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FLUIMUCIL Acetylcysteine NAC 600mg Adult 10 sachets
Over-the-counter medication

FLUIMUCIL Acetylcysteine NAC 600mg Adult 10 sachets

Brand : Zambon Zambon

FLUIMUCIL Acetylcysteine (NAC) 600mg Adult 10 sachets in our organic pharmacy is a medicine indicated in adults for the treatment of bronchial disorders in which a reduction in the viscosity of bronchial secretions is necessary to facilitate expectoration, particularly during episodes of acute bronchitis.

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Fluimucil Acetylcysteine NAC 600 mg Adult 10 sachets is a medicine indicated in adults for the treatment of bronchial disorders in which a reduction in the viscosity of bronchial secretions is necessary to facilitate expectoration, particularly during episodes of acute bronchitis.

Description of FLUIMUCIL Acetylcysteine 600mg Adult 10 sachets

Acetylcysteine is a mucolytic. Mucolytic activity is mediated by a reduction in bronchial mucus viscosity. This can be explained by depolymerization, with the opening of disulfide bridges between macromolecules. Acetylcysteine is also a precursor of glutathione. Acetylcysteine is derived from the naturally occurring amino acid cysteine, which is a substrate for glutathione synthesis in the body. Acetylcysteine can normalize glutathione depletion. Acetylcysteine is rapidly absorbed after oral administration and distributed throughout the body.

Directions for use and dosage

For adults only
1 sachet once a day
Dissolve in half a glass of water.

Give your opinion on the recommendations for use and dosage of FLUIMUCIL Acetylcysteine 600mg Adult 10 sachets with our partner Verified opinions after your purchase.

Composition

For one sachet :

Acetylcysteine: 600 mg

Notable effect excipients:

75 mg aspartam (E 951)
2,025 mg sorbitol (E 420)
300 mg orange flavoring (contains glucose and lactose)

Excipients:

Aspartam (E 951), sorbitol (E 420), orange flavor (contains glucose and lactose).

Precautions for use

Contraindicated in cases of hypersensitivity to the active substance or to any of the excipients listed under Composition.

Presentation of FLUIMUCIL Acetylcysteine 600mg Adult 10 sachets

Fluimucil comes in a box of 10 sachets.

Our advice and expert opinions

Acute bronchitis is an acute inflammation of the bronchial mucosa and often of the trachea, most often following a viral infection, particularly during the winter months. In some cases, especially in frail people or those with chronic respiratory problems, bronchitis may be due to a bacterial infection. Inflammation makes breathing more difficult, as the bronchial walls become swollen and produce large quantities of mucus.

Symptoms of bronchitis

  • A deep cough. Coughing intensifies when lying down, outdoors when the air is cold and dry, and if the air is laden with irritating substances, such as cigarette smoke.
  • Viscous, light-colored, yellowish or greenish sputum.
  • General malaise: chills, fatigue, loss of appetite, headaches, body aches. A slight fever may also be present.
  • Chest pain and a feeling of lung compression.
  • Shortness of breath.

Ginger + honey to eliminate phlegm
Ginger has powerful therapeutic properties. That's why it's often used to treat colds. Ginger also acts on stubborn mucus. It reduces coughing and soothes the respiratory tract.
Honey has antibacterial and antifungal properties: it's ideal if you're suffering from a sore throat or have a cold and are congested with mucus. Honey deposits a protective layer in your throat. This reduces irritation and helps repair damaged mucous membranes.

Fluimucil Acetylcysteine NAC 600 mg: The Solution to Facilitate Expectoration of Bronchial Secretions

Fluimucil Acetylcysteine NAC 600 mg is a drug for the treatment of bronchial disorders in adults, where it is necessary to reduce the viscosity of bronchial secretions to facilitate their expectoration. It is particularly effective during episodes of acute bronchitis. Find out how this medicine can help relieve the symptoms associated with these conditions.

Indications :

Fluimucil Acetylcysteine NAC 600 mg is indicated in adults for the treatment of bronchial conditions where a reduction in the viscosity of bronchial secretions is necessary to facilitate expectoration. This condition is often observed during episodes of acute bronchitis, an inflammation of the bronchial tubes characterized by a productive cough.

Mechanism of Action:

Acetylcysteine, the active ingredient in Fluimucil, acts by breaking down the chemical bonds responsible for the viscosity of bronchial secretions. By making these secretions less thick, it facilitates their elimination by coughing, helping to clear the airways and relieve bronchial congestion.

Directions for use :

  • Take Fluimucil Acetylcysteine NAC 600 mg as recommended by your healthcare professional.
  • Dosage and duration of treatment are determined according to your individual state of health.
  • Dissolve the contents of the sachet in a glass of water before taking.

Precautions and Warnings :

  • Consult a health care practitioner if symptoms persist or worsen.
  • Inform your doctor of all medications you are currently taking, including supplements, to avoid possible interactions.
  • Avoid taking medications containing acetylcysteine at the same time as Fluimucil without the advice of your doctor.

Fluimucil Acetylcysteine NAC 600 mg is an effective solution for reducing the viscosity of bronchial secretions and facilitating expectoration in adults suffering from bronchial diseases, particularly acute bronchitis. However, it is essential to follow your healthcare professional's recommendations and take appropriate precautions to ensure safe and effective use of this medication.

Pharmacovigilance Report an adverse drug reaction(s)

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NOTICE

ANSM - Updated: 22/10/2018

Name of the drug

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution

acetylcysteine

framed

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use this medicine exactly as described in this leaflet or by your doctor, pharmacist or nurse.

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

· Talk to your pharmacist for any advice or information.

· If you get any side effects, whether or not mentioned in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

· You should talk to your doctor if you do not feel better or feel worse after 8-10 days.

What does this booklet contain ?

1. What is FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution and in which cases is it used?

2. What you need to know before using FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution?

3. How to use FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution?

4. What are the possible side effects?

5. How to store FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution?

6. Contents of the package and other information.

1. WHAT IS FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution AND WHAT IT IS USED FOR?

Pharmacotherapeutic class - ATC code: R05C B01.

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, contains acetylcysteine which is the active substance. This medicine is a mucolytic. It degrades and thins the thick mucus, making it more liquid and easier to remove by coughing. FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, is used in adults for the treatment of bronchial affections in which a reduction in viscosity is necessary to facilitate expectoration, especially during episodes of acute bronchitis.

You should talk to your doctor if you do not feel better or feel worse after 8-10 days.

2. BEFORE YOU USE ACETYLCYSTEINE ALPEX 600 mg granules for oral solution?

Do not use FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution:

· if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).

This medication should not be used (contraindicated) in children under 2 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS granules for oral solution in the situations described below.

· If breathing difficulties, such as shortness of breath that may be associated with coughing and / or increased bronchial secretions, occur after taking this medication. It may be bronchospasm (sudden decrease in the size of the bronchi). In this case, you should immediately stop treatment with FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, and seek medical attention.

· If you have a peptic ulcer or if you have had a peptic ulcer in the past. FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, may irritate the stomach lining, especially if you are taking other medicines known to irritate the lining of the stomach.

· Rare cases of severe hypersensitivity reactions with fever (high), redness of the skin, joint pain and / or eye damage (Stevens-Johnson syndrome) or sudden hypersensitivity reactions with fever and vesicles on skin or skin detachment have been reported during treatment with acetylcysteine. If any abnormalities occur in the skin or mucous membranes, you should immediately stop using acetylcysteine and consult a doctor.

· When the thick bronchial mucus becomes more liquid, its volume increases, especially at the beginning of the treatment. If you have difficulty expectorating and evacuating fluid mucus while coughing, you should consult a doctor who will take the appropriate measures.

A slight smell of sulfur (smell of rotten egg) can be released when opening the package. This odor is normal and characteristic of the active substance. It does not indicate an alteration of the drug.

Consult your doctor if you are concerned with any of the situations described above.

Children and adolescents

Medications, such as FLUIMUCIL EXPECTORANT ACETYLCYSTEINE, that thin mucus (mucolytics) can cause airway obstruction in children under 2 years of age due to airway features in these patients. As a result, the ability to remove bronchial secretions by sputum (spitting) can be reduced. Also, FLUIMUCIL EXPECTORANT ACETYLCYSTEINE should not be used (contraindicated) in children under 2 years of age.

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution should not be used in children and adolescents. Other pharmaceutical forms suitable for children and adolescents are available. Ask your doctor or pharmacist.

Consult your doctor if you are concerned with any of the situations described above.

Other medicines and FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you use other medicines, you should not dissolve them in the solution of FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution.

If you are taking antibiotics (medicines prescribed for the treatment or prevention of infections), you should take these medicines 2 hours before or after taking FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution.

You should not use antitussive drugs (cough-reducing medications) at the same time as FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, because coughing helps you to expectorate (spit) bronchial secretions (mucus) whose fluidity is increased by the treatment.

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, may increase the antihypertensive effect (decreases blood pressure) of nitroglycerin which is a drug used to treat angina pectoris (feeling of oppression of cardiac origin in the thorax). Caution is required.

Taking activated charcoal (a drug used to treat traveler's diarrhea) may decrease the effect of FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution.

This medicine does not contain sodium or sugar.

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution with food, beverages and alcohol

Not applicable.

Pregnancy and breast feeding

There is limited data on the use of acetylcysteine in pregnant women. Studies in animals have not shown any direct or indirect harmful effect on the pregnancy or development of the child before, during or after birth. FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, should be used during pregnancy only if necessary, after a careful evaluation of the risks and benefits.

It is not known if acetylcysteine is excreted in breast milk. FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, should be used during breastfeeding only if necessary, after a careful evaluation of the risks and benefits.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No data on the effect of acetylcysteine on the ability to drive and use machines are available. An effect of acetylcysteine is unlikely, however.

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution contains:

Not applicable.

3. HOW TO USE FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution?

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

adults

The recommended dose is 1 sachet once a day.

Patients who have difficulty expectorating mucus (elderly patients or debilitated patients) should take the medicine in the morning.

Dissolve this medicine in half a glass of water. Drink the solution immediately.

If you have used more FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution than you should:

If you have used more FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, than you should, contact your doctor or pharmacist immediately.

Possible symptoms of overdose are nausea, vomiting and diarrhea.

If you forget to use FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution:

If you missed a dose and the next dose is close, do not take the missed dose, but continue with the rate of intake listed under "How to use FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for solution drinkable".

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

If you stop using FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution:

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

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

You should immediately stop using FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, and contact your doctor or the emergency department of your local hospital if any of the following side effects occur:

· Hypersensitivity reaction manifested by a significant drop in blood pressure, pallor, agitation, slowing of the pulse, moist skin, decreased consciousness (anaphylactic shock causing sudden dilation of the blood vessels).

· Allergic reaction manifested by angioedema (sudden swelling of the skin or mucous membranes, for example in the throat or tongue), difficulty breathing and / or itching and rash

The reactions described above are serious side effects. If you get these reactions, you may have developed a severe allergic reaction to FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution. You must receive urgent medical attention or be hospitalized.

This serious side effect is very rare (seen in less than 1 in 10,000 users).

There is also a very rare risk of bleeding.

You should tell your doctor if you develop any of the following side effects after taking this treatment:

· bronchospasm: difficulty breathing with shortness of breath (dyspnea) or shortness of breath in connection with a sudden narrowing of the size of the bronchi (do not renew the catch)

· feeling of heaviness in the stomach, pain in the stomach, regurgitation, nausea and heartburn (dyspepsia)

These side effects are rare (observed in 1 to 10 users out of 10,000).

· Hypersensitivity (allergic reaction)

may manifest as bronchospasm (abrupt reduction of the size of the bronchi) and dyspnea (feeling of choking, see above), an acceleration of the heart rate (tachycardia), itching (pruritus), a rash with severe itching and plaque formation (urticaria) and angioedema.

· Headache (headache)

· Tinnitus (tinnitus)

· Inflammation of the oral mucosa (stomatitis)

· Diarrhea

· Fever (pyrexia)

· Decreased blood pressure (hypotension)

· Abdominal pain

· nausea

· vomiting

These side effects are uncommon (seen in 1 to 10 users in 1,000).

If you have a stomach ulcer or have had a stomach ulcer in the past, acetylcysteine can have a harmful effect on your gastrointestinal lining.

If you get any side effects, whether or not mentioned in this leaflet, please tell your doctor or pharmacist. Consult your doctor or pharmacist if you notice that the effect of FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, is too strong or too weak.

Declaration of side effects

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

By reporting side effects, you can help provide more information on the safety of the medicine.

5. HOW TO STORE FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution?

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

Do not use this medicine after the expiry date which is stated on the sachet or carton after "EXP". The expiry date refers to the last day of this month.

Store the medicine in the original package to protect from moisture.

Do not use this medicine if you notice any visible signs of deterioration.

It is possible that you feel a slight smell of sulfur when opening the package. It's normal and harmless.

Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.

6. CONTENTS OF PACKAGING AND OTHER INFORMATION

What FLUIMUCIL EXPECTORANT ACETYLCYSTEINE contains 600 mg ADULTS, granules for oral solution

· The active substance is:

acetylcysteine

· The other excipients are:

maltodextrin (E1542), sucralose (E955), anhydrous colloidal silica (E551) and orange flavor (containing gum arabic (E414), butylated hydroxyanisole (E320), citric acid monohydrate (E330) and maltodextrin).

What FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution and contents of the pack

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, is in the form of white to yellowish granules packaged in sachets. Cardboard boxes containing 6, 10, 12, 20 or 30 sachets per box.

Not all presentations may be marketed.

Marketing Authorization Holder

ALPEX PHARMA (UK) LIMITED

PO BOX 849

HAYNES, BEDFORD

MK45 9EG

UNITED KINGDOM

Operator of the marketing authorization

ZAMBON FRANCE SA

13 RENE JACQUES STREET

92138 ISSY-LES-MOULINEAUX CEDEX

LA FRANCE

Maker

KYMOS PHARMA SERVICES, SL

RONOLA OF CAN FATJO, 7B

PARC TECHNOLOGICO DEL VALLES

CERDAYOLA DEL VALLES

BARCELONA

SPAIN

Names of the medicine in the member states of the European Economic Area

This medicine is authorized in the member states of the European Economic Area under the following names:.

Netherlands: ACETYLCYSTEINE ALPEX 600 mg, granulaat voor drank

France: FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution

The last date this leaflet was revised is:

[to be completed later by the holder]

Other

Not applicable.

Bronchial fluid

acetylcysteine

. Presentations . Composition . Indications . Contraindications . Attention . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon

PRESENTATIONS (summary)

FLUIMUCIL 200 mg Adult: granulated for oral solution (orange flavor); box of 18 sachets.
Not refunded - Free price -

FLUIMUCIL 2% Adult: oral solution (raspberry flavor); bottle of 200 ml with measuring cup of 10 ml.
Not refunded - Free price -

FLUIMUCIL 600 mg Adult: granulated for oral solution (orange flavor); box of 10 sachets.
Not refunded - Free price -

Zambon France Laboratory

COMPOSITION (summary)
p bag p 10 ml p bag
acetylcysteine 200mg 200mg 600 mg
aspartame +
Sodium 37.5 mg
parabens +

INDICATIONS (summary)
This drug fluidifies the secretions (phlegm) present in the bronchi. It facilitates their evacuation by coughing.
It is used in cases of heavy cough with difficulty in spitting during acute bronchitis.
CONTRAINDICATIONS (summary)
200 mg sachets should not be used in cases of phenylketonuria (presence of aspartame).
ATTENTION (summary)
Precautions are necessary in case of ulcer of the stomach or duodenum .
Do not use antitussive in addition to this medicine without the advice of your doctor or pharmacist.
If secretions persist for more than a few days, if they are colored or if you have a fever, consult your doctor.
The oral solution contains salt ( sodium ) in a significant amount.
PREGNANCY and BREASTFEEDING (summary)
The effect of this medicine during pregnancy or breastfeeding is poorly understood. The evaluation of the potential risk linked to its use is individual: ask your pharmacist or your doctor for advice.
DIRECTIONS AND DOSAGE (summary)
This medication can be taken interchangeably during or after meals.
The contents of the sachet must be dissolved in half a glass of water.

Usual dosage:

  • Adult: 1 200 mg bag or 1 scoop of 10 ml, 3 times a day or 1 sachet at 600 mg a day.
Treatment can be stopped as soon as the symptoms improve. Its duration must not exceed 6 days without medical advice.
TIPS (summary)
Smoking, or being exposed to the smoke of others, is a major obstacle to the evacuation of phlegm.
It is necessary to fight against the drought of the ambient air (humidifier ...) to avoid the drying of the secretions. It is also recommended to drink a lot.
In the elderly, the inability to evacuate sputum can justify the help of a physiotherapist, on prescription.
After opening the bottle, the oral solution is stored for 15 days at room temperature. Rinse the measuring cup after each use.
200 mg sachets and 2% oral solution may be freely accessible (or direct access) in some pharmacies; in this case, have your choice validated by your pharmacist
ADVERSE POSSIBLE EFFECTS (summary)
Allergic skin reaction (itching, rash, hives ...).
Stomach pain, nausea, diarrhea, requiring a decrease in doses.
Aggravation of bronchial congestion and risk of respiratory complications, especially in infants.


LEXICON (summary)


antitussive
Drug that fights coughs. The most powerful antitussives contain codeine or codethyline.


duodenum
Part of the intestine into which food from the stomach enters.


phenylketonuria
Hereditary disease that is characterized by the absence of an enzyme and which leads to the accumulation in the blood of a toxic product. Its screening is systematic at birth. Treatment is based on a specific diet during infancy.


Allergic reaction
Reaction due to the hypersensitivity of the body to a drug. Allergic reactions can be very varied: urticaria, angioedema, eczema, rash of measles-like pimples, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort by sudden drop in blood pressure.


salt
Chemical substance of which the best known is sodium chloride, or table salt. Diet salt does not contain sodium; this one is replaced generally by potassium.


sodium
Mineral substance that can form salts, especially with chlorine (sodium chloride, or table salt).


ulcer
Intense lesion of the skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Gastroduodenal ulcer: localized wound of the lining of the stomach or duodenum, due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and taking certain medications (aspirin, NSAIDs, etc.).

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