CARDIOPLEN XL

For oral administration Hypertension:

Adults (including older people): The dose should be adjusted to the individual requirements of the patient. The recommended starting dose is 5mg once daily. If necessary the dose may be further increased or another antihypertensive agent added.

The usual maintenance dose is 5-10mg once daily. Doses higher than 20mg daily are not usually needed. 5mg daily should be considered.

Angina pectoris:

Adults: The dose should be adjusted individually. Treatment should be started with 5mg once daily and if needed be increased to 10mg once daily.

Elderly population:

Initial treatment with lowest available dose should be considered.

Administration:

The tablets should regularly be taken in the morning without food or with a light meal. 5mg Prolonged Release Tablets must not be chewed or crushed. They should be swallowed whole with half a glass of water. 5mg Prolonged Release Tablets in children has not been established.

5mg Prolonged Release Tablets can be used in combination with β-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. Patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to lower doses. The pharmacokinetics are not significantly affected in patients with impaired renal function.

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. 5mg 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.

g. angio-oedema, fever Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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5mg Prolonged Release Tablets may, in rare cases, precipitate significant hypotension with tachycardia which in susceptible individuals may result in myocardial ischaemia. 5mg Prolonged Release Tablets are useful for secondary prevention of myocardial infarction.

5mg Prolonged Release Tablets in the treatment of malignant hypertension and hypertensive emergencies has not been studied. 5mg Prolonged Release Tablets should be used with caution in patients with severe left ventricular dysfunction.

Felodipine is cleared by the liver. Consequently higher therapeutic concentrations and response can be expected in patients with clearly reduced liver function. Concomitant administration of drugs that strongly induce or inhibit CYP3 A4 enzymes result in extensively decreased or increased plasma levels of felodipine, respectively.

5). Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis. The enlargement can be avoided or reversed by careful oral hygiene. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Unstable angina pectoris. Pregnancy. 5mg Prolonged Release Tablets or other dihydropyridines because of the theoretical risk of cross-reactivity. 5mg Prolonged Release Tablets should not be used in patients with clinically significant aortic stenosis, and during or within one month of a myocardial infarction.

5mg Prolonged Release Tablets should be discontinued in patients who develop cardiogenic shock. Decompensated heart failure. Haemodynamically significant cardiac valvular obstruction. Dynamic cardiac outflow obstruction.