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Flavamed® Max

Flavamed® Forte

Trade proprietary name: Flavamed® International nonproprietary name: ambroxol Chemical name: trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride Dosage form: oral solution

Composition: 5 ml of solution contains: Active ingredient: ambroxol hydrochloride – 15.00 mg; Excipients: benzoic acid – 5.75 mg, glycerol 85% – 500.00 mg, sorbitol 70% (non-crystallizing) – 2500.00 mg, hyaetellose (hydroxyethylcellulose) (degree of molar substitution 2.5; average viscosity 6000 mPa c) – 5.00 mg, raspberry flavor No. 516028 – 5.00 mg, purified water – 2719.25 mg.

Description: clear, colorless or brownish liquid with a raspberry odor.

Pharmacotherapeutic group: Mucolytic expectorant.

ATX code: R05CB06.

Pharmacological properties Pharmacodynamics 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 secretions and, thus, normalizing the disturbed ratio of serous and mucous components of sputum. Ambroxol increases the content of mucous secretions, the formation of surfactant (surfactant) and its content 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 single dose. Pharmacokinetics Absorption. After oral administration, ambroxol is quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in blood plasma (Cmax) is reached after approximately 1-3 hours. The absolute bioavailability of ambroxol when taken orally as a result of metabolism associated with the first-pass effect through the liver is reduced by approximately 1/3. The resulting metabolites (such as dibromoantranilic acid, glucuronides) are excreted by the kidneys. Distribution. Binding to plasma proteins is approximately 80 - 90%. Ambroxol penetrates the blood-brain and placental barriers and is also excreted in breast milk. Metabolism. Ambroxol is metabolized in the liver by conjugation to form pharmacologically inactive metabolites. Excretion. The half-life from blood plasma (T1/2) is 7-12 hours. T1/2 of ambroxol and its metabolites (in total) is about 22 hours. About 90% is excreted by the kidneys, mainly in the form of metabolites. Less than 10% of the amount excreted through the kidneys is ambroxol 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 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 for use 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 ambroxol and other components of the drug (see section "Composition"); - hereditary fructose intolerance; — First trimester of pregnancy and breastfeeding period.

With caution - impaired bronchial motility and increased mucus secretion (for example, in the rare syndrome of primary ciliary dyskinesia); - severe renal failure (creatinine clearance less than 30 ml/min) and/or severe liver failure; - peptic ulcer of the stomach and duodenum, including a history of it; — II and III trimesters of pregnancy; - children under 2 years of age (used only as prescribed by a doctor).

Use during pregnancy and breastfeeding Use of the drug Flavamed®

Contraindicated in the first trimester of pregnancy and during breastfeeding. The use of the drug in the second and third trimesters of pregnancy is possible only after a careful assessment of the balance between the benefits of treatment and possible risks.

Directions for use and dosage Oral solution. Unless otherwise prescribed, the following dosages are recommended: Children under 2 years of age: 1⁄2 scoop (2.5 ml) of Flavamed® solution 2 times daily (equivalent to 15 mg ambroxol hydrochloride/day). Children aged 2 to 5 years: 1⁄2 scoop (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: 1 scoop of Flavamed® solution

2 - 3 times a day (which corresponds to 30 - 45 mg of ambroxol hydrochloride / day). Adults and children over 12 years of age: during the first 2-3 days, 2 scoops (10 ml) of Flavamed® solution 3 times a day (which corresponds to 90 mg of ambroxol hydrochloride/day), then 2 scoops (10 ml) Flavamed® solution 2 times a day (which corresponds to 60 mg of ambroxol hydrochloride/day). If necessary, to enhance the therapeutic effect, adults can take 4 scoops (20 ml) of Flavamed® solution 2 times a day (which corresponds to 120 mg of ambroxol hydrochloride/day). In case of severe renal and liver failure, the duration of the interval between doses should be increased or the dose of Flavamed® should be reduced.

Flavamed® solution is taken after meals; use a measuring spoon to dose the drug. The duration of use is determined individually depending on the indications and course of the disease. Without a doctor's prescription, Flavamed® should not be taken for more than 4-5 days.

Side effects Possible side effects are listed below in descending frequency of occurrence: very common (> 1/10), common (> 1/100, <1/10), uncommon (> 1/1000, <1/100), rare (> 1/10000, <1/1000), very rare (<1/10000), including isolated reports. Gastrointestinal disorders Common: nausea; Uncommon: vomiting, dry mouth, diarrhea, dyspepsia, abdominal pain. Immune system disorders Uncommon: fever; 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: epidermal necrolysis; Steven-Johnson syndrome (see section "Special instructions"). Nervous system disorders Common: dysgeusia (impaired sense of taste). Disorders of the respiratory system, chest and mediastinal organs Often: decreased sensitivity in the oral cavity and pharynx; 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 other drugs When using ambroxol and antitussive drugs, for example, codeine, due to the suppression of the cough reflex, there may be a risk of accumulation of sputum in the respiratory tract with difficulty in removing it, therefore the simultaneous use of ambroxol and antitussive drugs should be carried out with extreme caution. Ambroxol 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 Stevens-Johnson syndrome and 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), the risk of accumulation of ambroxol metabolites must be taken into account. 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 during the period of use of the drug Flavamed®, it is necessary to ensure that a sufficient amount of fluid enters the body. The drug Flavamed® contains sorbitol (sorbitol), therefore its use in patients with hereditary fructose intolerance is contraindicated. Information for patients with diabetes: 5 ml of solution (1 scoop) contains 1.75 g of sorbitol, which corresponds to 0.15 bread units (XU). Effect on the ability to drive vehicles and operate machinery The drug does not affect the performance of potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Release form Oral solution 15 mg/5 ml. 60, 100 or 200 ml of solution in dark glass bottles (type III), sealed with a screw cap. 1 bottle complete with a measuring spoon along with instructions for use in a cardboard box.

Storage conditions At a temperature not higher than 25 oC. Keep the medicine out of the reach of children.

Shelf life 3 years in original packaging. 6 months - after the first opening of the bottle. Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies Without a prescription.

Manufacturer Berlin-Chemie AG Glienicker Weg, 125 12489 Berlin, Germany

Berlin-Chemie AG Glieniker Weg 125 12489 Berlin, Germany

Address for filing claims: 123317, Moscow, Presnenskaya embankment, building 10, BC “Tower on Naberezhnaya”, block B, tel., fax.

Flavamed Forte 30 mg/5 ml 100 ml oral solution

Latin name

FLAVAMED®

Release form

Oral solution.

Package

In a bottle of 100 ml. solution.

pharmachologic effect

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 secretions and, thus, normalizing the disturbed ratio of serous and mucous components of sputum. Ambroxol increases the content of mucous secretions, the formation of surfactant (surfactant) and its content 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 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 ambroxol or other components of the drug;

— congenital fructose intolerance (for solution);

— First trimester of pregnancy and breastfeeding period.

Carefully

the drug should be prescribed for: impaired bronchial motility and the formation of secretions in significant quantities (for example, with a rare syndrome of immobile cilia), for renal or liver failure, for peptic ulcers of the stomach and duodenum, as well as for children under 2 years of age (solution).

Use during pregnancy and breastfeeding

Ambroxol penetrates the placental barrier. Animal studies have not revealed direct or indirect adverse effects on pregnancy, embryo/fetal development, childbirth or the postnatal period. The use of the drug is not recommended in the first trimester of pregnancy. In the 2nd and 3rd trimester of pregnancy, the drug can be used subject to a careful assessment of the possible benefits of treatment and the associated risks.

Ambroxol is excreted in breast milk, so its use during breastfeeding is not recommended.

special instructions

In case of severe renal failure, it is necessary to take into account the possibility of accumulation of ambroxolol metabolites formed in the liver.

To maintain the secretolytic effect of ambroxol during the period of taking the drug, it is necessary to ensure that sufficient quantities of fluid enter the body.

When prescribing the drug to patients with diabetes mellitus, it should be taken into account that 5 ml of solution (1 scoop) contains 1.75 g of sorbitol, which corresponds to 0.15 XE.

Impact on the ability to drive vehicles and other mechanisms that require increased concentration

Not installed.

Compound

Active ingredient: 5 ml of oral solution contains ambroxol hydrochloride 30 mg;

Excipients: benzoic acid (E 210), glycerin (85%), sorbitol solution, does not crystallize (E 420), hydroxyethylcellulose, purified water, raspberry flavor No. 516028.

Directions for use and doses

Flavamed Forte is intended for oral use. The drug is taken orally after meals with a glass of water. To dose the drug, use a measuring spoon located in the package, which is marked 1/4 and 1/2, according to the amount of its filling, and holds 5 ml of solution, which corresponds to 30 mg of ambroxol hydrochloride.

The secretolytic effect of ambroxol hydrochloride is maintained provided that a sufficient amount of fluid enters the body, so during treatment the patient should drink plenty of fluid.

Children under 2 years of age are prescribed 1/4 measuring spoon 2 times a day; at the age of 2–5 years - 1/4 measuring spoon 3 times a day; at the age of 6–12 years - 1/2 measuring spoon of solution 2–3 times a day.

Adults and adolescents over 12 years of age - 1 measuring spoon of solution 3 times a day for the first 2-3 days, then 1 measuring spoon 2 times a day. If necessary, adults can take 2 scoops 2 times a day.

The duration of treatment is determined by the doctor depending on the course of the disease, but the drug should not be used for more than 4-5 days without medical supervision.

Side effects

Possible side effects are listed below in descending frequency of occurrence: very common (> 1/10), common (> 1/100, <1/10), uncommon (> 1/1000, <1/100), rare (> 1/10) 10000, <1/1000), very rare (<1/10000), including isolated reports.

Gastrointestinal disorders

Often: nausea;

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

Immune system disorders

Uncommon: fever;

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: epidermal necrolysis;

Steven-Johnson syndrome (see section "Special instructions").

Nervous system disorders

Common: dysgeusia (impaired sense of taste).

Respiratory, thoracic and mediastinal disorders

Often: decreased sensitivity in the mouth and pharynx;

In isolated cases: dryness of the pharyngeal mucosa.

Drug interactions

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.

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.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25°C.

Best before date

3 years.

Flavamed tablets

Release form

The tablets are white or almost white with a yellowish tint, round, flat-cylindrical with beveled edges and a one-sided score.

Compound

Active substance: ambroxol hydrochloride (30 mg).

Excipients: lactose monohydrate, corn starch, microcrystalline cellulose, croscarmellose sodium, povidone (K-30), magnesium stearate.

Pharmacological group

Secretolytics and stimulants of motor function of the respiratory tract.

Action

Mucolytic agent with expectorant action. Ambroxol increases the secretion of the glands of the respiratory tract, stimulates the activity of the villi of the respiratory tract, and enhances the formation of surfactant in the lungs. Ambroxol is a metabolite of bromhexine.

Ambroxol - description of the substance

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 and restrictions

congenital galactose intolerance, lactase deficiency and glucose and galactose malabsorption syndrome;
children under 6 years of age;
I trimester of pregnancy;
hypersensitivity to ambroxol or other components of the drug.

Carefully:

when bronchial motility is impaired and secretion is formed in significant quantities (with immotile cilia syndrome);
II and III trimesters of pregnancy;
with renal or liver failure;
with peptic ulcer of the stomach and duodenum (including with a history).

In case of renal failure or severe liver damage, the interval between doses should be increased or the dose reduced.

Application and dosage

The drug is taken orally after meals, without chewing and with a sufficient amount of liquid.

For adults and children over 12 years of age, during the first 2-3 days, 30 mg (one tablet) is prescribed 3 times a day, then 30 mg (one tablet) 2 times a day.
Children aged 6 to 12 years – 2-3 times a day, 15 mg (1/2 tablet).

Flavamed should not be taken for more than 4-5 days without a doctor's prescription.

special instructions

The drug Flavamed contains lactose, therefore its use in patients with hereditary galactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome is contraindicated.

Storage

Store out of the reach of children at a temperature not exceeding 25°C. Shelf life: 2 years.

Production

Berlin-Chemie AG (Germany); Menarini-Von Heyden GmbH (Germany).

Package

10 tablets in a blister. 1, 2 or 5 blisters in a cardboard box.

Recipe

Available without a prescription.