Prozep (fluoxetine) – Abbreviated Prescribing Information 

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].