Coralan心健朗

Coralan Special Precautions

ivabradine

Manufacturer:

Servier

Distributor:

Zuellig
/
The Glory Medicina
Full Prescribing Info
Special Precautions
Patients with Hypotension: Limited data are available in patients with mild to moderate hypotension and ivabradine should therefore be used with caution in these patients. Ivabradine is contraindicated in patients with severe hypotension (blood pressure <90/50 mmHg) (see Contraindications).
Atrial Fibrillation (Cardiac Arrhythmias): There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with ivabradine. However, in the absence of extensive data, non-urgent DC-cardioversion should be considered 24 hrs after the last dose of ivabradine.
Use in Patients with Congenital QT Syndrome or Treated with QT-Prolonging Medicinal Products: The use of ivabradine in patients with congenital QT syndrome or treated with QT-prolonging medicinal products should be avoided (see Interactions). If the combination appears necessary, close cardiac monitoring is needed.
Heart rate reduction, as caused by ivabradine, may exacerbate QT-prolongation, which may give rise to severe arrhythmias, in particular Torsade de Pointes.
Hypertensive Patients Requiring Blood Pressure Treatment Modifications: In the SHIFT trial, more patients experienced episodes of increased blood pressure while treated with ivabradine (7.1%) compared to patients treated with placebo (6.1%). These episodes occurred most frequently shortly after blood pressure treatment was modified, were transient, and did not affect the treatment effect of ivabradine. When treatment modifications are made in chronic heart failure patients treated with ivabradine, blood pressure should be monitored at an appropriate interval (see Adverse Reactions).
Excipients: Since tablets contain lactose, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take Coralan.
Effects on the Ability to Drive or Operate Machinery: A specific study to assess the possible influence of ivabradine on driving performance has been performed in healthy volunteers where no alteration of the driving performance was evidenced. However, in post-marketing experience, cases of impaired driving ability due to visual symptoms have been reported. Ivabradine may cause transient luminous phenomena consisting mainly of phosphenes (see Adverse Reactions). The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night.
Ivabradine has no influence on the ability to use machines.
Women of Childbearing Potential: Women of childbearing potential should use appropriate contraceptive measures during treatment (see Contraindications).
Impairment of Fertility: Studies in rats have shown no effect on fertility in males and females (see Toxicology under Actions).
Use in children: The safety and efficacy of ivabradine in children <18 years have not yet been established.
No data are available.
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