BI-CARZEM SR

Posology Patients should be advised that the capsule membrane may pass through the gastro-intestinal tract unchanged.

Adults Angina and hypertension:

The usual starting dose is one capsule (60 mg) three times daily. Patient responses may vary and dosage requirements can differ significantly between individual patients. Doses of 360 mg/day may be required to provide adequate BP control in hypertensive patients.

Higher divided doses up to 480 mg/day have been used with benefit in some patients especially in unstable angina. 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 60 mg capsule twice daily. This dose may be increased to one 90 mg or 120 mg capsule twice daily.

Hypertension:

The starting dose should be one 120 mg capsule daily. Dose adjustment to one 90 mg or one 120 mg capsule 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 Method of administration Oral use.

The capsule should be swallowed whole with a little water and without chewing or crushing.

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 ≤ 1/1000); 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) Very common Common Uncommon Rare Not known 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) Gastrointestinal disorders Constipation, dyspepsia, gastric pain, nausea Vomiting, diarrhoea Dry mouth Gingival hyperplasia Metabolism and nutrition disorders Hyperglycaemia 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 eruption Reproductive system and breast disorders Gynecomastia 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 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 pre-existing bronchial hyper-reactivity.

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).