Tildiem LA 200mg Prolonged-Release Capsules

• Hypersensitivity to diltiazem or to any of the excipients listed in section 6.1. • Sick sinus syndrome, 2nd or 3rd degree AV block in patients without a functioning pacemaker. • Severe bradycardia (less than 50 beats per minute). • Left ventricular failure with pulmonary s …

… of the excipients listed in section 6.1. • Sick sinus syndrome, 2nd or 3rd degree AV block in patients without a functioning pacemaker. • Severe bradycardia (less than 50 beats per minute). • Left ventricular failure with pulmonary stasis. • Lactation. • Concurrent use with dantrolene infusion (see section 4.5). • Combination with ivabradine (see section 4.5). • Concurrent use with lomitapide (see section 4.5). • Concurrent …

… be monitored for signs and symptoms of respiratory impairment during diltiazem therapy. This medicine contains less than 1 mmol sodium (23 mg) per capsule that is to say essentially 'sodium-free'. 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 Interactions).

… 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. 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. In the case of general anaesthesia, the anaesthetist must be informed that the patient is taking diltiazem. The depression of cardiac contractility, conductivity and automaticity as well as the vas …

… entricular function, bradycardia (risk of exacerbation) or with a 1st degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block). Increase of plasma concentrations of diltiazem may be observed in the elderly and 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. 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 …

… entricular function, bradycardia (risk of exacerbation) or with a 1st degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block). Increase of plasma concentrations of diltiazem may be observed in the elderly and 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. 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 …

… 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. 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. In the case of general anaesthesia, the anaesthetist must be informed that the patient is taking diltiazem. The depression of cardiac contractility, conductivity and automaticity as well as the vas …

… 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 medicine contains less than 1 mmol sodium (23 mg) per capsule that is to say essentially 'sodium-free'. 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 …

… entricular function, bradycardia (risk of exacerbation) or with a 1st degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block). Increase of plasma concentrations of diltiazem may be observed in the elderly and 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. 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 …

… 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 …

… ee section 4.8). Amiodarone, Digoxin Increased risk of bradycardia; caution is required when these are combined with diltiazem, particularly in elderly subjects and when high doses are used. 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 addit …

Pregnancy There is very limited data from the use of diltiazem in pregnant patients. Diltiazem has been shown to have reproductive toxicity (see section 5.3) in certain animal species (rat, mice, rabbit). Di …

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