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Medicine information : FELOTENS XL Tablets
| Drug class description : | Antagonist |
| Generic Name : | Felodipine |
| Drug description : | Light pink, round, biconvex, film coated prolonged-release tablets with imprint 5. Reddish brown, round, biconvex, film coated prolonged-release tablets with imprint 10. |
| Presentation : | Felotens XL 5 mg Prolonged Release Tablets - Contains 5 mg of felodipine. Felotens XL 10 mg Prolonged Release Tablets - Contains 10mg of felodipine. |
| Indications : | In the management of hypertension and prophylaxis of chronic stable angina pectoris. |
| Adult Dosage : | For oral administration Hypertension: Adults (including elderly): The dose should be adjusted to the individual requirements of the patient. The recommended starting dose is 5 mg once daily. If necessary the dose may be further increased or another antihypertensive agent added. The usual maintenance dose is 5-10 mg once daily. Doses higher than 20 mg daily are not usually needed. For dose titration purposes a 2.5 mg tablet is available. In elderly patients an initial treatment with 2.5 mg daily should be considered. Angina pectoris: Adults: The dose should be adjusted individually. Treatment should be started with 5 mg once daily and if needed be increased to 10 mg once daily. Administration: The tablets should regularly be taken in the morning without food or with a light meal. Felotens XL 5 mg Prolonged Release Tablets must not be chewed or crushed. They should be swallowed whole with half a glass of water. Felotens XL 5 mg Prolonged Release Tablets can be used in combination with ß-blockers, ACE inhibitors or diuretics. The effects on blood pressure are likely to be additive and combination therapy will usually enhance the antihypertensive effect. Care should be taken to avoid hypotension. In patients with severely impaired liver function the dose of felodipine should be low. The pharmacokinetics are not significantly affected in patients with impaired renal function. |
| Child Dosage : | The safety and efficacy of Felotens XL 5 mg Prolonged Release Tablets in children has not been established. |
| Contra Indications : | Unstable angina pectoris. Pregnancy. Patient with a previous allergic reaction to Felotens XL 5 mg Prolonged Release Tablets or other dihydropyridines because of the theoretical risk of cross-reactivity. Felotens XL 5 mg Prolonged Release Tablets should not be used in patients with clinically significant aortic stenosis, and during or within one month of a myocardial infarction. As with other calcium channel blockers, Felotens XL 5 mg Prolonged Release Tablets should be discontinued in patients who develop cardiogenic shock. |
| Special Precautions : | As with other vasodilators, Felotens XL 5 mg Prolonged Release Tablets may, in rare cases, precipitate significant hypotension with tachycardia which in susceptible individuals may result in myocardial ischaemia. There is no evidence that Felotens XL 5 mg Prolonged Release Tablets are useful for secondary prevention of myocardial infarction. The efficacy and safety of Felotens XL 5 mg Prolonged Release Tablets in the treatment of malignant hypertension has not been studied. Felotens XL 5 mg Prolonged Release Tablets should be used with caution in patients with severe left ventricular dysfunction. |
| Interactions : | Concomitant administration of substances which interfere with the cytochrome P450 system may affect plasma concentrations of felodipine. Enzyme inhibitors such as cimetidine, erythromycin and itraconazole impair the elimination of felodipine, and Felotens XL 5 mg Prolonged Release Tablets dosage may need to be reduced when drugs are given concomitantly. Conversely, powerful enzyme inducing agents such as some anticonvulsants (phenytoin, carbamazepine, phenobarbitone) can increase felodipine elimination and higher than normal Felotens XL 5 mg Prolonged Release Tablets doses may be required in patients taking the drugs. No dosage adjustment is required when Felotens XL 5 mg Prolonged Release Tablets are given concomitantly with digoxin. Felodipine does not appear to affect the unbound fraction of other extensively plasma protein bound drugs such as warfarin. Grapefruit juice results in increased peak plasma levels and bioavailability possibly due to an interaction with flavonoids in the fruit juice. This interaction has been seen with other dihydropyridine calcium antagonists and represents a class effect. Therefore grapefruit juice should not be taken together with Felotens XL 5 mg Prolonged Release Tablets. Pregnancy and lactation : Felodipine should not be given during pregnancy. In a study on fertility and general reproductive performance in rats, a prolongation of parturition resulting in difficult labour, increased foetal deaths and early postnatal deaths were observed in the medium- and high-dose groups. Reproductive studies in rabbits have shown a dose-related reversible enlargement of the mammary glands of the parent animals and dose-related digital abnormalities in the foetuses when felodipine was administered during stages of early foetal development. Felodipine has been detected in breast milk, but it is unknown whether it has harmful effects on the new-born. |
| Adverse Reactions : | As with other calcium antagonists, flushing, headache, palpitations, dizziness and fatigue may occur. These reactions are usually transient and are most likely to occur at the start of treatment or after an increase in dosage. As with other calcium antagonists ankle swelling, resulting from precapillary vasodilation, may occur. The degree of ankle swelling is dose related. In patients with gingivitis/periodontitis, mild gingival enlargement has been reported with Felotens XL 5 mg Prolonged Release Tablets, as with other calcium antagonists. The enlargement can be avoided or reversed by careful dental hygiene. As with other dihydropyridines, aggravation of angina has been reported in a small number of individuals especially after starting treatment. This is more likely to happen in patients with symptomatic ischaemic heart disease. The following adverse events have been reported from clinical trials and from Post Marketing Surveillance. In the great majority of cases a causal relationship between these events and treatment with felodipine has not been established. Skin: rarely - rash and/or pruritus, and isolated cases of photosensitivity. Musculoskeletal: in isolated cases arthralgia and myalgia. Central and peripheral nervous system: headache, dizziness. In isolated cases paraesthesia. Gastrointestinal: in isolated cases nausea, gum hyperplasia. Hepatic: in isolated cases increased liver enzymes. Cardiovascular: rarely - tachycardia, palpitations and syncope. Vascular (extracardiac):peripheral oedema, flush. Other: rarely - fatigue, in isolated cases hypersensitivity reactions e.g. urticaria, angiooedema. |
| Manufacturer : | Genus Pharmaceuticals |
| Drug Availability : | (POM) |
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