VASCALPHA

Posology Hypertension The dose should be adjusted individually. Treatment can be started with 5 mg once daily. 5 mg or increased to 10 mg daily. If necessary another antihypertensive agent may be added. The standard maintenance dose is 5 mg once daily.

Angina Pectoris The dose should be adjusted individually. Treatment should be initiated with 5 mg once daily and, if needed, increased to 10 mg once daily. Elderly Initial treatment with lowest available dose should be considered. Renal impairment Dose adjustment is not needed in patients with impaired renal function.

4). 2). Method of administration The tablets should be taken in the morning and be swallowed with water. In order to keep the prolonged-release properties, the tablets must not be divided, crushed or chewed. The tablets can be administered without food or following a light meal not rich in fat or carbohydrate.

5 mg felodipine, as Vascalpha (felodipine) prolonged release tablets is not available in this strength.

Summary of the safety profile Felodipine can cause flushing, headache, palpitations, dizziness and fatigue. Most of these adverse reactions are dose-dependent and appear at the start of treatment or after a dose increase. Should such adverse reactions occur, they are usually transient and diminish with time.

Dose-dependent ankle swelling can occur in patients treated with felodipine. This results from precapillary vasodilatation and is not related to any generalised fluid retention. Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis.

The enlargement can be avoided or reversed by careful oral hygiene. Tabulated list of adverse reactions The adverse reactions listed below have been identified from clinical trials and from post marketing surveillance. g. angio- oedema, fever Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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The efficacy and safety of felodipine in the treatment of hypertensive emergencies has not been studied. Felodipine may cause significant hypotension with subsequent tachycardia. This may lead to myocardial ischaemia in susceptible patients.

Felodipine is cleared by the liver. 2). 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. Excipients Vascalpha (felodipine) prolonged release tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1 - Decompensated heart failure - Acute myocardial infarction - Unstable angina pectoris - Haemodynamically significant cardiac valvular obstruction - Dynamic cardiac outflow obstruction