Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DILTIAZEM HYDROCHLORIDE
Sanofi-Aventis Ireland Limited
300 Milligram
Prolonged Release Capsules
2008-04-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tildiem LA 300 mg Prolonged-Release Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 300 mg diltiazem hydrochloride as the active ingredient in a combination of immediate-release and coated prlonged-release pellets. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release, hard capsule. Opaque capsules with a white body and a yellow cap. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a calcium antagonist for use in the management of angina pectoris and mild to moderate hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage and administration: Tildiem LA 200 and Tildiem LA 300 are sustained release products for once daily dosing. The capsules should not be crushed or chewed but swallowed whole with water, ideally before or during a meal. The dosage requirements may differ in patients with angina or hypertension. Tildiem (diltiazem hydrochloride) is available in a range of presentations to enable dosage to be adjusted to meet the individual requirements of the patient. Careful titration of the dose should be considered where appropriate, as individual patient response may vary. When changing from one type of Tildiem formulation to another, it may be necessary to adjust the dosage until a satisfactory response is obtained. To ensure consistency of response once established, particularly in the sustained release formulations, Tildiem LA 200 and Tildiem LA 300 should continue to be prescribed by brand name. Tildiem LA 300 has been used following an acute myocardial infarction initially treated with thrombolysis, in the absence of congestive heart failure (see section 5.1 Pharmacodynamics). Adults: Angina and hypertension: The usual starting dose Read the complete document