PEZIUS

Posology Adults:

The treatment of hypertension should be adapted to the severity of the condition, and according to the individual response. The recommended initial dose is 2 mg once daily. The dose may be increased to 4 mg (and then, if necessary, to 6 mg) after adequate time has been allowed for the full pharmacological effect to occur.

In practice, this should not be less than 3 to 4 weeks. Daily doses above 6 mg have not been shown to be significantly more effective. Lacidipine should be taken at the same time each day, preferably in the morning. Treatment with Lacidipine may be continued indefinitely.

Patients with hepatic impairment:

Lacidipine is metabolised primarily by the liver and therefore in patients with hepatic impairment, the bioavailability of Lacidipine may be increased and the hypotensive effect enhanced. These patients should be carefully monitored, and in severe cases, a dose reduction may be necessary.

Patients with kidney disease:

As Lacidipine is not cleared by the kidneys, the dose does not require modification in patients with kidney disease.

Paediatric population:

No experience has been gained with Lacidipine in children. Method of administration For oral administration.

Lacidipine is generally well tolerated. Some individuals may experience minor side effects which are related to its known pharmacological action of peripheral vasodilation. Such effects, indicated by a hash (#), are usually transient and usually disappear with continued administration of Lacidipine at the same dosage.

The following convention has been utilised for the classification of undesirable effects: Very common > 1/10 Common > 1/100, <1/10 Uncommon >1/1000, <1/100 Rare >1/10000, <1/1000 Very rare <1/10000 Not known Cannot be estimated from the available data Adverse event frequencies have been estimated from spontaneous reports from post- marketing data.

Psychiatric disorders:

Depression very rare Nervous system disorders: Dizziness# common Headache# common Tremor very rare Cardiac disorders: Palpitations# common Tachycardia common Syncope uncommon Angina pectoris uncommon As with other dihydropyridines aggravation of underlying angina pectoris has been reported in a small number of individuals, especially at the start of treatment.

This is more likely to happen in patients with symptomatic ischaemic heart disease. Lacidipine should be discontinued under medical supervision in patients who develop unstable angina.

Vascular disorders:

Flushing# common Hypotension uncommon Gastrointestinal disorders: Abdominal discomfort common Nausea common Gingival uncommon hyperplasia Skin and subcutaneous tissue disorders: Rash common Erythema common Pruritus common Angioedema rare Urticaria rare Musculoskeletal and connective tissue disorders: Muscle cramps rare Renal and urinary disorders: Polyuria common General disorders and administration site conditions: Asthenia common Oedema# common Investigations: Blood alkaline phosphatase increased common Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

) the use of the product is contraindicated. 4 Special warnings and precautions for use In specialised studies lacidipine has been shown not to affect the spontaneous function of the SA node or to cause prolonged conduction within the AV node.

However, the theoretical potential for a calcium antagonist to affect the activity of the SA and AV nodes should be noted, and therefore lacidipine should be used with caution in patients with pre-existing abnormalities in the activity of the SA and AV nodes.

As has been reported with other dihydropyridine calcium channel antagonists, lacidipine should be used with caution in patients with congenital or documented acquired QT prolongation. g. g. terfenadine). As with other calcium antagonists, lacidipine should be used with caution in patients with poor cardiac reserve.

There is no evidence that lacidipine is useful for secondary prevention of myocardial infarction. The efficacy and safety of Lacidipine in the treatment of malignant hypertension has not been established. Lacidipine should be used with caution in patients with impaired liver function because antihypertensive effect may be increased.

There is no evidence that lacidipine impairs glucose tolerance or alters diabetic control. This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Lacidipine should only be used with great care in patients with a previous allergic reaction to another dihydropyridine because there is a theoretical risk of cross- reactivity. As with other calcium antagonists, Lacidipine should be discontinued in patients who develop cardiogenic shock and unstable angina.

In addition, dihydropyridines have been shown to reduce coronary arterial blood-flow in patients with aortic stenosis and in such patients Lacidipine is contraindicated. Lacidipine should not be used during or within one month of a myocardial infarction.

In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to section