DILTIAZEM MODIFIED RELEASE

Posology Adults:

The usual dose is one tablet (60 mg) three times daily. however patient responses may vary and dose requirements can differ significantly between individual patients. If necessary, the divided dose may be increased to 360 mg/day. Higher doses up to 480 mg/day have been used with benefit in some patients especially in unstable angina.

There is no evidence of any decrease in efficacy at these high doses.

Elderly and patients with impaired hepatic or renal function:

The recommended starting dose is one tablet (60 mg) twice daily, The heart rate should be measured regularly in these groups of patients and the dose should not be increased if the heart rate falls below 50 beats per minute.

Paediatric population:

The safety and efficacy of diltiazem in children have not been established. Therefore diltiazem is not recommended for use in children. Method of Administration For oral administration. The tablets should not be crushed or chewed, but swallowed whole with a glass of water.

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 Thrombocytopeni a. 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 Atrioventricula r 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), Gastrointestin Constipation, Vomiting, Dry mouth Gingival al disorders dyspepsia, gastric pain, nausea diarrhoea hyperplasia, Metabolism and nutrition disorders Hyperglycemia Hepatobiliary disorders Hepatic enzymes increase (AST, ALT, LDH, ALP increase).

Hepatitis Skin and subcutaneous tissue disorders Erythema Urticaria Photosensitivity (including lichenoid keratosis at sun- exposed skin areas), angioneurotic oedema, rash, erythema multiforme (including Steven-Johnson’s syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalised exanthematous pustulosis, occasionally desquamative erythema with or without fever, Lupus-like syndrome, Lichenoid drug erruption.

Reproductive system and breast disorders Gynaecomastia, General disorders and administration site conditions Peripheral oedema Malaise, Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. 3) 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.

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.

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.

Treatment with diltiazem may be associated with mood changes, including depression. 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.

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).