sifrol er pramipeksol dki1152502614a1 2015

8/18/2019 Sifrol ER Pramipeksol DKI1152502614A1 2015

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PT. Boehringe lccm IdsaDu Rutoy Af Dept 1.

BASIC PRODUCT INFOMAION

No. 0186-16 25 July 2012

SIFROL®

pramipexole

Composition

tabet contains 025, 025 mg(S)2aino4,5,6,7tetrahydro6propyaminobenzothiazoe dihydrochorideonohydrate equivaent to 0088, 08 mg pramipexoe baseExcipents: mannlto, maize starch anhydrous cooida sica poyvdone magesium steaate1 extendedreease tablet contains 0375, 075 mg(S)2aino4,5,6,7tetrahydro6royamino-benzothiazoe dihydrochloridemonoydrate equivaent to 026, 052 mg praipexoe baseExcipents . hyproeose 2208 maize starch carbmer 941 cooida ahydrous siica magnesum stearae

Indication

SFROLG tablets and extendedreease tabets are indicated for the treatment o the signsand symptoms o idiopathic parkinson's disease when the eect o evodopa wears off orbecomes inconsistent and fuctuatons o the therapeutic eect occur (end of dose "onof fuctuations). t may be used alone (without evodopa) or in cobination withlevodopa

�; bets are indicated for the symptomatic treatet f io atCe _t I

I 'Uf d� l. :

Dosage and administration ,L .r0.�!E :.� 0 .: !

(A dose informaion efers to pramiexole sat m) j : h ·.: • IPakinson 's disease

Tabetshe tablets should be taken orally, swaowed wth water and can b taken either wth orwithout foodhe daiy dosage is adinistered in equally divided doses 3x per day

Remarks: Yelow (CCDS 0186·13), blue (CCDS 0186-14 geen (CCDS 018615), ge (CCDS 018616)SIFROLI CCDS 018616_ Re May 12


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sifrol er pramipeksol dki1152502614a1 2015

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