Hypersensitivity to ambroxol, acetylcysteine or other components that make up the preparation. peptic ulcer of the stomach and duodenum in the acute stage. hemoptysis, pulmonary hemorrhage.
From the immune system: hypersensitivity reactions, including anaphylactic reactions or even shock, rash, urticaria, reactions from the mucous membranes, angioedema, fever, dyspnea, itching, etc.
Skin and subcutaneous tissue disorders: erythema, eczema, severe skin lesions - Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).
From the digestive system: dry mouth, salivation, heartburn, nausea, vomiting, dyspepsia, stomatitis, abdominal pain, diarrhea, constipation, bad breath.
On the part of the respiratory system: rhinorrhea, dry airways, bronchospasm (mainly in patients with hyperresponsiveness of the bronchial system, which is associated with asthma).
From the urinary system: dysuria.
From the side of the organ of hearing: ringing in the ears.
From the nervous system: headache.
From the side of the cardiovascular system: tachycardia, arterial hypotension.
With the use of acetylcysteine, bleeding was very rarely reported, which was most often associated with the development of hypersensitivity reactions; cases of anemia, hemorrhages. There have been cases of a decrease in platelet aggregation, but there is no clinical confirmation of this.
When taking the preparation in the form of a powder for oral suspension, it is possible to develop a mild laxative effect due to the content of mannitol (E421).
Special instructions
Several severe skin reactions (Stevens-Johnson and Lyell syndromes) have been reported that coincided with the use of ambroxol hydrochloride or acetylcysteine. in most cases, they could be explained by the severity of the underlying disease in patients with / or the simultaneous use of another preparation. also in the early stages of Stevens-Johnson syndrome or Lyell's syndrome, patients may have nonspecific flu-like symptoms such as fever, aches, rhinitis, cough, and sore throat. erroneously, with such nonspecific symptoms, symptomatic treatment with preparations for cough and cold can be used. therefore, if new lesions of the skin or mucous membranes appear, you should immediately seek medical attention and stop taking Ambroxol hydrochloride.
Since ambroxol can increase mucus secretion, the preparation should be used with caution in case of impaired bronchial motility and increased mucus secretion (for example, in such a rare disease as primary ciliary dyskinesia).
The use of acetylcysteine causes dilution of bronchial secretions. If the patient is unable to effectively cough up sputum, postural drainage and bronchoaspiration are necessary.
Use the preparation with caution in patients with asthma, with a history of gastric and duodenal ulcers.
Use with caution in patients with impaired renal function, severe liver disease (namely, the interval between use should be increased or the dose reduced); in patients with severe renal impairment, the accumulation of metabolites that are formed in the liver is expected.
Pulmobreathe, a powder for oral suspension, contains aspartame, which is a source of phenylalanine, so the preparation should not be used in patients with phenylketonuria.
Use during pregnancy and lactation. The preparation is not recommended for use in the first trimester of pregnancy.
There are no relevant data on the teratogenic effect of ambroxol hydrochloride and acetylcysteine on the fetus, therefore, the preparation can be used in the II – III trimesters of pregnancy only when the expected benefit to the mother outweighs the potential risk to the fetus.
Since ambroxol hydrochloride and acetylcysteine pass into breast milk, it is undesirable to take the preparation during breastfeeding. If necessary, the appointment of the preparation should stop breastfeeding.
The ability to influence the reaction rate when driving or working with other mechanisms. There is no data on the effect on the reaction rate when driving vehicles or other mechanisms.
Children. For use in children over 12 years of age.
Interactions
There is a synergism of acetylcysteine with bronchodilators.
Acetylcysteine reduces the hepatotoxic effect of paracetamol; can donate cysteine and increase glutathione levels, which helps detoxify free oxygen radicals and certain toxic substances in the body.
The use of ambroxol increases the concentration of antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline in sputum and bronchopulmonary secretions.
The simultaneous use of the preparation and cough suppressants can lead to excessive accumulation of mucus due to inhibition of the cough reflex. Therefore, such a combination is possible only after a thorough assessment by the doctor of the ratio of the expected benefit and the possible risk of use.
With simultaneous use with antibiotics such as tetracycline (with the exception of doxycycline), ampicillin, amphotericin B, cephalosporins, aminoglycosides, their interaction with the thiol group of acetylcysteine is possible, which leads to a decrease in the activity of both preparations. Therefore, the interval between the use of these preparations should be at least 2 hours. This does not apply to cefixime and loracarbef.
Activated carbon reduces the effectiveness of acetylcysteine.
The simultaneous intake of nitroglycerin and acetylcysteine can lead to an increase in the vasodilating effect of nitroglycerin.
Acetylcysteine affects the metabolism of histamine, therefore, long-term therapy should not be prescribed to patients with histamine intolerance, as this can lead to symptoms of intolerance (headache, vasomotor rhinitis, itching).
The use of acetylcysteine may alter colorimetric assays and urine ketones.
When the powder for oral suspension comes into contact with metals or rubber, sulfides with a characteristic odor are formed, therefore, glassware should be used to dissolve the preparation.
Overdose
There are no data on cases of overdose of oral dosage forms of acetylcysteine.
Ambroxol is well tolerated after parenteral administration at doses up to 15 mg / kg / day and after oral administration up to 25 mg / kg / day. In the case of an overdose with ambroxol, no severe signs of intoxication were noted. Cases of short-term anxiety and diarrhea, hypersalivation have been reported. Children are at risk of hypersecretion.
Similar to preclinical studies, excessive overdose can lead to hypersalivation, nausea, vomiting, and low blood pressure.
Treatment. Urgent measures such as inducing vomiting and gastric lavage are generally not indicated and should be used in cases of acute intoxication. Symptomatic treatment is recommended.
Storage conditions
Keep out of the reach of children in the original packaging at a temperature not exceeding 25 ° C.