Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DILTIAZEM HYDROCHLORIDE
Orion Corporation
90 Milligram
Tablets
2006-06-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Entrydil S.R. 90 mg Prolonged-release Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release film-coated tablet contains 90 mg diltiazem hydrochloride. Excipients: Each prolonged-release film-coated tablet contains 85.5 mg lactose as lactose monohydrate Each prolonged-release film-coated tablet contains 0.6 mg sucrose For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release, film-coated tablet. White or almost white, capsule-shaped film-coated tablet with code “DL/90” marked on one side and a score line on both sides. The score line is for identification of the tablet, the tablets should be swallowed whole. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Angina Pectoris including Prinzmetal’s angina • Mild to moderate hypertension 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The tablets should be swallowed whole and not chewed. Adults only: The usual starting dose is 90 mg twice daily or 60 mg three times daily (corresponding to 180 mg of diltiazem hydrochloride). Depending upon clinical response the patient’s dosage may be increased to 180 mg twice daily or 120 mg three times daily if required. Elderly (over 65 years) and those with renal and hepatic impairment Dosage should commence at the lower level of 60mg twice daily and be increased slowly. Do not increase the dose if the heart rate falls below 50 beats per minute. Children (below 18 years of age): There are no data available on use of diltiazem in children below the age of 18 years, and diltiazem is not recommended for use in children. IRISH MEDICINES BOARD ______________________________________________________________________________________________________________________ Read the complete document