Zemtard 120XL 120mg Prolonged-release Capsules

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Diltiazem is contraindicated in patients with severe bradycardia (below 40 bpm); in sick sinus syndrome or in second- or third-degree AV block, in patients without a functioning pacemaker; in left ventricular failure with pulmonary congestion. Diltiazem should not be given concomitantly with dantrolene infusion (see section 4.5). Diltiazem is also contraindicated in combination with ivabradine (see section 4.5). Diltiazem should not be used concurrently with lomitapide (see section 4.5). Diltiazem is contraindicated in pregnancy, in women of childbearing potential not using effective contraception and while breast-feeding (see section 4.6).

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Diltiazem is contraindicated in patients with severe bradycardia (below 40 bpm); in sick sinus syndrome or in second- or third-degree AV block, in patients without a functioning pacemaker; in left v …

… antrolene infusion (see section 4.5). Diltiazem is also contraindicated in combination with ivabradine (see section 4.5). Diltiazem should not be used concurrently with lomitapide (see section 4.5). Diltiazem is contraindicated in pregnancy, in women of childbearing potential not using effective contraception and while breast-feeding (see section 4.6).

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Diltiazem is contraindicated in patients with severe bradycardia (below 40 bpm); in sick sinus syndrome or in second- or third-degree AV block, in patients without a functioning pacemaker; in left ventricular failure with pulmonary congestion. Diltiazem should not be given concomitantly with dantrolene infusion (see section 4.5). Diltiazem is also contraindicated in combination with ivabradine (see section 4.5). Diltiazem should not be used concurrently with lomitapide (see section 4.5). Diltiazem is contraindicated in pregnancy, in women of childbearing potential not using effective contraception and while breast-feeding (see section 4.6).

… product contains sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Caution should be exercised when direct oral anticoagulants (DOACs) are co-administered with diltiazem which is a moderate CYP3A4 and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see section 4.5).

Close observation is necessary in patients with heart failure or reduced left ventricular function, bradycardia (risk of exacerbation), or with first-degree AV block or prolonged PR interval detected on the electrocardiogram (ECG) (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 s …

… 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 closely observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment. Treatment with diltiazem may be associated with mood changes, including depression (see section 4.5 and 4.8). Early recognition of relevant symptoms is important, especially in predisposed patients …

… ith preexisting 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. This product contains sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Caution should be exercised when direct oral anticoagulants (DOACs) are co-administered with diltiazem which is a moderate CYP3A4 and a weak P-gp inhibitor, particularly in patients at high risk of …

… 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 closely observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment. Treatment with diltiazem may be associated with mood changes, including depression (see section 4.5 and 4.8). Early recognition of relevant symptoms is important, especially in predisposed patients …

… lar function, bradycardia (risk of exacerbation), or with first-degree AV block or prolonged PR interval detected on the electrocardiogram (ECG) (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 anaesthetist must be informed of ongoing diltiazem treatment. Depression of cardiac contractility, conductivity and automaticity, as well as the vascular dilatation …

… ith preexisting 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. This product contains sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Caution should be exercised when direct oral anticoagulants (DOACs) are co-administered with diltiazem which is a moderate CYP3A4 and a weak P-gp inhibitor, particularly in patients at high risk of …

… es, including depression (see section 4.5 and 4.8). Early recognition of relevant symptoms is important, especially in predisposed patients. In such cases, drug discontinuation should be considered. Diltiazem has an inhibitory effect on intestinal motility. Therefore, it should be used with caution in patients at risk of developing an intestinal obstruction. 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 …

… lar function, bradycardia (risk of exacerbation), or with first-degree AV block or prolonged PR interval detected on the electrocardiogram (ECG) (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 anaesthetist must be informed of ongoing diltiazem treatment. Depression of cardiac contractility, conductivity and automaticity, as well as the vascular dilatation …

… scontinuation should be considered. Diltiazem has an inhibitory effect on intestinal motility. Therefore, it should be used with caution in patients at risk of developing an intestinal obstruction. 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 aggravation, especially in patients with preexisting bronchial hyper-reactivity. Cases have also been reported after dose increase. Pat …

… ose 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 (see section 4.8). Antiarrhythmic agents: Since diltiazem has antiarrhythmic properties, its concomitant prescription with other antiarrhythmic agents is not recommended due to the risk of increased cardiac adverse effects due to an additive effect. 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. Phenytoin: …

… 4 (e.g. pravastatin) with diltiazem. Cilostazol: Inhibition of cilostazol metabolism (CYP3A4). Diltiazem has been shown to increase cilostazol exposure and to enhance its pharmacological activity. Antidepressants: Diltiazem may increase the plasma concentration of imipramine and possibly other tricyclics, possibly accompanied by undesirable ECG changes. Enhanced hypotensive effect when calcium-channel blockers are given with MAOIs. Anti-fungals: Negative inotropic effect possibly increased when calcium-channel blockers are given with itraconazole. Antimalarials: Possible increased risk of bradycardia when calcium-channel bloc …

… araffin Talc Capsule Components Red iron oxide (E172) Yellow iron oxide (E172) Erythrosine (E127) Indigotine (E132) Titanium dioxide (E171) Gelatin Overprint Ink Constituents Shellac Propylene glycol Black iron oxide (E172)

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.