Regulatory Information
EISAI (SINGAPORE) PTE. LTD.
EISAI (SINGAPORE) PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**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_).
ORAL
Medical Information
**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. \[Intestinal obstruction may be aggravated.\]
Pending
xpending
Manufacturer Information
EISAI (SINGAPORE) PTE. LTD.
EA Pharma Co., Ltd. Fukushima Plant
Active Ingredients
Documents
Package Inserts
Goofice Tablet PI.pdf
Approved: October 2, 2023