Simvastatin 80mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Simvastatin

متاح من:

Waymade Healthcare Plc

ATC رمز:

C10AA01

INN (الاسم الدولي):

Simvastatin

جرعة:

80mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 02120000

نشرة المعلومات

Simvastatin film-coated tablet contains the active substance
simvastatin. Simvastatin film-coated tablets is a medicine used
to lower levels of total cholesterol, “bad” cholesterol (LDL
cholesterol), and fatty substances called triglycerides in the
blood.
In addition, Simvastatin raises levels of “good” cholesterol (HDL
cholesterol). Simvastatin film-coated tablets is a member of the
class of medicines called statins.
Cholesterol is one of several fatty substances found in the
bloodstream. Your total cholesterol is made up mainly of LDL
and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can
build up in the walls of your arteries forming plaque. Eventually
this plaque build-up can lead to a narrowing of the arteries.
This narrowing can slow or block blood flow to vital organs such
as the heart and brain. This blocking of blood flow can result in
a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it
helps keep the bad cholesterol from building up in the arteries
and protects against heart disease.
Triglycerides are another form of fat in your blood that may
increase your risk for heart disease.
You should stay on a cholesterol-lowering diet while taking this
medicine.
Simvastatin film-coated tablets is used in addition to your
cholesterol lowering diet if you have:
•
a raised cholesterol level in your blood (primary
hypercholesterolaemia) or elevated fat levels in your blood
(mixed hyperlipidaemia)
•
a hereditary illness (homozygous familial
hypercholesterolaemia) that increases the cholesterol level in
your blood. You may also receive other treatments.
•
coronary heart disease (CHD) or are at high risk of CHD
(because you have diabetes, history of stroke, or other blood
vessel disease). Simvastatin film-coated tablets may prolong
your life by reducing the risk of heart disease problems,
regardless of the amount of cholesterol in your blood.
In most people, there are no immediate symptoms of high
cholesterol. Your doctor can meas

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 80mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg of simvastatin.
Excipients with known effect
Each film-coated tablets contains 533.7 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Light green coated, oval, scored, convex tablet coded “SIM 80” on
one side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Hypercholesterolaemia _
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as
an adjunct to
diet, when response to diet and other non-pharmacological treatments
(e.g. exercise,
weight reduction) is inadequate.
Treatment of homozygous familial hypercholesterolaemia as an adjunct
to diet and
other lipid-lowering treatments (e.g. LDL apheresis) or if such
treatments are not
appropriate.
_Cardiovascular prevention _
Reduction of cardiovascular mortality and morbidity in patients with
manifest
atherosclerotic cardiovascular disease or diabetes mellitus, with
either normal or
increased cholesterol levels, as an adjunct to correction of other
risk factors and other
cardioprotective therapy (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose range is 5-80 mg/day of simvastatin given orally as a single
dose in the
evening. Adjustments of dose, if required, should be made at intervals
of not less than
4 weeks, to a maximum of 80 mg/day given as a single dose in the
evening. The 80
mg dose is only recommended in patients with severe
hypercholesterolaemia and at
high risk for cardiovascular complications, who have not achieved
their treatment
goals on lower doses and when the benefits are expected to outweigh
the potential
risks (see sections 4.4 and 5.1).
_Hypercholesterolaemia _
_ _
The patient should be placed on a standard cholesterol-lowering diet,
and should
continue on this diet during treatment with simvastatin. The u