Flavamed max - instructions for use, dose, side effects, contraindications

Excipients: 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.

Description:

Round white tablets, with a smooth surface, with a notch for dividing on one side, with the smell of cherries.

Appearance of the solution: a colorless, transparent solution that does not contain visible mechanical impurities.

Pharmacotherapeutic group:expectorant mucolytic

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol is active N-detylated 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 the drug on ingestion is manifested after 30 minutes, the duration of the action is 6-12 hours, depending on the dose taken.

Pharmacokinetics:

Suction. After oral administration ambroxol quickly and almost completely absorbed from the gastrointestinal tract. Time to reach the maximum concentration in the blood plasma (TC_max) is 1-3 hours. Absolute bioavailability of ambroxol with oral intake as a result of "primary passage" through the liver decreases by approximately 1/3.

Distribution. The connection with plasma proteins is 80-90%. Ambroxol penetrates through the placental and blood-brain barrier, excreted in breast milk.

Metabolism. Ambroxol metabolized in the liver by conjugation with the formation of pharmacologically inactive metabolites.

Excretion. Terminal half-life of blood plasma (T_1/2) is 7-12 hours. The total half-life of ambroxol and its metabolites is about 22 hours. It is excreted by the kidneys: 90% in the form of metabolites (such as dibromoanthranilic acid, glucuronides), about 10% - unchanged. With severe renal dysfunction (creatinine clearance less than 30 ml / min) accumulation of metabolites of ambroxol is possible; in severe hepatic insufficiency, ambroxol clearance is reduced by 20-40%.

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

Indications:

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 drug components (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.

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 the drug 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.

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 of age: by 1/2 Flavamed® Max tablet 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 preparation twice 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).

Have patients with renal insufficiency and / or severe hepatic impairment the drug 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:

Possible side effects are shown below in the descending frequency of the occurrence of the event: very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), rarely (<1/10000), including individual messages, frequency unknown (according to available data, the frequency can not be established).

Disorders from the gastrointestinal tract

Often: nausea;

Infrequently: vomiting, dryness of the oral mucosa, diarrhea, dyspepsia, abdominal pain.

Immune system disorders

Infrequently: hyperthermia;

Rarely: skin rash, hives;

In a few cases: anaphylactic reactions up to the development of shock, angioedema, skin itching and other hypersensitivity reactions.

Disturbances from the skin and subcutaneous tissues

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, organs of the chest and mediastinum

Often: decreased sensitivity in the oral cavity and pharynx;

Rarely: dryness of the mucous membrane of the respiratory tract, rhinorrhea;

In a few cases: dryness of the mucous membrane of the pharynx.

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.

Interaction:

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.

Special instructions:

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 disease 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 can strengthen 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 of 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 mellitus: 1 tablet contains 29 mg of sorbitol, which corresponds to 0.0024 grain units (XE).

Effect on the ability to drive transp. cf. and fur:

The drug has no effect on the performance of potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Tablets effervescent, 60 mg.

Packaging:

For 10 tablets in a polypropylene tube, sealed with a polyethylene lid containing a desiccant.

For 1 or 2 tubes together with the instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C in a tightly closed container.

Keep the medicinal product out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003475

Date of registration:26.02.2016

Expiration Date:26.02.2021

The owner of the registration certificate:Berlin-Chemie, AGBerlin-Chemie, AG Germany

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany

Information update date: & nbsp29.07.2016

Illustrated instructions

Instructions

Flavamed® max (Flavamed max)