Mirtazapine Abbreviated Prescribing Information

Abbreviated Prescribing Information: Mirtazapine 15mg/ml oral solution. Consult Summary of Product Characteristics before prescribing. Presentation: Oral solution. Clear, colourless-to-straw aqueous solution containing 15 mg of mirtazapine per 1ml. Therapeutic Indications: Mirtazapine is indicated in adults for the treatment of episodes of major depression. Posology and Method of Administration: Adults: The effective daily dose is between 15 mg and 45 mg; the starting dose is 15 mg or 30 mg. Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment. With an insufficient response, the dose can be increased up to the maximum dose. If there is no response within a further 2-4 weeks, then treatment should be stopped. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. Mirtazapine should be discontinued gradually to avoid withdrawal symptoms. Renal or hepatic impairment: The clearance of mirtazapine may be decreased in patients with moderate to severe renal or hepatic impairment. This should be taken into account when prescribing Mirtazapine to this category of patients. Mirtazapine should not be used in children and adolescents under the age of 18 years as efficacy was not demonstrated and because of safety concerns. Method of administration: To be taken preferably as a single night-time dose before going to bed, but it may also be given in two divided doses, with the higher dose taken at night. The solution is withdrawn from the bottle with the oral syringe and can be swallowed directly from the oral syringe. Alternatively, it can be dosed onto a spoon or into a glass of water using the syringe. Paediatric population: Mirtazapine should not be used in patients under the age of 18 years. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Concomitant use of mirtazapine with monoamine oxidase (MAO) inhibitors. Special Warnings and Precautions for use: Not to be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking. Caution should be exercised in patients with depression associated with history of suicide-related events or are those exhibiting a significant degree of suicidal ideation prior to commencement of treatment. It is general clinical experience that the risk of suicide may increase in the early stages of recovery requiring close monitoring during this period and following dose change. With regard to the chance of suicide, in particular at the beginning of treatment, only a limited quantity of Mirtazapine oral solution should be given to the patient consistent with good patient management, in order to reduce the risk of overdose.  Bone marrow depression usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with Mirtazapine. In the post-marketing period with Mirtazapine very rare cases of agranulocytosis have been reported, mostly reversible, but in some cases fatal, mostly involving patients of an age above 65. The physician should be alert for symptoms like fever, sore throat, stomatitis or other signs of infection; when such symptoms occur, treatment should be stopped and blood counts taken.  Treatment should be discontinued if jaundice occurs. Careful dosing as well as regular and close monitoring is necessary in patients with: epilepsy and organic brain syndrome, hepatic impairment, renal impairment, cardiac diseases, low blood pressure, diabetes mellitus. Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified and the depressive phase of bipolar disorder can transform into the manic phase. Mirtazapine should be discontinued in any patient entering a manic phase. Abrupt termination of treatment after long term administration may sometimes result in . Among the various reported withdrawal symptoms, dizziness, agitation, anxiety, headache and nausea are the most frequently reported. Even though they have been reported as withdrawal symptoms, it should be realized that these symptoms may be related to the underlying disease. Care should be taken in patients with micturition disturbances like prostate hypertrophy and in patients with acute narrow-angle glaucoma and increased intra-ocular pressure. Akathisia/psychomotor restlessness: patients who develop these symptoms, increasing the dose may be detrimental. This is most likely to occur within the first few weeks of treatment. Caution should be exercised when prescribed for patients with known cardiovascular disease or a family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QTc interval and in patients concomitantly treated with medications known to cause hyponatraemia, especially in the elderly population. Serotonin syndrome may occur when selective serotonin reuptake inhibitors (SSRIs) are used concomitantly with other serotonergic active substances. Concomitant administration of mirtazapine and buprenorphine/opioids may result in serotonin syndrome, a potentially life-threatening condition. If clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.   If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.  Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), bullous dermatitis and erythema multiforme, which can be life threatening or fatal have been reported in association with mirtazapine treatment. If signs and symptoms suggestive of these reactions appear, mirtazapine should be withdrawn immediately and must not be restarted. Care should be taken when switching from tablets to oral solution since there are slight pharmacokinetic differences between oral solution and tablets; although these differences are likely to be of no clinical relevance. Any warning from the MC, CHM CSM or MHRA: No Black Triangle notice: Not applicable. Note: depressed patients display a number of symptoms that are associated with the illness itself. It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with Mirtazapine. The very common and commonly reported undesirable effects are: Very common: weight increased, increase in appetite, somnolence, sedation, headache, and dry mouth. Common: abnormal dreams, confusion, anxiety, insomnia, lethargy, dizziness, tremor, amnesia, orthostatic hypotension, nausea, diarrhoea, vomiting, constipation, exanthema, arthralgia, myalgia, back pain, oedema peripheral, and fatigue. Serious undesirable effects include mania. hallucination, psychomotor restlessness (incl. akathisia, hyperkinesia), syncope, hypotension, myoclonus, pancreatitis, elevations in serum transaminase activities, bone marrow depression (granulocytopenia, agranulocytosis, aplastic anaemia, thrombocytopenia), inappropriate antidiuretic hormone secretion, hyperprolactinemia (and related symptoms galactorrhea and gynecomastia), hyponatraemia, suicidal ideation, suicidal behaviour, convulsions (insults),  serotonin syndrome, oral paresthesia, dysarthria, mouth oedema, Stevens-Johnson syndrome,  dermatitis bullous,  erythema multiforme, toxic epidermal necrolysis,  drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, priapism, urinary retention, Increased creatine kinase, generalised oedema and localised oedema. Refer to the SmPC for full details of undesirable effects. Pack Size and NHS Price: 66 ml – £143.10. Legal Category: Prescription only medicine. Marketing Authorisation Number: PL 00427/0241. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: October 2025