LACIDIPINE Film-coated tablet Ref.[8327] Active ingredients: Lacidipine

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 caution in patients treated concomitantly with medications known to prolong the QT interval such as class I and III antiarrhythmics, tricyclic antidepressants, some antipsychotics, antibiotics (e.g. erythromycin) and some antihistamines (e.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.

Co-administration of lacidipine with other agents recognised to have a hypotensive effect, including anti-hypertensive agents, (e.g. diuretics, beta-blockers or ACE-inhibitors), may have an additive hypotensive effect. However, no specific interaction problems have been identified in studies with common antihypertensive agents (e.g. beta-blockers and diuretics) or with digoxin, tolbutamide or warfarin.

The plasma level of lacidipine may be increased by simultaneous administration of cimetidine.

Lacidipine is highly protein-bound (more than 95%) to albumin and alpha-1-glycoprotein.

As with other dihydropyridines, lacidipine should not be taken with grapefruit juice as bioavailability may be altered.

In clinical studies in patients with a renal transplant treated with cyclosporin, lacidipine reversed the decrease in renal plasma flow and glomerular filtration rate induced by cyclosporin.

Lacidipine is known to be metabolised by cytochrome CYP3A4 and, therefore, significant inhibitors and inducers of CYP3A4 (e.g. rifampicin, itraconazole) administered concurrently may interact with the metabolism and elimination of lacidipine.

Concomitant use of lacidipine and corticoids or tetracosactide might decrease antihypertensive effect.

Pregnancy

Although some dihydropyridine compounds have been found to be teratogenic in animals, data in the rat and rabbit for lacidipine provide no evidence of a teratogenic effect. Using doses far above the therapeutic range, in animals lacidipine shows evidence of maternal toxicity resulting in increased pre- and post-implantation losses and possibly delayed ossification. Evidence from experimental animals has indicated that administration of lacidipine results in prolongation of gestational period and prolonged and difficult labour as a consequence of relaxation of uterine muscle.

There are no data on the safety of lacidipine in human pregnancy.

Lacidipine should only be used in pregnancy when the potential benefits for the mother outweigh the possibility of adverse effects in the foetus or neonate.

The possibility that lacidipine can cause relaxation of the uterine muscle at term should be considered.

Breast-feeding

Milk transfer studies in animals have shown that lacidipine (or its metabolites) are likely to be excreted into breast milk.

Lacidipine should only be used during lactation when the potential benefits for the mother outweigh the possibility of adverse effects in the foetus or neonate.

Lacidipine may cause dizziness. Patients should be warned not to drive or operate machinery if they experience dizziness or related symptoms.

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.

Adverse events have been ranked under headings of frequency using the following convention: 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.

ychiatric 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. Lacidipine 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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App Store.

Not applicable.