Flavamed Max tabs 60mg #10

Flavamed Max user manual

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pharmachologic effect

Ambroxol is an active N-demethylated metabolite of bromhexine.
Has a secreto-motor, secretolitic and expectorant action. It stimulates the work of the bronchial glands, increases the motor activity of the ciliated epithelium by influencing the pneumocytes of type 2 in the alveoli and the Clara cells in the bronchioles, enhances the formation of an endogenous surfactant, a surface-active substance that ensures the gliding of the bronchial secretion in the airway lumen. Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure, contributing to a decrease in viscosity and liquefaction of sputum; as a result of which mucociliary transport improves and the excretion of sputum from the bronchial tree is facilitated.
On average, the effect of Flavamed Max on ingestion is manifested after 30 minutes, the duration of the action is 6-12 hours, depending on the dose taken.

Indications for Flavamed Max

Disturbance of secretion and transport of sputum in acute and chronic diseases of the respiratory system:
    acute and chronic bronchitis;
    pneumonia;
    chronic obstructive pulmonary disease;
    bronchial asthma;
    bronchiectatic disease.

Contraindications

    Hypersensitivity to the components of Flavamed Max (see section "Composition");
    hereditary intolerance to fructose;
    hereditary intolerance of galactose, lactase deficiency or glucose malabsorption syndrome and galactose;
    I trimester of pregnancy and the period of breastfeeding;
    children under 12 years.

Carefully

    Disturbance of bronchial motility and increased secretion of mucus (for example, with a rare syndrome of primary dyskinesia of cilia);
    renal failure and / or severe hepatic impairment;
    peptic ulcer of the stomach and duodenum, including in the anamnesis;
    II and III trimesters of pregnancy.

Application in pregnancy and lactation

The use of the drug Flavamed max in the first trimester of pregnancy and the period of breastfeeding is contraindicated.
The use of Flavamed Max in the II and III trimesters of pregnancy is possible only after a thorough assessment of the relationship between the benefits of treatment and the possible risks.

special instructions for Flavamed Max

There is evidence of the occurrence in very rare cases of skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis) with ambroxol. If allergic reactions occur, discontinue use immediately and consult a doctor.
In severe renal failure (creatinine clearance less than 30 ml / min), it is necessary to take into account the danger of accumulation of metabolites of ambroxol formed in the liver.
Mucolytics can damage the mucous barrier of the gastrointestinal tract, so ambroxol should be used with caution in patients with peptic ulcer of the stomach and duodenum, including in the anamnesis.
To maintain the secretolytic action of the drug Flavamed max during the period of application of the drug, it is necessary to ensure that a sufficient amount of liquid is supplied to the body.
In patients with bronchial asthma, ambroxol may increase cough.
In one effervescent tablet of the preparation Flavamed max contains 126.5 g of sodium, which should be taken into account for patients who follow a diet with a low sodium content.
The preparation Flavamed max contains sorbitol (sorbitol) and lactose, therefore its use in patients with hereditary intolerance to fructose, hereditary intolerance to galactose, a deficiency of lactase or a syndrome of malabsorption of glucose and galactose is contraindicated.
Information for patients with diabetes: 1 tablet contains 29 mg of sorbitol, which corresponds to 0.0024 of a grain unit (XE).

Composition

For 1 tablet:
active ingredient: ambroxol hydrochloride - 60.00 mg;
additives: citric acid anhydrous - 846.90 mg, sodium hydrogen carbonate - 298.00 mg, sodium carbonate anhydrous - 71.00 mg, sodium saccharinate - 9.00 mg, sodium cyclamate - 45.00 mg, sodium chloride - 20, 00 mg, sodium citrate 0.70 mg, anhydrous lactose 110.00 mg, mannitol 180.00 mg, sorbitol 29.00 mg, cherry flavor 30.00 mg, simethicone 0.40 mg.

Dosing and Administration

Inside. It is recommended to take after eating. The tablet is dissolved in a glass of water at room temperature, the resulting solution immediately drink.
If the doctor is not prescribed otherwise, the following doses are recommended:
Adults and children over 12 years: 1/2 tablet of the Flavamed Max preparation 3 times a day (corresponding to 90 mg ambroxol hydrochloride / day) for the first 2-3 days, then 1/2 tablet of the Flavamed max 2 once a day (corresponding to 60 mg ambroxol hydrochloride / day).
If necessary, adults can take 1 tablet of Flavamed Max twice a day (corresponding to 120 mg ambroxol hydrochloride / day).
In patients with renal insufficiency and / or severe hepatic insufficiency, Flavamed Max should be taken with longer intervals between doses or in reduced doses.
Duration of application is determined individually, depending on the indications and course of the disease. Usually the preparation of Flavamed max is taken no more than 4-5 days, longer application requires a doctor.

Side effects of Flavamed Max

Possible side effects are shown below in the descending frequency of the occurrence of the event: very often (≥ 1/10), often (≥ 1/100,
Disorders from the gastrointestinal tract
Often: nausea;
Infrequent: vomiting, dryness of the oral mucosa, diarrhea, dyspepsia, abdominal pain.
Immune system disorders
Infrequently: hyperthermia;
Rare: skin rash, hives;
In isolated cases: anaphylactic reactions up to the development of shock, angioedema, skin itching and other hypersensitivity reactions.
Disturbances from the skin and subcutaneous tissues
Very rarely: toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome (see section "Special instructions");
Frequency unknown: acute generalized exanthematous pustulosis.
Disturbances from the nervous system
Often: dysgeusia (a violation of taste sensations).
Disturbances from the respiratory system, chest and mediastinal organs
Often: decreased sensitivity in the oral cavity and pharynx;
Rarely: dryness of the mucous membrane of the respiratory tract, rhinorrhea;
In single cases: dryness of the mucous membrane of the pharynx.

Drug Interactions

With the simultaneous use of ambroxol and antitussive drugs, for example, codeine, by suppressing the cough reflex, there may be a danger of sputum congestion in the airway lumen with difficulty in removing it, so simultaneous use of ambroxol and antitussive drugs should be carried out with extreme caution.
Increases the penetration of the bronchial lumen of amoxicillin, cefuroxime, erythromycin and doxycycline.

Overdose

Symptoms: specific symptoms of an overdose of ambroxol in humans are not described. Observed symptoms of overdose corresponded to known side effects of ambroxol used in recommended doses (nausea, vomiting, abdominal pain, diarrhea, indigestion).
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products; symptomatic therapy.
Because of the high degree of binding of ambroxol to blood plasma proteins, 80-90%, forced diuresis and hemodialysis are ineffective.

Storage conditions

At a temperature of no higher than 25 ° C in a tightly closed container.
Shelf life - 3 years.

Terms of sell

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