MOTENS

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. MOTENS should be taken at the same time each day, preferably in the morning. Treatment with MOTENS 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 MOTENS 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 MOTENS 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 MOTENS in children. Method of administration For oral administration.

MOTENS 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 MOTENS 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 (≥1/10,000, ≤1/1000), very rare (≤1/10,000), not known (cannot be estimated from the available data).

Adverse event frequencies have been estimated from spontaneous reports from post- marketing data.

Psychiatric disorders Very rare:

Depression Nervous system disorders Common: Dizziness#, headache# Very rare: Tremor Cardiac disorders Common: Palpitations#, tachycardia Uncommon: Syncope, angina pectoris 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. MOTENS should be discontinued under medical supervision in patients who develop unstable angina.

Vascular disorders Common:

Flushing# Uncommon: Hypotension Gastrointestinal disorders Common: Abdominal discomfort, nausea Uncommon: Gingival hyperplasia Skin and subcutaneous tissue disorders Common: Rash, erythema, pruritus Rare: Angioedema, urticaria Musculoskeletal and connective tissue disorders Rare: Muscle cramps Renal and urinary disorders Common: Polyuria General disorders and administration site conditions Common: Asthenia, oedema# Investigations Common: Blood alkaline phosphatase increased 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 MOTENS 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. 2 mg lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.

1. MOTENS 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, MOTENS 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 MOTENS is contraindicated. MOTENS 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