METOPROLOL 200 STADA RETARD PROLONGED RELEASE TABL 200 Milligram Tablet Prolonged Release

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

METOPROLOL TARTRATE

Διαθέσιμο από:

Stada Arzneimittel AG

INN (Διεθνής Όνομα):

METOPROLOL TARTRATE

Δοσολογία:

200 Milligram

Φαρμακοτεχνική μορφή:

Tablet Prolonged Release

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2007-07-12

Αρχείο Π.Χ.Π.

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metoprolol 200 Stada Retard Prolonged-release Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Metoprolol Tartrate 200mg
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release film-coated tablet.
White, round, biconvex, prolonged-release tablet, scored on
one side. 
Approximate dimensions: diameter 10mm x height 5.7mm.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Hypertension, angina pectoris, prophylaxis of migraine.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral use only. 
Metoprolol 200 Stada Retard 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: One Metoprolol 200 Stada Retard tablet daily, taken
in the morning. Most patients may be expected to 
respond satisfactorily within 14 days.
Further antihypertensive effect may be achieved by the addition
of a diuretic or 
vasodilator.
Metoprolol 200 Stada Retard 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 200 Stada Retard added into the regime with
adjustment of the concurrent therapy if necessary.
Angina pectoris: Initially, one Metoprolol 200 Stada Retard
tablet daily. The dose may be increased to two tablets once 
daily if required. In general a significant improvement in
exercise tolerance and a reduction of anginal attacks may be 
expected with a dose of one Metoprolol 200 Stada Retard
tablet daily.
Prophylaxis of migraine: One Metoprolol 200 Stada Retard
tablet daily given in the morning.
_Elderly: _
Whilst there is no evidence to
suggest that dosage r