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- GOOFICE FILM-COATED TABLET 5MG [SIN16878P]
GOOFICE FILM-COATED TABLET 5MG [SIN16878P]
Active ingredients: GOOFICE FILM-COATED TABLET 5MG
Product Info
GOOFICE FILM-COATED TABLET 5MG
[SIN16878P]
Product information
Active Ingredient and Strength | ELOBIXIBAT MONOHYDRATE EQV ELOBIXIBAT - 5 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | EA PHARMA CO., LTD. FUKUSHIMA PLANT - JAPAN |
Registration Number | SIN16878P |
Licence Holder | EISAI (SINGAPORE) PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | PENDING |
4.1 Therapeutic indications
GOOFICE® is indicated for the treatment of chronic idiopathic constipation in adults.
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).
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.]
