Amlodipine Abbreviated Prescribing Information

Abbreviated Prescribing Information Amlodipine 1mg/ml and 2mg/ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear, pale straw coloured viscous liquid. Each ml contains 1mg of amlodipine for 1 mg/ml concentration and each ml contain 2mg of amlodipine for 2 mg/ml concentration Therapeutic Indications: Amlodipine is indicated for Hypertension, Chronic stable angina pectoris and Vasospastic (Prinzmetal’s) angina. Posology and Method of Administration: For adults with hypertension or angina, the recommended starting dose of amlodipine is 5 mg once daily, which may be increased to a maximum of 10 mg based on patient response. Amlodipine can be used alone or in combination with other antihypertensive or antianginal agents. No dose adjustment is required when co-administered with thiazide diuretics, beta blockers, or ACE inhibitors. In elderly patients, the usual dose is well tolerated; however, dose increases should be approached cautiously. For patients with mild to moderate hepatic impairment, initiate treatment at the lower end of the dosing range. In severe hepatic impairment, start at the lowest dose and titrate slowly. No dose adjustment is necessary in renal impairment, and amlodipine is not dialysable. Paediatric population: In paediatric patients aged 6–17 years with hypertension, the recommended starting dose is 2.5 mg once daily, which may be increased to 5 mg if needed after 4 weeks. Doses above 5 mg daily have not been studied. Amlodipine is not recommended in children under 6 years due to lack of data. Amlodipine is for oral use and may be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. It should not be shaken or mixed with food or beverages prior to administration. Contraindications: Amlodipine is contraindicated in patients with hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients, Severe hypotension, Shock (including cardiogenic shock), Obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis), Haemodynamically unstable heart failure after acute myocardial infarction. Special Warnings and Precautions for use: The safety and efficacy of amlodipine in hypertensive crisis have not been established. Caution is advised when treating patients with heart failure, particularly those with NYHA class III and IV, as an increased incidence of pulmonary oedema has been reported. Calcium channel blockers, including amlodipine, may elevate the risk of future cardiovascular events and mortality in this population. In patients with hepatic impairment, amlodipine exposure is increased due to prolonged half-life and elevated AUC values. Therefore, treatment should begin at the lower end of the dosing range, with slow titration and close monitoring, especially in severe hepatic impairment. Elderly patients may tolerate amlodipine well, but dose increases should be approached cautiously. In renal impairment, no dosage adjustment is required, and plasma concentrations do not correlate with the degree of impairment. Amlodipine is not dialysable. Due to its viscous nature, care should be taken when administering amlodipine via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes, as under-dosing may occur. Refer to section 6.6 for accurate administration guidance. This product contains liquid maltitol (E965) and glycerol (E422). Patients with hereditary fructose intolerance should not take this medicine. Glycerol may cause headache, gastrointestinal discomfort, and diarrhoea. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. : Very common adverse reactions: oedema. Common adverse reactions: somnolence, dizziness, headache (especially at the beginning of the treatment), visual disturbance (including diplopia), palpitations, flushing, dyspnoea, abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation), ankle swelling, muscle cramps, fatigue, asthenia, Serious adverse reactions include: Leukocytopenia, thrombocytopenia, allergic reactions, hyperglycaemia, insomnia, mood changes (including anxiety), depression, confusion, paraesthesia, hypertonia, peripheral neuropathy, extrapyramidal disorder, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, hypotension, vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, hepatic enzyme increased mostly consistent with cholestasis, alopecia, purpura , angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity, toxic epidermal necrolysis, back pain, micturition disorder, impotence, gynaecomastia, chest pain, . Please refer to summary of product characteristic for full details of adverse events. Pack Size and NHS Price: 150ml 1mg/ml – £72.00, 2mg/ml – £110.00. Legal Category: POM. Marketing Authorisation Number: PL 00427/0234 and PL 00427/0235 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [August 2025]