PRAVASTATIN TEVA 20 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PRAVASTATIN SODIUM

Available from:

TEVA ISRAEL LTD

ATC code:

C10AA03

Pharmaceutical form:

TABLETS

Composition:

PRAVASTATIN SODIUM 20 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA ISRAEL LTD, ISRAEL

Therapeutic area:

PRAVASTATIN

Therapeutic indications:

Pravastatin is indicated as a component of multiple risk factor intervention in those individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia . Pravastatin should be used in addition to a diet restricted in saturated fat and cholesterol when the response to diet and other nonpharmacological measures alone has been inadequate. *Primary prevention of coronary events: In hypercholesterolemic patients whthout clinically evident coronary heart disease pravastatin is indicated to: - Reduce the risk of myocardial infarcton. - Reduce the risk for revascularization. - Reduce the risk of deaths due to cardiovascular causes with no increase in deaths from non-cardiovascular causes. *Secondary prevention of cardiovascular events: Atherosclerosis: in hypercholesterolemic patients with clinically evident coronary artery disease including prior MI Pravastatin is indicated to: - Slow the progression of coronary atherosclerosis. - Reduce the risk of acute coronary events. Myocardial infarction: in patients with previous myocardial infarction and normal cholesterol levels Pravastatin is indicated to: - Reduce the risk of recurrent myocardial infarction. - Reduce the risk of undergoing myocardial revascularization procedures. - Reduce the risk of stroke and transient ischemic attack (TIA). *Hypercholesterolemia and mixed dyslipidemia: Pravastatin is indicated as an adjunct to diet to reduce elevated Total-C LDL-C and TG levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson type IIa and IIb).

Authorization date:

2022-01-31

Patient Information leaflet

ءاودلا تابكرم ضعب نع ةماه تامولعم
هابتنلإا زوتكلل لمحت مدع مهيدل نيذلا
نيجلاعملا ىلع بجوتي
●
نم ةليلق ةيمك ىلع يوتحت عڤيت
نيتاتساﭬارﭘ صارقأ نأب
لمحت مدع كيدل نأب بيبطلا لبق نم كل ليق
اذإ .زوتكللا
.ءاودلا اذه لوانت لبق بيبطلا عجار
،ةنيعم تايركسل
صرق لكب مويدوص غلم 23 نم لقأ ىلع ءاودلا
اذه يوتحي
●
.مويدوصلا نم
ٍ
لاخ ربتعي كلذل
؟ءاودلا لامعتسإ ةيفيك )3
كيلع .بيبطلا تاميلعت بسحب
ً
امئاد رضحتسملا لامعتسإ بجي
اميف
ً
اقثاو نكت مل اذإ يلديصلا نم وأ بيبطلا
نم حاضيتسلإا
.رضحتسملاب جلاعلا ةقيرطو يئاودلا
رادقملاب قلعتي
لوانتل ةفاضلإاب موحشلاب ةريقفلا
ةيذغتلا ةيمهأ بيبطلا كل حرشي
.جلاعلا ةرتف ةليطل ةيذغتلا هذه ةلصاوم
كيلعو ،عڤيت نيتاتساﭬارﭘ بيبطلا لبق نم ناددحي جلاعلا ةقيرطو
يئاودلا رادقملا
:وه ةداع يدايتعلإا يئاودلا رادقملا
.طقف
10-40 :مدلاب موحشلاو لورتسلوكلا بسن
عافترإ ةجلاعمل ●
.ءاسملا يف لضف
ُ
ي ،مويلاب ةرم ،غلم
،مويلاب ةرم ،غلم 40 :ةيومدلا ةيعولأاو
بلقلا ضارمأ عنمل ●
.ءاسملا يف لضف
ُ
ي
.هب ىصوملا يئاودلا رادقملا زواجت زوجي
لا ●
جلاعلا ةرتف
لامعتسإ بجي .عڤيت نيتاتساﭬارﭘ ـب
جلاعلا ةرتف بيبطلا ددح
ُ
ي
،بيبطلا اهددح يتلا ةينمزلا ةرتفللو
،مئاد لكشب ءاودلا اذه
فقوتلا زوجي لا .ةليوط ةينمز ةرتف
دوصقملا ناك ولو ىتح
.كسفن ءاقلت نم

Summary of Product characteristics

Pravastatin Teva 20, 40mg-Tab-Notification-MW-SPC 07/2023
SUMMARY OF PRODUCT CHARACTERISTICS
Pravastatin Teva 20 mg
Pravastatin Teva 40 mg
1 NAME OF THE MEDICINAL PRODUCT
Pravastatin Teva 20 mg Tablets
Pravastatin Teva 40 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pravastatin Teva 20 mg- each tablet contains pravastatin sodium 20 mg.
Pravastatin Teva 40 mg- each tablet contains pravastatin sodium 40 mg.
Excipient(s) with known effect:
Lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Pravastatin Teva 20 mg - white to off-white, round, biconvex tablet,
plain on both sides.
Pravastatin Teva 40 mg - white to off white, capsules shaped tablet,
scored on one side of the
tablet, deossed P o the other side. The tablet can be divided into
equal halves.
4 CLINICAL PARTICULARS
4.1. Therapeutic indications
Pravastatin is indicated as a component of multiple risk factor
intervention in those individuals at
increased risk for atherosclerotic vascular disease due to
hypercholesterolaemia.
Pravastatin should be used in addition to a diet restricted in
saturated fat and cholesterol when
the response to diet and other nonpharmacological measures alone has
been inadequate.
_Primary prevention of coronary events: _
In hypercholesterolaemic patients without clinically evident coronary
heart disease pravastatin is
indicated to:
- Reduce the risk of myocardial infarction.
- Reduce the risk for revascularization.
- Reduce the risk of deaths due to cardiovascular causes with no
increase in deaths from non-
cardiovascular causes.
_Secondary prevention of cardiovascular events: _
Atherosclerosis:
In hypercholesterolaemic patients with clinically evident coronary
artery disease including prior MI
Pravastatin is indicated to:
- Slow the progression of coronary atherosclerosis.
- Reduce the risk of acute coronary events.
Pravastatin Teva 20, 40mg-Tab-Notification-MW-SPC 07/2023
Myocardial infarction:
In patients with previous myocardial infarction and normal cholesterol
levels Prava