Important Precautions Precaution on Special Populations Precaution Concerning Dosage & Administration Precaution Concerning Use


Important Precautions

Effects on Ability to Drive, Operate Machinery

There is no evidence of drug effects on the ability to drive or operate machinery.

Drug Compatibility

Because there are no studies on drug compatibility, do not mix this drug with other drugs.


Precautions on Special Populations

Careful Administration (Elobixibat should be administered with care in the following patients.)

Patient with serious liver disorder

Elobixibat (GOOFICE®) may fail to achieve its expected efficacy in patients with biliary obstruction or reduced bile acid secretion, etc.]

Use in the Elderly

Since the elderly generally have reduced physiological functions, cautions should be exercised, such as reducing the dose.

Pediatric Use

Safety has not been established in low-birth-weight infants, neonates, nursing infants, infants, or pediatric patients (no clinical experience).

Precaution Concerning Indication

No clinical experience of use in drug-induced and disease-induced constipations.


Precaution Concerning Dosage & Administration

Elobixibat (GOOFICE®) may cause abdominal pain or diarrhea; dose reduction, drug withdrawal, or discontinuation should be considered depending on the patient’s symptoms, and the need for continuing treatment with Elobixibat (GOOFICE®) should be carefully evaluated on a regular basis to avoid continuing aimless administration.


Precaution Concerning Use

Precaution Concerning the Dispensing of Drug

Patients who are given drugs supplied in PTP package must be instructed to remove the drugs from the PTP sheet before taking drugs. [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa causing perforation and resulting in serious complications, such as mediastinitis.]