ARCALION 200 MG state of tiredness

ARCALION 200 MG state of tiredness View larger

ARCALION 200 MG STATE OF FATIGUE PASSENGER

It is indicated in some states of the adult passenger fatigue (15 + years).

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Used for : fatique, tiredness, tiredness

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For warnings, precautions for use and cons-indications, please refer to the user guide of Arcalion.

Description ARCALION 200 MG STATE OF FATIGUE PASSENGER

It is indicated in some states of the adult passenger fatigue (15 + years).

Dosage Arcalion

RESERVED FOR ADULTS

2-3 tablets per day.
The tablets should be swallowed as is with a glass of water, taken by distributing the morning meal and lunch.
Duration of treatment limited to 4 weeks.

Method and route of administration of Arcalion
Oral

Duration of treatment Arcalion

Do not use more than 4 weeks

If you have taken more ARCALION 200 mg coated tablet that it should:
In case of overdose, symptoms can include restlessness and tremors of the extremities.
If you have taken more ARCALION 200 mg coated tablet that you should contact your doctor.

The active substance is:
Sulbutiamine ............................ 200 mg
For a coated tablet

Sulbutiamine is a derivative of vitamin B1 molecule. It is used as a non-amphetamine psychostimulant, especially in case of memory impairment and asthenia. Sulbutiamine is marketed by Servier under the brand Arcalion
   
The other ingredients are:
Corn starch, starch paste, anhydrous glucose, lactose monohydrate, magnesium stearate, talc, sodium bicarbonate, sodium carmelose, white beeswax, titanium dioxide (E171), ethyl cellulose, aluminum lake yellow FCF ( E110), glycerol monooleate, polysorbate 80, povidone, sucrose, colloidal anhydrous silica (Aerosil 130).
   

List of excipients with known effects: glucose, lactose, aluminum lacquer yellow (E110) and sucrose.

Conditioning Arcalion: Box of 30 or 60 tablets.

Summary of product characteristics Arcalion (MSNA)

If your doctor has told you (e) an intolerance to some sugars, contact your doctor before taking this medicine.

Never ARCALION 200 mg coated tablet in the following cases:

  • History of allergy to any component of the tablet.

IF IN DOUBT, YOU MUST ASK YOUR DOCTOR OR PHARMACIST.


Take special care with ARCALION 200 mg coated tablet:

Special warnings
Use of this medicine is not recommended Arcalion in patients with malabsorption of glucose and / or galactose (rare hereditary), galactose intolerance, the Lapp lactase deficiency or sucrase / isomaltase (rare hereditary ) or fructose intolerance.

This medication contains an azo Arcalion agent (E110) and can cause allergic reactions.

Precautions
In case of persistent troubles beyond 4 weeks, consult your doctor.
IF IN DOUBT DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST.

Using other medicines
TO AVOID POSSIBLE INTERACTIONS WITH OTHER MEDICINES SHOULD TELL ALL OTHER TREATMENT TO YOUR DOCTOR OR PHARMACIST.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

Pregnancy and lactation
It is best not to use this drug during pregnancy Arcalion.
If you discover that you are pregnant during treatment, consult your doctor, only he can judge the need for continued treatment.
The use of this drug should be avoided during breastfeeding.
In general, it is necessary during pregnancy and lactation always ask your doctor or pharmacist before taking any medicine.

List of excipients with known effects: glucose, lactose, aluminum lacquer yellow (E110) and sucrose.

Warnings on drugs

Attention drug Arcalion is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find the instructions for this medicine Arcalion on the website of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Declare one or effect (s) undesirable (s) connected (s) the use of a drug Arcalion.

VIDAL OF THE FAMILY

ARCALION

psychostimulant

sulbutiamine

. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

ARCALION 200: tablet (orange); box of 30.
-

ARCALION 200: tablet (orange); box of 60.
-

Laboratory Servier

COMPOSITION (summary)
p cp
Sulbutiamine 200 mg
Lactose +

INDICATIONS (summary)
It is a drug belonging to the family of psychostimulants .
It is used in states of apathy, abasement, lack of energy.
WARNING (Contents)
Apathy, abatement may be the only symptoms of depression that requires specific treatment: see your doctor.
PREGNANCY AND BREAST-FEEDING (summary)
The effect of this medication during pregnancy or lactation is not well known. The assessment of the possible risk associated with its use is individual: ask your pharmacist or doctor for advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
The tablets should be swallowed with a large glass of water during the morning and midday meals.

Usual dosage:

  • Adult: 2 or 3 tablets per day.
The duration of treatment should not exceed 4 weeks without medical advice.
TIPS (summary)
Persistent fatigue should not lead you to increase or prolong the intake of this medication; consult your doctor.
POSSIBLE ADVERSE EFFECTS (summary)
Tremors, headache, restlessness, malaise, allergic skin reaction , digestive intolerance .


GLOSSARY (summary)


depression
Disease usually associates a feeling of fatigue, uselessness, guilt, inability to perform daily tasks. Loss of appetite and sleep disorders are common. Suicidal impulses are one of the signs of severity of depression.


intolerance
Undesirable effect, most often digestive, when taking a drug. The irritation of the stomach due to aspirin is intolerance and not an allergy.


psychostimulants
Medication that stimulates attention and alertness.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


symptoms
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 17/08/2017

Name of the medicinal product

ARCALION 200mg, coated tablet

Sulbutiamine

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should contact your doctor if you experience no improvement or feel less well after 4 weeks.

What is in this leaflet?

1. What is ARCALION 200 mg , coated tablet and in which cases it is used?

2. What you need to know before taking ARCALION 200 mg coated tablet?

3. How to take ARCALION 200 mg coated tablet ?

4. What are the possible side effects?

5. How to store ARCALION 200 mg coated tablet ?

6. Package contents and other information.

1. WHAT ARCALION, 200 mg, coated tablet AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group: Vitamin B1, unassociated - ATC code: A11DA02

This drug is indicated in some states of adult fatigue (more than 15 years).

You should contact your doctor if you experience no improvement or feel less well after 4 weeks.

2. BEFORE YOU TAKE ARCALION, 200 mg, coated tablet?

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Never take ARCALION 200 mg, coated tablet:

· if you are allergic to sulbutiamine or any of the other ingredients of this medication mentioned in section 6.

Warnings and Precautions

This medicine contains glucose, lactose and sucrose. The use of this medication is not recommended in patients with glucose and / or galactose malabsorption syndrome (rare hereditary diseases), galactose intolerance, Lapp lactase deficiency or sucrase / isomaltase (rare hereditary diseases), or fructose intolerance.

This medicinal product contains an azo coloring agent, orange yellow S (E110) and may cause allergic reactions (see section 4. "What are the possible adverse effects?").

If symptoms persist for more than 4 weeks, consult your doctor.

Talk to your doctor, pharmacist or nurse before taking ARCALION 200 mg coated tablet.

Children and Youth

ARCALION should not be used in children and adolescents.

Other medicines and ARCALION 200 mg coated tablet

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines. ARCALION can interact with the following medications:

· diuretics (used in the treatment of high blood pressure) may increase urinary excretion of thiamine (vitamin B1, derived from sulbutiamine).

· Neuro-muscular blocking agents (used in general anesthesia) whose effects can be increased with thiamine (vitamin B1, derived from sulbutiamine).

ARCALION 200 mg, coated tablet, with food, beverages and alcohol

Not applicable.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

As a precaution, it is preferable to avoid the use of ARCALION during pregnancy. Tell your doctor if you think you are pregnant.

feeding

You should not take ARCALION if you are breast-feeding. Tell your doctor immediately if you are breast-feeding or are about to start breast-feeding.

Driving and using machines

Not applicable.

ARCALION 200 mg, coated tablet contains: glucose, lactose, orange yellow lacquer S (E 110) and sucrose.

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

Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage

RESERVED FOR ADULTS

2 to 3 tablets per day.

The tablets should be swallowed as they are with a large glass of water, spreading the catch to the morning and midday meals.

Treatment time limited to 4 weeks.

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.

Administration mode

Oral use.

Duration of treatment

Do not use more than 4 weeks.

If you take more ARCALION 200 mg, coated tablet than you should

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

Immediately consult your doctor or pharmacist

If you forget to take ARCALION 200 mg, coated tablet

Not applicable.

If you stop taking ARCALION 200 mg, coated tablet

Not applicable.

If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

The following adverse reactions were observed:

Uncommon (occurred in less than 1 user in 100 but in more than 1 user in 1000)

· skin rash,

· want to vomit (nausea), vomiting,

· agitation,

· headache,

· tremors,

· discomfort.

Frequency not known (can not be estimated from available data)

· pain in the stomach, diarrhea.

Due to the presence of orange-yellow S, there is a risk of allergic reactions.

Declaration of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE ARCALION 200 mg coated tablet?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

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

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

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What ARCALION 200 mg contains: coated tablet

· The active substance is:

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

For a coated tablet

· The other components are:

Starch starch, anhydrous glucose, lactose monohydrate, magnesium stearate, talc, sodium bicarbonate, sodium carmellose, white beeswax, titanium dioxide (E171), ethylcellulose, E 110), glycerol monooleate, polysorbate 80, povidone, sucrose, anhydrous colloidal silica (Aerosil 130).

What is ARCALION 200 mg, coated tablet and contents of the pack

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

SERVIER LABORATORIES

50, RUE CARNOT

92284 SURESNES CEDEX

LA FRANCE

Marketing Authorization Operator

SERVIER LABORATORIES

50, rue Carnot

92284 SURESNES Cedex

LA FRANCE

Maker

LABORATOIRES SERVIER INDUSTRIE

905 route de Saran

45520 GIDY

LA FRANCE

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

{MM / YYYY} {YYYY months}.

Other

Detailed information on this medicine is available on the ANSM website (France).

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