Page 7 - P4403.59-V50_Numark Magazine April 24

FOR HEALTHCARE
PROFESSIONALS ONLY

Phoenix Codes Product Strength Presentation Unit of Measure

6776744 Sertraline 150mg tablet 30

6776777 Sertraline 200mg tablet 30

Sertraline is available in two new unique

strengths, reducing tablet burden for patients

Sertraline 150 mg and 200 mg film-coated tablets Prescribing Information. monitored. Discontinue in any patient who develops seizures. Suicide/suicidal thoughts/suicide attempts or reactions, in some neonates, whose mothers had been on sertraline. Sertraline is not recommended in
See Summary of Product Characteristics (SmPC) before prescribing. clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide. pregnancy, unless the clinical condition of the woman is such that the benefit of the treatment is expected to
Presentation: Available in two strengths. Each film-coated tablet contains sertraline hydrochloride, equivalent to Monitor patients closely until improvement occurs. The risk of suicide may increase in the early stages of outweigh the potential risk. Neonates should be observed if maternal use of sertraline continues into the later
150 mg or 200 mg sertraline. Indications: Treatment of major depressive episodes; prevention of recurrence of recovery. Other psychiatric conditions can also be associated with an increased risk of suicide-related events. In stages of pregnancy, particularly the third trimester. Epidemiological data have suggested that the use of SSRIs
major depressive episodes; panic disorder with or without agoraphobia; obsessive compulsive disorder (OCD) addition, these conditions may be co-morbid with major depressive disorder. Close supervision of patients in pregnancy, particular in late pregnancy, may increase the risk of persistent pulmonary hypertension in the
in adults and paediatric patients aged 6-17 years; social anxiety disorder; post-traumatic stress disorder (PTSD). (particularly those at high risk, such as those with history of suicidal ideation) is advised, especially in early newborns (PPHN). Lactation: Published data concerning sertraline levels in breast milk show that small
Dosage: For oral use. It should be administered once daily, in the morning or evening, with or without food. Initial treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to quantities of sertraline and its metabolite N-desmethylsertraline are excreted in milk. To date, no adverse effects
treatment: Depression and OCD: treatment should be started at a dose of 50 mg/day. Panic Disorder, PTSD, and monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek on the health of infants nursed by mothers using sertraline have been reported, but a risk cannot be excluded.
Social Anxiety Disorder: therapy should be initiated at 25 mg/day. After one week, the dose should be increased medical advice immediately if these symptoms present. Paediatric population: Not to be used in the treatment of Use in nursing mothers is not recommended unless, in the judgment of the physician, the benefit outweighs the
to 50 mg once daily. This dosage regimen has been shown to reduce the frequency of early treatment emergent children and adolescents under the age of 18 years, except for patients with obsessive compulsive disorder aged risk. Effects on ability to drive and use machines: Sertraline has no effect on psychomotor performance,
side effects characteristic of panic disorder. Titration: Depression, OCD, Panic Disorder, Social Anxiety Disorder 6-17 years old. Suicide-related behaviours and hostility have been more frequently observed among children however, as psychotropic drugs may impair mental/physical abilities required driving or operating machinery,
and PTSD: Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be and adolescents treated with antidepressants. Patients should be carefully monitored for appearance of suicidal patients should be cautioned accordingly. Undesirable effects: Refer to SmPC for full information. Very
made in steps of 50 mg at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose symptoms. Monitor paediatric patients on long term treatment for abnormalities in growth and development. Common (≥1/10): Insomnia, dizziness, headache, somnolence, nausea, diarrhoea, dry mouth, ejaculation
should not be made more frequently than once per week given the 24-hour elimination half-life of sertraline. The Abnormal bleeding/Haemorrhage: Caution is advised in patients taking SSRIs, particularly in concomitant use failure, fatigue. Common (≥1/100 to <1/10): upper respiratory tract infection, pharyngitis, rhinitis. anxiety,
onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to with drugs known to affect platelet function, as well as in patients with a history of bleeding disorders. depression, agitation, decreased libido, nervousness, depersonalisation, nightmare, bruxism, tremor, movement
demonstrate therapeutic response, especially in OCD. Maintenance: Dosage during long-term therapy should Hyponatraemia: Hyponatraemia may occur as a result of treatment with SSRIs or SNRIs including sertraline. disorders (including extrapyramidal symptoms), paraesthesia, hypertonia, disturbance in attention, dysgeusia,
be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response. Elderly patients and those taking diuretics/otherwise volume-depleted may be at greater risk. Discontinuation of visual disturbance, tinnitus, palpitations, hot flush, yawning, dyspepsia, constipation, abdominal pain, vomiting,
Depression: Longer-term treatment may also be appropriate for prevention of recurrence of major depressive sertraline should be considered in patients with symptomatic hyponatraemia and appropriate medical flatulence, hyperhidrosis, rash, back pain, arthralgia, myalgia, irregular menstruation, erectile dysfunction,
episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same intervention should be instituted. Withdrawal symptoms seen on discontinuation of sertraline treatment: malaise, chest pain, asthenia, pyrexia, increased weight, injury. Withdrawal symptoms seen on discontinuation
as the one used during current episode. Patients with depression should be treated for at least 6 months to Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt. It is of sertraline treatment: Discontinuation of sertraline (particularly when abrupt) commonly leads to withdrawal
ensure they are free from symptoms. Panic disorder and OCD: Continued treatment in panic disorder and OCD advised that sertraline should be gradually tapered when discontinuing treatment over a period of several weeks symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia
should be evaluated regularly, as relapse prevention has not been shown for these disorders. Elderly patients: or months, according to the patient’s needs. Akathisia/psychomotor restlessness: The use of sertraline has been and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly
should be dosed carefully, as elderly may be more at risk for hyponatraemia. Patients with hepatic impairment: associated with the development of akathisia, characterised by a subjectively unpleasant or distressing reported effects. Generally, these events are mild to moderate and are self-limiting; however, in some patients
approached with caution. A lower or less frequent dose should be used. Sertraline should not be used in cases restlessness and need to move often accompanied by an inability to sit or stand still. In patients who develop they may be severe and/or prolonged. It is advised that when sertraline treatment is no longer required, gradual
of severe hepatic impairment as no clinical data are available. Patients with renal impairment: No dosage these symptoms, increasing the dose may be detrimental. Hepatic impairment: If sertraline is administered to discontinuation by dose tapering should be carried out. Elderly population: SSRIs or SNRIs including sertraline
adjustment is necessary. Paediatric population: Children and adolescents with OCD: Age 13-17 years: Initially patients with hepatic impairment, a lower or less frequent dose should be considered. Do not be use in patients have been associated with cases of clinically significant hyponatraemia in elderly patients, who may be at
50 mg once daily. Age 6-12 years: Initially 25 mg once daily. The dosage may be increased to 50 mg once daily with severe hepatic impairment. Renal impairment: Sertraline is extensively metabolised, and excretion of greater risk for this adverse event. Paediatric population: Very common (≥1/10): Headache (22%), insomnia
after one week. Subsequent doses may be increased in case of less than desired response in 50 mg increments unchanged drug in urine is a minor route of elimination. Dosing does not have to be adjusted based on the (21%), diarrhoea (11%) and nausea (15%). Common (≥1/100 to <1/10): Chest pain, mania, pyrexia, vomiting,
over a period of some weeks, as needed. The maximum dosage is 200 mg daily. The generally lower body degree of renal impairment. Use in elderly: SSRIs or SNRIs including sertraline have been associated with cases anorexia, affect lability, aggression, agitation, nervousness, disturbance in attention, dizziness, hyperkinesia,
weights of children compared to those of adults should be taken into consideration when increasing the dose of clinically significant hyponatraemia in elderly patients, who may be at greater risk for this adverse event. migraine, somnolence, tremor, visual disturbance, dry mouth, dyspepsia, nightmare, fatigue, urinary
from 50 mg. Dose changes should not occur at intervals of less than one week. Efficacy is not shown in Diabetes: In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral incontinence, rash, acne, epistaxis, flatulence. Uncommon (≥1/1000 to <1/100): ECG QT prolonged, suicide
paediatric major depressive disorder. No data are available for children under 6 years of age. Withdrawal hypoglycaemic dosage may need to be adjusted. Electroconvulsive therapy: There are no clinical studies attempt, etc. Class effects: Epidemiological studies, mainly conducted in patients 50 years of age and older,
symptoms seen on discontinuation of sertraline: Abrupt discontinuation should be avoided. When stopping establishing the risks or benefits of the combined use of ECT and sertraline. Grapefruit juice: The administration show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this
treatment with sertraline the dose should be gradually reduced over a period of at least one to two weeks in order of sertraline with grapefruit juice is not recommended. Interference with urine screening tests: False-positive risk is unknown. Overdose: See SmPC for management guidance. Marketing Authorisation number and
to reduce the risk of withdrawal reactions. If intolerable symptoms occur following a decrease in the dose or upon urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline. Basic NHS Price: Both strengths sold in packs of 30. Sertraline 150 mg PL 01883/0364 - £13.50; Sertraline 200
discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish sertraline from mg PL 01883/0365 - £18.00. Marketing Authorisation Holder: Macarthys laboratories Limited, T/A Martindale
the physician may continue decreasing the dose, but at a more gradual rate. Contraindications: benzodiazepines. Angle-Closure glaucoma: Sertraline should therefore be used with caution in patients with Pharma, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom. Legal Category: POM.
Hypersensitivity to the active substance or any of the excipients. Concomitant treatment with irreversible angle-closure glaucoma or history of glaucoma. Sertraline contains Lactose Monohydrate: Patients with rare Further information: Martindale Pharma, Bampton Road, Romford, RM3 8UG. Tel: 01277 266 600. Date of
monoamine oxidase inhibitors (MAOIs) due to the risk of serotonin syndrome with symptoms such as agitation, hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should Preparation: 20th March 2023. Job Bag Number: UK-SER-2
tremor and hyperthermia. Sertraline must not be initiated for at least 14 days after discontinuation of treatment not take sertraline. Sexual dysfunction: SSRIs may cause symptoms of sexual dysfunction. Interactions: Refer
with an irreversible MAOI. Sertraline must be discontinued for at least 7 days before starting treatment with an to SmPC for full details. Sertraline interacts with the following medicinal products: MAOIs; Pimozide; CNS
irreversible MAOI. Concomitant intake of pimozide is contraindicated. Precautions and Warnings: Please depressants and alcohol; Other serotonergic drugs; fentanyl and other opiate drugs; drugs that prolong the QT
consult SmPC for full details. Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS): Monitor Interval; lithium; phenytoin; warfarin; digoxin; atenolol; cimetidine; drugs affecting platelet function; Adverse events should be reported. Reporting forms and
for the emergence of signs and symptoms of SS or NMS syndrome. Switching from SSRIs, antidepressants or neuromuscular blockers. Triptans: Symptoms of serotonergic syndrome may occur; Rare post-marketing reports
anti-obsessional drugs: Care and prudent medical judgment should be exercised when switching, particularly describe weakness, hyperreflexia, incoordination, confusion, anxiety and agitation following use with information can be found at https://yellowcard.mhra.gov.uk/
from long-acting agents such as fluoxetine. Other serotonergic drugs e.g. tryptophan, fenfluramine and 5-HT sumatriptan. CYP3A4 Inducers: It cannot be excluded that CYP3A4 inducers and inhibitors affect sertraline or search for MHRA Yellow Card in the Google Play or Apple App
agonists: Co-administration with other drugs which enhance the effects of serotonergic neurotransmission plasma levels. Avoid potent CYP3A4 inhibitors. Drugs Metabolized by Cytochrome P450: Mild-moderate
should be undertaken with caution and avoided whenever possible. QTc Prolongation/Torsade de Pointes: Use inhibitor of CYP2D6. Sertraline does not inhibit CYP3A4, CYP2C9, CYP2C19 and CYP1A2 to a clinically Store. Adverse events should also be reported to
with caution in patients with additional risk factors for QTc prolongation such as cardiac disease, hypokalaemia significant degree. Grapefruit juice: avoid. Sertraline plasma levels are enhanced by about 50% in poor Martindale Pharma, an Ethypharm Group Company.
or hypomagnesemia, familial history of QTc prolongation, bradycardia and concomitant use of medications which metabolizers of CYP2C19 compared to rapid metabolizers. Interaction with strong inhibitors of CYP2C19 cannot Tel: 01277 266 600.
prolong QTc interval. Activation of hypomania or mania: Use with caution in patients with a history of mania/ be excluded. Fertility, pregnancy and lactation. Fertility: No impact shown on animal fertility. Impact on human
hypomania. Close surveillance by the physician is required. Discontinued in patients entering a manic phase. fertility has not been observed so far. Pregnancy: There are no well controlled studies in pregnant women. e-mail: drugsafety.uk@ethypharm.com
Schizophrenia: Psychotic symptoms might become aggravated in schizophrenic patients. Seizures: Seizures However, a substantial amount of data did not reveal evidence of induction of congenital malformations by
may occur: avoid in patients with unstable epilepsy and patients with controlled epilepsy should be carefully sertraline. Use of sertraline during pregnancy has been reported to cause symptoms, compatible with withdrawal
Date of preparation: September 2023 UK-SER-4a
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