Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Addmedica, 37 rue de Caumartin, 75009 Paris, France, Phone: +33 1 72 69 01 86, Fax: +33 1 73 72 94 13, E-mail: contact@addmedica.com
Siklos 100 mg film-coated tablets.
Siklos 1000 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Siklos 100 mg film-coated tablets: Off-white oblong-shaped, film-coated tablet with half-scoring on both sides. The tablet can be divided into two equal parts. Each half of tablet is embossed “H” on one side. Siklos 1000 mg film-coated tablets: Off-white, capsule-shaped, film-coated tablet with triple scoring on both sides. The tablet can be divided into four equal parts. Each quarter of tablet is embossed “T” on one side. |
Siklos 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of hydroxycarbamide.
Siklos 1000 mg film-coated tablets: Each film-coated tablet contains 1,000 mg of hydroxycarbamide.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hydroxycarbamide |
One of the mechanisms by which hydroxycarbamide acts is the elevation of foetal haemoglobin (HbF) concentrations in sickle cell patients. In addition hydroxycarbamide causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or protein. |
| List of Excipients |
|---|
|
Sodium stearyl fumarate |
High density polyethylene (HDPE) bottle with polypropylene child-resistant closure with a dessicant unit.
Siklos 100 mg film-coated tablets: Pack sizes of 60, 90 or 120 tablets.
Not all pack sizes may be marketed.
Siklos 1000 mg film-coated tablets: Pack size of 30 tablets.
Addmedica, 37 rue de Caumartin, 75009 Paris, France, Phone: +33 1 72 69 01 86, Fax: +33 1 73 72 94 13, E-mail: contact@addmedica.com
Siklos 100 mg film-coated tablets:
EU/1/07/397/002
EU/1/07/397/003
EU/1/07/397/004
Siklos 1000 mg film-coated tablets:
EU/1/07/397/001
Date of first authorisation: 29/06/2007
Date of latest renewal: 24/04/2017
| Drug | Countries | |
|---|---|---|
| SIKLOS | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom, United States |
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