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
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