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 brad …

… cept 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 …

… ients with reduced left ventricular function, bradycardia (risk of exacerbation) or with first degree AV block detected on the electrocardiogram (risk of exacerbation and rarely, of complete block). 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 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 …

… 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. Like other calcium channel antagonists, diltiazem has an inhibitory effect on intestin …

… ients 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. 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. Like other calcium channel antagonists, diltiazem has an inhibitory effect on intestin …

… ients 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. As Slozem contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

… ring, 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. 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. 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. Like other calcium channel antagonists, diltiazem has an inhibitory effect on intestin …

… 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. 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. …

… ed due to the additional heart rate lowering effect of diltiazem to ivabradine (see section 4.3). Concomitant use requiring caution: Lithium: Risk of increase in lithium-induced neurotoxicity Nitrate derivatives: Increased hypotensive effects and faintness (additive vasodilatating effects): In all the patients treated with calcium antagonists, the prescription of nitrate derivatives should only be carried out at gradually increasing doses. Theophylline: Increase in circulating theophylline levels. Care should be exercised in patients taking these drugs. Alpha-antagonists: Increased antihypertensive effects: Concomitant treatment wit …

… -ventricular conduction disturbances and heart failure (synergistic effect). Such a combination must only be used under close clinical and ECG monitoring, particularly at the beginning of treatment. 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 combination should only be used under close clinical and ECG monitoring. Carbamazepine: Increase in circulating carbamazepine levels: It is recommended that the plasma carbamazepine concentrations be assayed and that the dose should be adjusted if necessary. Rifampicin: …

… nce of adequate evidence of safety in human pregnancy, dilitiazem 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 …

… vidence of safety in human pregnancy, dilitiazem 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 should be avoided. 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.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.