Arcalion 200

arcalion
sulbutiamine

COMPOSITION
Each sugar-coated tablet contains 200 mg of sulbutiamine.

INDICATIONS
Treatment of certain physical or mental inhibition states involving reduced activity and apathy.
In confirmed depressive states, this medicine does not eliminate the need for specific antidepressant treatment.

DOSAGE AND ADMINISTRATION
FOR ADULT USE ONLY.
2 to 3 tablets daily.
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.

CONTRA-INDICAT10NS
ARCALION is contra-indicated in case of past-history of hypersensibility to one of the ingredients of the tablets.

WARNINGS AND PRECAUTIONS
Due to the presence of lactose, this drug is contra-indicated in the case of congenital galactosemia, the syndrome of malabsorption of glucose and galactose or a deficit in lactase.

Pregnancy and Lactation
There have been no teratogenic studies in animals.
Clinically, no fetal toxicity or malformation has been reported. However, follow-up of women exposed to ARCALION during pregnancy is insufficient to exclude such a risk.

Due to the absence of data concerning the excretion of ARCALION in breast milk, its use should be avoided in breastfeeding women.

SIDE EFFECTS
Possibility of neuro-physic side effects (tremor, malaise, headaches, agitation), of skin allergy and digestive disorders.
Due to the presence of sunset yellow FCF, risk of allergic reactions.

OVERDOSAGE
In cases of massive absorption, there may be agitation with euphoria and tremor of the extremities.
These disorders are transient and rapidly resolved.

PHARMACODYNAMIC PROPERTIES
In man:
ARCALION 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.

PHARMACOKINETIC PROPERTIES
Sulbutiamine is rapidly absorbed and the peak blood concentration is reached between one and two hours after administration.
The half-life is about five hours.
The elimination is urinary.

STORAGE
Store at room temperature (25°-30°C)
Shelf life: 3 years

PRESENTATION
Box of 60 sugar-coated tablets in 10 strips of 6 tablets

Reg. No.: DKL7604519516A1

HARUS DENGAN RESEP DOKTER

Manufactured by:
PT Darya-Varia Laboratoria Tbk
Gunung Putri, Bogor-lndonesia

Under licence of:
SERVIER
Les Laboratoires Servier

Share this :