Zaluron® XL Prescribing Information

Zaluron® XL 50 mg, 150 mg, 200 mg, 300 mg and 400 mg prolonged-release tablets (quetiapine) – Abridged Prescribing Information

Please consult the full Summaries of Product Characteristics (SmPC) for prescribing information.
Presentation: Prolonged release tablets containing 50 mg, 150 mg, 200 mg, 300 mg or 400 mg quetiapine (as quetiapine fumarate) per tablet.
Indication: Schizophrenia. Bipolar Disorder: Moderate to severe manic episodes. Major depressive episodes associated with bipolar disorder. Prevention of the recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment. Add-on treatment for major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.
Dosage and Administration: Different dosing schedules exist for each indication. Zaluron® XL should be administered once daily, without food. The tablets should be swallowed whole and not split, chewed or crushed.
For schizophrenia and moderate to severe manic episodes in bipolar disorder. Administer Zaluron® XL at least one hour before a meal. Daily dose is 300 mg on Day 1 and 600 mg for Day 2. Recommended daily dose is 600 mg, but this may be increased to 800 mg daily if clinically justified. Adjust dose within the effective dose range of 400 mg to 800 mg per day depending on the clinical response and tolerability of patient. No dosage adjustment is necessary for maintenance therapy in schizophrenia.
For the treatment of major depressive episodes in bipolar disorder. Administer Zaluron® XL at bedtime. The total daily dose for the first four days of therapy is 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. Individual patients may benefit from a 600 mg dose. Doses greater than 300 mg should be initiated by physicians experienced in treating bipolar disorder. In the event of tolerance concerns, clinical trials have indicated that dose reduction to a minimum of 200 mg could be considered.
For preventing recurrence in bipolar disorder. Patients who have responded to Zaluron® XL for acute treatment of bipolar disorder should continue on Zaluron® XL at the same dose administered at bedtime. Dose can be adjusted depending on clinical response and tolerability of the individual patient within the dose range of 300 mg to 800 mg/day. Use the lowest effective dose for maintenance therapy.
For add-on treatment of major depressive episodes in MDD. Administer prior to bedtime. The daily dose at the start of therapy is 50 mg on Days 1 and 2, and 150 mg on Days 3 and 4. Increased risk of adverse events at higher doses. Use the lowest effective dose for treatment starting with
50 mg/day. The need to increase the dose from 150 to 300 mg/day should be based on individual patient evaluation.
Switching from Quetiapine immediate-release tablets. For more convenient dosing, patients who are currently being treated with divided doses of immediate release Quetiapine tablets may be switched to Zaluron® XL at the equivalent total daily dose taken once daily. Individual dosage adjustments may be necessary.
Elderly people. Use with caution in the elderly, especially during the initial dosing period. May need slower rate of dose titration and a lower daily therapeutic dose, than that used in younger patients. Elderly patients should be started on 50 mg/day. Dose can be increased in increments of 50 mg/day to an effective dose, depending on clinical response and tolerability.
In elderly patients with major depressive episodes in MDD, begin dosing with 50 mg/day on Days 1- 3, increasing to 100 mg/day on Day 4 and
150 mg/day on Day 8. Use the lowest effective dose, starting from 50 mg/day. For individual patients, if a dosage increase to 300 mg/day is required, this should not be prior to Day 22 of treatment.

Paediatric Population. Zaluron® XL is not recommended for use in children and adolescents below 18 years of age.

Renal impairment. Dosage adjustment is not necessary in patients with renal impairment.
Hepatic impairment. Use with caution in patients with known hepatic impairment, especially during initial dosing period. Patients with hepatic impairment should be started on 50 mg/day. The dose can be increased in increments of 50 mg/day to an effective dose, depending on clinical response and tolerability.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Concomitant administration of cytochrome P450 3A4 inhibitors.
Warnings and Precautions: Paediatric population: Quetiapine is not recommended for use in those below 18 years of age. Suicide/suicidal thoughts or clinical worsening. Metabolic Risk: Given the observed risk for worsening of their metabolic profile in clinical trials, assess patient’s metabolic parameters at treatment initiation and changes in these parameters should be regularly controlled for during treatment. Extrapyramidal symptoms. Tardive Dyskinesia. Somnolence and dizziness. Orthostatic Hypotension. Seizures. Neuroleptic Malignant Syndrome: This has been associated with antipsychotic treatment. In such an event, discontinue quetiapine and administer appropriate medical treatment. Severe neutropenia and agranulocytosis: Discontinue quetiapine in patients with a neutrophil count <1.0 x109/L. Advise patients to immediately report evidence of agranulocytosis or infection. Interactions: Concomitant use with a strong hepatic enzyme inducer, e.g. carbamazepine or phenytoin, decreases quetiapine plasma concentrations. Weight gain. Hyperglycaemia: This or an exacerbation of diabetes has been reported in rare cases. Monitor regularly and appropriately. Lipids: Increase in triglycerides, LDL and total cholesterol and decrease in HDL have been observed. Manage appropriately. QT prolongation: Exercise caution in patients with cardiovascular disease, family history of QT prolongation or where prescribed with medicines known to increase QT interval. Cardiomyopathy and Myocarditis. Withdrawal: Gradual withdrawal over 1-2 weeks is recommended. Elderly patients with dementia-related psychosis: Increased risk of cerebrovascular adverse events. Use quetiapine with caution. Dysphagia. Constipation and intestinal obstruction. Venous Thromboembolism (VTE). Pancreatitis. Lactose: Zaluron® XL tablets contain lactose. Patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Please see SmPC for full and further information.
Interactions: Caution in combination with other centrally acting medicinal products and alcohol. Caution should be exercised treating patients receiving other medications having anti-cholinergic (muscarinic) efforts Concomitant use with CYP3A4 inhibitors is contraindicated. Do not consume grapefruit juice while on quetiapine therapy. Co-administration of quetiapine and carbamazepine significantly increased the clearance of quetiapine in a clinical trial, resulting in lower plasma concentrations of quetiapine. Co-administration of quetiapine and phenytoin caused an increased clearance of quetiapine by 450%. Initiation of quetiapine in patients receiving a hepatic enzyme inducer should only occur if the physician considers the benefits of quetiapine to outweigh the risks of removing the hepatic enzyme inducer. Concomitant use of quetiapine and thioridazine caused an increased clearance of quetiapine by approximately 70%. There is some evidence of extrapyramidal related events, weight gain and somnolence in patients with acute mania when lithium and quetiapine were administered concomitantly. There may be a raised incidence of leucopenia and neutropenia where quetiapine is administered in combination with sodium valproate compared with monotherapy groups. Exercise caution when quetiapine is used concomitantly with medicinal products known to cause electrolyte imbalance or to increase QT interval. There have been reports of false positive results in enzyme immunoassays for methadone and tricyclic antidepressants in patients who have taken quetiapine. Confirmation of questionable immunoassay screening results by an appropriate chromatographic technique is recommended.
Fertility, Pregnancy and Lactation: Pregnancy: First Trimester – Only use quetiapine if the benefits justify potential risks. Third Trimester – Risk of adverse reactions including extrapyramidal and/or withdrawal symptoms following delivery. Reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder, therefore newborns should be monitored closely. Breastfeeding: Lack of robust data on quetiapine excretion into human breast milk, therefore the physician must weigh the risk of potential excretion into breast milk with the benefit of quetiapine treatment to the mother, whilst taking into account the benefit of breastfeeding for the child. Fertility: Effects on human fertility have not been assessed.

Driving: Caution is advised.

Undesirable Effects: Very common (1/10) – Decreased haemoglobin, elevated serum triglyceride levels, elevated total cholesterol (predominantly LDL), decreased HDL, weight gain, dizziness, somnolence, headache, extrapyramidal symptoms, dry mouth and withdrawal symptoms. Common (1/100 to <1/10) – Leucopenia, decreased neutrophil count, increased eosinophil count, hyperprolactinaemia, decreased total T4, decreased free T4, decreased total T3, increased TSH levels, increased appetite, hyperglycaemia, abnormal dreams and nightmares, suicidal ideation and behaviour, dysarthria, tachycardia, palpitations, blurred vision, orthostatic hypotension, dyspnoea, constipation, dyspepsia, vomiting, elevated serum alanine aminotransferase (ALT), elevations in gamma-GT levels, mild asthenia, peripheral oedema, irritability and pyrexia. Uncommon (1/1000 to < 1/100) Neutropenia – Thrombocytopenia, anaemia, decreased platelet count, hypersensitivity, decreased free T3, hypothyroidism, hyponatraemia, diabetes mellitus, exacerbation of pre-existing diabetes, seizure, restless legs syndrome, tardive dyskinesia, syncope, QT prolongation, bradycardia, rhinitis, dysphagia, elevations in serum aspartate aminotransferase (AST), urinary retention and sexual dysfunction. Rare (1/10,000 to <1/1000) – Agranulocytosis, metabolic syndrome, somnambulism and related reactions such as sleep talking and sleep related eating disorder, venous thromboembolism, pancreatitis, intestinal obstruction/ileus, jaundice, hepatitis, priapism, galactorrhoea, breast swelling, menstrual disorder, neuroleptic malignant syndrome, hypothermia, elevated blood creatine and phosphokinase. Very Rare (<1/10,000) – Anaphylactic reaction, inappropriate anti-diuretic hormone secretion, angioedema, Stevens-Johnson syndrome and rhabdomyolysis. Not known (cannot be estimated from the available data) – Toxic Epidermal Necrolysis, Erythema Multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), neonatal drug withdrawal syndrome. See SmPC for further detail.
Marketing Authorisation Numbers, Package Quantities and Basic NHS Price:
Zaluron® XL 50 mg – PL 42924/0007; 60 tablet packs (£27.96).
Zaluron® XL 150 mg – PL 42924/0008; 60 tablet packs (£46.96).
Zaluron® XL 200 mg – PL 42924/0009; 60 tablet packs (£46.96).
Zaluron® XL 300 mg – PL 42924/0010; 60 tablet packs (£70.71).
Zaluron® XL 400 mg – PL 42924/0011; 60 tablet packs (£93.98).
Legal Category: POM.
Marketing Authorisation Holder: Fontus Health Ltd.
60 Lichfield Street, Walsall. WS4 2BX. United Kingdom.
Date of Marketing Authorisation: December 2014.
Distributed by: Fontus Health Ltd. 60 Lichfield Street, Walsall. WS4 2BX. Tel: 0121 661 4615
E-mail: info@fontushealth.com
Last date of revision: August 2018.
Zaluron® is a registered trademark of Fontus Health Ltd.

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk. Adverse events should also be reported to Fontus Health Limited. Tel: 0121 661 4615 or click here.

References: 1. Zaluron® XL prolonged-release tablets 50 mg Summary of Product Characteristics. 2. Zaluron® XL prolonged-release tablets 150 mg Summary of Product Characteristics. 3. Zaluron® XL prolonged-release tablets 200 mg Summary of Product Characteristics. 4. Zaluron® XL prolonged-release tablets 300 mg Summary of Product Characteristics. 5. Zaluron® XL prolonged-release tablets 400 mg Summary of Product Characteristics.

© Fontus Health Ltd. 2018

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