Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DILTIAZEM HYDROCHLORIDE
PCO Manufacturing
120 Milligram
Capsules Hard
2005-08-26
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dilzem XL120mg Prolonged-release hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release capsule contains 120mg diltiazem hydrochloride. For excipients, see 6.1 3 PHARMACEUTICAL FORM Prolonged release, hard capsule. _Product imported from the UK:_ White gelatin capsules, printed with ‘e120’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Prophylaxis and treatment of angina pectoris. 2. Treatment of mild to moderate hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use only. ADULTS _Hypertension: _The usual initial dose is one 180 mg capsule per day (corresponding to 180 mg of diltiazem hydrochloride once daily). Depending upon the clinical response the patient's dosage may be increased stepwise to 360 mg/day if required. _Angina Pectoris: _The usual initial dose is one 180 mg capsule per day (corresponding to 180 mg of diltiazem hydrochloride once daily). Depending on the clinical response the patient's dosage may be increased stepwise to 360 mg/day if required. _ELDERLY PATIENTS AND THOSE WITH RENAL OR HEPATIC IMPAIRMENT_ Dosage should commence at the lower level of 120 mg once-daily and be increased slowly. Do not increase the dose if the heart rate falls below 50 beats per minute. _CHILDREN_ This product is not recommended for use in children. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/04/2009_ _CRN 2064906_ _page number: 1_ 4.3 CONTRAINDICATIONS Use in women of child-bearing potential. 2. Concomitant administration of dantrolene infusion due to the risk of ventricular fibrillation. 3. Shock. 4. Acute cardiac infarct with complications (bradycardia, severe hypotension, left hea Read the complete document