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. 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. Older people: The recommended dose is the same as that for adults. In elderly patients an increase in dosing should be done under close supervision. Renal or hepatic impairment: The clearance of mirtazapine may be decreased in patients with moderate to severe renal or hepatic impairment. 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, the higher dose taken at night. 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/suicidal thoughts or clinical worsening, bone marrow depression, jaundice, 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, 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 withdrawal symptoms. 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. Caution should be exercised when prescribed in patients with known cardiovascular disease or 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. Serotonin syndrome may occur when selective serotonin reuptake inhibitors (SSRIs) are used concomitantly with other serotonergic active substances. Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), bullous dermatitis and erythema multiforme, 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. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. Undesirable Effects: Very common: weight increased, increase in appetite, somnolence, sedation, headache, dry mouth, Common: abnormal dreams, confusion, anxiety, insomnia, lethargy, dizziness, tremor, amnesia, orthostatic hypotension, nausea, diarrhea, vomiting, constipation, exanthema, arthralgia, myalgia, back pain, oedema peripheral, fatigue, Uncommon: nightmares, mania, agitation, hallucinations, psychomotor restlessness, paraesthesia, restless legs, syncope, hypotension, oral hypoaesthesia, Rare: aggression, myoclonus, pancreatitis, elevations in serum transaminase activities. Frequency not known: bone marrow depression, eosinophilia, inappropriate antidiuretic hormone secretion, hyponatremia, suicidal ideation, suicidal behaviour, somnambulism, convulsions, serotonin syndrome, oral paresthaesia, dysarthria, mouth oedema, increased salivation, Stevens-Johnson Syndrome, dermatitis bullous, erythema multiforme, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, priapism, urinary retention, generalised or localised oedema, increased creatine kinase. Pack Size and NHS Price: 66ml – £131.04. 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: December 2022