Sertraline Abbreviated Prescribing Information

Abbreviated Prescribing Information: Sertraline 20mg/ml Concentrate for Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: Clear colourless solution. Each ml of concentrate for oral solution contains sertraline hydrochloride equivalent to 20 mg of sertraline. Therapeutic Indications: Sertraline is used to treat major depressive episodes, pain disorders, with or without agoraphobia, obsessive compulsive disorder (OCD), social anxiety, and post- traumatic stress disorder (PTSD). Posology and Method of Administration: The recommended dosage for adults with depression and OCD is 50 mg/day. For panic disorder, social anxiety disorder, and PTSD, treatment starts at 25mg/day and increases to 50 mg once daily after one week. Increases in dosage may be helpful for patients who do not respond to a 50 mg dose. Dosage adjustments should be made up to 200 mg/day in increments of 50 mg at least one week apart. Elderly people should be given careful dosages because they may be more susceptible to hyponatraemia. For patients with hepatic impairment, a lower or less frequent dose is recommended; in cases of severe hepatic impairment, it should not be used. No dosage adjustment is necessary in patients with renal impairment. Paediatric population: Sertraline Concentrate for Oral Solution is recommended for treating OCD in children and adolescents aged 6-17 years old. Starting dose is 25 mg daily, increasing to 50 mg daily after a week, and maximum dose is 200 mg daily. In paediatric major depression, efficacy is not demonstrated and is therefore not recommended. Sertraline Oral solution is for oral use only and can be administered with or without food, either in the morning or evening. Abrupt discontinuation should be avoided as withdrawal symptoms are reported; therefore, the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions. Contra- indications: Hypersensitivity to the active substance and concurrent treatment with irreversible monoamine oxidase inhibitors (MAOIs), pimozide, and disulfiram. Sertraline must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI and must be discontinued for at least 7 days before starting treatment with an irreversible MAOI. Special Warnings and Precautions for use: Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) can develop with SSRIs, including sertraline treatment. Switching from SSRIs, antidepressants, or anti-obsessional drugs to sertraline requires careful medical judgment. Co-administration of sertraline with other drugs which enhance the effects of serotonergic neurotransmission should be avoided due to potential pharmacodynamic interactions. Caution should be exercised in patients with risk factors for QTc prolongation and/or with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation. Drug therapy should be closely monitored, especially during the early stages of treatment and after dose adjustments, for patients, especially those who are at high risk. Cases of hypomania or mania, schizophrenia, and seizures have been reported with sertraline. Sertraline, a selective serotonin reuptake inhibitor (SSRI), may cause sexual dysfunction. It should not be used in children and adolescents under 18 years old, except for those with obsessive compulsive disorder aged 6-17 years old. Sertraline has also been linked to abnormal bleeding/hemorrhage, including cutaneous bleeding and gastrointestinal or gynaecological bleeding. Hyponatraemia may occur due to treatment with SSRIs or SNRIs, with elderly patients at greater risk. Discontinuation of sertraline should be considered in patients with symptomatic hyponatraemia, and appropriate medical intervention should be instituted. Withdrawal symptoms are common when treatment is discontinued. Sertraline has been associated with akathisia/psychomotor restlessness. Sertraline use in patients with hepatic disease must be managed carefully. Caution should be exercised in elderly and diabetic patients. There are no clinical studies establishing the risks or benefits of the combined use of electroconvulsive therapy and sertraline. Administration of sertraline with grapefruit juice is not recommended because of the potential interaction and possible risk of elevated sertraline plasma levels following concomitant consumption. False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline. Sertraline, an SSRI, may cause mydriasis. Caution should be exercised in patients with angle-closure glaucoma or history of glaucoma. Sertraline oral solution contains ethanol, which can cause a rise in blood alcohol concentration. Co-administration with medicines containing e.g., propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity. Women who are pregnant or nursing should be treated with caution. Any warning from the MC, CHM CSM or MHRA: N/A Black Triangle notice (if relevant) N/A. Legal Category: POM. A list of common and serious adverse reactions are upper respiratory tract infection, pharyngitis, rhinitis, decreased appetite, increased appetite, insomnia, anxiety, depression, agitation, libido decreased, nervousness, depersonalisation, nightmare, bruxism, dizziness, headache, somnolence, tremor, movement disorders (including extrapyramidal symptoms such as hyperkinesia, hypertonia, dystonia, teeth grinding or gait abnormalities), serotonin syndrome, neuroleptic malignant syndrome, paraesthesia, hypertonia, disturbance in attention, dysgeusia, visual disturbance, tinnitus, palpitations, hot flush, yawning, nausea, diarrhoea, dry mouth, dyspepsia, constipation, abdominal pain, vomiting, flatulence, hyperhidrosis, rash, back pain, arthralgia, myalgia, ejaculation failure, menstruation irregular, erectile dysfunction, fatigue, malaise, chest pain, asthenia, pyrexia, weight increased, injury, thrombocytopenia, leukopenia, anaphylactoid reaction, Hypersensitivity, hypercholesterolaemia, hyperglycaemia, hyponatraemia, suicidal ideation/behaviour, amnesia, convulsion, coma, cerebral vasoconstriction syndrome, Call-Fleming syndrome, interstitial lung disease, gastrointestinal bleeding, pancreatitis, Stevens-Johnson syndrome and epidermal necrolysis, skin reaction and photosensitivity, postpartum haemorrhage, rhabdomyolysis, serious liver events (including hepatitis, jaundice, and hepatic failure), neuroleptic malignant syndrome, hypertension, tachycardia, glaucoma, cardiac disorder, myocardial infarction, Torsade de Pointes, QTc abnormalilty, abnormal bleeding, bronchospasm, and osteoarthritis, Refer to the SmPC for details of other adverse reactions. Pack Size and NHS Price: 180ml – £90.00 Marketing Authorisation Number: PL 00427/0275 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [November-2024].