ARCALION 200MG 60 COATED TABLETS

Promotes well-being indications

This drug is indicated for certain temporary states of fatigue in adults (+ 15 years old).

2. WHAT YOU NEED TO KNOW BEFORE TAKING ARCALION 200 mg Coated Tablet?

List of information needed before taking the medication

If your doctor has told you that you are intolerant to certain sugars, contact them before taking this medication.

Contraindications

Do not take ARCALION 200 mg coated tablet in the following case:

·history of allergy to any of the components of the tablet.

IF IN DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST

Precautions for use; Special warnings

Be careful with ARCALION 200 mg coated tablet:

Special warnings

The use of this drug is not recommended in patients with glucose and/or galactose malabsorption syndrome (rare hereditary diseases), galactose intolerance, Lapp lactase or sucrase/isomaltase deficiency (rare hereditary diseases), or fructose intolerance

This medication contains an azo dye agent (E110) and may cause allergic reactions.

Precautions for use

If the symptoms persist beyond 4 weeks, consult your doctor.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Interactions with other drugs

Use of other medications

IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICATIONS, YOU SHOULD SYSTEMATICALLY REPORT ANY OTHER assist withMENT IN PROGRESS TO YOUR DOCTOR OR PHARMACIST.

If you are taking or have recently taken any other medication, including an over-the-counter medication, talk to your doctor or pharmacist.

Food and Beverage Interactions

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and breastfeeding

Pregnancy and Breastfeeding

It is best not to use this medication during pregnancy.

If you discover that you are pregnant during assist withment, consult your doctor, only he or she can judge whether to continue assist withment.

The use of this medication should be avoided while breastfeeding.

In general, during pregnancy and breastfeeding, it is advisable to always ask your doctor or pharmacist for advice before taking any medication.

Sports

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

List of excipients with known effect: glucose, lactose, orange-yellow aluminium lake S (E110) and sucrose.

3. HOW TO TAKE ARCALION 200 mg, coated tablet?

Instructions for proper use

Not applicable.

Dosage, Mode and/or route(s) of administration, Frequency of administration and Duration of assist withment

Posologie

RESERVE A L’ADULTE

2 à 3 comprimés par jour.

Les comprimés sont à avaler tels quels avec un grand verre d’eau, en répartissant les prises au repas du matin et du midi.

assist withment duration limited to 4 weeks.

Method and route of administration

Oral.

Duration of assist withment

Do not use for more than 4 weeks.

Symptoms and instructions in case of overdose

If you have taken more than ARCALION 200 mg coated tablet than you need:

In case of overdose, symptoms may include restlessness and tremors of the extremities.

If you have taken more than the right amount of ARCALION 200 mg coated tablet, contact your doctor.

Instructions for missing one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medications, ARCALION 200 mg, coated tablet is likely to have adverse effects, although not everyone is prone to them.

·Possible skin allergy, digestive intolerance, restlessness, headaches, tremors and malaise,

·due to the presence of orange-yellow S, risk of allergic reactions.

If you notice any side effects not listed in this leaflet, or if some side effects become serious, please tell your doctor or pharmacist.

5. HOW DO I STORE ARCALION 200 mg, coated tablet?

Keep out of reach and sight of children.

Expiry date

Do not use ARCALION 200 mg coated tablet after the expiry date stated on the outer packaging

Storage conditions

Blister pack: Tablets should be stored at a temperature not exceeding 25°C.

Pill box: Tablets should be stored at a temperature not exceeding 30°C.

If necessary, warnings against some visible signs of deterioration

Medications should not be disposed of down the drain or with household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Complete list of active substances and excipients

What does ARCALION 200 mg coated tablet contain?

The active substance is:

Sulbutiamine …………………………………………………………………………………………………………………… 200 mg

For a coated tablet.

The other components are:

Corn starch, starch starch, glucose anhydrous, lactose monohydrate, magnesium stearate, talc, sodium bicarbonate, carmellose sodium, white beeswax, titanium dioxide (E 171), ethyl cellulose, orange-yellow aluminium lake S (E 110), glycerol monooleate, polysorbate 80, povidone, sucrose, colloidal anhydrous silica (Aerosil 130).

Pharmaceutical form and content

What is ARCALION 200 mg, coated tablet and contents of the outer package?

This medication comes in the form of a coated tablet. Box of 15, 20, 30, 60 or 100 coated tablets.