FELOTENS XL

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. 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. 5 mg Prolonged Release Tablets must not be chewed or crushed. They should be swallowed whole with half a glass of water. 5 mg Prolonged Release Tablets in children has not been established.

5 mg 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. 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.

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. 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: very rarely - leucocytoclastic vasculitis, rarely - rash and/or pruritus, cutaneous vasculitis and isolated cases of photosensitivity. Musculoskeletal: in isolated cases arthralgia and myalgia. Psychiatric: rarely impotence/sexual dysfunction.

Central and peripheral nervous system: headache, dizziness. In isolated cases paraesthesia. Gastrointestinal: rarely - gum hyperplasia, very rarely – gingivitis, in isolated cases abdominal pain, nausea, vomiting, Hepatic: in isolated cases increased liver enzymes.

Urinary system: rarely - urinary frequency. Cardiovascular: rarely - tachycardia, palpitations and syncope. Vascular (extracardiac): peripheral oedema, flush. g. urticaria, angio-oedema. 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. uk/yellowcard

5 mg Prolonged Release Tablets may, in rare cases, precipitate significant hypotension with tachycardia which in susceptible individuals may result in myocardial ischaemia. Withdraw if ischaemic pain occurs or existing pain worsens shortly after initiating treatment.

5 mg Prolonged Release Tablets are useful for secondary prevention of myocardial infarction. 5 mg Prolonged Release Tablets in the treatment of malignant hypertension has not been studied. 5mg Prolonged Release Tablets should be used with caution in patients with severe left ventricular dysfunction.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

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

5 mg Prolonged Release Tablets should be discontinued in patients who develop cardiogenic shock.