ANGITIL XL

Posology:

Individual patients' responses to diltiazem may vary, necessitating careful titration. Angitil SR 90 mg, 120 mg and 180 mg Capsules are taken twice daily. Angitil XL 240 mg and 300 mg Capsules are taken once daily.

Adults:

The usual initial dose is 90 mg twice daily. Dosage may be increased gradually to 120 mg twice daily or 180 mg twice daily if required. Patients currently receiving a total daily dose of 180 mg diltiazem (as 90 mg bd), may be titrated up to 240 mg (od).

A patient receiving 240 mg per day of diltiazem (as 120 mg bd), should commence treatment on the 240 mg capsule (od), titrating to the 300 mg capsule (od), if required.

Elderly and patients with impaired renal or hepatic dysfunction:

The starting dose should be 60 mg diltiazem twice daily. If necessary, the dose may be increased gradually but careful monitoring of this group of patients is advised. Where the patient is currently prescribed 120 mg this dose may, by careful titration, be increased to 240 mg (od).

Paediatric population:

Diltiazem preparations are not recommended for children. Safety and efficacy in children have not been established. In order to avoid confusion, it is suggested that patients once titrated to an effective dose should remain on this treatment and should not be changed between different presentations.

Method of administration Route of administration:

Oral The capsules should be swallowed whole and not chewed. Dosage may be taken with or without food.

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 Atrioventric ular 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) Gastro- intestinal disorders Constipatio n, dyspepsia, gastric pain, nausea Vomiting, diarrhoea Dry mouth Gingival hyperplasia Metabolism and nutrition disorders Hyperglycemia Hepato- biliary disorders Hepatic enzymes increase (AST, ALT, LDH, ALP increase) Hepatitis Skin and sub- cutaneous 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 generalized exanthematous pustulosis, occasionally desquamative erythema with or without fever, lupus-like syndrome, lichenoid drug eruption Reproductiv e system and breast disorders Gynecomastia General disorders and administrati on site conditions Periphera l oedema Malaise Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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).

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.

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. Diltiazem in considered unsafe in patients with acute porphyria. Residues from slow-release formulations of the product may pass into the patient's stools; however, this finding has no clinical relevance.

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. • Decompensated cardiac failure. • Lactation.

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