Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
SIFROL 0.088 mg tablets.
SIFROL 0.18 mg tablets.
SIFROL 0.35 mg tablets.
SIFROL 0.7 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. SIFROL 0.088 mg tablets: The tablets are white, flat, of round shape, and have a code embossed (one side with the code P6, and one side with the Boehringer Ingelheim company symbol). SIFROL 0.18 mg tablets: The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P7, and one side with the Boehringer Ingelheim company symbol). Tablets can be divided into equal halves. SIFROL 0.35 mg tablets: The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P8, and one side with the Boehringer Ingelheim company symbol). Tablets can be divided into equal halves. SIFROL 0.7 mg tablets: The tablets are white, flat, of round shape, scored on both sides, and have a code embossed (one side with the code P9, and one side with the Boehringer Ingelheim company symbol). Tablets can be divided into equal halves. |
SIFROL 0.088 mg tablets: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
SIFROL 0.18 mg tablets: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
SIFROL 0.35 mg tablets: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
SIFROL 0.7 mg tablets: Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Please note:
Pramipexole doses as published in the literature refer to the salt form. Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pramipexole |
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity. Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum. Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover. |
| List of Excipients |
|---|
|
Mannitol |
OPA/aluminium/PVC-aluminium blisters.
Each blister strip contains 10 tablets.
Cartons containing 3 or 10 blister strips (30 or 100 tablets).
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
SIFROL 0.088 mg tablets: EU/1/97/050/001-002
SIFROL 0.18 mg tablets: EU/1/97/050/003-004
SIFROL 0.35 mg tablets: EU/1/97/050/011-012
SIFROL 0.7 mg tablets: EU/1/97/050/005-006
Date of first authorisation: 14 October 1997
Date of latest renewal: 14 October 2007
| Drug | Countries | |
|---|---|---|
| SIFROL | Austria, Australia, Brazil, Germany, Estonia, Finland, France, Croatia, Ireland, Israel, Lithuania, Mexico, Netherlands, Poland, Singapore, Tunisia |
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