Neo-Bronchol^® (Tablets) Instructions for Use

Marketing Authorization Holder

Divapharma, GmbH (Germany)

Manufactured By

Bolder Arzneimittel, GmbH & Co. KG (Germany)

ATC Code

R05CB06 (Ambroxol)

Active Substance

Ambroxol (Rec.INN registered by WHO)

Dosage Form

Neo-Bronchol®

Sugar-free lozenges 15 mg: 20, 30, or 40 pcs.

Dosage Form, Packaging, and Composition

Sugar-free lozenges light brown in color, round, convex on one side and concave on the other, with a rough surface and a light minty aroma; uneven coloring, the presence of air bubbles in the tablet mass, and slight unevenness of the edges are allowed.

Excipients: acacia – 850 mg, sorbitol solution 70% – 922.2 mg, peppermint leaf oil – 10 mg, eucalyptus oil (eucalyptus leaf) – 2 mg, sodium saccharin dihydrate – 1.8 mg, liquid paraffin – 2.4 mg, purified water – 196.6 mg.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Mucolytic and expectorant drug

Pharmacotherapeutic Group

Mucolytic expectorant

Pharmacological Action

Mucolytic and expectorant agent, is an active N-demethylated metabolite of bromhexine. It has secretomotor, secretolytic, and expectorant actions. It stimulates the serous cells of the bronchial mucosa, increases the motor activity of the ciliated epithelium by acting on type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, and enhances the production of endogenous surfactant, a surface-active substance that ensures the sliding of bronchial secretions in the airway lumen.

Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure and contributing to a reduction in viscosity and liquefaction of sputum; as a result, mucociliary transport is improved and the removal of sputum from the bronchial tree is facilitated.

When Ambroxol is taken orally, the effect, on average, occurs after 30 minutes and lasts for 6-12 hours, depending on the single dose.

Pharmacokinetics

After oral administration, Ambroxol is rapidly and almost completely absorbed. T_max is 1-3 hours. Plasma protein binding is approximately 85%. It crosses the placental barrier and is excreted in breast milk. It is metabolized in the liver to form metabolites (dibromanthranilic acid, glucuronic conjugates), which are excreted by the kidneys. It is excreted mainly by the kidneys – 90% as metabolites, less than 10% unchanged. T_1/2 from plasma is 7-12 hours. T_1/2 of ambroxol and its metabolites is approximately 22 hours.

Due to high protein binding and large V_d, as well as slow back penetration from tissues into the blood, significant elimination of ambroxol does not occur during dialysis or forced diuresis. The clearance of ambroxol in patients with severe hepatic impairment is reduced by 20-40%. In severe renal impairment, the T_1/2 of ambroxol metabolites is increased.

Indications

Diseases of the respiratory tract accompanied by the production of viscous sputum and difficulty in expectoration: acute and chronic bronchitis; pneumonia; bronchial asthma; bronchiectasis; COPD.

ICD codes

Dosage Regimen

Administer the lozenges by allowing them to dissolve slowly in the mouth.

Adhere strictly to the following dosing schedule based on patient age. For adults and children 12 years and older, take one 15 mg lozenge three times daily.

For children from 6 to under 12 years of age, take one 15 mg lozenge twice daily.

This formulation is contraindicated for children under 6 years due to the risk of choking and the dosage form.

The total daily dose for adults should generally not exceed 90 mg. The total daily dose for children 6 to under 12 years should not exceed 30 mg.

Maintain an adequate fluid intake during therapy to enhance the secretolytic effect.

Do not use the drug for more than 4-5 days without medical consultation. If symptoms persist or worsen, seek medical advice.

Avoid taking the dose immediately before bedtime to prevent the accumulation of liquefied bronchial secretions overnight.

For patients with renal or severe hepatic impairment, use with caution and consider a reduced dosage frequency under medical supervision.

Do not co-administer with antitussive medications that suppress the cough reflex, such as codeine.

Adverse Reactions

Allergic reactions rarely – skin rash, urticaria, exanthema, facial edema, shortness of breath, itching, fever; frequency unknown – anaphylactic reactions, including anaphylactic shock, angioedema, skin itching, allergic contact dermatitis.

From the digestive system often – nausea; infrequently – vomiting, diarrhea, dyspepsia, abdominal pain.

From the nervous system often – dysgeusia.

From the skin and subcutaneous tissues very rarely – toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome; frequency unknown – acute generalized exanthematous pustulosis.

From the respiratory system often – decreased sensitivity in the oral cavity or pharynx; rarely – dryness of the respiratory mucosa, rhinorrhea; in isolated cases – dryness of the pharyngeal mucosa.

Contraindications

Hypersensitivity to ambroxol or auxiliary components of the drugs; first trimester of pregnancy; lactation period (breastfeeding); children under 6 years of age (for tablets); children under 12 years of age (for prolonged-release dosage forms).

With caution

Impaired bronchial motility and increased mucus secretion (e.g., in the rare syndrome of immotile cilia); renal impairment and/or severe hepatic impairment; gastric and duodenal ulcer (including history); second and third trimesters of pregnancy; children under 2 years of age (oral solution; only as prescribed by a doctor).

Use in Pregnancy and Lactation

Ambroxol is contraindicated in the first trimester of pregnancy. If necessary, use in the second and third trimesters should evaluate the potential benefit of therapy for the mother and the possible risk to the fetus.

If it is necessary to use ambroxol during lactation, the issue of discontinuing breastfeeding should be considered.

Use in Hepatic Impairment

Use with caution in severe hepatic impairment.

Use in Renal Impairment

Use with caution in renal impairment.

Pediatric Use

Can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the ambroxol drug leaflets regarding contraindications for the use of specific ambroxol dosage forms in children of different ages.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Ambroxol should not be taken simultaneously with antitussive drugs that may inhibit the cough reflex, such as codeine, as this may hinder the removal of liquefied sputum from the bronchi.

Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.

Patients taking Ambroxol are not recommended to perform breathing exercises due to difficulty in expectoration. In patients in serious condition, aspiration of liquefied sputum should be performed.

Ambroxol should not be taken immediately before bedtime.

In patients with bronchial asthma, Ambroxol may intensify coughing.

In patients with severe skin lesions – Stevens-Johnson syndrome or toxic epidermal necrolysis – an influenza-like condition may be observed in the early phase: fever, body aches, rhinitis, cough, pharyngitis. With symptomatic therapy, mucolytic agents such as ambroxol hydrochloride may be erroneously prescribed.

Drug Interactions

Antitussives (e.g., codeine) – due to suppression of the cough reflex, accumulation of sputum in the airway lumen with difficulty in its removal is possible (simultaneous use is not recommended).

Amoxicillin, doxycycline, cefuroxime, erythromycin – increased penetration of antibiotics into the bronchial secretion.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.