Each tablet contains the following excipients: Maize starch, sodium carboxymethylcellulose, white beeswax, titanium dioxide, pregelatinized maize starch, ethylcellulose, anhydrous glucose, lactose, sunset yellow FCF, glyceryl mono-oleate, polysorbate 80, polyvidone excipient, saccharose, anhydrous colloidal silica, magnesium stearate and talc.
Pharmacotherepeutic Group: Antiasthenic drug.
Pharmacology: In Man: The activity of sulbutiamine has been studied in functional asthenia in the course of controlled clinical studies (against placebo or reference products) using psychometric scales (Middlesex Hospital Questionnaire, Crocq Scale for the evaluation of nonpsychotic depressive conditions, Lipman auto-evaluation scale), with statistical analysis of the results. These studies showed the activity of sulbutiamine in the symptomatic treatment of functional asthenia.
Pharmacokinetics: Sulbutiamine is rapidly absorbed and the blood concentration is maximum in 1-2 hrs after oral administration. The molecule is rapidly distributed in the whole organism and is eliminated with a biological half-life of 5 hrs.
Certain physical or mental inhibition states involving reduced activity and apathy. In confirmed depressive episodes, this medicine does not eliminate the need for specific antidepressant treatment.
Hypersensitivity to active substance or to any of the excipients.
This medicinal product contains lactose, glucose and sucrose. This medicine should not be used by patients with galactose or fructose intolerance, Lapp lactase deficiency or glucose and galactose malabsorption syndrome (rare hereditary diseases) or a sucrase/isomaltase deficiency.
This medicine contains an azo colouring agent (E110) and may provoke allergic reactions.
Use in Pregnancy: No fetal toxicity or malformation has been reported. However, follow-up of women exposed to sulbutiamine during pregnancy is insufficient to exclude such a risk. Therefore, as a precautionary measure, it is preferable not to use this drug during pregnancy.
Use in Lactation: In the absence of data concerning the diffusion into breast milk, breastfeeding is not recommended during treatment.
Pregnancy: No fetal toxicity or malformation has been reported. However, follow-up of women exposed to sulbutiamine during pregnancy is insufficient to exclude such a risk. Therefore, as a precautionary measure, it is preferable not to use this drug during pregnancy.
Lactation: In the absence of data concerning the diffusion into breast milk, breastfeeding is not recommended during treatment.
Possibility of neuro-physic side effects (tremor, malaise, headache, agitation), skin allergy and digestive disorders (nausea, vomiting, gastralgia, diarrhoea).
No drug interactions have been reported.
A11DA02 - sulbutiamine ; Belongs to the class of vitamin B1. Used as dietary supplements.
Arcalion 200 sugar-coated tab 200 mg
60's (Rp655,557/pak)
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