LIPITOR TABLET 10MG

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
29-04-2019
Ciri produk Ciri produk (SPC)
19-02-2020

Bahan aktif:

ATORVASTATIN CALCIUM

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ATORVASTATIN CALCIUM

Unit dalam pakej:

30Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

PFIZER PHARMACEUTICALS LLC

Risalah maklumat

                                Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LIPITOR
®
TABLET
Crystalline atorvastatin calcium (10 mg, 20 mg, 40 mg or 80 mg)
1
PLD TITLE
:LIPITOR
®
PLD DATE
:24 April 2019
COUNTRY
:Malaysia
REFERENCE DOCUMENT
:10 mg, 20 mg, 40 mg and 80 mg Lipitor film-coated tablets of Malaysia
LPD Information for the user dated
08 February 2018
REASON FOR CHANGE
:To update PRH address
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LIPITOR
®
TABLET
Crystalline atorvastatin calcium (10 mg, 20 mg, 40 mg or 80 mg)
WHAT IS IN THIS LEAFLET
1. What LIPITOR is used for
2. How LIPITOR works
3. Before you use LIPITOR
4. How to use LIPITOR
5. While you are using it
6. Side effects
7. Storage and Disposal of LIPITOR
8. Product Description
9. Manufacturer and Product Registration
Holder
10.
Date of revision
11.
Serial Number
WHAT LIPITOR IS USED FOR
LIPITOR belongs to a group of
medicines known as statins, which are
lipid (fat) regulating medicines.
LIPITOR is used to lower lipids known
as cholesterol [total cholesterol, low-
density lipoprotein cholesterol (LDL-C)]
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.
LIPITOR 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.
LIPITOR 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.
Cholesterol:
Everyone has cholesterol and
triglycerides in their blood. They are
types of blood fat needed by the body for
many things, including building cell
walls, making bile acids (which help to
digest food) and certain hormones.
However, too much cholesterol can be a
problem.
Your body makes cholesterol, but it also
comes from fo
                                
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Ciri produk

                                Pfizμb	Confidμbntial
1
Lipit\br	Tablets	®
Crystalline	At\b	
m
1.TRA	DENAME(S	)OFTH	EMEDICIN	ALPRODU	CT
LIPITOR
2.QUAL	ITAT	IVEAN	D	QUANTITATI	VECOMP	OSITION
Ac	tivμbIngrμb	diμbnt:crystal	linμbato	rvastatin
Thμbtablμbtsfororaladministrationcon	taincrystallinμbatorvastati	ncalcium	μb:i	valμb	ntto10mg	,
20 mg	,40 mg	or80 mgatorva	statin.
3.PHA	RMACEUTICA	LFO	RM
Atorvas	tatin tab	lμbts for ora	ladministra	tion conta	in10 mg	, 20 mg	,40 m g	or80mgcrystalli	nμb
atorvastat	in.
10	mg:	Wh	itμb6 round,	film	-coatμbd	tablμb	tsdμb!\bd	“10”	on	onμb	sidμb	and	“ATV”	on	thμb	othμb
sidμb.
20	mg:	Wh	itμb6 round,	film	-coatμbd	tablμb	tsdμb!\bd	“20”	on	onμb	sidμb	and	“ATV”	on	thμb	othμb
sidμb.
40	mg:	Wh	itμb6 round,	film	-coatμbd	tabl	μbtsdμb!\bd	“40”	on	onμb	sidμb	and	“ATV”	on	thμb	othμb
sidμb.
80	mg:	Wh	itμb6 round,	film	-coatμbd	tablμb	tsdμb!\bd	“80”	on	onμb	sidμb	and	“ATV”	on	thμb	othμb
sidμb.
4.CLI	NICA	LPARTICULA	RS
4.1Ther	apeut	icindicati\bn	s
Atorvastatin	is	indicatμbd	as	an	adjunct	to	diμbt	for	thμb	trμba	tmμbt	of	patiμbs	with	μb\bvatμbd	total
cholμb\brol (tot	al-C),	low dμb" lipoprotμbn	cholμb\brol (LDL	-C),	apolipoprotμbn	B (apo B),
and	trig	lycμbr	idμbs	(TG)	and	to	incrμb\b	high dμb" lipoprotμb cholμbs	tμb (HDL	-C) in
patiμbn	ts	with	primary	hypμb	rcholμb\brolμb	mia	(hμb	tμbz	ygous	familial and	nonfa	milial
hypμb	/o	lμb\brolμb,	combinμbd	(mixμb
)	hypμb	
\b	mia	(Fre	dr\bn	Typμb IIa	and	IIb),
μb\bvatμbd	sμbr	um	TG	lμb\bls	(Fredr\bc	kson	Typμb	IV),	and	for	patiμb with
dysbμbp	rotμb\b	mia	(Fredr\bn	Ty	pμb	III)	who	do	not	rμbd	adμb:\bly	todiμb.
Atorvastatin	is	also	indicatμbd	for	thμb	rμb
t	ion	of	total	-C	and	LDL	-C	in	patiμbs	with
ho	moz	ygous	familial h	ypμbrcholμb\brolμb.
Prevent\bn	of	Card\b	r	D\be
In	adult	patiμbs	without	clinically	μbi	dμbt	cardiovascular	disμb\b (CVD),	bu
                                
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