PLETAAL 100MG TABLETS

국가: 말레이시아

언어: 영어

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

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제품 특성 요약 제품 특성 요약 (SPC)
23-08-2023

유효 성분:

CILOSTAZOL

제공처:

A. MENARINI SINGAPORE PTE. LTD.

INN (International Name):

CILOSTAZOL

패키지 단위:

100 Tablets

Manufactured by:

KOREA OTSUKA PHARMACEUTICAL CO LTD

제품 특성 요약

                                1
- ANTIPLATELET AGENT -
PLETAAL	 Tablets 50 mg
PLETAAL	 Tablets 100 mg
< Cilostazol >
Designated Drug and Prescription	-only Drug
Storage	: Store below	30℃.
Expiration date	: Three years after the date of manufacture.
(The expiration date is indicated on the package.)
CONTRAINDICATIONS
Cilostazol and several of its metabolites are inhibitors
of phosphodiesterase III. Several drugs with this
pharmacologic effect have caused decreased survival
compared to placebo in patients with class III	-IV
cong	estive heart failure. Pletaal is contraindicated in
patients with congestive heart failure of any severity.
Pletaal is contraindicated in patients with haemostatic
disorders or active pathologic bleeding, such as
bleeding peptic ulcer and intracranial ble	eding. P	letaal
inhibits platelet aggregation in a reversible manner.
Pletaal is contraindicated in patients with known or
suspected hypersensitivity to any of its components.
DESCRIPTION
1. Composition
Each	tablet of	PLETAAL Tablets 50 mg contains 50 mg
of cilostazol and the following inactive ingredients:
microcrystalline cellulose, corn starch, carboxymethyl
cellulose calcium, hydroxypropyl methyl cellulose 2910,
and magnesium stearate	.
Each	tablet of	PLETAAL Tablets 100 mg contains 100
mg of cilostaz	ol and the following inactive ingredients:
microcrystalline cellulose, corn starch, carboxymethyl
cellulose calcium, hydroxypropyl methyl cellulose 2910,
and magnesium stearate	.
2. Product Description
Pletaal Tablets are white compressed tablets.	Appear	ance	Diame	-	ter	(mm)
Thick	-	ness	(mm)
Weight	(mg)	Code
PLETAAL	Tablets	50 mg	7	2.5	Approx.
115	OG31
PLETAAL	Tablets	100 mg	8	3.0	Approx.
170	OG30
INDICATIONS
Pletaal is indicated for the improvement of the maximal and
pain	-free walking distances in patients with intermittent
claudication, who do not have rest pain and who do not have
evidence of peripheral tissue necrosis.
Pletaal is indicated for p	revention of recurrence of cerebral
infarction (excluding cardiogenic cerebral embolism)	. The
effects of PLE
                                
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