TILDIEM Modified-release tablets Ref.[6804] Active ingredients: Diltiazem

Adults

The usual dose is one tablet (60mg) three times daily. However, patient responses may vary and dosage requirements can differ significantly between individual patients. If necessary the divided dose may be increased to 360mg/day. Higher doses up to 480mg/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 (60mg) 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.

Children

Safety and efficacy in children have not been established. Therefore diltiazem is not recommended for use in children.

The clinical effects of acute overdose can involve pronounced hypotension leading to collapse and acute kidney injury, sinus bradycardia with or without isorhythmic dissociation, sinus arrest, atrioventricular conduction disturbances and cardiac arrest.

Treatment, under hospital supervision, will include gastric lavage, osmotic diuresis. Conduction disturbances may be managed by temporary cardiac pacing.

Proposed corrective treatments: atropine, vasopressors, inotropic agents, glucagon and calcium gluconate infusion.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

PVC/foil blister packs of 90 and 100 tablets. Securitainers, polypropylene body with polyethylene cap containing 50, 100 and 500 tablets.

Not all pack sizes may be marketed.

No special requirements.