1. Name of the medicinal product
Motens® 4 mg Tablets.

2. Qualitative and quantitative composition
Tablets containing lacidipine 4 mg.

Excipient with known effect:

Lactose 255.25 mg per tablet.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Film coated tablets.

4. Clinical particulars
4.1 Therapeutic indications
MOTENS is indicated for the treatment of hypertension either alone or in combination with other antihypertensive agents, including ß-adrenoceptor antagonists, diuretics, and ACE-inhibitors.

4.2 Posology and method of administration
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.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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 4.4 Special Warnings and Precautions for Use) the use of the product is contraindicated.

4.4 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. Lacidipine should also be used with cau