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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Odrik 1 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 1.0 mg of trandolapril.
Excipients: Each hard capsule contains 55.5mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (capsule)
Opaque red/orange capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
All grades of essential hypertension. Odrik may be used alone or in combination with other antihypertensive agents.
Left Ventricular Dysfunction after Myocardial Infarction: It has been demonstrated that Odrik improves survival
following myocardial infarction in patients with left ventricular dysfunction (ejection fraction < 35 percent), with or
without symptoms of heart failure, and/or, with or without residual ischaemia.
Long term treatment with Odrik reduces significantly the overall mortality, especially from cardiovascular mortality. It
significantly decreases the risk of sudden death and the occurrence of severe or resistant heart failure, and tends to
decrease the incidence of fatal and non-fatal re-infarctions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
_Hypertension_
The starting dose is 1 mg once daily as a single dose. The daily dose can be adjusted
according to patient response up to a maximum 4 mg given as a single daily dose.
_Left ventricular dysfunction after myocardial infarction_
Following a myocardial infarction, therapy may be initiated as early as the third day.
Treatment should be initiated as a daily dose of 0.5 mg. The dose should be progressively increased to a maximum of 4
mg as a single daily dose. Depending upon the tolerability such as symptomatic hypotension, this forced titration can be
temporarily suspended.
In the event of
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