Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Sick sinus syndrome
Lercanidipine should be administered with caution in patients with sick sinus syndrome (without a pacemaker).

Left ventricular dysfunction
Although hemodynamic controlled studies revealed no impairment of ventricular function, care is required in patients with left ventricular dysfunction.

Ischaemic heart disease
It has been suggested that some short-acting dihydropyridines may be associated with increased cardiovascular risk in patients with ischaemic heart disease. Although lercanidipine is long-acting, caution is required in such patients.
Some dihydropyridines may rarely lead to precordial pain or angina pectoris. Very rarely patients with pre- existing angina pectoris may experience increased frequency, duration or severity of these attacks. Isolated cases of myocardial infarction may be observed (see section 4.8).

Use in renal or hepatic impairment
Special care should be exercised when treatment is commenced in patients with mild to moderate renal impairment. Although the usual recommended dose of 10 mg daily may be tolerated, an increase to 20 mg daily should be approached with caution.
The antihypertensive effect may be enhanced in patients with moderate hepatic impairment and consequently an adjustment of the dosage should be considered.
Lercanidipine is contraindicated in patients with severe hepatic impairment or renal impairment (GFR < 30 ml/min) (see section 4.2 and section 4.3).

Peritoneal Dialysis
Lercanidipine has been associated with the development of cloudy peritoneal effluent in patients on peritoneal dialysis. The turbidity is due to an increased triglyceride concentration in the peritoneal effluent. Whilst the mechanism is unknown, the turbidity tends to resolve soon after withdrawal of lercanidipine. This is an important association to recognise as cloudy peritoneal effluent can be mistaken for infective peritonitis with consequential unnecessary hospitalisation and empiric antibiotic administration.

Inducers of CYP3A4
Inducers of CYP3A4 like anticonvulsants (e.g. phenytoin, carbamazepine) and rifampicin may reduce lercanidipine plasma levels and therefore the efficacy of lercanidipine may be less than expected (see section 4.5).

Alcohol
Alcohol should be avoided since it may potentiate the effect of vasodilating antihypertensive drugs (see section 4.5).

Lactose
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Paediatric population
The safety and efficacy of Vasodip have not been demonstrated in children.



Effects on Driving

4.7 Effects on ability to drive and use machines

Lercanidipine has minor influence on the ability to drive and use machines. However, caution should be exercised because dizziness, asthenia, fatigue and rarely somnolence may occur.