Indications: Hypertension; stable angina pectoris. Dosage & Administration: Adjust dose based on individual response. Hypertension: initial and maintenance dose: 5mg once daily. Dose adjustments to 2.5mg or 10mg permitted per response, and additional antihypertensives may be added if necessary. Angina pectoris: initial dose: 5mg once daily. Dose increase to 10mg once daily permitted if required. Elderly: consider lowest available dose for initiation. Paediatric: limited data available – please see ‘Precautions, Warnings and Interactions’. Renal impairment: no dose adjustment required. Hepatic impairment: patients may respond to lower doses due to elevated felodipine plasma concentrations. Swallow whole with water in the morning, do not divide, crush, or chew. Administer without food or following a light meal low in fat/carbohydrate. Contraindications: Pregnancy; hypersensitivity to felodipine or any of the excipients; decompensated heart failure; acute myocardial infarction; unstable angina pectoris; haemodynamically significant cardiac valvular obstruction; dynamic cardiac outflow obstruction. Precautions, Warnings, and Interactions: May cause significant hypotension with subsequent tachycardia, which may lead to myocardial ischaemia in susceptible patients. Higher therapeutic concentrations and response in patients with clearly reduced liver function. Metabolised by CYP3A4 – avoid concomitant administration of CYP3A4 inducers (carbamazepine, phenytoin, phenobarbital, rifampicin, barbiturates, efavirenz, nevirapine, hypericum perforatum [St. John’s wort]), or inhibitors (itraconazole, erythromycin, cimetidine, ketoconazole, anti-HIV/protease inhibitors [ritonavir], and certain flavonoids present in grapefruit juice) as these extensively decrease or increase felodipine plasma levels, respectively; consider felodipine dose adjustment and discontinuation of CYP3A4 inducer/inhibitor in the event of reduced efficacy/clinically significant adverse events due to depressed/elevated felodipine exposure, respectively. Do not take in combination with grapefruit juice. May increase tacrolimus concentration – follow tacrolimus serum concentration and adjust dose as required when administered with felodipine. Not suitable for patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contains castor oil – may cause stomach upset/diarrhoea. Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis – can be avoided/reversed with careful oral hygiene. Paediatrics: Long-term effects of felodipine on growth, puberty and general development have not been studied; long-term efficacy of paediatric antihypertensive therapy to reduce adult cardiovascular morbidity/mortality has not been established. Hypertensive emergencies: efficacy and safety has not been studied in this setting. Pregnancy and Lactation: Contraindicated in pregnancy – foetal developmental effects observed in non-clinical reproductive toxicity studies. Not recommended during breast feeding – detected in breast milk, insufficient data available on effect on infants. No data available on fertility impact. Effects on ability to drive and use machinery: Minor or moderate influence on ability to drive and use machinery; caution recommended especially at the start of treatment. Ability to react may be impaired in patients with headache, nausea, dizziness, or fatigue. Adverse Events: Most events are dose-dependent, transient (diminish with time), and appear at the start of treatment or after a dose increases. Very common (≥1/10): peripheral oedema. Common (≥1/100, <1/10): headache, flush. Felodipine can also cause palpitations, dizziness, and fatigue. Dose-dependent ankle swelling can occur due to precapillary vasodilatation (unrelated to generalised fluid retention). Overdose: May cause excessive peripheral vasodilation with marked hypotension and sometimes bradycardia. Please refer to SmPC for full information on adverse events (including those of uncommon, rare, or very rare frequency) and management of overdose. Legal Category: POM. Price: 28 tablets: 2.5mg £4.25; 5mg £1.98; 10mg £1.98. Marketing Authorisation Number: 2.5mg PL 20117/0397; 5mg PL 20117/0398; 10mg PL 20117/0399. Marketing Authorisation Holder: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK. Date reviewed: November 2024 Version number: 101013111713 v 2.0
