SLOZEM

Posology Adults 240mg once daily Dosage titration in 60mg to 120mg steps at 2-weekly intervals may be required to obtain satisfactory clinical response (usually 240mg to 360mg daily will suffice). Dosage should be reduced in the presence of adverse reactions or if the pulse rate falls below 50 per minute.

Older people and patients with hepatic or renal impairment Starting dose 120mg once daily. Paediatric population Not recommended

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 Metabolism and nutrition disorders Hyperglycemia Psychiatric disorders Nervousne ss, insomnia Mood changes (including depression) Nervous system disorders Headache, dizziness Extrapyramidal syndrome.

Drug-induced Parkinsonism Cardiac disorders Atrioventric ular block (may be of first, second or third degree; bundle branch block may occur), palpitations Bradycar dia Sinoatrial block, sinus arrest, congestive heart failure, cardiac arrest Vascular disorders Flushing Orthostati c hypotensi on Vasculitis (including leukocytoclastic vasculitis) Respiratory, thoracic and mediastinal disorders Bronchospasm (including asthma aggravation) Gastrointestinal disorders Constipatio n, dyspepsia, gastric pain, Vomiting, diarrhea Dry mouth Gingival hyperplasia 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 generalized exanthematous pustulosis and hyperpigmentation in sun-exposed areas have also been reported.

Reproductive system and breast disorders Gynecomastia General disorders and administration site conditions Peripheraloe dema Malaise Hepatic enzymes increase (AST, ALT, LDH, ALP increase) typically observed at the start of the treatment.

4 Special warnings and special precautions for use Close observation and caution is necessary in patients with reduced left ventricular function, bradycardia (risk of exacerbation) or with first 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.

Prior to general anaesthesia, the anaesthesist 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 carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment.

Calcium channel blocking agents, such as diltiazem, may be associated with mood changes, including depression. Early recognition of relevant symptoms is important, especially in predisposed patients. In such cases, drug discontinuation should be considered.

Like other calcium channel antagonists, diltiazem has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk to develop an intestinal obstruction. Tablet residues from slow release formulations of the product may pass into the patient’s stools; however, this finding has no clinical relevance.

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 pre-existing bronchial hyper-reactivity.

1. • Sick sinus syndrome except in the presence of a functioning ventricular pacemaker. • Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. 5). • Additionally, for the intravenous forms, patients known to have an accessory bypass (Wolf-Parkinson-White syndrome or short PR syndrome), and who develop atrial fibrillation or flutter, should not be administered intravenous diltiazem.

5) • Lactation