Slozem 120mg Capsules

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Sick sinus syndrome except in the presence of a functioning ventricular pacemaker. • Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. • Severe bradycardia (below 40 bpm) • Left ventricular failure with pulmonary congestion • Concomitan …

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Sick sinus syndrome except in the presence of a functioning ventricular pacemaker. • Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. • Severe bradyca …

… except in the presence of a functioning ventricular pacemaker. • Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. • Severe bradycardia (below 40 bpm) • Left ventricular failure with pulmonary congestion • Concomitant use of dantrolene infusion (see section 4.5). • Additionally, for the intravenous forms, patients known to have an accessory bypass (Wolf-Parkinson-White syndrome or short PR syndrome), …

… th pre-existing bronchial hyper-reactivity. Cases have also been reported after dose increase. Patients should be monitored for signs and symptoms of respiratory impairment during diltiazem therapy. Caution should be exercised when direct oral anticoagulants (DOACs) are administered concomitantly with diltiazem, a moderate CYP3A4 inhibitor and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see section 4.5). Sucrose As Slozem contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medici …

… ntricular function, bradycardia (risk of exacerbation) or with first degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block). Cases of acute renal failure secondary to decreased renal perfusion have been reported in patients with existing cardiac disease especially reduced left ventricular function, severe bradycardia or severe hypotension. Careful monitoring of renal function is advised. Prior to general anaesthesia, the anaesthesist must be informed of ongoing diltiazem treatment. Depression of cardiac contractility, conductivity and automaticity, as well as the vascular dilatation …

… ltiazem treatment. Depression of cardiac contractility, conductivity and automaticity, as well as the vascular dilatation associated with anaesthetics may be potentiated by calcium channel blockers. Increase of plasma concentrations of diltiazem may be observed in the elderly and in patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment. Calcium channel blocking agents, such as diltiazem, may be associated with mood changes, including depression. Early recognition of relevant symptoms is important, especially in predisposed patients …

… agulants (DOACs) are administered concomitantly with diltiazem, a moderate CYP3A4 inhibitor and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see section 4.5). Sucrose As Slozem contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

… ltiazem treatment. Depression of cardiac contractility, conductivity and automaticity, as well as the vascular dilatation associated with anaesthetics may be potentiated by calcium channel blockers. Increase of plasma concentrations of diltiazem may be observed in the elderly and in patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment. Calcium channel blocking agents, such as diltiazem, may be associated with mood changes, including depression. Early recognition of relevant symptoms is important, especially in predisposed patients …

… ntricular function, bradycardia (risk of exacerbation) or with first degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block). Cases of acute renal failure secondary to decreased renal perfusion have been reported in patients with existing cardiac disease especially reduced left ventricular function, severe bradycardia or severe hypotension. Careful monitoring of renal function is advised. Prior to general anaesthesia, the anaesthesist must be informed of ongoing diltiazem treatment. Depression of cardiac contractility, conductivity and automaticity, as well as the vascular dilatation …

… agulants (DOACs) are administered concomitantly with diltiazem, a moderate CYP3A4 inhibitor and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see section 4.5). Sucrose As Slozem contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

… ssociated with mood changes, including depression. Early recognition of relevant symptoms is important, especially in predisposed patients. In such cases, drug discontinuation should be considered. Like other calcium channel antagonists, diltiazem has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk to develop an intestinal obstruction. Tablet residues from slow release formulations of the product may pass into the patient's stools; however, this finding has no clinical relevance. Careful monitoring is necessary in patients with latent or manifest diabetes mellitus due to a possible increase in blood glucose. The use of diltiazem may induce bronchospasm, including asthma agg …

… ntricular function, bradycardia (risk of exacerbation) or with first degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block). Cases of acute renal failure secondary to decreased renal perfusion have been reported in patients with existing cardiac disease especially reduced left ventricular function, severe bradycardia or severe hypotension. Careful monitoring of renal function is advised. Prior to general anaesthesia, the anaesthesist must be informed of ongoing diltiazem treatment. Depression of cardiac contractility, conductivity and automaticity, as well as the vascular dilatation …

… al or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment. Calcium channel blocking agents, such as diltiazem, may be associated with mood changes, including depression. Early recognition of relevant symptoms is important, especially in predisposed patients. In such cases, drug discontinuation should be considered. Like other calcium channel antagonists, diltiazem has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk to develop an intestinal obstruction. …

… be used under close clinical and ECG monitoring, particularly at the beginning of treatment. An increased risk of depression has been reported when diltiazem is co-administered with beta-blockers. Other antiarrhythmic agents Since diltiazem has antiarrhythmic properties, its concomitant prescription with other antiarrhythmic agents is not recommended (additive risk of increased cardiac adverse effects). This combinati …

… te evidence of safety in human pregnancy, diltiazem is therefore not recommended during pregnancy as well as in women of child- bearing potential not using effective contraception. Breast-feeding Diltiazem hydrochloride is excreted in breast milk at low concentrations. One report suggests that concentrations in breast milk reach similar levels to those in serum. Breast-feeding while taking this drug is contra-indicated. If use of diltiazem is considered medically essential, an alternative method of infant feeding should be instituted.

Pregnancy There is very limited data from the use of diltiazem in pregnant patients. Diltiazem has been shown to have reproductive toxicity (teratogenic) in some animal species (rat, mice, rabbit). In the a …

Maize starch, sucrose, povidone, shellac, ethylcellulose, talc, gelatin, erythrosine (E127), indigo carmine (E132) and (180mg, 240mg and 300mg only), titanium dioxide (E171). Printing ink: black iron oxide (E172), shellac, propylene glycol.

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