Flavamed max instructions for use effervescent tablets. Flavamed forte, effervescent tablets

Instructions for medical use of the drug

Flavamed® Forte

Tradename

Flavamed® Forte

International nonproprietary name

Ambroxol

Dosage form

Effervescent tablets 60 mg

One effervescent tablet contains

active substance - 60 mg ambroxol hydrochloride.

excipients: anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, sodium saccharin, sodium cyclamate, sodium chloride, sodium citrate, anhydrous lactose, mannitol, sorbitol, cherry flavor "ALH" (code 801), simethicone.

Description

White tablets with a smooth surface, round in shape, with a notch for breaking on one side, with a cherry odor.

Pharmacotherapeutic group

Expectorants. Mucolytics.

ATC code R05CB06

Pharmacological properties

Pharmacokinetics

Ambroxol is almost completely absorbed after oral administration. Tmax ranges from 1 to 3 hours. The absolute bioavailability of ambroxol decreases by about a third after first passing through the liver. During this process, metabolites are formed (for example, dibromo-substituted orthoaminobenzoic (dibromomantronilic) acid, glucuronides), which are then excreted through the kidneys. Plasma protein binding is approximately 85% (80 - 90%). The final plasma half-life is 7 - 12 hours. The plasma half-life for ambroxol and its metabolites is approximately 22 hours.

Ambroxol overcomes the placental barrier and penetrates into the cerebrospinal fluid and breast milk.

90% of the substance is excreted by the kidneys in the form of metabolites formed in the liver. The amount of unchanged ambroxol excreted by the kidneys is less than 10%.

Due to the high level of protein binding and large volume of distribution, as well as the slow redistribution of ambroxol from tissues to the blood, large amounts of ambroxol should not be expected to be excreted by dialysis or forced diuresis.

In severe liver diseases, the clearance of sambroxol is reduced by 20 - 40%. In cases of severe renal dysfunction, accumulation of ambroxol metabolites should be expected.

Pharmacodynamics

The active substance Flavamed® Forte - ambroxol is a benzylamine derivative and a metabolite of bromhexine. It differs from bromhexine in the absence of a methyl group and the presence of a hydroxyl group in the trans position of the cyclohexyl ring. Despite the fact that the mechanism of action of this substance is not yet fully understood, its secretolytic and secretomotor effects have been discovered in various studies.

On average, when administered orally, the effect of the drug begins 30 minutes after administration and lasts from 6 to 12 hours, depending on the size of a single dose.

Flavamed® Forte leads to an increase in the proportion of serous secretion. Acceleration of secretion discharge apparently occurs due to a decrease in its viscosity and activation of the ciliated epithelium.

The active substance Flavamed® Forte ambroxol causes the activation of surfactants, acting directly on type II pneumocytes of the alveoli and Claire cells in the area of ​​the small airways.

Indications for use

mucolytic therapy for acute and chronic bronchopulmonary diseases accompanied by impaired formation and elimination of sputum

Adults and teenagers over 12 years old:

As a rule, 1/2 tablet of effervescent Flavamed®Forte should be taken 3 times a day for the first 2 - 3 days (equivalent to three 30 mg doses of ambroxol hydrochloride); subsequently, ½ Flavamed® Forte effervescent tablet is taken twice a day (equivalent to two 30 mg doses of ambroxol hydrochloride).

Typically, the maximum daily dose of Flavamed® Forte is 90 mg. If necessary, for adults the dose can be increased to 60 mg twice daily (equivalent to 120 mg ambroxol hydrochloride per day).

Dissolve the effervescent tablets in a glass of water and drink the resulting solution after meals.

Flavamed® Forte effervescent tablets should not be taken for more than 4-5 days without a doctor’s prescription.

For dosage information for liver and kidney diseases, see Special Instructions

Side effects

Sometimes (≥ 1/1000 -< 1/100)

nausea, stomach pain, vomiting

allergic reactions (skin rash, facial swelling, respiratory failure, itching), fever

Very rarely(< 1/10000)

severe skin reactions such as Stevens-Johnson syndrome and epidermal necrosis

anaphylactic reactions up to shock

Contraindications

in the presence and occurrence of allergic reactions to the active substance or other components of the drug

children's age up to 12 years

Drug interactions

The combined use of Flavamed® Forte effervescent tablets and cough suppressants (antitussives) can cause dangerous stagnation of secretions due to a weakening of the cough reflex. Therefore, the decision to prescribe combination treatment should be made with particular care

special instructions

There is evidence of very rare cases of severe skin reactions after the use of ambroxol, such as Stevens-Johnson syndrome and Lyell's syndrome. If unusual changes occur on the skin or mucous membranes, you should immediately stop using ambroxol and consult a doctor.

Due to the possible stagnation of sputum, in some rare diseases of the bronchi, accompanied by the formation of a large amount of secretion (for example, with primary ciliary dyskinesia), Flavamed® Forte effervescent tablets should be used with extreme caution.

Flavamed® Forte effervescent tablets should be taken with extreme caution (i.e., reducing the dose or increasing the time interval between doses) in case of impaired renal function or severe liver disease.

In case of severe renal failure, accumulation of ambroxol breakdown products formed in the liver should be expected.

Since mucolytic agents can destroy the mucosal barrier of the gastric mucosa, ambroxol should be prescribed to patients with peptic ulcers with extreme caution.

Each tablet of this medicinal product contains 5.5 millimol (126.5 mg) sodium in the form of salts. This should be taken into account in patients who control their intake of sodium salts.

Caution when using Flavamed® Forte should be observed in patients with histamine intolerance. Since ambroxol affects the metabolism of histamine and can cause allergy symptoms (headache, nasal congestion, itching, etc.), long-term use of Flavamed® Forte should be avoided.

Pregnancy and lactation

There is no sufficient information regarding the use of ambroxol in pregnant women. In particular, this applies to the period up to the 28th week of pregnancy. Flavamed® Forte effervescent tablets should be used during pregnancy, especially during the first trimester, only after the benefit/risk ratio has been carefully weighed.

Since there is currently no sufficient experience with the use of Flavamed® Forte in nursing mothers, the drug should be prescribed only after a thorough assessment of the risks and benefits.

Features of the effect of the drug on the ability to drive cars and operate machinery

Flavamed® Forte effervescent tablets do not have a significant effect on the ability to drive a car or use other equipment.

Overdose

Symptoms: with an overdose of ambroxol, no severe symptoms of intoxication were observed. There is information about the occurrence of short-term restless states and diarrhea.

Ambroxol is well tolerated when administered parenterally at a dosage of up to 15 mg/kg/day, and when administered orally at a dosage of up to 25 mg/kg/day.

By analogy with preclinical studies, a significant overdose of ambroxol can lead to increased salivation, gagging, vomiting and a decrease in blood pressure.

Treatment: symptomatic treatment in accordance with existing signs of overdose.

Release form and packaging

10 effervescent tablets in polypropylene tubes, closed with polyethylene stoppers with a desiccant.

The tube, together with instructions for medical use in the state and Russian languages, is placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ºС.

Keep out of the reach of children!

Shelf life

After the expiration date, the medicine cannot be used.

Conditions for dispensing from pharmacies

Over the counter

Name and country of the holder of the registration certificate Berlin-Chemie AG (Menarini Group), Germany

Address of the organization receiving claims from consumers regarding the quality of products (products) in the territory of the Republic of Kazakhstan:

Representative office of JSC Berlin-Chemie AG in the Republic of Kazakhstan

Phone number: +77272446183, 2446184, 2446185

fax number:+7 727 2446180

Active substance

Ambroxol

Dosage form

soluble tablets

Manufacturer

Berlin-Chemie AG, Germany

Compound

Active ingredient: ambroxol hydrochloride - 60.00 mg;

excipients: anhydrous citric acid - 846.90 mg, sodium bicarbonate - 298.00 mg, anhydrous sodium carbonate - 71.00 mg, sodium saccharinate - 9.00 mg, sodium cyclamate - 45.00 mg, sodium chloride - 20 .00 mg, sodium citrate - 0.70 mg, lactose anhydrous - 110.00 mg, mannitol - 180.00 mg, sorbitol - 29.00 mg, cherry flavor - 30.00 mg, simethicone - 0.40 mg.

pharmachologic effect

Expectorant mucolytic agent. Ambroxol is an active N-demethylated metabolite of bromhexine. It has secretomotor, secretolytic and expectorant effects. Stimulates the serous cells of the glands of the bronchial mucosa, increasing the content of mucous secretion and, thus, changing the disturbed ratio of serous and mucous components of sputum. Ambroxol increases the content of mucous secretion and the release of surfactant (surfactant) in the alveoli and bronchi. Increases the motor activity of the ciliated epithelium, increases mucociliary transport of sputum.

On average, when taken orally, the effect occurs within 30 minutes, the duration of action is 6-12 hours, depending on the size of the single dose.

Indications

Acute and chronic diseases of the respiratory tract, accompanied by impaired secretion and transport of sputum:

  • acute and chronic bronchitis;
  • pneumonia;
  • chronic obstructive pulmonary disease;
  • bronchial asthma with difficulty in sputum discharge;
  • bronchiectasis.

Contraindications

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

With caution:

Impaired bronchial motility and increased mucus secretion (for example, in the rare syndrome of primary ciliary dyskinesia); renal failure and/or severe liver failure; peptic ulcer of the stomach and duodenum, including a history; II and III trimesters of pregnancy.

Side effects

Digestive system disorders

Sometimes: nausea, stomach pain, vomiting

Skin and subcutaneous tissue disorders

Very rare: severe skin reactions such as Lyell's syndrome and Stevens–Johnson syndrome

General disorders and local reactions

Sometimes: allergic reactions such as skin rash, facial swelling, shortness of breath, itching, fever

Very rare: severe allergic (anaphylactic) reactions up to shock

Interaction

With the combined use of ambroxol and antitussive drugs that suppress the cough reflex, due to a weakening of the cough reflex, there may be a risk of congestion in the bronchi.

Increases the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secretions.

How to take, course of administration and dosage

Adults and children over 12 years of age: 1/2 tablet of Flavamed® max 3 times a day (corresponding to 90 mg ambroxol hydrochloride/day) for the first 2-3 days, then 1/2 tablet of Flavamed® max 2 times a day (which corresponds to 60 mg of ambroxol hydrochloride/day).

If necessary, adults can take 1 tablet of Flavamed® max 2 times a day (which corresponds to 120 mg of ambroxol hydrochloride/day).

In patients with renal failure and/or severe liver failure, the drug should be taken at longer intervals between doses or in reduced doses.

The duration of use is determined individually, depending on the indications and course of the disease. Typically, Flavamed® max is taken for no more than 4-5 days; longer use requires consulting a doctor.

Overdose

Symptoms: short-term anxiety, diarrhea, nausea, vomiting. If the dose of the drug is significantly exceeded (more than 25 mg/kg/day), a decrease in blood pressure and salivation may occur.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, taking fat-containing foods, symptomatic therapy.

Special instructions

There is evidence of the occurrence in very rare cases of skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis) when using ambroxol. If allergic reactions occur, you should immediately stop using the drug and consult a doctor.

In severe renal failure (creatinine clearance less than 30 ml/min), it is necessary to take into account the risk of accumulation of ambroxol metabolites formed in the liver.

Mucolytics can damage the mucous barrier of the gastrointestinal tract, so ambroxol should be used with caution in patients with gastric and duodenal ulcers, including a history of them.

To maintain the secretolytic effect of the drug Flavamed® max during the period of use of the drug, it is necessary to ensure that a sufficient amount of fluid enters the body.

In patients with bronchial asthma, ambroxol may increase cough.

One effervescent tablet of Flavamed® max contains 126.5 g of sodium, which must be taken into account by patients on a low-sodium diet.

Barcode: 4013054023884

Weight: 0.035 kg;

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

Description:

Round white tablets, with a smooth surface, scored on one side, with a cherry flavor.
Appearance of the solution: colorless, transparent solution, containing no visible mechanical inclusions.

Pharmacotherapeutic group:

mucolytic expectorant

Pharmacodynamics:

Ambroxol is an active N-demethylated metabolite of bromhexine.
It has secretomotor, secretolytic and expectorant effects. Stimulates the work of the bronchial glands, increases the motor activity of the ciliated epithelium by influencing type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, enhances the formation of endogenous surfactant - a surfactant that ensures the sliding of bronchial secretions in the lumen of the respiratory tract. Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure, helping to reduce viscosity and dilute sputum; as a result, mucociliary transport improves and the removal of sputum from the bronchial tree is facilitated.
On average, the effect of the drug when taken orally appears after 30 minutes, the duration of action is 6-12 hours, depending on the dose taken.

Pharmacokinetics:

Suction. After oral administration, ambroxol is quickly and almost completely absorbed from the gastrointestinal tract. The time to reach maximum concentration in blood plasma (TC max) is 1-3 hours. The absolute bioavailability of ambroxol when taken orally as a result of “primary passage” through the liver decreases by approximately 1/3.
Distribution. Communication with plasma proteins is 80-90%. Ambroxol penetrates the placental and blood-brain barriers and is excreted in breast milk.
Metabolism. Ambroxol is metabolized in the liver by conjugation to form pharmacologically inactive metabolites.
Excretion. The terminal half-life from blood plasma (T 1/2) is 7-12 hours. The total half-life of ambroxol and its metabolites is about 22 hours. Excreted by the kidneys: 90% in the form of metabolites (such as dibromoanthranilic acid, glucuronides), about 10% - in unchanged form. In case of severe renal dysfunction (creatinine clearance less than 30 ml/min), accumulation of ambroxol metabolites is possible; in severe liver failure, the clearance of ambroxol is reduced by 20-40%.
Due to the high degree of binding to plasma proteins and the significant volume of distribution, as well as slow redistribution from tissues to the blood, effective elimination of ambroxol by dialysis or forced diuresis is unlikely.

Indications:

Impaired secretion and transport of sputum in acute and chronic respiratory diseases:
- acute and chronic bronchitis;
- pneumonia;
- chronic obstructive pulmonary disease;
- bronchial asthma;
- bronchiectasis.

Contraindications:

- Hypersensitivity to the components of the drug (see section "Composition");
- hereditary fructose intolerance;
- hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;
- I trimester of pregnancy and breastfeeding period;
- children's age up to 12 years.

Carefully:

- Impaired bronchial motility and increased mucus secretion (for example, in the rare syndrome of primary ciliary dyskinesia);
- renal failure and/or severe liver failure;
- peptic ulcer of the stomach and duodenum, including a history of it;
- II and III trimesters of pregnancy.

Pregnancy and lactation:

The use of Flavamed max in the first trimester of pregnancy and breastfeeding is contraindicated.
The use of the drug in the second and third trimesters of pregnancy is possible only after a thorough assessment of the balance between the benefits of treatment and possible risks.

Directions for use and dosage:

Inside. Recommended to be taken after meals. Dissolve the tablet in a glass of water at room temperature and drink the resulting solution immediately.
Unless otherwise directed by a physician, the following doses are recommended:
Adults and children over 12 years of age: 1/2 tablet of Flavamed max 3 times a day (corresponding to 90 mg ambroxol hydrochloride/day) for the first 2-3 days, then 1/2 tablet of Flavamed max 2 times a day day (which corresponds to 60 mg ambroxol hydrochloride/day).
If necessary, adults can take 1 tablet of Flavamed max 2 times a day (which corresponds to 120 mg of ambroxol hydrochloride/day).
In patients with renal failure and/or severe liver failure, the drug should be taken at longer intervals between doses or in reduced doses.
The duration of use is determined individually, depending on the indications and course of the disease. Typically, Flavamed max is taken for no more than 4-5 days; longer use requires consulting a doctor.

Side effects:

Possible side effects are listed below in descending frequency of occurrence: very common (≥ 1/10), common (≥ 1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10000, <1/1000), очень редко (< 1/10000), включая отдельные сообщения, частота неизвестна (по имеющимся данным частота не может быть установлена).
Gastrointestinal disorders
Often: nausea;
Uncommon: vomiting, dry mouth, diarrhea, dyspepsia, abdominal pain.
Immune system disorders
Uncommon: hyperthermia;
Rarely: skin rash, urticaria;
In isolated cases: anaphylactic reactions up to the development of shock, angioedema, skin itching and other hypersensitivity reactions.
Skin and subcutaneous tissue disorders
Very rare: toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome (see section "Special instructions");
Frequency unknown: acute generalized exanthematous pustulosis.
Nervous system disorders
Common: dysgeusia (impaired sense of taste).
Respiratory, thoracic and mediastinal disorders
Often: decreased sensitivity in the mouth and pharynx;
Rarely: dryness of the mucous membrane of the respiratory tract, rhinorrhea;
In isolated cases: dryness of the pharyngeal mucosa.

Overdose:

Symptoms: Specific symptoms of ambroxol overdose in humans have not been described. The observed symptoms of overdose were consistent with the known side effects of ambroxol used in recommended doses (nausea, vomiting, abdominal pain, diarrhea, dyspepsia).
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; intake of fat-containing foods; symptomatic therapy.
Due to the high degree of binding of ambroxol to plasma proteins (80-90%), forced diuresis and hemodialysis are ineffective.

Interaction:

With the simultaneous use of ambroxol and antitussive drugs, for example, codeine, due to the suppression of the cough reflex, there may be a danger of accumulation of sputum in the lumen of the respiratory tract with difficulty in its removal, therefore the simultaneous use of ambroxol and antitussive drugs should be carried out with extreme caution.
Increases the penetration into the bronchial lumen of amoxicillin, cefuroxime, erythromycin and doxycycline.

Special instructions:

There is evidence of the occurrence in very rare cases of skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis) when using ambroxol. If allergic reactions occur, you should immediately stop using the drug 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 ambroxol metabolites formed in the liver.
Mucolytics can damage the mucous barrier of the gastrointestinal tract, so ambroxol should be used with caution in patients with gastric and duodenal ulcers, including a history of them.
To maintain the secretolytic effect of the drug Flavamed max during the period of use of the drug, it is necessary to ensure that a sufficient amount of fluid enters the body.
In patients with bronchial asthma, ambroxol may increase cough.
One effervescent tablet of Flavamed Max contains 126.5 g of sodium, which must be taken into account by patients on a low-sodium diet.
The drug Flavamed max contains sorbitol (sorbitol) and lactose, therefore its use in patients with hereditary fructose intolerance, hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome is contraindicated.
Information for patients with diabetes: 1 tablet contains 29 mg of sorbitol, which corresponds to 0.0024 bread units (XE).

Storage conditions:
At a temperature not exceeding 25 ° C in a tightly closed package.
Keep the medicine out of the reach of children.

Best before date:
3 years.
Do not use after the expiration date stated on the packaging.

Is a medicine. A doctor's consultation is required.

    Flavamed Max 10 effervescent tablets, 10 ml.

    Dosage form

    Round white tablets, with a smooth surface, scored on one side, with a cherry flavor.
    Appearance of the solution: colorless, transparent solution containing no visible mechanical inclusions.

    Compound

    Composition per 1 tablet: Active substance: ambroxol hydrochloride - 60.00 mg;
    Excipients: anhydrous citric acid - 846.90 mg, sodium bicarbonate - 298.00 mg, anhydrous sodium carbonate - 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.

    Pharmachologic effect:

  • Ambroxol is an active N-demethylated metabolite of bromhexine.
  • It has secretomotor, scretolytic and expectorant effects.
  • Stimulates the work of the bronchial glands, increases the motor activity of the ciliated epithelium by influencing type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, enhances the formation of endogenous surfactant - a surfactant that ensures the sliding of bronchial secretions in the lumen of the respiratory tract.
  • Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure, helping to reduce viscosity and dilute sputum; as a result, mucociliary transport improves and the removal of sputum from the bronchial tree is facilitated.
  • On average, the effect of the drug when taken orally appears after 30 minutes, the duration of action is 6-12 hours, depending on the dose taken.
  • Pharmacokinetics
    Suction. After oral administration, ambroxol is quickly and almost completely absorbed from the gastrointestinal tract. The time to reach maximum plasma concentration (TCmax) is 1-3 hours. The absolute bioavailability of ambroxol when taken orally as a result of “primary passage” through the liver decreases by approximately 1/3.
    Distribution. Communication with plasma proteins is 80-90%. Ambroxol penetrates the placental and blood-brain barriers and is excreted in breast milk
    Metabolism. Ambroxol is metabolized in the liver by conjugation to form pharmacologically inactive metabolites. Excretion. The terminal half-life from blood plasma (T1/2) is 7-12 hours. The total half-life of ambroxol and its metabolites is about 22 hours.
    Excreted by the kidneys: 90% in the form of metabolites (such as dibromoanthranilic acid, glucuronides), about 10% unchanged. In case of severe renal dysfunction (creatinine clearance less than 30 ml/min), accumulation of ambroxol metabolites is possible; in severe liver failure, the clearance of ambroxol is reduced by 20-40%. Due to the high degree of binding to plasma proteins and the significant volume of distribution, as well as slow redistribution from tissues to the blood, effective elimination of ambroxol by dialysis or forced diuresis is unlikely.

    Side effects

    Possible side effects are listed below in descending order of occurrence: very common (> 1/10), common (> 1/100, 1/1000, 1/10000, Gastrointestinal disorders Common: nausea; Uncommon: vomiting, dryness of the oral mucosa, diarrhea, dyspepsia, abdominal pain.
  • Immune system disorders Uncommon: hyperthermia; Rarely: skin rash, urticaria; In isolated cases: anaphylactic reactions up to the development of shock, angioedema, skin itching and other hypersensitivity reactions.
  • Disorders of the skin and subcutaneous tissues Very rare: toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome (see section "Special instructions") Frequency unknown: acute generalized exanthematous pustulosis.
  • Nervous system disorders Often dysgeusia (impaired sense of taste).
  • Disorders of 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 isolated cases: dryness of the pharyngeal mucosa.

    Selling Features

    Available without a prescription

    Special conditions

    There is evidence of the occurrence in very rare cases of skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis) when using ambroxol. If allergic reactions occur, you should immediately stop using the drug 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 ambroxol metabolites formed in the liver.
    Mucolytics can damage the mucous barrier of the gastrointestinal tract, so ambroxol should be used with caution in patients with gastric and duodenal ulcers, including those with a history.
    To maintain the secretolytic effect of the drug Flavamed "max during the period of use of the drug, it is necessary to ensure that a sufficient amount of fluid enters the body.
    In patients with bronchial asthma, ambroxol may increase cough.
    One effervescent tablet of Flavamed "max contains 126.5 g of sodium, which must be taken into account by patients on a low-sodium diet.
    The drug Flavamed "" max contains sorbitol (sorbitol) and lactose, therefore its use in patients with hereditary fructose intolerance, hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome is contraindicated.
    Information for patents with diabetes: 1 tablet contains 29 mg of sorbitol, which corresponds to 0.0024 bread units (XE).
    Effect on the ability to drive vehicles and operate machinery The drug has no effect on the performance of potentially hazardous activities that require increased attention and speed of psychomotor reactions.

    Indications

    Violation of secretion and transport of sputum in acute and chronic respiratory diseases: acute and chronic bronchitis; pneumonia; chronic obstructive pulmonary disease; bronchial asthma; bronchiectasis.

    Contraindications

  • hypersensitivity to the components of the drug (see section "Composition")
  • hereditary fructose intolerance;
  • hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;
  • I trimester of pregnancy and breastfeeding period;
  • children up to 12 years of age. Be careful with impaired bronchial motility and increased mucus secretion (for example, with the rare syndrome of primary ciliary dyskinesia);
  • renal failure and/or severe liver failure;
  • peptic ulcer of the stomach and duodenum, including a history;
  • 11th and 3rd trimesters of pregnancy.

    Use during pregnancy and breastfeeding

    The use of Flavamed max in the first trimester of pregnancy and breastfeeding is contraindicated. The use of the drug in the second and third trimesters of pregnancy is possible only after a thorough assessment of the balance between the benefits of treatment and possible risks.

    Drug interactions

    With the simultaneous use of ambroxol and antitussive drugs, for example, codeine, due to the suppression of the cough reflex, there may be a danger of accumulation of sputum in the lumen of the respiratory tract with difficulty in its removal, therefore the simultaneous use of ambroxol and antitussive drugs should be carried out with extreme caution.
    Increases the penetration of amoxipilline, cefurousim, erythromycin and doxycycline into the bronchial lumen.

Instructions for use

Flavamed instructions for use

Dosage form

Round white tablets, with a smooth surface, scored on one side, with a cherry flavor.

Appearance of the solution: colorless, transparent solution, containing no visible mechanical inclusions.

Compound

Composition per 1 tablet:

Active ingredient: ambroxol hydrochloride - 60.00 mg;

Excipients:

Anhydrous citric acid - 846.90 mg, sodium bicarbonate - 298.00 mg, anhydrous sodium carbonate - 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.

Pharmacodynamics

Ambroxol is an active N-demethylated metabolite of bromhexine.

It has secretomotor, scretolytic and expectorant effects. Stimulates the work of the bronchial glands, increases the motor activity of the ciliated epithelium by influencing type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, enhances the formation of endogenous surfactant - a surfactant that ensures the sliding of bronchial secretions in the lumen of the respiratory tract. Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure, helping to reduce viscosity and dilute sputum; as a result, mucociliary transport improves and the removal of sputum from the bronchial tree is facilitated.

On average, the effect of the drug when taken orally appears after 30 minutes, the duration of action is 6-12 hours, depending on the dose taken.

Pharmacokinetics

Suction. After oral administration, ambroxol is quickly and almost completely absorbed from the gastrointestinal tract. The time to reach maximum plasma concentration (TCmax) is 1-3 hours. The absolute bioavailability of ambroxol when taken orally as a result of “primary passage” through the liver decreases by approximately 1/3.

Distribution. Communication with plasma proteins is 80-90%. Ambroxol penetrates the placental and blood-brain barriers and is excreted in breast milk. Metabolism. Ambroxol is metabolized in the liver by conjugation to form pharmacologically inactive metabolites.

Excretion. The terminal half-life from blood plasma (T1/2) is 7-12 hours. The total half-life of ambroxol and its metabolites is about 22 hours. Excreted by the kidneys: 90% in the form of metabolites (such as dibromoanthranilic acid, glucuronides), about 10% - unchanged. In case of severe renal dysfunction (creatinine clearance less than 30 ml/min), accumulation of ambroxol metabolites is possible; in severe liver failure, the clearance of ambroxol is reduced by 20-40%.

Due to the high degree of binding to plasma proteins and the significant volume of distribution, as well as slow redistribution from tissues to the blood, effective elimination of ambroxol by dialysis or forced diuresis is unlikely.

Side effects

Possible side effects are listed below in descending frequency of occurrence: very common (> 1/10), common (> 1/100,<1/10), нечасто (>1/1000, < 1/100), редко (>1/10000, <1/1000), очень редко (< 1/10000), включая отдельные сообщения, частота неизвестна (по имеющимся данным частота не может быть установлена).

Gastrointestinal disorders Common: nausea;

Uncommon: vomiting, dry mouth, diarrhea, dyspepsia, abdominal pain.

Immune system disorders Uncommon: hyperthermia;

Rarely: skin rash, urticaria;

In isolated cases: anaphylactic reactions up to the development of shock,

Angioedema, skin itching and other hypersensitivity reactions.

Skin and subcutaneous tissue disorders

Very rare: toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome (see section "Special instructions")

Frequency unknown: acute generalized exanthematous pustulosis.

Nervous system disorders Often dysgeusia (impaired sense of taste).

Disorders of 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 isolated cases: dryness of the pharyngeal mucosa.

Selling Features

Available without a prescription

Special conditions

There is evidence of the occurrence in very rare cases of skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis) when using ambroxol. If allergic reactions occur, you should immediately stop using the drug 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 ambroxol metabolites formed in the liver.

Mucolytics can damage the mucous barrier of the gastrointestinal tract, so ambroxol should be used with caution in patients with gastric and duodenal ulcers, including those with a history.

To maintain the secretolytic effect of the drug Flavamed "max during the period of use of the drug, it is necessary to ensure that a sufficient amount of fluid enters the body.

In patients with bronchial asthma, ambroxol may increase cough.

One effervescent tablet of Flavamed "max contains 126.5 g of sodium, which must be taken into account by patients on a low-sodium diet.

The drug Flavamed "" max contains sorbitol (sorbitol) and lactose, therefore its use in patients with hereditary fructose intolerance, hereditary

Contraindicated for galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Information for patents with diabetes: 1 tablet contains 29 mg of sorbitol, which corresponds to 0.0024 bread units (XE).

Effect on the ability to drive vehicles and operate machinery The drug has no effect on the performance of potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Indications

Impaired secretion and transport of sputum in acute and chronic respiratory diseases:

Acute and chronic bronchitis; pneumonia;

Chronic obstructive pulmonary disease; bronchial asthma; bronchiectasis.

Contraindications

Hypersensitivity to the components of the drug (see section "Composition")

Hereditary fructose intolerance;

Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

I trimester of pregnancy and breastfeeding period;

Children's age up to 12 years.

Carefully

Impaired bronchial motility and increased mucus secretion (for example, in the rare syndrome of primary ciliary dyskinesia);

Renal failure and/or severe liver failure; peptic ulcer of the stomach and duodenum, including a history;

11th and 3rd trimesters of pregnancy.

Use during pregnancy and breastfeeding

The use of Flavamed max in the first trimester of pregnancy and breastfeeding is contraindicated. The use of the drug in the second and third trimesters of pregnancy is possible only after a thorough assessment of the balance between the benefits of treatment and possible risks.

Drug interactions

With the simultaneous use of ambroxol and antitussive drugs, for example, codeine, due to the suppression of the cough reflex, there may be a danger of accumulation of sputum in the lumen of the respiratory tract with difficulty in its removal, therefore the simultaneous use of ambroxol and antitussive drugs should be carried out with extreme caution.

Increases the penetration of amoxipilline, cefurousim, erythromycin and doxycycline into the bronchial lumen.

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If necessary, adults can take 1 tablet of Flavamed max 2 times a day (which corresponds to 120 mg of ambroxol hydrochloride/day).

In patients with renal failure and/or severe liver failure, the drug should be taken at longer intervals between doses or in reduced doses.

The duration of use is determined individually, depending on the indications and course of the disease. Typically, Flavamed’max is taken for no more than 4-5 days; longer use requires consulting a doctor.

Overdose

Symptoms: Specific symptoms of ambroxol overdose in humans have not been described. The observed symptoms of overdose were consistent with the known side effects of ambroxol used in recommended doses (nausea, vomiting, abdominal pain, diarrhea, dyspepsia).

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; intake of fat-containing foods; symptomatic therapy.

Due to the high degree of binding of ambroxol to plasma proteins (80-90%), forced diuresis and hemodialysis are ineffective.

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