Lumeblue (previously known as Methylthioninium chloride Cosmo)

Methylthioninium chloride Cosmo can only be obtained with a prescription.

It is available as 25 mg tablets. The recommended total dose is 200 mg methylthioninium chloride (8 tablets) by mouth taken the day before the colonoscopy together with a bowel cleansing preparation (a medicine that clears all solid matter from the colon) of 4 litres in total. The first 3 tablets should be taken after drinking at least 1 litre of the bowel cleansing preparation; the next 3 tablets should be taken 1 hour after the first dose and the last 2 tablets should be taken 1 hour after the second dose.

For more information about using Methylthioninium chloride Cosmo, see the package leaflet or contact your doctor or pharmacist.

The active substance in Methylthioninium chloride Cosmo, methylthioninium chloride (also called methylene blue), has been widely used for medical purposes. Methylthioninium chloride enters cells such as those in the small intestine and colon and temporarily stains the lining of these organs. Because the amount of methylthioninium chloride taken up by different types of cells varies, the medicine helps doctors identify any abnormalities in the makeup of the lining.

The tablets have a special coating which allows the medicine to reach the colon before methylthioninium chloride is slowly released to stain the lining evenly.

Methylthioninium chloride Cosmo improved detection of adenoma (a type of tumour linked to increased risk of cancer) or carcinoma (a type of cancer) during colonoscopy.

At least one adenoma or carcinoma was detected in 56% of patients (273 out of 485) who received Methylthioninium chloride Cosmo compared with 48% of patients (229 out of 479) who did not receive it. The presence of adenoma and carcinoma was later confirmed by examining tissue after removing it from the colon. Using Methylthioninium chloride Cosmo did not lead to a higher number of ‘false positive’ results.

The most common side effects with Methylthioninium chloride Cosmo (which may affect more than 1 in 10 people) are discoloration of the urine and faeces, which disappears after a few days. Short-lived nausea and vomiting are also common (they can affect up to 1 in 10 people).

Methylthioninium chloride Cosmo must not be used in patients who are hypersensitive (allergic) to peanuts, soya or any ingredients in the medicine. It must also not be used in patients in whom the enzyme glucose-6-phosphate dehydrogenase (G6PD) is not working (G6PD deficiency). It must not be taken during pregnancy and when breastfeeding.

Methylthioninium chloride Cosmo improves detection of adenoma and carcinoma in the colon during colonoscopy, which may lead to a reduction in the risk of colorectal cancer if removed. The safety profile of Methylthioninium chloride Cosmo is well known from other medicines and products containing the same active substance; the side effects are mainly mild or moderate and of short duration. The European Medicines Agency therefore decided that Methylthioninium chloride Cosmo’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Methylthioninium chloride Cosmo have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Methylthioninium chloride Cosmo are continuously monitored. Side effects reported with Methylthioninium chloride Cosmo are carefully evaluated and any necessary action taken to protect patients.

Methylthioninium chloride Cosmo received a marketing authorisation valid throughout the EU on 19 August 2020.