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Amitriptyline Hydrochloride Abbreviated Prescribing Information

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), prophylactic treatment of migraine. The treatment of nocturnal enuresis in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have 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. Patients over 65 years of age and patients with cardiovascular disease initially 10 mg – 25 mg daily, increased up to 100 mg – 150 mg divided into two doses. 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. 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. Neuropathic pain: symptomatic. 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: Amitriptyline should not be used in children aged less than 18 yearsNocturnal 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. Maximum treatment course should not exceed 3 months. If repeated courses are needed, a medical review should be conducted every 3 months. 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). Severe liver disease. Children under 6 years of age. Special warnings and Precautions for use: Cardiac arrhythmias and severe hypotension with high dosage, QT interval prolongation, anaesthetics, 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, in manic depressives, a shift towards the manic phase may occur, amitriptyline may modify insulin and glucose responses, hyperpyrexia, withdrawal symptoms such as headache, malaise, insomnia and irritability may occur. Used with caution in patients receiving SSRIs. Concomitant administration of amitriptyline and buprenorphine/opioids may result in serotonin syndrome. Nocturnal enuresis: ECG to be performed prior to initiating therapy. Not to be combined with an anticholinergic drug. Same precautions observed when treating patients with depression should be followed when treating patients with enuresis. Any warning from the MC, CHM CSM or MHRA: No, Black Triangle notice: Not applicable. Legal Category: POM. The very common and common reactions are presented below and refer the SmPC for other adverse reactions: Very common: aggression, somnolence, tremor, dizziness, headache, drowsiness, speech disorder (dysarthria), accommodation disorder, palpitations, tachycardia, orthostatic hypotension, congested nose, dry mouth, constipation, nausea, hyperhidrosis, 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. 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: December 2022

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400