Full Prescribing Info
The active substance is: Sulbutiamine 200 mg.
For one coated tablet.
Excipients with known effect: glucose, lactose, sunset yellow FCF aluminium lake (E 110), sucrose.
Antiasthenic drug.
Pharmacology: In Animals: Pharmacological studies carried out in animals, either with acute or chronic administration, have evidenced the following actions: Sulbutiamine increases physical resistance to fatigue, neuromuscular efficiency and learning and memory; and improves the metabolic functions of the cerebral cortex.
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 t½ of 5 hrs.
The urinary excretion is maximal 2-3 hrs after administration.
This medicine is indicated in certain transient adult (+ 15 years) fatigue conditions.
Symptomatic treatment of functional asthenia: Physical and intellectual overwork; Memory disorders, difficulty in concentration; Psychogenic impotence of recent onset; Reactive asthenia; Fatigue related to states of depression and anxiety; Fatigue following infections and operations; Fatigue in post-partum conditions; Geriatric psychosomatic disorders.
Dosage/Direction for Use
Always take this medicine exactly as the doctor or pharmacist has told you. Check with the doctor or pharmacist if not sure.
Posology: FOR ADULT USE ONLY (over 15 years old).
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.
Always take this medicine exactly as described in this leaflet or as the doctor, pharmacist or nurse has told you.
Check with the doctor, pharmacist or nurse if not sure.
Method of administration: Oral route.
Duration of treatment: Do not use for more than 4 weeks.
Missed dose: Not applicable.
In case of overdose, the symptoms may include agitation and limb tremors. These symptoms are transient.
If the patient has taken more than the recommended dosage: Contact immediately the doctor or pharmacist.
Overdose symptoms can be treated according to the doctor's assessment.
If patient is allergic to sulbutiamine or any of the other ingredients of this medicine.
Special Precautions
This medicinal product contains lactose, glucose and sucrose. This medicine should not be used by patients with glucose and galactose malabsorption syndrome (rare hereditary diseases), galactose intolerance, Lapp lactase deficiency or a sucrase/isomaltase deficiency or fructose intolerance.
This medicine contains an azo coloring agent (E110) and may provoke allergic reactions (see Adverse Reactions).
If symptoms persist for more than 4 weeks, consult the physician.
Talk to the doctor, pharmacist or nurse before taking Sulbutiamine (Arcalion).
When to consult a doctor: Talk to the doctor if the patient is not feeling better or feeling worse after 4 weeks.
Driving and using machines: Not applicable.
Sulbutiamine (Arcalion) 200 mg coated tablet contains: glucose, lactose, sunset yellow FCF aluminium lake (E110) and sucrose.
Use in Children: Sulbutiamine (Arcalion) should not be used in children and adolescents.
Use In Pregnancy & Lactation
If the patient is pregnant or breastfeeding, thinks the patient may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Pregnancy: The use of Sulbutiamine (Arcalion) should generally be avoided during pregnancy. Tell the doctor if the patient is pregnant.
Breastfeeding: The patient should not take Sulbutiamine (Arcalion) if the patient is breastfeeding. Tell the doctor immediately if the patient is breastfeeding or about to start breastfeeding.
Adverse Reactions
Like all medicines, Sulbutiamine (Arcalion), coated tablet can cause side effects, although not everybody gets them.
The following side effects have been observed: Uncommon (may affect up to 1 in 100 patients but not more than 1 in 1,000): cutaneous eruption, nausea, vomiting, agitation, headaches, tremor, malaise.
Not known (frequency cannot be estimated from the available data): stomach pain, diarrhea.
Due to the presence of Sunset Yellow FCF, risk of allergic reaction.
Drug Interactions
Other medicines and Sulbutiamine (Arcalion): Tell the doctor or pharmacist if the patient is taking, have recently taken or might take any other medicines. Sulbutiamine (Arcalion) may interact with the following medicines: diuretics (used for treatment of high blood pressure), which may increase the thiamine urinary excretion (Vitamine B1, derived from sulbutiamine), neuromuscular blocking agents (used in general anesthesia) whose effects may be increased with thiamine (Vitamine B1, derived from sulbutiamine).
Sulbutiamine (Arcalion) with food, drinks and alcohol: Not applicable.
Store at temperatures not exceeding 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
ATC Classification
A11DA02 - sulbutiamine ; Belongs to the class of vitamin B1. Used as dietary supplements.
Tab 200 mg x 100's.
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