NEOFEL XL

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.

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 population Initial treatment with lowest available dose should be considered.

Renal Impairment Dose adjustment is not needed in patients with impaired renal function. Hepatic Impairment Patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to lower doses (see section

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 dental 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 If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed on this leaflet. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

). 2. Neofel XL 5 mg Prolonged Release Tablets can be used in combination with
-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. 4 Special warnings and precautions for use 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 Posology and method of administration). Concomitant administration of drugs that strongly induce or inhibit CYP 3A4 enzymes result in extensively decreased or increased plasma levels of felodipine, respectively.

5). Neofel contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Mild gingival enlargement has been reported in patients with pronounced gingivitis/ periodontitis.

The enlargement can be avoided or reversed by careful oral hygiene.

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