Arcalion Tablet (10 Tab)

ARCALION TABLET (10 TAB) by SERDIA PHARMACEUTICALS (INDIA) PVT. LTD.

Name

• Common Name: Sulbutiamine
• Brand Name: Arcalion Tablet

Composition

Arcalion Tablet contains Sulbutiamine 200 mg as its active ingredient. It also includes excipients such as glucose, lactose, sucrose, and Sunset Yellow FCF (E110) aluminium lake. Sulbutiamine is a synthetic derivative of thiamine (Vitamin B1).

Uses

Arcalion Tablet is primarily indicated for the symptomatic treatment of asthenia, a condition characterized by generalized tiredness, weakness, or lack of energy in adults over 15 years of age. It aims to improve psychological balance, physical resistance, and intellectual performance. The medicine works by increasing thiamine levels in the brain, which is thought to have mild stimulant effects. It may also be used as an adjunct therapy in Alzheimer's disease and psychogenic erectile dysfunction.

Dosage and Administration

For adults, the typical dosage is 2 to 3 tablets per day. Tablets should be swallowed whole with a large glass of water, dividing the doses between morning and midday meals. It should be taken with food. The duration of treatment is limited to a maximum of 4 weeks.

Side Effects

Common side effects may include:

• Skin allergy or rash
• Digestive intolerance or disorders such as nausea, vomiting, stomach discomfort, and diarrhea
• Neuro-psychic effects like restlessness or mild agitation (especially in elderly patients), headache, tremor, and malaise

Due to the presence of Sunset Yellow FCF (E110), there is a risk of allergic reactions. In cases of overdose, symptoms may include restlessness, agitation, and tremors.

Precautions

• Do not take Arcalion Tablet if you have a history of allergy to sulbutiamine or any of its components.
• This medicine contains glucose, lactose, and sucrose, and is contraindicated in patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption syndrome, or fructose intolerance.
• The use of Arcalion Tablet is generally not recommended during pregnancy and breastfeeding due to limited data; consult your doctor if you are pregnant, planning a pregnancy, or breastfeeding.
• Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements, as Arcalion may interact with diuretics (increasing thiamine excretion) and neuromuscular blocking agents (potentially enhancing their effects).
• Caution is advised for patients with kidney problems or psychiatric disorders.
• If you experience dizziness or sleepiness, do not drive or operate machinery.
• If symptoms persist beyond 4 weeks, consult your doctor.

Storage

Store Arcalion Tablet in a cool and dry place, away from direct sunlight and moisture. Blister packs should be stored at a temperature not exceeding 25°C, while pill boxes should be stored below 30°C. Keep this medicine out of the sight and reach of children.

What is ARCALION TABLET used for?

ARCALION TABLET, which contains sulbutiamine, is primarily used for the symptomatic treatment of asthenia, a condition characterized by generalized tiredness, weakness, or a lack of energy. It is also indicated to improve psychological balance, physical resistance, and intellectual performance. Additionally, it may be used as an adjunct therapy in conditions like Alzheimer's disease and psychogenic erectile dysfunction, and to combat fatigue associated with certain infections or multiple sclerosis.

How does ARCALION TABLET work?

The active ingredient, sulbutiamine, is a synthetic derivative of vitamin B1 (thiamine). It is designed to be highly lipophilic, allowing it to cross the blood-brain barrier more easily than conventional thiamine. Once in the brain, sulbutiamine increases thiamine levels, which is crucial for nerve function and energy production. It is thought to have mild psychostimulant properties and exhibits cholinergic effects, potentially improving memory and overall cognitive function and mood regulation.

What is the usual dosage for ARCALION TABLET?

For adults, the usual dosage is 2 to 3 tablets per day. The tablets should be swallowed whole with a large glass of water, with doses divided between the morning and midday meals. It is recommended to take the tablets with food. The duration of treatment is typically limited to a maximum of 4 weeks.

What are the possible side effects of ARCALION TABLET?

Common side effects may include nausea, vomiting, stomach discomfort or pain, diarrhea, headache, anxiety, irritability, tremors, insomnia, skin rashes, and other allergic reactions. Some individuals, particularly the elderly, might experience mild agitation or general malaise. If an overdose occurs, symptoms such as heightened anxiety, agitation, and tremors of the extremities may be observed.

Is ARCALION TABLET safe during pregnancy or breastfeeding?

It is generally not recommended to use ARCALION TABLET during pregnancy or breastfeeding due to insufficient reliable information regarding its safety. While no fetal toxicity or malformation has been consistently reported, data from studies in pregnant or breastfeeding women are limited, making it difficult to fully exclude potential risks. It is advisable to consult a doctor before using this medicine if you are pregnant, planning to become pregnant, or breastfeeding.

Can ARCALION TABLET be taken with other medications?

While some sources suggest no reported drug interactions, it is crucial to inform your doctor or pharmacist about all other medications you are currently taking, including over-the-counter drugs and herbal supplements. ARCALION TABLET may interact with diuretics, potentially increasing the urinary excretion of thiamine, and it could enhance the effects of neuromuscular blocking agents.

What precautions should be taken while taking ARCALION TABLET?

Do not take ARCALION TABLET if you have a known hypersensitivity or allergy to sulbutiamine or any other ingredients in the tablet. Caution is advised if you have metabolic disorders such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, or sucrase/isomaltase deficiency, as the medicine contains certain sugars. The presence of an azo coloring agent (E110) in the tablet may also cause allergic reactions. The treatment duration should not exceed 4 weeks; consult your doctor if symptoms persist beyond this period. Individuals with psychiatric disorders, such as bipolar disorder, should use sulbutiamine cautiously due to a potential for abuse. It is also advisable to avoid alcohol consumption, as it may worsen side effects. If you experience dizziness or sleepiness, do not drive or operate machinery. The medicine is generally not recommended for children under 15 years of age.

What happens if a dose of ARCALION TABLET is missed?

If you miss a dose of ARCALION TABLET, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should ARCALION TABLET be stored?

ARCALION TABLET should be stored at room temperature, ideally below 30°C (or below 25°C if in blister packs). Keep the medicine in a dry place, away from direct sunlight and moisture. It is essential to keep ARCALION TABLET out of the sight and reach of children. Always ensure the medicine is used before its expiry date.