GOOFICE FILM-COATED TABLET 5MG

4.1 Therapeutic indications

GOOFICE® is indicated for the treatment of chronic idiopathic constipation in adults.

4.3 Contraindications

(1) Patients with medical history of hypersensitivity to the ingredients of GOOFICE®.

(2) Patients with a documented intestinal obstruction associated with a tumor or hernia or with the suspicion of such conditions. [Intestinal obstruction may be aggravated.]

4.2 Posology and method of administration

The usual adult dose for oral use is 10 mg once daily as elobixibat before meal. The dosage may be adjusted depending on the patient’s symptoms but must not exceed the highest dose of 15 mg per day.

Special populations

Elderly

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

Pediatric population

GOOFICE® is not recommended for use in pediatric patients due to a lack of clinical data in this population (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Discontinuation of treatment

There is no data showing that discontinuation of GOOFICE® does not lead to rebound effects (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).