LUMEBLUE Prolonged-release tablet Ref.[50405] Active ingredients: Methylthioninium chloride

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

Product name and form

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.

Qualitative and quantitative composition

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)
Soya lecithin (E322)
Microcrystalline cellulose (E460)
Hypromellose 2208 (E464)
Mannitol (E421)
Talc (E553b)
Silica colloidal anhydrous (E551)
Magnesium stearate (E470b)

Tablet coating:

Methacrylic acid – methyl methacrylate copolymer (1:1)
Methacrylic acid – methyl methacrylate copolymer (1:2)
Talc (E553b)
Titanium dioxide (E171)
Triethyl citrate (E1505)

Pack sizes and marketing

Polyamide/aluminium/PVC foil blister with aluminium push-through foil.

Packs contain 8 prolonged-release tablets.

Marketing authorization holder

Alfasigma S.p.A., Via Ragazzi del ’99, n. 5, 40133 Bologna, Italy
+39 0516489511
info.it@alfasigma.com

Marketing authorization dates and numbers

EU/1/20/1470/001

Date of first authorisation: 19 August 2020

Drugs

Drug Countries
LUMEBLUE Austria, Estonia, Ireland, Poland

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