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קולוטאל טבליות 135 מ"ג COLOTAL TABLETS 135 MG (MEBEVERINE HYDROCHLORIDE)
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צורת מתן:
פומי : PER OS
צורת מינון:
טבליה : TABLETS
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מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
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Physicians Leaflet
Pharmacological properties : תכונות פרמקולוגיות
Pharmacodynamic Properties
5.1 Pharmacodynamic properties Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group, ATC-Code: A03AA04 Mechanism of action and pharmacodynamic effects Mebeverine is a musulotrophic antispasmodic with a direct effect on the smooth muscle of the gastro-intestinal tract, relieving spasm without affecting normal gut motility. Since this effect is not mediated by the autonomic nervous system, the typical anti-cholinergic side-effects are absent.
Pharmacokinetic Properties
5.2 Pharmacokinetic properties Absorption: Mebeverine is rapidly and completely absorbed after oral administration of tablets. Distribution: No significant accumulation occurs after multiple doses. Biotransformation: Mebeverine hydrochloride is mainly metabolised by esterases, which split the ester bonds into veratric acid and mebeverine alcohol firstly. The main metabolite in plasma is DMAC (demethylated carboxylic acid). The steady state elimination half-life of DMAC is 2.45 h. During multiple dosing the Cmax of DMAC for the coated tablets with 135 mg is 1670ng/ml and tmax is 1 h. Elimination: Mebeverine is not excreted as such, but metabolised completely; the metabolites are excreted nearly completely. Veratric acid is excreted into the urine, mebeverine alcohol is also excreted into the urine, partly as the corresponding carboxylic acid (MAC) and partly as the demethylated carboxylic acid (DMAC). Paediatric population The safety and efficacy of the product has only been evaluated in adults.
שימוש לפי פנקס קופ''ח כללית 1994
Spastic functional disturbances of the colon (irritable bowel syndrome)
תאריך הכללה מקורי בסל
01/01/1995
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