FLUIMUCIL children's juice acetylcysteine

Zambon Ltd

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FLUIMUCIL children's juice acetylcysteine

Fluimucil® children 's juice
Active ingredient: acetylcysteine
​​Application:
liquefaction of mucus and facilitation of expectoration in bronchitis caused by a cold.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist 

Active ingredient: acetylcysteine

For bronchitis caused by a cold.

active ingredients

  • 200 mg acetylcysteine

excipients

  • 10 mg methyl 4-hydroxybenzoate
  • disodium edetat-2 water
  • 15 mg sodium benzoate
  • carmellose sodium
  • Sodium saccharine
  • Sodium hydroxide for pH adjustment
  • sodium hydroxide
  • Raspberry flavor containing propylene glycol
  • 18.75 mg propylene glycol
  • 4.9 mg ethanol
  • water, purified

indication

  • The preparation is a medicine to liquefy tough mucus in the airways.
  • For dissolving mucus and making it easier to cough up in respiratory diseases with tough mucus.

dosage

  • Always take this medicine exactly as described here or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
  • The following information applies unless your doctor has prescribed the medicine differently.
  • Please follow the instructions for use, otherwise the drug will not work properly!
  • Use in children and adolescents
    • Children from 2 - 5 years:
      • 5 ml solution 2 - 3 times a day corresponding to 100 mg acetylcysteine ​​2 - 3 times a day.
    • Children from 6 - 14 years:
      • 10 ml solution twice a day corresponding to 200 mg acetylcysteine ​​twice a day.
    • Adults and young people aged 14 and over:
      • 10 ml solution 3 times a day corresponding to 200 mg acetylcysteine ​​3 times a day.

 

  • duration of use
    • If the clinical picture worsens or does not improve after 4 - 5 days, you should consult a doctor.
  • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

 

  • If you take more than you should
    • In the event of an overdose, symptoms of irritation in the gastrointestinal tract (e.g. abdominal pain, nausea, vomiting, diarrhea) can occur.
    • Serious side effects or symptoms of poisoning have not been observed to date, even after a massive overdose of acetylcysteine ​​tablets. If you suspect an overdose, please notify your doctor.

 

  • If you forget to take a dose
    • If you forget to take the medicine or have taken too little, next time please continue to take it as described in the dosing instructions.

 

  • If you stop taking it
    • Please do not stop treatment without consulting your doctor.
    • Your illness might worsen by this.

 

  • If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

way

  • The medicine is taken after meals according to the dosing instructions.
  • A notice:
    • A slight odor of hydrogen sulphide occurring when the preparation is stored is due to the normal aging process of the preparation. However, as long as the expiry date has not passed, it is harmless and irrelevant with regard to the effectiveness and tolerability of the preparation.
  • See instructions for use for more information!

side effects

  • Like all medicines, this can cause side effects, although not everyone gets them.
  • The frequency of side effects is based on the following categories:
    • Very common: affects more than 1 in 10 people
    • Common: affects 1 to 10 users in 100
    • Uncommon: affects 1 to 10 users in 1,000
    • Rare: affects 1 to 10 users in 10,000
    • Very rare: affects less than 1 in 10,000 people
    • Not known: frequency cannot be estimated from the available data
  • The following side effects may occur:
    • Occasionally:
      • hypersensitivity reactions
      • headache
      • ringing in the ears (tinnitus)
      • tachycardia
      • Vomiting, diarrhea, inflammation of the oral mucosa, abdominal pain, nausea
      • Allergic reaction:
        • Wheal formation, itching, rash, skin and mucous membrane swelling
      • Fever
      • lowering blood pressure
    • Rarely:
      • Shortness of breath, bronchospasm - predominantly in patients with a hyperreactive bronchial system in bronchial asthma
      • Upper abdominal complaints (dyspepsia)
    • Very rare:
      • Hypersensitivity reactions up to shock
      • bleeding
    • Not known:
      • accumulation of water on the face
  • Severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported very rarely in temporal relation to the use of acetylcysteine.
  • In most of these reported cases, at least one other drug was taken at the same time, which could possibly increase the described skin and mucosal effects.
  • If serious skin and mucous membrane changes occur, you should therefore seek medical advice immediately and stop using the product. You must stop taking the medicine.
  • Various studies have confirmed a decrease in platelet aggregation (aggregation of certain blood components) during the use of acetylcysteine. The clinical significance of this is so far unclear.
  • countermeasures
    • If the first signs of a hypersensitivity reaction appear (see above), the drug must not be taken again. In this case, please consult a doctor.
    • Please tell your doctor or pharmacist if any of the side effects gets serious, or if you notice any side effects that are not listed.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

interactions

  • Taking with other medicines
    • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
    • Interaction studies have only been performed in adults.
    • Acetylcysteine/cough suppressants (antitussives)
      • With the combined use of expectorants such. B. this medicinal product and cough suppressants (antitussives) can result in a dangerous build-up of secretion due to the restricted cough reflex, so that the indication for this combination treatment should be determined with particular care. It is therefore essential to consult your doctor before combined use.
    • Acetylcysteine/Activated Charcoal
      • Activated charcoal may reduce the effects of acetylcysteine.
    • acetylcysteine/antibiotics
      • Experimental studies indicate that acetylcysteine ​​reduces the effectiveness of antibiotics (tetracycline, aminoglycosides, penicillins). For safety reasons, antibiotics should therefore be taken separately and at least two hours apart. This does not apply to medicines containing the active ingredients cefixime and loracarbef.
      • These can be taken at the same time as acetylcysteine.
    • acetylcysteine/nitroglycerin
      • Simultaneous administration can possibly lead to an increase in the vasodilating effect of glyceryl trinitrate (nitroglycerin). A possible blood-thinning effect could contribute to this.
      • If your doctor considers it necessary to treat nitroglycerin and this medicine together, he will monitor you for a possible fall in blood pressure (hypotension), which can be severe and may be indicated by the possibility of a headache.
    • acetylcysteine/carbamazepine
      • With simultaneous use with carbamazepine, the effect of carbamazepine may be reduced due to decreased plasma levels.
    • Changes in the determination of laboratory parameters
      • Acetylcysteine ​​can affect the level determination of salicylates.
      • In urine tests, acetylcysteine ​​can affect the results of the determination of ketone bodies.
    • Dissolving other medicines in the solution is not recommended.

Contraindications

  • The drug must not be taken
    • if you are allergic to acetylcysteine ​​or any of the other ingredients of this medicine.
  • The medicine should not be used in children under 2 years of age.

pregnancy and breast feeding period

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  • Since there is not enough experience with the use of acetylcysteine ​​during pregnancy and breastfeeding, you should only use the drug during pregnancy and breastfeeding if your doctor considers it absolutely necessary.

patient notes

  • Warnings and Precautions
    • Talk to your doctor or pharmacist before taking this medicine if you
      • notice skin changes. Severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported very rarely in temporal relation to the use of acetylcysteine.
      • If new skin and mucous membrane changes occur, medical
        advice should therefore be sought immediately and the use of acetylcysteine ​​should be discontinued.
      • suffer from bronchial asthma.
      • have ever had a stomach or gut ulcer, especially if you are taking other medicines that can irritate the lining of the stomach.
      • suffer from histamine intolerance. Long-term therapy should be avoided in these patients, since the drug has a moderate effect on histamine metabolism and can lead to intolerance symptoms (e.g. headaches, runny nose, itching).
      • have difficulty coughing up secretions. The use of the drug can lead to liquefaction and thus to an increase in volume of the bronchial secretion, especially at the beginning of treatment. If you are not able to cough it up sufficiently, your doctor will take appropriate measures.
    • children and young people
      • Mucolytics can cause airway obstruction in children less than 2 years of age due to their airway characteristics and limited ability to expectorate mucus. Therefore, mucolytics should not be used in children under 2 years of age.

 

  • Ability to drive and use machines
    • The drug has no or negligible influence on the ability to drive or use machines