Ambroxol Velfarm 30 mg 30 tablets blister

Acute and chronic respiratory diseases with the production of viscous sputum:

• acute and chronic bronchitis;

• pneumonia;

• chronic obstructive pulmonary disease;

• asthma with difficulty in sputum expectoration;

• bronchiectasis.

Orally.
Children aged 6 to 12 years: 15 mg (1/2 tablet) 2-3 times a day.
Adults and children over 12 years: 30 mg (1 tablet) 3 times a day.
If necessary, to enhance the therapeutic effect, 60 mg (2 tablets) can be prescribed 2 times a day. The medication should be taken with liquid.
Tablets can be taken regardless of meals.
If symptoms persist for 4-5 days after starting treatment, it is recommended to consult a doctor.

Composition per tablet:
Active ingredient: ambroxol hydrochloride - 30.0 mg
Excipients: lactose monohydrate (milk sugar), corn starch, microcrystalline cellulose, povidone K17 (low molecular weight medical polyvinylpyrrolidone 12600 ± 2700), magnesium stearate, colloidal silicon dioxide (aerosil).

Round flat-cylindrical tablets of white or almost white color with a bevel and a score line.

• hypersensitivity to ambroxol and other components of the product;

• hereditary lactose intolerance, lactase deficiency, and glucose-galactose malabsorption;

• first trimester of pregnancy and breastfeeding period;

• children under 6 years of age. Use with caution

• disorder of bronchial motility and increased mucus secretion (e.g., in rare primary ciliary dyskinesia syndrome);

• renal insufficiency and/or severe liver disease;

• peptic ulcer disease of the stomach and duodenum, including history;

• second and third trimesters of pregnancy.
Use during pregnancy and breastfeeding
Ambroxol crosses the placental barrier. Preclinical studies have not revealed any direct or indirect adverse effects on pregnancy, embryonic/fetal, postnatal development, and labor.
Extensive clinical experience with ambroxol after the 28th week of pregnancy has not found evidence of negative effects on the fetus.
However, standard precautions should be observed when using the medication during pregnancy. Ambroxol is particularly not recommended in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the use of the product is possible only if the potential benefit to the mother outweighs the potential risk to the fetus.
Ambroxol may be excreted in breast milk. Although no adverse effects have been observed in breastfed children, the use of ambroxol during lactation is not recommended.
Preclinical studies of ambroxol have not revealed any negative impact on fertility.

Do not combine with cough suppressants that hinder mucus clearance.
One tablet contains 145 mg of lactose. The maximum daily dose (4 tablets) contains 580 mg of lactose.
In patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - early symptoms may include fever, body aches, rhinitis, cough, and throat inflammation. In symptomatic treatment, there may be a mistaken prescription of mucolytics such as ambroxol. There are isolated reports of Stevens-Johnson syndrome and toxic epidermal necrolysis occurring concurrently with the administration of the drug; however, a causal relationship with the use of the drug is absent.
If the above syndromes develop, it is recommended to discontinue treatment and seek medical attention immediately.
In cases of renal impairment, ambroxol should only be used on a doctor's recommendation.
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 quick psychomotor reactions.

Possible side effects are listed below in descending order of frequency: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (based on available data, the frequency cannot be established).Gastrointestinal disorders: common - nausea; uncommon - vomiting, diarrhea, dyspepsia, abdominal pain.Immune system disorders: rare - hypersensitivity reactions; frequency unknown - anaphylactic reactions up to the development of shock, angioedema, skin itching.Skin and subcutaneous tissue disorders: rare - skin rash, urticaria; frequency unknown - severe skin adverse reactions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis.If any of the side effects listed in the instructions worsen or you notice any other side effects not mentioned in the instructions, inform your doctor.Symptoms: Specific symptoms of ambroxol overdose have not been described. The observed symptoms of overdose corresponded to the known side effects of ambroxol used at recommended doses (nausea, vomiting, abdominal pain, diarrhea, dyspepsia). Treatment: Induced vomiting, gastric lavage within the first 1-2 hours after taking the drug, consumption of fatty foods; symptomatic therapy. Due to the high degree of binding of ambroxol to plasma proteins (80-90%), effective elimination of ambroxol through forced diuresis and hemodialysis is unlikely.The simultaneous use of ambroxol and antitussive medications (e.g., codeine) is not recommended, as the suppression of the cough reflex may lead to the risk of mucus accumulation in the airways, making its expulsion difficult. Ambroxol increases the penetration of amoxicillin, cefuroxime, erythromycin, and doxycycline into the bronchial lumen.

Studies have shown that ambroxol increases secretion in the respiratory tract. It enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to an increase in the flow and transport of mucus (mucociliary clearance). Enhanced mucociliary clearance improves sputum expectoration and eases coughing.
In patients with chronic obstructive pulmonary disease, long-term therapy with ambroxol (for at least 2 months) resulted in a significant reduction in the number of exacerbations. A statistically significant decrease in the duration of exacerbations and the number of days of antibiotic therapy was observed.

All immediate-release forms of ambroxol are characterized by rapid and nearly complete absorption with a linear dose-dependent relationship within the therapeutic concentration range. The maximum plasma concentration (Cmax) after oral administration is reached within 1-2.5 hours. The absolute bioavailability of ambroxol is 79%. The volume of distribution is 552 L. In the therapeutic concentration range, plasma protein binding is approximately 90%.

The transfer of ambroxol from blood to tissues during oral administration occurs rapidly. The highest concentrations of the active substance are observed in the lungs.

Approximately 30% of the orally administered dose undergoes first-pass metabolism in the liver. Studies on human liver microsomes have shown that the CYP3A4 isoenzyme is the predominant isoform responsible for the metabolism of ambroxol to dibromantranilic acid. The remaining portion of ambroxol is metabolized in the liver, primarily through glucuronidation and partial cleavage to dibromantranilic acid (approximately 10% of the administered dose), as well as a small amount of additional metabolites. The terminal half-life of ambroxol is about 10 hours. The total clearance is within the range of 660 mL/min, with renal clearance accounting for approximately 8% of total clearance. Using radioactive labeling, it has been estimated that after a single dose of the drug, about 83% of the administered dose is excreted in urine over the following 5 days.

No clinically significant influence of age and sex on the pharmacokinetics of ambroxol has been found, therefore there is no basis for dose adjustment based on these factors.