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Amlodipine Abbreviated Prescribing Information

Abbreviated Prescribing Information: Amlodipine 1mg/ml and 2mg/ml Oral Solutions, and 1 mg/ml Oral suspension. Consult Summary of Product Characteristics before prescribing. Presentation: Oral solution, each 1 ml contains 1 mg and 2 mg of amlodipine, respectively, and Oral suspension, . each 1 ml contains 1 mg of amlodipine. Therapeutic Indications: Hypertension, Chronic stable angina pectoris and Vasospastic (Prinzmetal’s) angina. Posology and method of administration: Adult: Hypertension and angina: 5mg – 10mg once daily in adults and the elderly. Hepatic impairment: Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment. Renal impairment: normal dosage is recommended. Paediatric population: 2.5mg – 5mg once daily for hypertension in children aged 6 – 17 years. Oral solution is suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. The product should not be shaken prior to administration or mixed with food or beverages before use. Oral suspension: Shake the suspension in the bottle lightly 5 times and then turn the bottle upside down to ensure that no precipitation is sedimented on the bottom of the bottle. Contra-indications: 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. Haemodynamically unstable heart failure after acute myocardial infarction. Special Warnings and Precautions for use: The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with heart failure should be treated with caution. Patients with impaired hepatic function should be initiated at the lower end of the dosing range and treated with caution. Dose titration should be done carefully in the elderly. Normal doses may be used in patients with renal failure. Amlodipine is not dialysable. Any warning from the MC, CHM CSM or MHRA. 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: Oedema. Common: 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, and asthenia. Pack Size and NHS Price: Oral solution: 1mg/ml 150ml – £72.00. 2mg/ml 150ml – £110.00. Oral suspension: 1mg/ml 150ml – £70.00. Marketing Authorisation Number: Oral solution: 1mg/ml PL 00427/0234 and 2mg/ml PL 00427/0235. Oral suspension: 1mg/ml PL 00427/0277. 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