DILZEM XL
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-03-2023
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Active ingredient:
DILTIAZEM HYDROCHLORIDE
Available from:
LTT Pharma Limited
Dosage:
240 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Authorization date:
2010-11-12
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Dilzem XL 240mg Prolonged-release Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Dilzem XL 240mg capsule contains diltiazem hydrochloride 240mg.
Excipients: Each capsule contains sucrose.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release capsules, hard
Product imported from Germany
White, hard gelatin capsules, printed with ‘D240 mg’ and containing roughly spherical white to off-white beads.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Prophylaxis and treatment of angina pectoris.
Treatment of mild to moderate hypertension.
4.2 Posology and method of administration
Oral use only.
Adults:
Hypertension: The usual initial dose is one 180mg capsule per day (corresponding to 180mg of diltiazem
hydrochloride). Depending upon clinical response the patient’s dosage may be increased
stepwise to 360mg/day if required.
Angina Pectoris: The usual initial dose is one 180mg capsule per day (corresponding to 180mg of diltiazem
hydrochloride once daily). Depending upon clinical response the patient’s dosage may be increased stepwise to
360mg/day if required.
Elderly patients and those with renal or hepatic impairment:
Dosage should commence at&
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