SIFROL TABLET 0.125 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:

0.125mg

Pharmaceutical form:

TABLET

Composition:

PRAMIPEXOLE 2HCl MONOHYDRATE EQV PRAMIPEXOLE 0.125mg

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

Abcd
SIFROL® TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
SIFROL tablet 0.125mg
SIFROL extended-release tablet 0.375mg
SIFROL extended-release tablet 1.5mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SIFROL tablet 0.125mg
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 extended-release tablet 0.375mg
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
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).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
SIFROL tablet 0.125mg
Flat, round, white tablets with marking ‘P6’.
SIFROL extended-release tablet 0.375mg
Biconvex, round, white tablets with marking ‘P1’.
SIFROL extended-release tablet 1.5mg
Biconvex, oval, white tablets with marking ‘P3’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tablets
SIFROL tablet is indicated in the treatment of signs and symptoms of
idiopathic Parkinson's disease. It may
be used as monotherapy or in combination with levodopa.
SIFROL tablet is indicated for the symptomatic treatment of moderate
to severe idiopathic Restless Legs
Syndrome.
Extended-release tablets
SIFROL extended-release tablet is indicated in the treatment of signs
and symptoms of idiopathic
Parkinson's disease. It may be used as monotherapy or in combination
with levodopa.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
(all dose information refers to pramipexole salt form)
PARKINSON’S DISEASE
DOSAGE
Initial treatment:
As shown below dosages should be increased gradually from a starting
dose of 0.375 mg per day and then
increased every 5 - 7 days. Providing patients do not experience
intolerable side effects, the dosage should
b