Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Alfasigma S.p.A., Via Ragazzi del ’99, n. 5, 40133 Bologna, Italy +39 0516489511 info.it@alfasigma.com
Lumeblue 25 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. Off white to light blue, round, biconvex, enteric coated tablets, with approximate dimensions of 9.5 mm x 5.3 mm. |
Each prolonged-release tablet contains 25 mg of methylthioninium chloride.
Excipients with known effect: Lumeblue contains 3 mg soya lecithin per prolonged-release tablet.
For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Methylthioninium chloride |
In vivo, in low concentration, methylthioninium chloride speeds up the conversion of methaemoglobin to haemoglobin. Methylthioninium chloride has been observed to stain tissues selectively. |
| List of Excipients |
|---|
|
Tablet core: Stearic acid 50 (E570) Tablet coating: Methacrylic acid – methyl methacrylate copolymer (1:1) |
Polyamide/aluminium/PVC foil blister with aluminium push-through foil.
Packs contain 8 prolonged-release tablets.
Alfasigma S.p.A., Via Ragazzi del ’99, n. 5, 40133 Bologna, Italy
+39 0516489511
info.it@alfasigma.com
EU/1/20/1470/001
Date of first authorisation: 19 August 2020
| Drug | Countries | |
|---|---|---|
| LUMEBLUE | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland |
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