Abbreviated Prescribing Information: Amitriptyline Hydrochloride 25mg/5ml and 50mg/5ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: Oral solutions containing either 25mg/5ml or 50mg/5ml amitriptyline hydrochloride. Therapeutic Indications: The treatment of major depressive disorder and neuropathic pain in adults, prophylactic treatment of chronic tension type headache (CTTH) and migraine in adults, and treatment of nocturnal enuresis in children aged 6 years and above when organic pathology, including spina bifida and related disorders, has been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin-related products. Posology and Method of Administration: Major depressive disorder: Adults: Initially 25 mg twice daily. The dose can be increased by 25 mg every other day up to 150 mg daily divided into two doses. Elderly: Patients over 65 years of age and patients with cardiovascular disease initially 10 mg – 25 mg daily, may be increased up to 100 mg – 150 mg divided into two doses, depending upon response and tolerance. Doses above 100 mg should be used with caution. Neuropathic pain, prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine prophylaxis: Adults: 25 mg – 75 mg daily in the evening. The initial dose should be 10 mg – 25 mg in the evening. Doses can be increased by 10 mg – 25 mg every 3 – 7 days. The dose can be taken once daily or be divided into two doses. A single dose above 75 mg is not recommended. Doses above 100 mg should be used with caution. Elderly: Patients over 65 years of age and patients with cardiovascular disease a starting dose of 10 mg – 25 mg in the evening. Doses above 75 mg should be used with caution. Duration of treatment: Major depressive disorder: Effect usually sets in after 2-4 weeks. Symptomatic and treatment should be continued up to 6 months after recovery in order to prevent relapse. Neuropathic pain: symptomatic with regular reassessment. Prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine in adults must be continued for an appropriate length of time and reassessed regularly. Special populations: Reduced renal function: the product can be given in usual doses to patients with renal failure. Reduced liver function: careful dosing and a serum level determination is advisable. Cytochrome P450 inhibitors of CYP2D6: a lower dose of amitriptyline should be considered if a strong CYP2D6 inhibitor is added to amitriptyline treatment. Known poor metabolisers of CYP2D6 or CYP2C19 consider a 50% reduction of the recommended starting dose. Method of administration: for oral use. When stopping therapy, the drug should be gradually withdrawn over several weeks. Paediatric population: Major depressive disorder, Neuropathic pain, prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine prophylaxis: Amitriptyline should not be used in children aged less than 18 years. Nocturnal enuresis: children aged 6 to 10 years: 10 mg – 20 mg, children aged 11 years and above: 25 mg – 50 mg daily. The dose should be increased gradually and administered 1-1½ hours before bedtime. An ECG should be performed prior to initiating therapy to exclude prolonged QT interval. Maximum treatment course should not exceed 3 months. If repeated courses are needed, a medical review should be conducted every 3 months. Sudden discontinuation should be avoided. When stopping treatment, amitriptyline should be withdrawn gradually. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Recent myocardial infarction. Any degree of heart block or disorders of cardiac rhythm and coronary artery insufficiency. Concomitant treatment with monoamine oxidase inhibitors (MAOIs). Treatment with amitriptyline may be instituted 14 days after discontinuation of irreversible non-selective MAOIs and minimum one day after discontinuation of the reversible moclobemide. Treatment with MAOIs may be introduced 14 days after discontinuation of amitriptyline. Severe liver disease. Children under 6 years of age. Special warnings and Precautions for use: Cases of cardiac arrhythmias and severe hypotension with high dosage (may also occur in patients with pre-existing heart disease taking normal dosage), and QT interval prolongation are reported. Caution is advised in patients with significant bradycardia, in patients with uncompensated heart failure, or in patients concurrently taking QT-prolonging drugs. Caution should be exercised if anaesthetics given during tri/tetracyclic antidepressant therapy, as it may increase the risk of arrhythmias and hypotension. Discontinue this medicinal product several days before surgery; if emergency surgery is unavoidable, the anaesthetist should be informed that the patient is being so treated). Administer with caution if administered to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop. Elderly patients susceptible to orthostatic hypotension. Use with caution in patients with convulsive disorders, urinary retention, prostatic hypertrophy, hyperthyroidism, paranoid symptomatology and advanced hepatic or cardiovascular disease, pylorus stenosis and paralytic ileus, in patients with the rare condition of shallow anterior chamber and narrow chamber angle, attacks of acute glaucoma due to dilation of the pupil may be provoked, suicide, suicidal thoughts, patients with a history of suicide-related events prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment, in manic depressives, a shift towards the manic phase may occur, amitriptyline may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients, hyperpyrexia. Used with caution in patients receiving SSRIs. Concomitant administration of amitriptyline and buprenorphine/opioids may result in serotonin syndrome. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. After prolonged administration, abrupt cessation of therapy may produce withdrawal symptoms such as headache, malaise, insomnia and irritability. Nocturnal enuresis: ECG to be performed prior to initiating therapy, exclude long QT syndrome. Not to be combined with an anticholinergic drug. Same precautions observed when treating patients with depression should be followed when treating patients with enuresis. Severe cutaneous reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with amitriptyline treatment, potentially life-threatening or fatal. Patients should be informed of these symptoms and monitored closely. If signs and symptoms suggestive of these reactions appear, amitriptyline should be withdrawn immediately and alternative treatment considered. Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available. Excipients Warnings: Contains methyl and propyl hydroxybenzoates, carmoisine may cause allergic reactions. Contains liquid maltitol, patients with rare hereditary problems of fructose intolerance should not take this medicine, may have a mild laxative effect. Any warning from the MC, CHM CSM or MHRA: No, Black Triangle notice: Not applicable. The list of adverse reactions includes-Very common: aggression, somnolence, tremor, dizziness, headache, drowsiness, speech disorder (dysarthria), accommodation disorder, palpitations, tachycardia, orthostatic hypotension, congested nose, dry mouth, constipation, nausea, hyperhidrosis, and weight increased. Common: confusional state, libido decreased, agitation, disturbance in attention, dysgeusia. paresthesia, ataxia, mydriasis, atrioventricular block, bundle branch block, micturition disorders, erectile dysfunction, fatigue, feeling thirst, electrocardiogram abnormal, electrocardiogram QT prolonged, electrocardiogram QRS complex prolonged, and hyponatremia. Serious: bone marrow depression, drug reaction with eosinophilia and systemic symptoms, arrhythmia, collapse conditions, worsening of cardiac failure, cardiomyopathies, hypersensitivity myocarditis, suicidal thoughts or behaviour, agranulocytosis, leucopenia, thrombocytopenia, delirium, torsades de pointes, alveolitis, Löffler’s syndrome, ileus paralytic, hepatic impairment, mania, hypomania, hallucination, convulsion, extrapyramidal disorder, acute glaucoma, anaphylaxis, angioedema, face oedema, tongue oedema, elevation or lowering of blood sugar levels, hypertension, hyperthermia, intraocular pressure increased, jaundice, liver function test abnormal, transaminases increased, blood alkaline phosphatase increased, urinary retention , photosensitivity reaction, and hepatitis. Refer to the SmPC for full details of adverse reactions. Legal Category: POM. Pack Size and NHS Price: 150ml: 25mg/5ml – £15.70 50mg/5ml – £17.20. Marketing Authorisation Number: 25 mg/5 ml: PL 00427/0115 and 50 mg/5 ml: PL 00427/0116. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: Oct-2025.