SIFROL TABLET 1 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

PRAMIPEXOLE 2HCl MONOHYDRATE EQV PRAMIPEXOLE

Available from:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC code:

N04BC05

Dosage:

1mg

Pharmaceutical form:

TABLET

Composition:

PRAMIPEXOLE 2HCl MONOHYDRATE EQV PRAMIPEXOLE 1mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

BOEHRINGER INGELHEIM PHARMA GMBH & CO KG

Authorization status:

ACTIVE

Authorization date:

2000-01-04

Patient Information leaflet

Proposed Package Insert- Final Copy  
0186-16 (SG) 

      20121003 

Abcd   
SIFROL
®
 TABLETS

COMPOSITION   
SIFROL® tablet 0.125mg   
Flat,  round,  white    tablets  with  marking  ‘P6’.    1  tablet  contains  0.125mg  of  pramipexole  dihydrochloride  monohydrate,  equivalent  to     
0.088mg (S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-benzothiazole (= pramipexole base). 
SIFROL
®
 tablet 0.25mg   
Flat,  oval,  white    tablets  with  marking  ‘P7’.    1  tablet  contains  0.25mg  of  pramipexole  dihydrochloride  monohydrate  equivalent  to             
0.18mg     (S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-benzothiazole (= pramipexole base). 
SIFROL
®
 tablet 1.00mg   
Flat,  round,  white    tablets  with  marking  ‘P9’.    1  tablet  contains  1.00mg  of  pramipexole  dihydrochloride  monohydrate  equivalent  to           
0.7mg    (S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-benzothiazole (= pramipexole base). 

Excipients: mannitol, maize starch, anhydrous colloidal silica, povidone K25, magnesium stearate   

SIFROL® extended-release tablet 0.375mg 
Biconvex, round, white tablets with marking ‘P1’. 1 tablet contains 0.375mg of pramipexole dihydrochloride monohydrate equivalent to 
0.26mg (S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-benzothiazole (= pramipexole base). 
SIFROL® extended-release tablet 0.75mg 
Biconvex, round, white tablets with marking ‘P2’. 1 tablet contains 0.75mg of pramipexole dihydrochloride monohydrate equivalent to 
0.52mg (S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-benzothiazole (= pramipexole base). 
SIFROL® extended-release tablet 1.5mg 
Biconvex,  oval,  white  tablets  with  marking  ‘P3’.  1  tablet  contains  1.5mg  of  pramipexole�

Summary of Product characteristics

0186- 19 (SG) 12122019
Abcd
SIFROL® TABLETS
COMPOSITION
SIFROL tablet 0.125mg
Flat, round, white tablets with marking ‘P6’. 1 tablet contains
0.125mg of pramipexole
dihydrochloride monohydrate, equivalent to 0.088mg
(S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-
benzothiazole (= pramipexole base).
SIFROL tablet 1.00mg
Flat, round, white tablets with marking ‘P9’. 1 tablet contains
1.00mg of pramipexole
dihydrochloride monohydrate equivalent to 0.7mg
(S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-
benzothiazole (= pramipexole base).
Excipients: mannitol, maize starch, anhydrous colloidal silica,
povidone K25, magnesium stearate
SIFROL extended-release tablet 0.375mg
Biconvex, round, white tablets with marking ‘P1’. 1 tablet
contains 0.375mg of pramipexole
dihydrochloride monohydrate equivalent to 0.26mg
(S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-
benzothiazole (= pramipexole base).
SIFROL extended-release tablet 1.5mg
Biconvex, oval, white tablets with marking ‘P3’. 1 tablet contains
1.5mg of pramipexole dihydrochloride
monohydrate equivalent to 1.05mg
(S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-benzothiazole (=
pramipexole base).
Excipients: hypromellose 2208, maize starch, carbomer 941, colloidal
anhydrous silica, magnesium
stearate
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: dopamine agonist, ATC code: N04BC05
MODE OF ACTION
Pramipexole, the active ingredient of SIFROL, is a dopamine agonist
and binds with high selectivity and
specificity to the dopamine D2 subfamily receptors and has a
preferential affinity to D3 receptors; it has
full intrinsic activity.
0186- 19 (SG) 12122019
SIFROL alleviates parkinsonian motor deficits by stimulation of
dopamine receptors in the striatum.
Animal studies have shown that pramipexole inhibits dopamine
synthesis, release, and turnover.
Pramipexole
protects
dopamine
neurones
from
degeneration
in
response
to
ischemia
or
methamphetamine neurotoxicity.
The precise mechanism of action of SIFROL as a treatment for Restless
Legs Syndrome is not known.
Altho