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

Posology

Adults including the elderly (≥65 years)

The recommended total dose is 200 mg methylthioninium chloride, corresponding to eight 25 mg tablets.

The total dose of the medicinal product must be taken orally during or after the intake of the 4 L polyethylene glycol (PEG) based bowel cleansing preparation and should be completed the evening prior to the colonoscopy to ensure there is enough time for the tablets to reach the colon and locally release the methylthioninium chloride prior to the colonoscopy.

Special populations

Elderly population

No dose adjustment is required for elderly patients (aged ≥65 years) (see section 5.2).

Renal impairment

No dose adjustment is required in patients with mild renal impairment. The medicinal product should be used with caution in patients with moderate to severe renal impairment as there are no data in this patient group and methylthioninium chloride is predominantly renally eliminated (see section 5.2).

Hepatic impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment. There is no experience in patients with severe hepatic impairment (see section 5.2).

Paediatric population

The safety and efficacy of the medicinal product in children aged less than 18 years have not been established. No data are available.

Method of administration

Lumeblue is for oral use.

Tablets should be swallowed whole, without crushing, breaking or chewing. The tablets are coated with a gastro-resistant film that facilitates the delivery of the dye into the colon. Breaking the gastroresistant film by crushing or chewing the tablets may cause early release of the dye in the upper part of the gastrointestinal tract, with a possible loss of the treatment effectiveness.

The patient should take the medicinal product with the 4 L PEG based bowel cleansing regimen chosen by the healthcare provider according to the dosing schedule below:

• The first dose of 3 tablets should be taken after drinking at least 1 L of the bowel cleansing preparation;
• The second dose of 3 tablets should be taken 1 hour after the first dose;
• The last dose of 2 tablets should be taken 1 hour after the second dose.

Tablets should be taken orally with the bowel cleansing preparation chosen by the healthcare provider or with equivalent water volumes and the proposed dosing schedule is compatible with either full dose or split dose bowel preparations.

Available information from other methylthioninium chloride class medicinal products administered via intravenous, or other non-oral routes in other indications, show that overdose can result in an exacerbation of adverse reactions. Administration of large intravenous doses (cumulative dose ≥7 mg/kg ) of a methylthioninium chloride caused nausea, vomiting, chest tightness, chest pain, dyspnoea, tachypnoea, tachycardia, apprehension, sweating, tremor, mydriasis, blue green staining of the urine, blue staining of the skin and mucous membranes, abdominal pain, dizziness, paraesthesia, headache, confusion, hypertension, mild methaemoglobinaemia (up to 7%) and electrocardiogram changes (T-wave flattening or inversion). These effects lasted 2 to 12 hours following administration.

In case of overdose of Lumeblue, the patient should be observed until signs and symptoms have resolved, including monitoring for cardiopulmonary, haematologic and neurologic toxicities, and instituting supportive measures as necessary.

Paediatric population

Hyperbilirubinaemia has been observed in infants after administration of 20 mg/kg methylthioninium chloride. Death occurred in 2 infants after administration of 20 mg/kg methylthioninium chloride. Both infants had complex medical circumstances and methylthioninium chloride was only partially responsible. The paediatric patient should be maintained under observation, the methaemoglobin level should be monitored and appropriate supportive measures taken as necessary.

3 years.

This medicinal product does not require any special storage conditions.

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

Packs contain 8 prolonged-release tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.