SIMVASTATIN PHARMA

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

SIMVASTATIN

متاح من:

Nycomed Danmark ApS

جرعة:

10 Milligram

الشكل الصيدلاني:

Coated Tablets

تاريخ الترخيص:

2002-10-11

خصائص المنتج

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simvastatin Pharma 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of simvastatin
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets
Oblong, biconvex, white to off-white tablets with a scoreline on
one side.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
To reduce increased plasma total and LDL cholesterol in
patients with primary hypercholesterolaemia (type IIa) or 
combined hyperlipidaemia (type IIb) in combination with dietary
measures when no adequate effect is obtained with 
dietary measures and
other non-pharmacological measures alone (e.g. fitness training
and weight loss).
Coronary heart disease
For secondary prevention of coronary heart disease in
patients with elevated plasma cholesterol levels (>5.5 mmol/l). 
Prophylaxis with simvastatin is indicated
if total cholesterol-serum concentration is 5.5 mmol/l (212
mg/dl) or higher 
despite lipid-lowering
diet and other non-pharmacological measures and should
be carried out in conjunction with diet 
and other non-pharmacological measures (e.g. physical training and
weight reduction).
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Route of Administration
Oral
Recommended Dosage Schedule
The patient should be placed on
a conventional cholesterol-lowering diet before initiating
simvastatin treatment and 
should continue on this diet during treatment with simvastatin. 
Simvastatin film-coated tablets should be taken with water.
The tablets can be taken either on an empty stomach or 
after a meal. 
_Hypercholesterolaemia_
The usual starting dose is 10 mg/day given as a single dose in
the evening. 
Adjustment of dosage should be based on
the measurement of plasma cholesterol levels and
overall cardiovascular risk 
assessment. Measurements should
be made at i