COMPOSITION

Each tablet contains Trimebutine Maleate ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥ 300 mg

DESCRIPTION,

White, oblong, sustained release, film-coated tablet

PHARMACODYNAMICS

Gastrointestinal motility modifier. Peripheral enkephalinergic agonist.

Trimebutine stimulates intestinal motility (triggering phase-III waves propagated by the migrating motor complex) and inhibits it in the event of prior stimulation.

PHARMACOKINETICS

Peak blood levels of trimebutine after oral administration of tablets were obtained after 1 to 2 hours.

Rapid elimination of trimebutine after oral administration of tablets was mainly in the urine, on average 70% in 24 hours.

INDICATIONS

Gastroesophageal reflux, lacunar hernia, pain associated gastroduodenitis, gastroduode ulcer, etc,

Dyspepsia, nausea, vomiting, functional colon disorder (hyperergia colitis, convulsive colon),

Habitable vomiting of infant, non-infectious enteric pain and functional disorder (diarrhea, constipation), motion stimulus of infant, dyskoimesis, post-enteral operative ileus, remission of pylorus and conclusive colon during X-ray (endoscopy) test.

DOSAGE AND ADMINISTRATION

1 tablet twice daily in empty stomach.

PRECAUTIONS

Although teratological studies have not shown in animal studies, the safety during pregnancy is not established. Therefore, the use of NEWBUTIN in trimester and nursing is not recommended.

Newbutin contains lactose and should not be taken by patients with rare hereditary problems of galactose intolerance,the Lapp lactase deficiency or glucose-galactose malabsorption.

ADVERSE REACTIONS

Rarely fatigue, hot/cold sensation, slight diarrhea, nausea, vomiting, constipation, dyspepsia, slight hypnosis, light vertigo may occur.

OVERDOSE

In the event of overdose, symptomatic treatment should be implemented. STORAGE Preserve in tight containers. Store at room temperatures not exceeding 30°C.

PACKAGING

10 Tablets/blister x 3 Blisters/box