TUSSIDANE cough syrup

TUSSIDANE cough syrup

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For the warnings, the precautions and cons-indications, see the manual of TUSSIDANE.

Description TUSSIDANE

TUSSIDANE cough syrup

Tussidane is a central cough syrup used in the acute treatment of dry cough and irritation cough.
Drowsiness risks: LEVEL 1.

Dosage:

Symptomatic treatment should be short (a few days):

In adults and children over 15 years: 3-4 tablespoons per day without exceeding 6 tablespoons.
Catches must be spaced at least 4 hours.

In children: the scoops are graduated in 2.5 ml and 5 ml.

  • Children 30 months to 6 years: 13-20 mg, 1/2 measuring spoon 4-6 times a day depending on age
  • Children 6 to 12 years: 20 to 35 mg, 3 to 4 measuring spoons per day by age
  • Children 12 to 15 years: 30 to 50 mg, or 4-6 measuring spoons per day by age
  • In the elderly or in cases of liver disease: consult your doctor so he can adjust the dosage.
Method and route of administration: Oral. Rinse the measuring spoon with water after use.

Frequency of administration: This medication is to be taken as schedules which occurs cough; for example, a cough that occurs only in the evening, a single dose of this medicine at night may be sufficient. Space out of a minimum of 4 hours.

If you have taken more Tussidane 1.5 mg / ml syrup you should: Ask your doctor or pharmacist.

If you miss Tussidane 1.5 mg / ml syrup: Do not take a double dose to make up for the dose you missed.
Composition Tussidane 1.5 mg / ml syrup
Active substance: dextromethorphan hydrobromide 1.5 mg per 1 ml of oral solution.

A measuring spoon (5 ml) contains 7.5 mg hydrobromide dextrométhrphane.
A half measuring spoon (graduation 2.5 ml) contains 3.75 mg of dextromethorphan hydrobromide.

Other components: sodium benzoate, orange flavor, sucrose, citric acid monohydrate, purified water.
Composition Tussidane 1.5 mg / ml sugar syrup
Active substance: dextromethorphan hydrobromide 1.5 mg per 1 ml of oral solution.

A measuring spoon (5 ml) contains 7.5 mg hydrobromide dextrométhrphane.
A half measuring spoon (graduation 2.5 ml) contains 3.75 mg of dextromethorphan hydrobromide.

Other components: liquid maltitol, sodium benzoate, sodium saccharin, caramel aroma, caramel powder (E150), citric acid monohydrate, purified water.

Packaging: a bottle of 250 ml

This medicine is available as an oral solution of yellowish-brown color, bottle of 125 ml or 250 ml with a measuring spoon with 5 ml graduation of 2.5 ml.

Warnings on drugs

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

Please tell your online pharmacist ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

To find the manual for this medicine TUSSIDANE on the site of the MSNA.

Pharmacovigilance: Reporting an or effect (s) junk (s) connected (s) to the use of a drug TUSSIDANE

VIDAL OF THE FAMILY

TUSSIDANE

Antitussive opiate

dextromethorphan

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

PRESENTATIONS (summary)

TUSSIDANE: syrup (orange flavor); 125 ml bottle with 5 ml measuring spoon.
Refunded at 30%. - price: 1,63 euro (s).
List I

TUSSIDANE: syrup (orange flavor); bottle of 250 ml with measuring spoon of 5 ml.
Refunded at 30%. - price: 2,06 euro (s).
List I

TUSSIDANE without sugar: oral solution (caramel flavoring); 125 ml bottle with 5 ml measuring spoon.
Refunded at 30%. - price: 1,63 euro (s).
List I

TUSSIDANE without sugar: oral solution (caramel flavoring); bottle of 250 ml with measuring spoon of 5 ml.
Refunded at 30%. - price: 2,06 euro (s).
List I

TUSSIDANE 30 mg: scored tablet (white); box of 12.
Refunded at 30%. - price: 1.58 euro (s).
List I

Elerté Laboratory

COMPOSITION (summary)
syrup pc my floor buv pc mes p cp
Dextromethorphan hydrobromide 7.5 mg 7.5 mg 30 mg
Sucrose 3.6 g
Sodium 1.99 mg
maltitol +

INDICATIONS (summary)
This medication contains an opiate antitussive which blocks the reflex of the cough by acting directly on the brain. It does not cause dependence or respiratory depression at the usual doses.
It is used in the symptomatic treatment of dry cough or irritation.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
This medication is not suitable for the treatment of fatty cough, which is a normal defense mechanism of the body allowing the evacuation of the mucus present in the bronchi.
Cough is a symptom that can reveal many diseases ( allergies , heart disease, lung, digestive ...): consult your doctor if it persists for more than a few days.
The syrup contains sugar (sucrose) in significant quantities.
Avoid drinking alcohol during treatment.
This medication may induce somnolence, sometimes intense in some people. This drowsiness can be increased by taking alcohol or other sedative drugs. Driving and using hazardous machines are not recommended, especially within hours of taking the medication.
DRUG INTERACTIONS (summary)
This drug should not be associated with antidepressants type MAOI nonselective (Marsilid) or selective A (MOCLAMINE): risk of rise in temperature, agitation, sudden drop in blood pressure.
Inform your doctor or pharmacist if you are taking a sedative medication (tranquilizers, sleeping pills, certain pain medications containing opioids , antidepressants , neuroleptics ...).
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
Use of this medication during pregnancy is possible, provided that the recommended dosage is followed. However, its use in the days prior to delivery should be reported to the physician; in fact, special surveillance of the newborn may be necessary.

Breastfeeding:
Some antitussives taken in excessive doses by mothers breastfeeding their children caused respiratory breaks in the latter. This risk has not been observed with dextromethorphan at the recommended doses; but this medication is nevertheless, for safety, contraindicated during breastfeeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
This drug is taken at the time of coughing, by spacing the catches for at least 4 hours.
The tablets should be swallowed with a glass of water.

Usual dosage:

  • Adult: 1 tablespoon (15 ml) or ½ to 1 tablet, 3 or 4 times a day.
  • Children 12 to 15 years: 4 to 6 measuring spoons (5 ml) per day.
  • Children 6 to 12 years: 3 or 4 measuring spoon (5 ml) per day.
  • Child from 30 months to 6 years: ½ measuring spoon (2.5 ml), 4 to 6 times a day.
The duration of treatment should not exceed 5 days without medical advice.
TIPS (summary)
Simple measures to calm dry coughs: hot drinks and humidification of the ambient air.
Smoking is irritating to the bronchi and maintains the cough: Avoid smoking or being exposed to the smoke of others.
A nocturnal cough worsened by this drug may be an allergic cough; ask your doctor for advice.
After opening the bottle, the oral solution should not be stored for more than 1 month.
POSSIBLE ADVERSE EFFECTS (summary)
Drowsiness, dizziness.
Nausea, vomiting, constipation.
Allergic reaction : rash, angioedema , exceptionally bronchospasm .
Cases of abuse and misuse of dextrometorphan have been observed. They can cause serious complications.
Oral solution (presence of maltitol):
Like all medicines and confections containing non-absorbable sugars (sorbitol, maltitol ...), possibility of diarrhea in case of important contribution.


GLOSSARY (summary)


alcohol
General name designating a family of substances that have the property of being able to be mixed with water and fatty substances. The most common alcohol is ethyl alcohol (ethanol), but there are many other alcohols: methanol, butanol, etc. The degree of alcoholic solution corresponds to the volume of pure alcohol present in 100 ml of solution, knowing that 1 glass of wine or 1/2 of beer (25 cl) contains about 8 g of alcohol.
When alcohol is used as an antiseptic, an unpleasant odor denaturant is often added to prevent drinking. Contrary to a widespread belief, alcohol at 70o (or even at 60o) is a better antiseptic than alcohol at 90o.


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


antidepressant
Medication that works against depression. Some antidepressants are also used to combat obsessive-compulsive disorder, generalized anxiety, certain rebellious pain, enuresis, etc.
Depending on their mode of action and adverse effects, antidepressants are divided into different families: imipraminic antidepressants, serotonin reuptake inhibitors, selective or non-selective MAOIs. Finally, other antidepressants do not belong to any of these families, because they possess original properties.
The mode of action of antidepressants has two main aspects: the relief of moral suffering and the fight against inhibition which removes all will to action from the depressed. There may be a time lag between these two effects: moral suffering may persist, while the capacity for action reappears. During this short period, the risk of suicide in some depressed people can be increased. The physician takes it into account in its prescription (possible association with a tranquillizer) and it must imperatively be respected.


asthma
Disease characterized by difficulty breathing, often resulting in wheezing. Asthma, permanent or occurring by crisis, is due to a narrowing and inflammation of the bronchi.


bronchospasm
Abnormal bronchial contraction resulting in difficult and often wheezing breathing. Bronchospasm is one of the factors responsible for asthma.


addiction
Psychic or physical need caused by taking certain natural or medicinal substances. This condition may be accompanied, at cessation of the catch, by various symptoms, grouped under the term of withdrawal syndrome.


respiratory depression
Reduction, or even cessation of respiration, by inhibition of the nervous centers which command the movements of inspiration and expiration.


diarrhea
The strict medical sense of diarrhea is "emission of stools too frequent and too abundant". In fact, common sense equates diarrhea with the notion of fluid and frequent stools. Normally, stools are pasty, but the emission of liquid or barely formed stools, without pain or particular associated disorder, is not pathological. Diarrhea can occur when liquid stool emissions are repeated during the day and the needs are overwhelming or painful.
Many medicines can accelerate intestinal transit and make the stools more liquid, without this undesirable effect being of real concern.
Antibiotics can alter the digestive flora, essential for digestion, and cause more or less troublesome but benign diarrhea. The effect appears immediately or after a few days of treatment. A severe and exceptional form of diarrhea, pseudomembranous colitis, can be observed after antibiotic treatment; this condition results in the emission of mucus and false membranes (resembling skin flaps) associated with abdominal pain; constipation may replace the initial diarrhea. Pseudomembranous colitis can occur several days after discontinuation of antibiotic treatment and requires urgent medical advice.


MAOIs
Abbreviation for mono-amine oxidase inhibitor. Family of drugs used in psychiatry and neurology (depression, Parkinson's disease). These drugs are divided into non-selective MAOIs, which are incompatible with many drugs and even certain foods, and selective MAOIs (A or B), for which these disadvantages are absent or limited.


respiratory failure
Inability of the lungs to properly oxygenate the blood and remove excess carbon dioxide.


neuroleptics
Family of medicines used in the treatment of certain nervous disorders or various symptoms: digestive disorders, menopausal disorders, etc.


new born
Child less than one month old.


opiate
A chemical family that includes opium and its derivatives. In addition to drugs such as opium or heroin, the opiate family includes morphine (strong analgesic), codeine (antitussive and analgesic) and many other substances.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


angioedema
Allergy edema usually affects the face. Quincke edema results in a sometimes spectacular swelling. Eyelids are often the first to be affected. In rare cases where edema affects the throat, respiratory problems may occur and urgent treatment is required.


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.


sedatives
  • Quiets, calms down.
  • Medication belonging to different families: anxiolytics, hypnotics, analgesics, cough suppressants, antiepileptics, neuroleptics, etc. but also antidepressants, antihistamines H1, antihypertensives. A sedative can be responsible for drowsiness and increase the effects of alcohol.


sugar
General term for various substances of which the most widely used is sucrose. Other sugars can be contained in drugs: glucose, fructose, lactose, etc. Glucose is the sugar used by the body; it is the only one to circulate in considerable quantity in the blood.
Sweeteners (false sugar) are allowed in diabetics or people on a diet, and are very low in calories.


symptom
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.


symptomatic treatment
Treatment that suppresses or alleviates the symptoms of a disease without addressing its cause.

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: 06/01/2017

Name of the medicinal product

TUSSIDANE 1.5 mg / ml SUGAR-FREE, oral solution sweetened with liquid maltitol and sodium saccharin

Dextromethorphan hydrobromide

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 or pharmacist.

· This medication is a specialty that can be used without consultation or prescription from a doctor.

· The persistence of the symptoms, the aggravation or the appearance of new disorders, require to take a medical opinion.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist or doctor.

· If you experience any of the side effects, please call your doctor or pharmacist. See section 4.

Do not use this medication for children.

What is in this leaflet?

1. What is TUSSIDANE 1.5 mg / ml SUGAR-FREE, oral solution sweetened with liquid maltitol and saccharin sodium and in which cases it is used?

2. What should I know before taking TUSSIDANE 1.5 mg / ml SUGAR-FREE, oral solution sweetened with liquid maltitol and saccharin sodium?

3. How to take TUSSIDANE 1.5 mg / ml WITHOUT SUGAR, oral solution sweetened with liquid maltitol and saccharin sodium?

4. What are the possible side effects?

5. How to store TUSSIDANE 1.5 mg / ml WITHOUT SUGAR, drinkable solution sweetened with liquid maltitol and saccharin sodium?

6. Package contents and other information.

1. WHAT IS TUSSIDANE 1.5 mg / ml sugar-free, oral solution sweetened with liquid maltitol and sodium saccharin AND WHAT IT IS USED FOR?

Pharmacotherapeutic group - ATC code: R05DA09

This drug is a central antitussive.

This medication is used in the short-term treatment of dry coughs and irritating coughs.

2. BEFORE YOU TAKE TUSSIDANE 1.5 mg / ml sugar-free, oral solution sweetened with liquid maltitol and sodium saccharin?

Do not use TUSSIDANE 1.5 mg / ml SUGAR-FREE, oral solution sweetened with liquid maltitol and saccharin sodium:

· if you are allergic (hypersensitive) to the active substance (dextromethorphan hydrobromide) or any of the other ingredients of this medication (see section 6 for the list of ingredients).

· if you are asthmatic,

· if you are respiratory insufficient,

· In combination with irreversible MAOIs (drugs used in depression).

· In association with cinacalcet (a drug used in the treatment of malignant hypercalcemia and hyperparathyroidism)

· in children under 30 months,

· in breastfeeding,

· (

If in doubt, you should seek the advice of your doctor or pharmacist.

Warnings and Precautions

Take special care with TUSSIDANE 1.5 mg / ml WITHOUT SUGAR, oral solution sweetened with liquid maltitol and saccharin sodium:

Warnings

In the case of chronic (long-term) bronchial or lung disease accompanied by cough with sputum, medical advice is essential.

Do not use a cough with this medicine. In this case, coughing is a natural defense necessary for the evacuation of bronchial secretions.

If the cough becomes fat, accompanied by congestion, sputum, fever, take the advice of your doctor.

Due to the presence of maltitol, this drug should not be used in cases of intolerance to fructose (hereditary metabolic disease).

Concomitant use of dextromethorphan hydrobromide is not recommended in combination with alcohol or other drugs containing alcohol ( see Other medicines and TUSSIDANE 1.5 mg / ml SUGAR-FREE, oral solution sweetened with liquid maltitol and sodium saccharin ).

Precautions for use

In the event of a fever, such as worsening or no improvement after 5 days, do not increase the doses beyond what is recommended, do not take another cough supportive jointly, but CONSULT YOUR DOCTOR.

Do not combine a liquefying medication with bronchial secretions (expectorant, mucolytic) with this antitussive.

Other drugs and TUSSIDANE 1.5 mg / ml SUGAR-FREE, oral solution sweetened with liquid maltitol and sodium saccharin

This medicine contains a dextromethorphan antitussive. Other medicines contain or contain another antitussive. Do not combine them, in order not to exceed the maximum recommended doses.

(See HOW TO TAKE TUSSIDANE 1.5 mg / ml SUGAR-FREE, oral solution sweetened with liquid maltitol and sodium saccharin, below)

This medication MUST NOT BE USED in combination with irreversible MAOIs and cinacalcet.

This medication MUST BE AVOIDED in combination with reversible MAO-A, linezolid and methylene blue, with sodium oxybate or with drugs containing alcohol.

It should be taken into account that many drugs or substances can add up their depressant effects of the central nervous system to that exerted by the dextrometrophane contained in this drug and help to decrease your vigilance.

INFORM YOUR DOCTOR OR PHARMACIST IF YOU TAKE, HAVE RECENTLY TAKEN OR MAY TAKE ANY OTHER MEDICINE, EVEN IF ANY MEDICINE WAS OBTAINED WITHOUT ORDER.

TUSSIDANE 1.5 mg / ml SUGAR-FREE, oral solution sweetened with liquid maltitol and sodium saccharin with food and drink and alcohol

This medication MUST BE AVOIDED in association with alcoholic beverages.

Pregnancy and breast feeding

Pregnancy

It is possible to take a drug containing dextromethorphan during your pregnancy, provided that it is for a short time (a few days) and recommended doses.

However, at the end of pregnancy, dextromethorphan abuse can cause adverse effects in the newborn.

Always seek the advice of your doctor before taking any medicine containing dextromethorphan.

feeding

This drug passes into breast milk.

Excessive doses of dextromethorphan administered to breastfeeding women may result in respiratory breaks or decreased infant tone. Therefore, taking this medication is contraindicated during breast-feeding.

Do not take this medicine without consulting your doctor or pharmacist.

Sport

Not applicable.

Driving and using machines

This medication sometimes causes discrete and transient somnolence or vertigo that may be dangerous for drivers of vehicles (automobile ...) and users of certain machines. This phenomenon diminishes after several catches. It may be helpful to start treatment at night.

This phenomenon is accentuated by the consumption of alcoholic beverages.

TUSSIDANE 1.5 mg / ml SUGAR-FREE, oral solution sweetened with liquid maltitol and sodium saccharin contains liquid maltitol

3. HOW TO TAKE TUSSIDANE 1.5 mg / ml without sugar, oral solution sweetened with liquid maltitol and saccharin sodium?

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

Dosage

In adults and children over 15 years of age : 3 to 4 tablespoons per day without exceeding 6 tablespoons. Catches should be spaced at least 4 hours apart.

In children:

· in children from 30 months to 6 years: 1/2 measuring spoon (2.5 ml) 4 to 6 times a day according to age.

· in children from 6 to 12 years: 3 to 4 measuring spoons (5 ml) per day according to age.

· in children aged 12 to 15 years: 4 to 6 measuring spoons (5 ml) per day according to age.

In the elderly or in case of liver disease : consult your doctor to adjust the dosage.

Administration mode

Oral use.

Rinse the measuring spoon with water after each use.

Frequency of Administration

This medication should only be taken when coughing occurs. For example, for a cough that occurs only in the evening, a single intake of this drug in the evening may suffice.

Space the outlets for a minimum of 4 hours.

Duration of treatment

The duration of use is limited to 5 days without medical advice.

If you take more TUSSIDANE 1.5 mg / ml SUGAR-FREE, oral solution sweetened with liquid maltitol and saccharin sodium you should:

In the event of acute overdose, the following symptoms may occur: nausea and vomiting, tachycardia (rapid heartbeat) and high blood pressure, urinary retention, mydriasis and accommodation disorders, neuropsychological signs: vertigo, ataxia hallucinations, nystagmus, somnolence, confusion, agitation, hyperexcitability and hypertonia (muscular tension).

Severe overdose can lead to convulsions, hyperthermia, coma and respiratory depression (respiratory failure).

In case of suspected overdosage, contact a doctor immediately.

If you forget to take TUSSIDANE 1.5 mg / ml WITHOUT SUGAR, drinkable solution sweetened with liquid maltitol and saccharin sodium:

Do not take a double dose to make up for the missed dose.

If you stop taking TUSSIDANE 1.5 mg / ml WITHOUT SUGAR, drinkable solution sweetened with liquid maltitol and sodium saccharin:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

· dizziness, drowsiness,

· nausea, vomiting, constipation,

· possible allergic reactions (rash, redness or swelling of the face, tongue and throat, rarely respiratory discomfort of sudden onset): stop treatment and consult your doctor,

· due to the presence of maltitol, may lead to digestive problems and diarrhea.

Cases of abuse have been reported.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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 (A nsm ) 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 TUSSIDANE 1.5 mg / ml without sugar, oral solution sweetened with liquid maltitol and saccharin sodium?

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 bottle. The expiry date refers to the last day of that month.

No special storage conditions.

After 1 st opening of the bottle: to keep maximum 30 days.

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 QUE TUSSIDANE contains 1.5 mg / ml sugar-free, oral solution sweetened with liquid maltitol and saccharin sodium

· The active substance is:

Dextromethorphan hydrobromide ............................................... .................................... 1.5 mg

For 1 ml of oral solution.

A measuring spoon (5 ml) contains 7.5 mg of dextromethorphan hydrobromide.

A half measuring spoon (graduation 2.5 ml) contains 3.75 mg of dextromethorphan hydrobromide.

· The other components are:

Liquid maltitol, sodium benzoate, sodium saccharin, caramel flavor, caramel powder (E150), citric acid monohydrate, purified water.

What is TUSSIDANE 1.5 mg / ml sugar-free, oral solution sweetened with liquid maltitol and saccharin sodium and contents of the pack

This medication is in the form of a drinkable solution, the solution is yellow-brown.

Box of 1 vial of 125 ml, 150 ml, 200 ml or 250 ml with a measuring spoon of 5 ml with graduation of 2.5 ml.

Marketing Authorization Holder

LABORATORIES OF ELERT THERAPEUTIC ACHIEVEMENTS

181-183 STREET ANDRE KARMAN

93300 AUBERVILLIERS

LA FRANCE

Marketing Authorization Operator

LABORATORIES OF ELERT THERAPEUTIC ACHIEVEMENTS

181-183 STREET ANDRE KARMAN

93300 AUBERVILLIERS

LA FRANCE

Maker

LABORATORIES OF ELERT THERAPEUTIC ACHIEVEMENTS

181-183 STREET ANDRE KARMAN

93300 AUBERVILLIERS

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:

[to be completed later by the holder]

Other

Not applicable.

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

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