FORTIPINE LA

Posology The following recommendations for dosing in adults are applicable:

In general, one modified release tablet of Fortipine LA 40 (40mg) once daily should be adequate. If necessary, this dose can be increased to 80 mg given once daily, or 40 mg twice daily.

Elderly:

Patients should be treated individually depending on the severity of the disease and the therapeutic response. The pharmacokinetics of nifedipine are altered in the elderly, so that a maintenance dose should be once daily modified release tablet of 40mg.

Regular assessment of the medical regime should be performed to minimise unwanted effects.

Renal Impairment:

In patients with renal dysfunction, a slight alteration of the pharmacokinetics of nifedipine may be seen. However, dose adjustment in these patients is not usually required.

Hepatic Impairment:

In patients with liver cirrhosis and chronic liver failure, significant alterations of the pharmacokinetics of nifedipine is usually seen. These patients should usually be carefully monitored when initiating therapy and during maintenance treatment with a dose that should not exceed one modified release tablet of 40mg.

Paediatric population:

The safety and efficacy of nifedipine in children and adolescents under the age of 18 years have not been established. 1. Method of administration For oral administration. g. breakfast. The modified release tablets should be swallowed whole with half a glass of water and must not be broken or chewed.

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9%). ADRs derived from post marketing reports are printed in bold italic. 1% Frequency Not Known Blood and lymphatic system disorders Agranulocytosis Leukopenia Immune System Disorders Allergic reaction Allergic Pruritus Urticaria Anaphylactic/anaphylactoid reaction oedema/angioedema (Incl.

6) In dialysis patients with malignant hypertension and hypovolaemia a distinct fall in blood pressure can occur as a result of vasodilation. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Patients at risk of hypotensive crisis should begin any therapy under close medical supervision. Ischaemic pain has been reported in a small proportion of patients following the introduction of nifedipine therapy. Although a 'steal' effect has not been demonstrated, patients experiencing this effect should discontinue nifedipine therapy.

Fortipine LA 40 is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be a gradual reduction of the dose of beta-blocker preferably over 8 - 10 days.

Fortipine LA 40 may be used in combination with beta-blocking drugs and other antihypertensive agents but the possibility of an additive effect resulting in postural hypotension should be borne in mind. Fortipine LA will not prevent possible rebound effects after cessation of other antihypertensive therapy.

Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less than 90 mm Hg. Fortipine LA 40 should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine.

6). 6). V. magnesium sulphate, owing to the possibility of an excessive fall in blood pressure, which could harm both mother and foetus. For further information regarding use in pregnancy, refer to section

1 Fortipine LA 40 should not be administered to patients with hypersensitivity to other dihydropyridines because of the theoretical risk of cross-reactivity, nor to patients with a cardiogenic shock. It is contra-indicated in women with child-bearing potential and those breastfeeding their babies.

Fortipine LA 40 is contra-indicated in patients with cardiac failure, with those with markedly severe hypotension with less than 90mm Hg systolic and with porphyria. Fortipine LA 40 should not be used in clinically significant aortic stenosis, patients who develop unstable angina, or during or within 1 month of a myocardial infarction.

Fortipine LA 40 should not be used for secondary prevention of myocardial infarction. Fortipine LA 40 should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine may not be achieved owing to enzyme induction.