TILDIEM RETARD

Tildiem Retard tablets should be swallowed whole with a little water and not crushed or chewed. Patients should be advised that the tablet membrane may pass through the gastro- intestinal tract unchanged. Tildiem (diltiazem hydrochloride) is available in a range of presentations to enable dosage to be adjusted to meet the individual requirements of the patient.

Careful titration of the dose should be considered where appropriate, as individual patient response may vary. When changing from one type of Tildiem formulation to another it may be necessary to adjust the dosage until a satisfactory response is obtained.

To ensure consistency of response once established, particularly in the sustained release formulations, Tildiem Retard 90 mg and 120 mg should continue to be prescribed by brand name.

Adults Angina and hypertension:

The usual starting dose is one tablet (90 mg or 120 mg) twice daily. Patient responses may vary, and dosage requirements can differ significantly between individual patients. Higher divided doses up to 480 mg/day have been used with benefit in some angina patients especially in unstable angina.

Doses of 360 mg/day may be required to provide adequate BP control in hypertensive patients. Elderly and patients with impaired hepatic or renal function Heart rate should be monitored in these patients and if it falls below 50 beats per minute the dose should not be increased.

Angina:

The recommended starting dose is one Tildiem 60 mg tablet twice daily. This dose may be increased to one 90 mg or 120 mg Tildiem Retard tablet twice daily.

Hypertension:

The starting dose should be one 120 mg Tildiem Retard tablet daily. Dose adjustment to one 90 mg or one 120 mg Tildiem Retard tablet twice daily may be required. Paediatric population Safety and efficacy in children have not been established.

Therefore, diltiazem is not recommended for use in children.

The following CIOMS frequency rating is used, when applicable:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to ≤ 1/100); rare (≥ 1/10,000 to ≤ 1/1,000); very rare (≤ 1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

Very common Common Uncommon Rare Not known Blood and lymphatic system disorders Thrombocytopenia Psychiatric disorders Nervousness, insomnia Mood changes including depression Nervous system disorders Headache, dizziness Extrapyramidal syndrome Respiratory, thoracic and mediastinal disorders Bronchospasm (including asthma aggravation) Cardiac disorders Atrioventricular block (may be of first, second or third degree; bundle branch block may occur), palpitations Bradycardia Sinoatrial block, congestive heart failure, sinus arrest, cardiac arrest (asystole) Vascular disorders Flushing Orthostatic hypotension Vasculitis (including leukocytoclastic vasculitis) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Close observation is necessary in patients with reduced left ventricular 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 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 vascular dilatation associated with anaesthetics may be potentiated by calcium channel blockers.

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 aggravation, especially in patients with 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 tablet 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).

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. 5). 5). 5). 5).