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

Excipients: Benzoic acid - 5.75 mg, glycerol 85% - 500,00 mg, sorbitol 70% (non-crystallisable) 2500.00 mg, hyetellose (hydroxyethylcellulose) (degree of molar substitution 2.5, average viscosity 6000 mPa.s) 5.00 mg, raspberry flavor no. 516028 - 5,0 mg, purified water - 2719.25 mg.

Description:Transparent colorless or brownish liquid with a crimson smell.

Pharmacotherapeutic group:Expectorant, mucolytic agent

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. Stimulates the serous cells of the glands of the bronchial mucosa, increasing the content of mucous secretions and, thus, normalizes the disturbed ratio of serous and mucous components of sputum. Ambroxol increases the content of mucous secretion, the formation of a surface-active substance (surfactant) and its content in the alveoli and bronchi. Increases the motor activity of the ciliated epithelium, increases the mucociliary transport of sputum.

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

Pharmacokinetics:

Suction. After taking inwards Ambroxol quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma (C_m_Oh) is achieved after approximately 1 to 3 hours. Absolute bioavailability of ambroxol when administered orally as a result of metabolism associated with the effect of the first passage through the liver,decreases by approximately 1/3. The resulting metabolites (such as, dibromantranilic acid, glucuronides) are excreted by the kidneys.

Distribution. Binding to plasma proteins is approximately 80 to 90%. Ambroxol penetrates through blood-brain and placental barriers, and also excretes in breast milk.

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

Excretion. The half-life of blood plasma (T1/ 2) is 7-12 hours. T12 Ambroxol and its metabolites (in total) is about 22 hours. It is excreted by the kidneys, about 90%, mainly in the form of metabolites. Less than 10% of the amount excreted through the kidneys account for the proportion of ambroxol in unchanged form. 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 the large volume of distribution, as well as the slow reverse distribution from tissues to the blood, significant elimination of ambroxol by dialysis or forced diuresis should not be expected.

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:

- increased sensitivity to ambroxol and other components of the drug (see section "Composition");

- hereditary intolerance to fructose;

- I trimester of pregnancy and the period of breastfeeding.

Carefully:

- violation of bronchial motility and increased secretion of mucus (for example, with a rare syndrome of primary dyskinesia of cilia);

- severe renal failure (creatinine clearance less than 30 ml / min) and / or severe hepatic impairment;

- peptic ulcer of the stomach and duodenum, including in the anamnesis; II and III trimesters of pregnancy;

- children's age up to 2 years (applies only as prescribed by the doctor).

Pregnancy and lactation:

The use of Flavamed ® in the first trimester of pregnancy and during 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:

Solution for oral administration.

Unless otherwise prescribed, the following doses are recommended:

Children under 2 years: by 1/2 measuring spoon (2.5 ml) of Flavamed® solution 2 times a day (corresponding to 15 mg ambroxol hydrochloride / day).

Children aged 2 to 5 years: by 1/2 measuring spoon (2.5 ml) of Flavamed® solution 3 times a day (corresponding to 22.5 mg of ambroxol hydrochloride / day).

Children aged 5 to 12 years: by 1 measuring spoon solution Flavamed® 3 times a day (corresponding to 30-45 mg of ambroxol hydrochloride / day).

Adults and children over 12 years of age: for the first 2-3 days, 2 measuring spoons (10 ml) of Flavamed® solution 3 once a day (corresponding to 90 mg ambroxol hydrochloride / day), then 2 scoops (10 ml) of Flavamed® solution 2 times a day (corresponding to 60 mg ambroxol hydrochloride / day).

If necessary, to increase the therapeutic effect, adults can take 4 measuring spoons (20 ml) of Flavamed® solution 2 times a day (corresponding to 120 mg ambroxol hydrochloride / day).

In renal and hepatic insufficiency of severe severity, the duration of the interval between doses should be increased or the dose of Flavamed® reduced.Flavamed ® solution is taken after a meal, use a measuring spoon for dosing. Duration of application is set individually in accordance with the indications and course of the disease. Without the appointment of a doctor, Flavamed® should not be taken for more than 4-5 days.

Side effects:

Possible side effects are listed below in the descending frequency of occurrence: very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000, <1/1000), very rarely (<1/10000), including individual messages.

Disorders from the gastrointestinal tract

Often: nausea; Infrequent: vomiting, dryness of the oral mucosa, diarrhea, dyspepsia, abdominal pain.

Immune system disorders

Infrequently: fever; 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: epidermal necrolysis, Stephen-Johnson syndrome (see section "Special instructions").

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; In single 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. Ambroxol increases penetration into the bronchial lumen of amoxicillin, cefuroxime, erythromycin and doxycycline.

Special instructions:There is evidence of the occurrence in very rare cases of Stevens-Johnson syndrome, toxic epidermal necrolysis with the use of 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. 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 secretory action during the period of application of the drug Flavamed®, it is necessary to ensure that sufficient fluids enter the body. The drug Flavamed® contains sorbitol (sorbitol), therefore its use in patients with hereditary intolerance to fructose is contraindicated. Information for patients with diabetes: in 5 ml of solution (1 measuring spoon) contains 1.75 g of sorbitol,which corresponds to 0.15 bread 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:Solution for oral administration 15 mg / 5 ml.

Packaging:For 60, 100 or 200 ml of the solution in dark glass bottles (type III), sealed with a screw cap. For 1 bottle complete with a measuring spoon, along with instructions for use in a cardboard bundle.

Storage conditions:At a temperature of no higher than 25 ° C.

Keep the medicinal product out of the reach of children.

Shelf life:3 years in the original packaging.

6 months after the first opening of the vial.

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

Terms of leave from pharmacies:Without recipe

Registration number:LSR-007251/08

Date of registration:10.09.2008

The owner of the registration certificate:Berlin-Chemie / Menarini Pharma, GmbH Berlin-Chemie / Menarini Pharma, GmbH Germany

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

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

Information update date: & nbsp25.09.2015

Illustrated instructions

Instructions

Flavamed® (Flavamed®)