Tulip® 40 mg Film-coated Tablet

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

ATORVASTATIN CALCIUM

Доступна з:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

ІПН (Міжнародна Ім'я):

ATORVASTATIN CALCIUM

Одиниць в упаковці:

30Tablet Tablets; 90Tablet Tablets

Виробник:

LEK PHARMACEUTICALS D.D.

інформаційний буклет

TULIP
® FILM-COATED
TABLETS
Atorvastatin (40 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What is Tulip used for
2.
How Tulip works
3.
Before you use Tulip
4.
How to use Tulip
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Tulip
8.
Product description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT IS TULIP USED FOR
You have been prescribed Tulip
because either:
(a) You have a high cholesterol
level. This means you are at risk of
getting a heart attack or stroke.
You have been advised to take a
statin, because changing your diet and
taking more exercise were not enough
to correct your cholesterol levels. You
should continue with your
cholesterol-lowering diet and exercise
while you are taking Tulip.
Or
(b) You have other factors that
increase your risk of getting a heart
attack, stroke or related health
problems.
Heart attack, stroke and other
problems can be caused by a disease
called atherosclerosis.
Atherosclerosis is due to build-up of
fatty deposits in your arteries.
HOW TULIP WORKS
Tulip belongs to a group of
medicines called statins.
There are different types of
cholesterol found in the blood,
including – ‘bad’ cholesterol (LDL-
C) and ‘good’ cholesterol (HDL-C).
•
Tulip can reduce the ‘bad’
cholesterol and increase the
‘good’ cholesterol.
•
It works by helping to block
your body’s production of ‘bad’
cholesterol in the liver. It also
improves your body’s ability to
remove it from your blood.
For most people, high cholesterol
does not affect the way they feel
because it does not produce any
symptoms. However, if it is left
untreated, fatty deposits can build up
in the walls of your blood vessels
causing them to narrow.
Sometimes, these narrowed blood
vessels can get blocked which can
cut off the blood supply to the heart
or brain leading to a heart attack or a
stroke. By lowering your cholesterol
levels, you can reduce your risk of
getting a heart attack, a stroke o r
related health problems

Характеристики продукта

1.
NAME OF THE MEDICINAL PRODUCT
Tulip
®
40 mg Film-coated Tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of atorvastatin in the form of
calcium salt.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Appearance: _Light yellow, round biconvex film-coated tablets,
debossed with “HLA 40” on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atorvastatin is indicated as an adjunct to diet for the treatment of
patients with elevated total cholesterol,
LDL-cholesterol, apolipoprotein B, and triglycerides and to increase
HDL-cholesterol in patients with primary
hypercholesterolemia (heterozygous familial and non-familial
hypercholesterolemia), combined (mixed)
hyperlipidemia (_Fredrickson _Types IIa and IIb), elevated serum
triglyceride levels (_Fredrickson _Type IV), and
for patients with dysbetalipoproteinemia (Fredrickson Type III) who do
not respond adequately to diet.
Atorvastatin is also indicated for the reduction of total cholesterol
and LDL-cholesterol in patients with
homozygous familial hypercholesterolemia when response to diet and
other non-pharmacological measures
are inadequate.
_ _
_Prevention of Cardiovascular Disease _
In adult patients without clinically evident coronary heart disease,
but with multiple risk factors for
coronary heart disease such as age, smoking, hypertension, low HDL-C,
or a family history of early
coronary heart disease, atorvastatin is indicated to:
•
Reduce the risk of myocardial infarction
•
Reduce the risk of stroke
•
Reduce the risk for revascularization procedures and angina
In patients with type 2 diabetes, and without clinically evident
coronary heart disease, but with multiple
risk factors for coronary heart disease such as retinopathy,
albuminuria, smoking, or hypertension,
atorvastatin is indicated to:
•
Reduce the risk of myocardial infarction
•
Reduce the risk of stroke
In patients with clinically evident coronary heart disease,
atorvastatin is indicated to:
•
reduce the risk of non-fatal myocardial inf