Zarator 80mg Film Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ATORVASTATIN CALCIUM

Boleh didapati daripada:

MYLAN HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

ATORVASTATIN CALCIUM

Unit dalam pakej:

30Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

VIATRIS PHARMACEUTICALS LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ZARATOR
® FILM-COATED TABLETS
Crystalline Atorvastatin calcium (10 mg, 20 mg, 40 mg or 80 mg)
WHAT IS IN THIS LEAFLET
1.
What ZARATOR is used for
2.
How ZARATOR works
3.
Before you use ZARATOR
4.
How to use ZARATOR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ZARATOR
8.
Product Description
9.
Manufacturer & Product Registration
Holder
10. Date of Revision
11. Serial Number
WHAT ZARATOR
IS USED FOR
ZARATOR belongs to a group of
medicines known as statins, which are
lipid (fat) regulating medicines.
ZARATOR is used to lower lipids known
as cholesterol [total cholesterol, low-
density lipoprotein cholesterol (LDL-C)],
apolipoprotein B (apo B) and other fats
(triglycerides) and to increase high
density lipoprotein cholesterol (HDL-C)
in the blood when a low-fat diet and
lifestyle changes on their own have
failed.
ZARATOR can lower the risk for heart
attack, stroke, certain types of heart
surgery, and chest pain in patients who
have heart disease or risk factors for heart
disease such as:
•
Age, smoking, high blood pressure,
low HDL-C, heart disease in the
family.
ZARATOR can lower the risk for heart
attack or stroke in patients with diabetes
and risk factors such as:
•
Eye problems, kidney problems,
smoking, or high blood pressure.
.
HOW ZARATOR WORKS
ZARATOR works by reducing the
amount of cholesterol made by the liver.
In terms of good and bad cholesterol,
ZARATOR reduces the bad cholesterol
and raises the good cholesterol
.
BEFORE YOU USE ZARATOR
_- When you must not use it_
Do not take ZARATOR
- if you are hypersensitive (allergic) to
ZARATOR or to any of the other
ingredients of the medicine;
- if you have active liver disease;
- if you have had any unexplained
abnormal blood tests for liver
function;
- if you are a woman of child-bearing
capacity and not using any type of
reliable contraception;
- if you are pregnant or trying to
become pregnant;
- if you are breast-feeding.
_- Pregnancy and lactation_
- Do not take ZARATOR if you ar

Ciri produk

1
ZARATOR
® TABLETS
CRYSTALLINE ATORVASTATIN CALCIUM
1. TRADE NAME OF THE MEDICINAL PRODUCT
ZARATOR
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: crystalline atorvastatin
The tablets for oral administration contain crystalline atorvastatin
calcium equivalent to 10 mg,
20 mg, 40 mg, or 80 mg atorvastatin.
3. PHARMACEUTICAL FORM
Atorvastatin tablets for oral administration contain 10 mg, 20 mg, 40
mg or 80 mg crystalline
atorvastatin.
10 mg: White, round, film-coated tablets debossed “10” on one side
and “ATV” on the other
side.
20 mg: White, round, film-coated tablets debossed “20” on one side
and “ATV” on the other
side.
40 mg: White, round, film-coated tablets debossed “40” on one side
and “ATV” on the other
side.
80 mg: White, round, film-coated tablets debossed “80” on one side
and “ATV” on the other
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 (total-C), low density lipoprotein cholesterol
(LDL-C), apolipoprotein B
(apo B), and triglycerides (TG) and to increase high density
lipoprotein cholesterol
(HDL-C) in patients with primary hypercholesterolemia (heterozygous
familial and non-
familial hypercholesterolemia), combined (mixed) hyperlipidemia (
_Fredrickson_
Types IIa
and IIb), elevated serum TG 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-C and LDL-C
in patients with
homozygous familial hypercholesterolemia.
_Prevention of Cardiovascular Disease_
In adult patients without clinically evident cardiovascular disease
(CVD), but with
multiple risk factors for coronary heart disease (CHD), such as age,
smoking,
hypertension, low HDL-C, or a family history of early CHD, ZARATOR is
indicated to:
-
Reduce the risk of
_ _
myocardial infarction (MI)
-
Reduce the risk of stroke
2
-
Reduce the