1. No category

Mintreleq XL® Quetiapine 50mg, 150mg, 200mg, 300mg, 400mg
Prolonged release tablets
Prescribing Information
PRESENTATION
Prolonged release tablets containing quetiapine (as quetiapine fumarate)
INDICATIONS
Treatment of schizophrenia; treatment of bipolar disorder (associated with
moderate to severe manic episodes, major depressive episodes, prevention of
recurrence of manic or depressed episodes in patients who previously
responded to quetiapine treatment); add-on treatment of major depressive
episodes in patients with Major Depressive Disorder (MDD) who have had suboptimal response to antidepressant monotherapy.
DOSAGE AND ADMINISTRATION
Administer once daily without food. Schizophrenia and moderate to severe manic
episodes in bipolar disorder: 600mg daily (300mg on day 1); major depressive
episodes in bipolar disorder: 300mg daily titrated -50 mg Day 1, 100 mg Day 2,
200 mg Day 3 and 300 mg Day 4. Preventing recurrence in bipolar disorder: 300
mg to 800 mg/day –use lowest effective dose is used for maintenance; MDD 150
to 300 mg/day titrate -50 mg on Day 1 and 2, 150 mg on Day 3 and 4. Dose may
need to be reduced in elderly. Patients with hepatic impairment should be
started on 50 mg/day.
CONTRAINDICATIONS
Hypersensitivity to active substance or excipients, concomitant administration of
cytochrome P450 3A4 inhibitors.
SPECIAL WARNINGS AND PRECAUTIONS
Not recommended in children and adolescents <18 years; Close supervision of
depressed patients required especially in early treatment and following dose
changes - risk of suicidal thoughts, self-harm and suicide (suicide-related events)
persists until significant remission occurs; risk of worsening metabolic profile,
including weight, blood glucose, and lipids; increased incidence of
extrapyramidal symptoms - increasing dose may be detrimental in patients who
develop akathisia; symptoms of tardive dyskinesia can worsen or even arise
after discontinuation of treatment; risk of somnolence, dizziness and orthostatic
hypotension; caution in patients with a history of seizures; exercise caution in
patients with cardiovascular disease or family history of QT prolongation;
caution in combination with other centrally acting medicinal products and
alcohol, concomitant consumption of grapefruit juice not recommended.
INTERACTIONS
Co-administration of carbamazepine, phenytoin or thioridazine significantly
increases clearance of quetiapine.
PREGNANCY AND LACTATION
Quetiapine should only be used during pregnancy if benefits justify potential
risks. Neonates exposed to antipsychotics (including quetiapine) during the third
trimester of pregnancy are at risk of adverse reactions including extrapyramidal
and/or withdrawal symptoms. No robust data on breast feeding.
SIDE EFFECTS
Somnolence, headache, dizziness, dry mouth, withdrawal symptoms, raised
triglycerides, raised total cholesterol, decreases in HDL cholesterol, weight gain,
decreased haemoglobin, extrapyramidal symptoms, suicidal ideation and
behaviour, hyponatraemia, dysarthria, seizure, tachycardia, , venous
thromboembolism, orthostatic hypotension, blurred vision, dyspnoea, raised
ALT, peripheral oedema, Uncommon/rare; thrombocytopenia, agranulocytosis,
hypersensitivity, anaphylactic reaction, hypothyroidism, inappropriate ADH
secretion, diabetes mellitus, bradycardia, QT prolongation, syncope, pancreatitis,
intestinal obstruction, jaundice, hepatitis, raise gamma GT, angioedema, StevensJohnson syndrome, Toxic Epidermal Necrolysis, Erythema Multiforme,
rhabdomyolysis, urinary retention, Neuroleptic malignant syndrome, sexual
dysfunction, priapism, raised CPK. Consult SmPC for more details.
PACKAGE QUANTITY
Pack of 60 tablets. 50mg £29.45; 150mg £49.45; 200mg £49.45; 300mg £74.45;
400mg £98.95
LEGAL CATEGORY
POM
MARKETING AUTHORISATION NUMBERS
50mg 43968/0001; 150mg 439680002; 200mg 43968/0003; 300mg
43968/0004; 400mg 43968/0005
MARKETING AUTHORISATION HOLDER
CEB Pharma Limited, Avro House, 49 Lancaster Way Business Park, Ely
Cambridgeshire, CB6 3NW
DATE
March 2015