PINEFELD XL

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. Dose increases should occur at intervals of at least 2 weeks.

The standard maintenance dose is 5-10 mg once daily. Doses higher than 20 mg daily are not usually required. 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.

Pinefeld XL can be used in combination with β-blockers, ACE inhibitors or diuretics. Combination therapy will usually enhance the antihypertensive effect. Care should be taken to avoid hypotension. Different prolonged-release preparations do not necessarily have the same effect.

2). Elderly population Initial treatment with lowest available dose should be considered. 2). Dose adjustment is not needed in patients with impaired renal function. 4). In mild to moderate hepatic impairment, the recommended starting dose should be lowered to the minimum therapeutic effective dose.

2). Felodipine is contraindicated in patients with severe hepatic impairment. 2). Felodipine should not be used in children. 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).

Summary of the safety profile Felodipine can cause flushing, headache, palpitations, dizziness and fatigue. Most of these reactions are dose-dependent and appear at the start of treatment or after a dose increase. Should such 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 Nervous system disorders Common Uncommon Headache Dizziness, paraesthesia Vascular disorders Common Uncommon Rare Flushing Hypotension Syncope Cardiac disorders Uncommon Tachycardia, palpitations Gastrointestinal disorders Uncommon Rare Very rare Abdominal pain, nausea, Vomiting Gingival hyperplasia, gingivitis Skin and subcutaneous system disorders Uncommon Rare Very rare Rash, pruritus Urticaria Photosensitivity reactions, leukocytoclastic vasculitis Reproductive system and breast disorders Rare Impotence/sexual dysfunction Musculoskeletal and connective tissue disorders Rare Myalgia, arthralgia Hepatobilliary disorders Very rare Increased liver enzymes Renal and urinary disorders Very rare Pollakisuria 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 dental hygiene. Pinefeld XL contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Felodipine.

Pinefeld XL contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

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