Sulbutiamine 200mg for one coated tablet.
Excipients/Inactive Ingredients: Excipients with known effect: glucose, lactose, sunset yellow FCF aluminium lake (E 110), sucrose.
Maize starch, starch pregelatinised, anhydrous glucose, lactose monohydrate, magnesium stearate, talc, sodium hydrogen carbonate, carmellose sodium, white beeswax, titanium dioxide (E 171), ethylcellulose, sunset yellow FCF aluminium lake (E 110), glycerol oleate, polysorbate 80, povidone, sucrose, colloidal anhydrous silica.
Pharmacotherapeutic Group: Vitamin B1, plain. ATC Code: A11DA02.
Pharmacology: Pharmacodynamics: In humans: This medicine has been studied in controlled clinical trials versus placebo or reference products, by using psychometric evaluation scales and tests. These trials demonstrate the psychoactive effect of this drug, with a predominant action on psychological and physical inhibition.
Pharmacokinetics: Sulbutiamine is rapidly absorbed and peak blood concentration is reached between 1 and 2 hours after administration.
The half-life is approximately 5 hours. Elimination is by the urinary route.
Toxicology: Preclinical safety data: No special hazards have been identified for use in humans on the basis of preclinical studies of acute, subchronic and chronic toxicity and reproduction toxicity (studies conducted in pregnant mice, rats and rabbits haven't shown any teratogenic potential). Sulbutiamine was not mutagenic in the Ames test. No studies of carcinogenicity have been performed.
Symptomatic treatment of all forms of asthenia.
Posology: For adult use only: 2 to 3 tablets a day.
Tablets should be swallowed whole with a large glass of water, dividing the doses between the morning and midday meals.
Duration of treatment is limited to 4 weeks.
Paediatric population: The safety and efficacy of ARCALION have not been established in children and adolescents, ARCALION should not be used in this population.
Method of administration: Oral use.
Symptoms: In case of overdose: agitation with euphoria and tremor of the extremities.
These symptoms are transient.
Treatment: Overdose symptoms can be treated according to the doctor's assessment.
Hypersensitivity to the active substance or to any of the excipients listed in Description.
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 (see Adverse Reactions).
Effects on ability to drive and use machines: No specific studies on the effect on ability to drive and to use machines have been performed.
Pregnancy: There is no or limited data available (less than 300 pregnancy outcomes) on the use of sulbutiamine in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of ARCALION during pregnancy.
Breastfeeding: It is unknown whether sulbutiamine/metabolites are excreted in human milk.
A risk to the newborns/infants cannot be excluded.
ARCALION should not be used during breast-feeding.
Fertility: There is no available data regarding the effects of sulbutiamine on fertility.
Tabulated list of undesirable effects: The following undesirable effects or events have been reported and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated form the available data). (See table.)
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Description of selected undesirable effects: Due to the presence of sunset yellow FCF (E110), risk of allergic reactions (see Precautions).
No specific interaction studies have been performed with ARCALION.
Concomitant use to be taken into consideration: Diuretics: The urinary excretion of thiamine (metabolite of sulbutiamine) is increased.
Neuromuscular blocking agents: The effect of these medicines may be increased when administered concomitantly with thiamine (metabolite of sulbutiamine).
Special precautions for disposal and other handling: No special requirements.
Incompatibilities: Not applicable.
Store below 30°C.
Shelf-Life: 2 years.
A11DA02 - sulbutiamine ; Belongs to the class of vitamin B1. Used as dietary supplements.
Arcalion 200 tab 200 mg
30's
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