue breast-feeding
              the medication. Quetiapine should be used with caution in patients  Myocarditis: Cardiomyopathy and myocarditis have been reported. In  or to discontinue Quetiapine therapy taking into account the benefit
 Livery  Accord  Accord  with known cardiovascular disease, cerebrovascular disease, or other  patients  with suspected  cardiomyopathy  or  myocarditis  of breast feeding for the child and the benefit of therapy for the
 Strength  50mg  400mg  conditions  predisposing  to hypotension.  Dose  reduction  or  more  discontinuation of quetiapine should be considered. Severe cutaneous   woman. Fertility: The effects of quetiapine on human fertility have
              gradual titration should be considered if orthostatic hypotension  adverse reactions  (SCARs): Including Stevens-Johnson syndrome
 Pack Size  60  60  occurs, especially in patients with underlying cardiovascular disease.  (SJS),  Toxic Epidermal Necrolysis (TEN), Acute Generalised   not been assessed.
 Product Format  Film-coated Tablet  Film-coated Tablet  Sleep apnoea syndrome: Sleep apnoea syndrome has been reported in  Exanthematous Pustulosis (AGEP), Erythema Multiforme (EM) and   Adverse Events include: Adverse events which could be considered
                                                                                     serious: Leucopenia, neutropenia, thrombocytopenia, anaemia,
              patients using quetiapine. In patients receiving concomitant central  Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
 Legal Category  POM  POM  nervous system depressants and who have a history of or are at risk  which can be life-threatening or fatal have been reported very rarely  agranulocytosis,  hypersensitivity,  anaphylactic  reactions,
 Pack Dimensions (HxWxD)  46mmx105mmx36mm  61mmx115mmx58mm  for sleep apnoea, such as those who are overweight/obese or are  with quetiapine treatment. SCARs commonly present with one or  hyperprolactinaemia,  hypothyroidism, inappropriate  antidiuretic
              male, quetiapine should be used with caution. Seizures: No data is  more of the following symptoms: extensive cutaneous rash which  hormone secretion, blood glucose increased to hyperglycaemic
 Shelf Life  24 months  24 months  available about the incidence of seizures in patients with a history of  may be pruritic or associated with pustules, exfoliative dermatitis,  levels, diabetes mellitus, suicidal ideation and suicidal behaviour,
 PIP Code  126-5446  126-5453  seizure disorder. As with other antipsychotics, caution is  fever, lymphadenopathy and possible eosinophilia or neutrophilia.  seizure, tardive dyskinesia, syncope, tachycardia, QT prolongation,
              recommended when treating patients with a history of seizures.  Most of these reactions occurred within 4 weeks after initiation of  bradycardia,  cardiomyopathy  and  myocarditis,  dyspnoea,  stroke,
 EAN Code  5055565781715  5055565781470  Neuroleptic malignant syndrome: Neuroleptic malignant syndrome  quetiapine therapy, some DRESS reactions occurred within 6 weeks  pancreatitis, intestinal obstruction/Ileus, jaundice, hepatitis,
              has been associated with antipsychotic treatment, including  after initiation of quetiapine therapy. If signs and symptoms  angioedema, Severe cutaneous adverse reactions (SCARs), including
              quetiapine. Clinical manifestations include hyperthermia, altered  suggestive of these severe skin reactions appear, quetiapine should  Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN),
 Prescribing Information: Quetiapine 50, 400 mg film-coated tablets  mental status, muscular rigidity, autonomic instability, and increased  be withdrawn immediately and alternative treatment should be  drug reaction with eosinophilia and systemic symptoms (DRESS),
 Please refer to the Summary of Product Characteristics (SmPC) before prescribing.   creatine phosphokinase. In such an event, quetiapine should be  considered.  Withdrawal: Acute withdrawal symptoms such as  erythema multiforme, acute generalised exanthematous pustulosis
              discontinued and appropriate medical treatment given.  Severe  insomnia, nausea, headache, diarrhoea, vomiting, dizziness and  (AGEP), cutaneous vasculitis, rhabdomyolysis, urinary retention,
              neutropenia and agranulocytosis:  Severe neutropenia (neutrophil  irritability have been described after abrupt cessation of quetiapine.  neuroleptic malignant disorder, hypothermia, ventricular arrhythmia,

 Presentation: Each tablet contains 50 or 400 mg of quetiapine  800 mg/day administered twice daily. It is important that the lowest  development  are  not  known.  Suicide/suicidal thoughts or clinical   count <0.5 X 10 /L) has been reported. Most cases of severe  Gradual withdrawal over a period of at least one to two weeks is  sudden unexplained death, cardiac arrest. Additional adverse events
                       9
 (as quetiapine fumarate).  effective dose is used for maintenance therapy. Elderly: Quetiapine  worsening:  Depression  in  bipolar  disorder  is  associated  with  an   neutropenia  have  occurred  within  a  couple  of  months  of  starting  advisable.  Elderly patients with dementia-related psychosis:   which could be considered serious in paediatric population: increases
 Indications: For treatment of schizophrenia. For treatment of   should be used with caution in the elderly, especially during the initial  increased risk of suicidal thoughts, self-harm and suicide (suicide-  therapy with quetiapine, with no apparent dose relationship, and  Quetiapine is not approved for the treatment of dementia-related   in blood pressure.
 bipolar disorder: treatment of moderate to severe manic episodes in   dosing period. The rate of dose titration may need to be slower, and  related events). This risk persists until significant remission occurs. As   some fatal cases. Possible risk factors for neutropenia include pre-  psychosis. An approximately 3-fold increased risk of cerebrovascular   Other Very Common adverse events: Decreased haemoglobin,
 bipolar disorder; treatment of major depressive episodes in bipolar   the daily therapeutic dose lower, than that used in younger subjects,  improvement may not occur during the first few weeks or more of   existing low white blood cell count (WBC) and history of drug induced  adverse events has been seen in the dementia population with some   elevations in serum triglyceride levels, elevations in total cholesterol
 depending on the clinical response and tolerability of the individual  treatment, patients should be closely monitored until such
 disorder; prevention of recurrence of manic or depressed episodes   neutropenia. However, some cases occurred in patients without pre-  atypical antipsychotics. The mechanism for this increased risk is not
              existing risk factors. Quetiapine should be discontinued in patients  known. An increased risk cannot be excluded for other antipsychotics  (predominantly LDL cholesterol), decreases in HDL cholesterol,
 in patients with bipolar disorder who previously responded to   patient. Efficacy and safety have not been evaluated in patients  improvement occurs. It is general clinical experience that the risk of   with a neutrophil count <1.0 X 10 /L. Patients should be observed for  or other patient populations. Quetiapine should be used with caution  weight gain, dizziness, somnolence, headache, extrapyramidal
                              9
 quetiapine treatment.  over 65 years with depressive episodes in the framework of bipolar  suicide may increase in the early stages of recovery. Physicians should
 disorder. Paediatric population: Quetiapine is not recommended for  consider the potential risk of suicide-related events after abrupt   signs and symptoms of infection and neutrophil counts followed.  in patients with risk factors for stroke. It has been reported that  symptoms, dry mouth, withdrawal (discontinuation) symptoms.
 Dosage and Administration: Different dosing schedules exist for  use in children and adolescents below 18 years of age, due to a lack  cessation of quetiapine treatment, due to the known risk factors for   Neutropenia should be considered in patients presenting with  elderly patients with dementia-related psychosis are at an increased  Additional very common adverse events in paediatric population:
 each indication. It must therefore be ensured that patients receive  of data to support use in this age group. Renal impairment: Dosage  the disease being treated. Other psychiatric conditions  for which   infection or fever, particularly in the absence of obvious predisposing  risk  of  death.  Elderly patients with Parkinson’s disease (PD)/  elevations in prolactin, increased appetite, vomiting.
 clear information on the appropriate dosage for their condition.  adjustment is not necessary.  Hepatic  impairment: Quetiapine is  quetiapine is prescribed can also be associated with an increased risk   factor(s), and should be managed as clinically appropriate. Patients  Parkinsonism: In patients with MDD, an increased risk of death during   Other Common adverse events:  Decreased neutrophil count,
 Adults:  For the treatment of  schizophrenia: Quetiapine should be  extensively metabolised by the liver. Therefore, Quetiapine should  of suicide related events. In addition, these conditions may be co-  should be advised to immediately report the appearance of signs/  use of quetiapine in patients aged >65 years has been observed. This
 administered twice a day. The total daily dose for the first 4 days of  be used with caution in patients with known hepatic impairment,  morbid with major depressive episodes.  The same precautions   symptoms consistent with agranulocytosis or infection (e.g., fever  association is not present in patients without PD. Caution should be   eosinophils increased, decreases in total  T4, decreases in free
 therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300  especially during the initial dosing period. Patients with known  observed when treating patients with major depressive episodes   weakness, lethargy, or sore throat) at any time during Quetiapine  exercised if quetiapine is prescribed to elderly patients with PD.   T4, decreases in total  T3, increases in  TSH, increased appetite,
 mg (Day 4). From day 4 onwards, the dose should be titrated to the  hepatic impairment should be started with 25 mg/day. The dosage  should therefore be observed when treating patients with other   therapy. Such patients should have a WBC count and an absolute  Dysphagia: Dysphagia has been reported with quetiapine. Quetiapine   abnormal dreams and nightmares, dysarthria, palpitations, vision
 usual effective dose of 300 to 450 mg/day. Depending on the clinical  should be increased daily with increments of 25 - 50 mg/day until an  psychiatric disorders. Patients with a history of suicide related events,   neutrophil count (ANC) performed promptly, especially in the  should be used with caution in patients at risk for aspiration   blurred, orthostatic hypotension, constipation, dyspepsia, vomiting,
 response and tolerability of the individual patient, the dose may be  effective dosage, depending on the clinical response and tolerability  or those exhibiting a significant degree of suicidal ideation prior to   absence of predisposing factors. Anti-cholinergic (muscarinic) effects:  pneumonia.  Constipation  and  intestinal  obstruction:  Constipation   elevations in serum aminotransferase (ALT), elevations in gamma-
 adjusted within the range 150 to 750 mg/day. For the treatment of  of the individual patient. Method of administration: Quetiapine can be  commencement of treatment are known to be at greater risk of   Nor-quetiapine, an active metabolite of quetiapine, has moderate to  represents a risk factor for intestinal obstruction. Constipation and   GT levels, mild asthenia, peripheral oedema, irritability, pyrexia.
 moderate to severe manic episodes in bipolar disorder:  Quetiapine  administered with or without food. Swallow the tablets whole with  suicidal thoughts or suicide attempts, and should receive careful   strong affinity for several muscarinic receptor subtypes.  This  intestinal obstruction have been reported with quetiapine, with some   Additional common adverse events in paediatric population: rhinitis.
 should be administered twice a day. The total daily dose for the first  water.  monitoring during treatment. Clinical trial analysis of antidepressant   contributes to ADRs reflecting anti-cholinergic effects when  fatal reports in patients who are at higher risk of intestinal  See SmPC for details of other adverse events.
 four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day   drugs in adult patients with psychiatric disorders showed an increased   quetiapine is used at recommended doses, when used concomitantly  obstruction, including those that are receiving multiple concomitant
 3) and 400 mg (Day 4). Further dosage adjustments up to 800 mg   Contraindications: Hypersensitivity to the active substance or to   risk of suicidal behaviour with antidepressants compared to placebo   with other medications having anti-cholinergic effects, and in the  medications that decrease intestinal motility and/or may not report   Presentation and Price:
 / day by Day 6 should be in increments of no greater than 200 mg/  any of the excipients of this product. Concomitant administration   in patients less than 25 years old. Close supervision of patients and in   setting of overdose. Quetiapine should be used with caution in  symptoms of constipation. Patients with intestinal obstruction/ileus   50 mg x 60 £6.25, 400 mg x 60 £25.00.
 day. The dose may be adjusted depending on clinical response and   of cytochrome P450 3A4 inhibitors, such as HIV- protease inhibitors,   particular those at high risk should accompany drug therapy   patients receiving medications having anti-cholinergic (muscarinic)  should be managed with close monitoring and urgent care. Venous  Legal Category: POM
 tolerability of the individual patient, within the range of 200 to 800   azole-antifungal agents, erythromycin, clarithromycin and   especially in early treatment and following dose changes. Patients   effects, in patients with a current diagnosis or prior history of urinary  thromboembolism (VTE): Cases of  VTE have been reported with   Further information is available from:
 mg/day. The usual effective dose is in the range of 400 to 800 mg/  nefazodone.  (and caregivers of patients) should be alerted about the need to   retention, clinically significant prostatic hypertrophy, intestinal  antipsychotic drugs. Since patients treated with antipsychotics often   Accord-UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS.
 day. For the treatment of major depressive episodes in bipolar disorder:  Warnings and Precautions: As quetiapine has several indications,  monitor for any clinical worsening, suicidal behaviour or thoughts   obstruction or related conditions, increased intraocular pressure or  present with acquired risk factors for VTE, all possible risk factors for
 Quetiapine should be administered once daily at bedtime. The total  the safety profile should be considered with respect to the individual  and unusual changes in behaviour and to seek medical advice   narrow angle glaucoma. Interactions: Concomitant use of quetiapine  VTE should be identified before and during treatment with quetiapine  Marketing  Authorisation Numbers:
 daily dose for the first four days of therapy is 50 mg (Day 1), 100  patient’s diagnosis and the dose being administered.  Paediatric  immediately if these symptoms present. A study of quetiapine for the   with a strong hepatic enzyme inducer such as carbamazepine or  and preventive measures undertaken. Pancreatitis: Pancreatitis has  PL 20075/1463, 1464.
 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). The recommended  population: Quetiapine is not recommended for use in children and  treatment of patients with major depressive disorder showed an   phenytoin substantially decreases quetiapine plasma concentrations,  been reported. While not all cases were confounded by risk factors,   Date of PI Preparation: December  2023
 daily dose is 300 mg. Individual patients may benefit from a 600 mg  adolescents below 18 years of age, due to a lack of data to support use  increased risk of self-harm and suicide in patients aged 25 to 64 years   which could affect the efficacy of Quetiapine therapy. In patients  many patients had factors which are known to be associated with
 dose. Doses greater than 300 mg should be initiated by physicians  in this age group. Clinical trials with quetiapine have shown that in  without a history of self-harm during use of quetiapine with other   receiving a hepatic enzyme inducer, initiation of quetiapine treatment  pancreatitis such as increased triglycerides, gallstones, and alcohol   Document Number:  UK-05641
 experienced in treating bipolar disorder. In individual patients, in  addition to the known safety profile identified in adults certain  antidepressants. Metabolic risk: Given the observed risk for worsening   should only occur if the physician considers that the benefits of  consumption. Additional information: Quetiapine use in combination
 the event of tolerance concerns, dose reduction to a minimum of 200  adverse events occurred at a higher frequency in children and  of their metabolic profile, including changes in weight, blood glucose   quetiapine outweigh the risks of removing the hepatic enzyme  with divalproex or lithium in acute moderate to severe manic   Adverse events should be reported.
 mg could be considered. For preventing recurrence in bipolar disorder:  adolescents, and one was identified that has not been previously seen  (hyperglycaemia) and lipids, patients’ metabolic parameters should   inducer. It is important that any change in the inducer is gradual, and  episodes is limited; however, combination therapy was well tolerated.   Reporting forms and information can be found at
 For preventing of recurrence of manic, mixed or depressive episodes  in adult studies (increases in blood pressure). Changes in thyroid  be assessed at the time of treatment initiation and changes in these   if required, replaced with a non-inducer (e.g. sodium valproate).  Misuse and abuse: Cases of misuse and abuse have been reported.   www.mhra.gov.uk/yellowcard
 in bipolar disorder, patients who have responded to quetiapine for  function tests have also been observed in children and adolescents.  parameters should be regularly controlled for during the course of   Weight: Weight gain has been reported in patients who have been  Caution may be needed when prescribing quetiapine to patients with   Adverse events should also be reported to
 acute treatment of bipolar disorder should continue therapy at the  Furthermore, the long-term safety implications of treatment with  treatment. Worsening in these parameters should be managed as   treated with quetiapine, and should be monitored and managed as  a history of alcohol or drug abuse.  Excipients:  Quetiapine contain   Accord-UK LTD on 01271 385257 or
 same dose. The dose may be adjusted depending on clinical response  quetiapine on growth and maturation have not been studied beyond  clinically appropriate.  Extrapyramidal symptoms:  In adult patients   clinically appropriate as in accordance with utilised antipsychotic  lactose. Patients with rare hereditary problems of galactose   email medinfo@accord-healthcare.com
 and tolerability of the individual patient, within the range of 300 to  26  weeks.  Long-term  implications  for cognitive  and  behavioural  quetiapine is associated with an increased incidence of extrapyramidal   guidelines. Hyperglycaemia: Hyperglycaemia and/or development or  intolerance, the total lactase deficiency, or glucose-galactose

 UK-Gen-Quet-01406  |  Date of Preparation: April 2024  UK-Gen-Quet-01406  |  Date of Preparation: April 2024

               or call us on 01904 558 350                                                                           5 5


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         P4304.1-V100_PS Magazine - August 24.indd   5                                                           09/07/2024   10:27:52
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