TRUBERZI Film-coated tablet Ref.[7577] Active ingredients: Eluxadoline

Posology

The treatment should be initiated and supervised by a physician experienced in diagnosis and management of gastrointestinal disorders.

The recommended dose is 200 mg daily (one 100 mg tablet, twice daily).

For patients who are unable to tolerate the 200 mg daily dose (one 100 mg tablet, twice daily), the dose can be lowered to 150 mg daily (one 75 mg tablet twice daily).

Elderly

In principle, general dose recommendations also apply to patients aged 65 years and above. However, given the potential for increased sensitivity to experience undesirable effects, it may be considered to initiate eluxadoline treatment in a dosage of 150 mg daily (one 75 mg tablet twice daily).

If this dosage is well tolerated, but not sufficiently effective, dosage may subsequently be increased to 200 mg daily (one 100 mg tablet twice daily). See section 4.4.

Patients with renal impairment

No dose adjustment is necessary based on renal function (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of eluxadoline in children aged 0 to18 years have not yet been established.

No data are available.

Benefits and risks of the treatment should be periodically assessed in the context of patient symptoms severity.

Method of administration

For oral use.

The tablets should be taken with food in the morning and in the evening (see section 5.2).

Patients should be instructed if they miss a dose (delay of 4 hours) to take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose.

Symptoms

Single supratherapeutic oral doses of eluxadoline up to 1,000 mg and single intranasal doses up to 200 mg were associated with a higher incidence of adverse events than a 100 mg single dose, especially gastrointestinal and central nervous system events. An overdose of eluxadoline may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product.

Management

In the event of acute overdose, the patient should be carefully observed and given standard supportive treatment as required. Gastric lavage or charcoal administration should be considered. Given eluxadoline’s action at opioid receptors, administration of a narcotic mu opioid antagonist, such as naloxone, should be considered. Considering the short half-life of naloxone, repeated administration may be necessary. In the event of naloxone administration, subjects should be monitored closely for the return of overdose symptoms, which may indicate need for repeated naloxone injection.

2 years.

This medicinal product does not require any special storage conditions.

PCTFE/PVC/Al-blister containing 14 film-coated tablets. Pack sizes of 28, 56 and a multipack containing 168 (3 packs of 56) film-coated tablets.

Not all pack sizes may be marketed.

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