Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
SIFROL 0.26 mg prolonged-release tablets.
SIFROL 0.52 mg prolonged-release tablets.
SIFROL 1.05 mg prolonged-release tablets.
SIFROL 1.57 mg prolonged-release tablets.
SIFROL 2.1 mg prolonged-release tablets.
SIFROL 2.62 mg prolonged-release tablets.
SIFROL 3.15 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
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Prolonged-release tablet. SIFROL 0.26 mg prolonged-release tablets: The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P1, and one side with the Boehringer Ingelheim company symbol). SIFROL 0.52 mg prolonged-release tablets: The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P2, and one side with the Boehringer Ingelheim company symbol). SIFROL 1.05 mg prolonged-release tablets: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P3, and one side with the Boehringer Ingelheim company symbol). SIFROL 1.57 mg prolonged-release tablets: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P12, and one side with the Boehringer Ingelheim company symbol). SIFROL 2.1 mg prolonged-release tablets: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P4, and one side with the Boehringer Ingelheim company symbol). SIFROL 2.62 mg prolonged-release tablets: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P13, and one side with the Boehringer Ingelheim company symbol). SIFROL 3.15 mg prolonged-release tablets: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P5, and one side with the Boehringer Ingelheim company symbol). |
SIFROL 0.26 mg prolonged-release tablets: Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
SIFROL 0.52 mg prolonged-release tablets: Each prolonged-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.52 mg pramipexole.
SIFROL 1.05 mg prolonged-release tablets: Each prolonged-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.05 mg pramipexole.
SIFROL 1.57 mg prolonged-release tablets: Each prolonged-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 1.57 mg pramipexole.
SIFROL 2.1 mg prolonged-release tablets: Each prolonged-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.1 mg pramipexole.
SIFROL 2.62 mg prolonged-release tablets: Each prolonged-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 2.62 mg pramipexole.
SIFROL 3.15 mg prolonged-release tablets: Each prolonged-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 3.15 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 |
|---|
|
Hypromellose 2208 |
OPA/aluminium/PVC-aluminium blisters.
Each blister strip contains 10 prolonged-release tablets.
Cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets).
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
SIFROL 0.26 mg prolonged-release tablets: EU/1/97/050/013-015
SIFROL 0.52 mg prolonged-release tablets: EU/1/97/050/016-018
SIFROL 1.05 mg prolonged-release tablets: EU/1/97/050/019-021
SIFROL 1.57 mg prolonged-release tablets: EU/1/97/050/028-030
SIFROL 2.1 mg prolonged-release tablets: EU/1/97/050/022-024
SIFROL 2.62 mg prolonged-release tablets: EU/1/97/050/031-033
SIFROL 3.15 mg prolonged-release tablets: EU/1/97/050/025-027
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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