METOPROLOL 100 STADA 100 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

METOPROLOL TARTRATE

Available from:

Stada Arzneimittel AG

INN (International Name):

METOPROLOL TARTRATE

Dosage:

100 Milligram

Pharmaceutical form:

Tablets

Authorization status:

Withdrawn

Authorization date:

2007-07-12

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metoprolol 100 Stada Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Metoprolol tartrate 100 mg.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, round, flat tablet, scored on one side.
Approximate dimensions: diameter 9.5 mm x height 3.85 mm.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Hypertension and angina pectoris.
Cardiac arrhythmias, especially supraventricular tachyarrhythmias.
Adjunct to treatment of thyrotoxicosis.
Early intervention with Metoprolol in acute myocardial infarction
reduces infarct size and the incidence of 
ventricular fibrillation. Pain relief may also decrease the need
for opiate analgesics.
Metoprolol has been shown to reduce mortality when administered to
patients with acute myocardial infarction.
Prophylaxis of migraine.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral use only.
Metoprolol 100 Stada tablets should be swallowed
whole; not chewed.
The dose must always be adjusted to
suit the individual needs of each patient but should
not exceed 400mg daily. The 
following are guidelines:
_Adults:_
Hypertension: The starting dose is 100 mg in the morning taken
either in single or divided doses. Depending on the 
patient’s response, the dosage may be increased to 200 mg daily
taken in single or divided doses. Most patients may be 
expected to respond rapidly and satisfactorily within
this dosage range. Further antihypertensive effect may be 
achieved by the addition of an
antihypertensive diuretic or other hypotensive agent.
Metoprolol 100 Stada may prove beneficial when administered in
patients with previously untreated hypertension; and 
in whom the response to previous therapy was inadequate.
Previous therapy may be continued, and Metoprolol 100 
Stada added into the regime with
adjustment of the concurrent t