ZEMTARD

Posology Zemtard/Angiozem is a prolonged-release product for once daily dosing. The dosage requirements may differ in patients with angina or hypertension. Zemtard/Angiozem (diltiazem hydrochloride) is available in a range of strengths 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. To ensure consistency of response once established, particularly in prolonged-release formulations, Zemtard/Angiozem should be prescribed by brand name.

Adults The recommended dose in adults is between 180 and 300mg given once daily. Doses of up to 360mg/day in hypertension and 480mg/day in angina may be of benefit in some patients. Elderly and patients with impaired renal or hepatic function In the elderly or renally or hepatically impaired a starting dose of 120mg daily is recommended.

Heart rate should be monitored and if it falls below 50 beats per minute (bpm) the dose should not be increased. Plasma levels of diltiazem can be increased in this group of patients. Paediatric population The safety and efficacy of the product in children have not been established.

This product is not recommended for use in children. Method of administration For oral use. Capsules should not be crushed or chewed but swallowed whole with half a glass of fluid, ideally before or during a meal.

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) Gastrointestina l disorders Constipation, dyspepsia, gastric pain, Anorexia, vomiting, diarrhoea, Dry mouth Gingival hyperplasia Very common Common Uncommon Rare Not known nausea taste disturbance, weight gain 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 Stevens-Johnson syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP), occasionally desquamative erythema with or without fever, lupus- like syndrome Reproductive system and breast disorders Gynecomastia General disorders and administration site conditions Peripheral oedema Malaise Fatigue Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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 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 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.

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 product contains sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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.

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