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

Excipients: lactose monohydrate - 40.0 mg, corn starch - 30.0 mg, microcrystalline cellulose - 30.0 mg, croscarmellose sodium - 5.3 mg, povidone (value of K = 30) - 4.0 mg, magnesium stearate - 0.7 mg.

Description:White or almost white with a yellowish tinge, round plane-parallel tablets with bevelled edges and one-sided risk.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol is an active N-demethylated 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 secretions and the formation of surfactant (surfactant) and its content in the alveoli and bronchi. Increases the motor activity of the ciliated epithelium, increases the mucociliary transport of sputum.

On average, when taken orally, the effect occurs 30 minutes later, the duration of the action is 6-12 hours.

Pharmacokinetics:

Suction. After oral administration ambroxol quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma (CmAch) is achieved in 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. Communication with blood plasma proteins is approximately 80 - 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 from plasma (T 1/2) is 7-12 hours. T1 / 2 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:

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

- Hereditary intolerance to galactose, deficiency of lactase and syndrome of malabsorption of glucose and galactose;

- I trimester of pregnancy and the period of breastfeeding;

- Children under 6 years.

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.

Pregnancy and lactation:

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

Dosing and Administration:

For oral administration.

Tablets are taken after meals without chewing and drinking with a sufficient amount of liquid. If the doctor is not prescribed otherwise, the following doses are recommended: Children aged 6 to 12 years: 1/2 tablet 2-3 times a day (corresponding to 30 - 45 mg ambroxol hydrochloride / day). Adults and children over 12 years: during the first 2-3 days, 1 tablet 3 times a day (corresponding to 90 mg ambroxol hydrochloride / day), then - 1 tablet 2 times a day (corresponding to 60 mg ambroxol hydrochloride / day ). If necessary, to enhance the therapeutic effect of adults can take 2 tablets 2 times a day (which corresponds to 120 mg ambroksola hydrochloride / day). For renal insufficiency or hepatic insufficiency of severe severity, the duration of the interval between doses should be increased or the dose of Flavamed® Duration of application is determined individually, depending on 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, diarrhea, indigestion, pain in the abdomen.

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, Stevens-Johnson syndrome (see section "Special instructions"). Because of the high degree of binding of ambroxol to blood plasma proteins (80-90%), forced diuresis and hemodialysis are ineffective.

Overdose:

Symptoms: specific symptoms an overdose of ambroxol in humans is 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, the intake 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 any 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 contains lactose, so its use in patients with hereditary intolerance to galactose, a deficit lactase and the syndrome of malabsorption of glucose and galactose are contraindicated.

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 30 mg.

Packaging:For 10 tablets in a contour squeeze box (blister), made of transparent rigid PVC film and aluminum foil.

For 1.2 or 5 blisters together 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:2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-007252/08

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

MENARINI-VON HEYDEN, GmbH Germany

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

Information update date: & nbsp25.09.2015

Illustrated instructions

Instructions

Flavamed® (Flavamed®)