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].
Abbreviated Prescribing Information: Prozep 20mg/5ml Oral Solution (Fluoxetine 20mg/5ml Oral Solution) Consult Summary of Product Characteristics before prescribing. Presentation: Clear, colourless liquid with an odour of peppermint; each 5 ml of oral solution contains 20 mg of fluoxetine. Therapeutic Indications: Fluoxetine Oral Solution is used to treat major depressive episodes, obsessive-compulsive disorder, and Bulimia nervosa, as a complement to psychotherapy for reducing binge eating and purging activity. Posology and Method of Administration: Fluoxetine is used for oral administration. The recommended dosage for major depressive episodes in adults and the elderly is 20 mg daily, with adjustments made within 3-4 weeks to a maximum of 60 mg For obsessive-compulsive disorder (OCD), 20 mg daily is recommended, with gradual increases up to 60 mg if necessary. If no improvement is seen within 10 weeks, fluoxetine treatment should be reconsidered. Long-term efficacy in OCD has not been demonstrated. For bulimia nervosa, 60 mg/day is recommended, but long-term efficacy (more than 3 months) has not been demonstrated. Doses above 80 mg/day have not been systematically evaluated. Elderly patients should avoid increasing the dose; the recommended daily dose of Prozep is 40 mg, with a maximum of 60 mg/day. A lower or less frequent dose (e.g. 20 mg every second day) should be considered in patients with hepatic impairment. Paediatric population: The Prozep Oral Solution is used to treat moderate to severe major depressive episodes in children and adolescents aged 8 years and above. The starting dose is 10 mg/day to a maximum of 20mg/day, with adjustments made individually. Dose increases may occur after one to two weeks. Lower weight children may benefit from lower doses; the need for continued treatment should be reviewed after 6 months. If no clinical benefit is achieved within 9 weeks, treatment should be reconsidered. Contra-indications: Fluoxetine is contra-indicated in patients hypersensitive to the active substance or excipients and in combination with irreversible, non-selective monoamine oxidase inhibitors (e.g., iproniazid) and metoprolol used in cardiac failure. Special Warnings and Precautions for use: Fluoxetine is recommended for children and adolescents aged 8-18 years for treating moderate to severe major depressive episodes. It should not be used for other indications and should be closely monitored for suicidal symptoms. Exercise caution with suicide-related behaviors (suicide attempt and suicidal thoughts) and hostility (mainly aggression, oppositional behavior, and anger), especially among high-risk patients who require close monitoring, particularly during the initial treatment phases and after dosage adjustments. Reduced height and weight gain were noted in children and adolescents receiving fluoxetine during a 19-week clinical trial and therefore growth and pubertal should be monitored during and after treatment with fluoxetine. There have been many reports of mania and hypomania, and any patient who is about to enter a manic phase should stop taking fluoxetine. Fluoxetine has been linked to cardiovascular effects, including QT interval prolongation and ventricular arrhythmia. Patients with conditions like congenital long QT syndrome, family history of QT prolongation, or increased exposure to fluoxetine should use it cautiously. If cardiac arrhythmia occurs during treatment, the treatment should be withdrawn and an ECG performed. Fluoxetine is also contra-indicated in combination with irreversible, non-selective monoamine oxidase inhibitors (MAOIs), which can cause serious reactions like serotonin syndrome. An MAOI should be started at least five (5) weeks after stopping fluoxetine treatment, and fluoxetine treatment should only be started two (2) weeks after stopping an MAOI. Fluoxetine treatment can lead to serotonin syndrome or neuroleptic malignant syndrome-like events, which can result in potentially life-threatening conditions. Treatment should be discontinued if they occur, and supportive symptomatic treatment should be initiated. Fluoxetine should not be used in combination with pethidine due to the risk of serotonin syndrome. SSRIs have been associated with cutaneous bleeding abnormalities. Cautions should be exercised with seizure; especially in patients on fluoxetine receiving ECT treatment. Caution is advised in patients taking SSRIs, particularly in concomitant use with oral anticoagulants, drugs known to affect platelet function. SSRIs/SNRIs may increase the risk of postpartum haemorrhage. Fluoxetine may lead to reduced concentrations of endoxifen, a potent inhibitor of CYP2D6, so it should be avoided during tamoxifen treatment. Akathisia/psychomotor restlessness is associated with fluoxetine use, and treatment with an SSRI may alter glycaemic control in patients with diabetes. For patients with severe hepatic dysfunction, a lower dose—such as every other day—is advised. Rash, anaphylactoid events, and progressive systemic events have been reported, and fluoxetine should be discontinued if an alternative aetiology cannot be identified. Patients taking fluoxetine may experience weight loss. Withdrawal symptoms should be handled carefully, and fluoxetine should be tapered off gradually over a minimum of one to two weeks, depending on the patient’s needs. Mydriasis has been linked to fluoxetine, requiring caution when prescribing it to patients with high intraocular pressure or those at risk of acute narrow-angle glaucoma. SSRIs and SNRIs may cause symptoms of sexual dysfunction, and reports of persistent sexual dysfunction have been made in which the symptoms persisted even after stopping SSRIs or SNRIs. There is 2.2 g of sorbitol in each 5 ml spoonful of fluoxetine Oral Solution which may affect the bioavailability of other products and should not be given to patients with hereditary fructose intolerance. It may cause gastrointestinal discomfort and mild laxative effects. The medicinal product contains 2.5 mg of benzoic acid and 50 mg of polyoxyl 40 hydrogenated castor oil in each 5 ml spoonful of fluoxetine oral solution. Castor oil may cause stomach upset and diarrhoea. 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: Decreased appetite, Insomnia, Headache, Anxiety, Nervousness, Restlessness, Tension, Libido decreased, Sleep disorder, Abnormal dreams, Disturbance in attention, Suicidal thoughts and behaviour, Dizziness, Dysgeusia, Lethargy, Somnolence, Tremor, Vision blurred, Palpitations, Electrocardiogram QT prolonged, Flushing, Yawning, Diarrhoea, Nausea, Vomiting, Dyspepsia, Dry mouth, Rash, Urticaria, Pruritus, Hyperhidrosis, Arthralgia, Frequent urination, Gynaecological bleeding, Erectile dysfunction, Ejaculation disorder, Fatigue, Feeling jittery, Chills, Weight decreased, Thrombocytopenia, Neutropenia, Leucopenia, Anaphylactic reaction, Serum Sickness, Inappropriate antidiuretic hormone secretion, Hyponatraemia, Mania / Hypomania, Hallucinations, Convulsions, Akathisia, Psychomotor hyperactivity, Serotonin syndrome, Ventricular arrhythmia including torsades de pointes, Vasculitis, Vasodilatation, Gastrointestinal haemorrhage, atelectasis, Interstitial lung disease, Pneumonitis, Idiosyncratic hepatitis, Photosensitivity reaction, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, , Mucosal haemorrhage, Urinary retention, Postpartum haemorrhage, and Gamma, Priapism Glutamyl transferase increased. Refer to the SmPC for details of other adverse reactions. Pack Size and NHS Price: 70ml – £12.95. Marketing Authorisation Number: PL 00427/0289 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [January-2025].