ARCALION 200MG 60 COATED TABLETS

Therapeutic indications

This medicine is indicated for certain transient states of fatigue in adults (over 15 years of age).

2. WHAT YOU SHOULD KNOW BEFORE TAKING ARCALION 200 mg, coated tablet

List of information needed before taking the medicine

If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.

Contraindications

Never take ARCALION 200 mg, coated tablet in the following cases:

ahistory ofallergy to any of the components of the tablet.

IF IN DOUBT, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST

Precautions for use; special warnings

Take care with ARCALION 200 mg, coated tablet:

Special warnings

This medicine should not be used 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 medicine contains an azoic colouring agent (E110) and may cause allergic reactions.

Precautions for use

In case of persistence of disorders beyond 4 weeks, consult your doctor.

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

Interactions with other medicines

Use of other drugs

IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINES, YOU MUST SYSTEMATICALLY INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT IN PROGRESS.

If you are taking or have recently taken any other medication, including one obtained without a prescription, talk to your doctor or pharmacist.

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and Nursing

It is preferable not to use this medicine during pregnancy.

If you discover that you are pregnant during treatment, consult your doctor, only he can judge the need to continue the treatment.

The use of this medicine should be avoided during breast-feeding.

In general, during pregnancy and breastfeeding, always ask your doctor or pharmacist for advice before taking any medicine.

Sportsmen

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with a known effect

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

3. HOW TO TAKE ARCALION 200 mg, coated tablet

Instructions for proper use

Not applicable.

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

Dosage

RESERVED FOR ADULTS

2 to 3 tablets per day.

The tablets are to be swallowed as they are with a large glass of water, dividing the doses between the morning and midday meals.

Duration of treatment limited to 4 weeks.

Mode and route of administration

Oral administration.

Duration of treatment

Do not use for more than 4 weeks.

Symptoms and instructions in case of overdose

If you have taken more ARCALION 200 mg coated tablets than you should have:

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

If you have taken more ARCALION 200 mg Coated Tablet than you should, contact your doctor.

Instructions in case of missed dose(s)

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, ARCALION 200 mg, coated tablet is likely to have adverse reactions, although not everyone is subject to them.

The following side effects may occur:-skinallergy, digestive intolerance, restlessness, headache, tremor and malaise,

duetothe presence of orange yellow S, risk of allergic reactions.

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

5. HOW TO USE ARCALION 200 mg, coated tablet

Keep out of the 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: the tablets should be stored at a temperature not exceeding 25°C.

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

If necessary, warnings against certain visible signs of deterioration

Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active ingredients and excipients

What does ARCALION 200 mg, coated tablet contain?

The active substance is:

Sulbutiamine .................................................................................................................................... 200 mg

For one coated tablet.

The other components are:

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

Pharmaceutical form and content

What is ARCALION 200 mg, coated tablet and what does it contain?

This medicine is presented as a coated tablet. Box of 15, 20, 30, 60 or 100 coated tablets.

Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

Holder

LES LABORATOIRES SERVIER

50, rue Carnot

92284 SURESNES Cedex