Bromhexine-zdorovya

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BROMHEXINE-ZDOROVIYA

Composition:

Active substance: 1 tablet contains bromhexine hydrochloride 8 mg;

Excipients: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, copovidone, calcium stearate.|....|

Pharmaceutical form. Tablets|tablets|.

Main physicochemical properties: white or almost white tablets, flat cylindrical shape, with bevelled edges. Marbling is permissible.

Pharmacotherapeutic group. Mucolytic agents. ATC code R05C B02.

Pharmacological properties.

Pharmacodynamics. Bromhexine is a synthetic derivative of the active substance of plant origin, vasicine. It exerts a secretolytic and secretomotor effect in the bronchial tract area, resulting in increased bronchial secretion, reduced viscosity of mucus (sputum), and stimulation of ciliary epithelium activity, thereby facilitating the movement of mucus (sputum) along the respiratory tract.

Pharmacokinetics. After oral administration, bromhexine is almost completely absorbed, with an elimination half-life of approximately 0.4 hours. The first-pass effect is about 80 %, during which biologically active metabolites are formed. Plasma protein binding is 99 %. The decline in plasma concentration is multiphasic. The half-life that limits the duration of action is about 1 hour. The terminal elimination half-life is approximately 16 hours. This is due to the redistribution of small amounts of bromhexine in tissues. The volume of distribution is about 7 L per 1 kg of body weight. Bromhexine does not accumulate. Bromhexine penetrates through the placenta, into cerebrospinal fluid, and into breast milk. It is primarily excreted by the kidneys in the form of metabolites. In acute liver diseases, a decrease in the clearance of the active substance is possible. In acute renal failure, an increase in the elimination half-life of bromhexine metabolites cannot be excluded. Under physiological conditions in the stomach, nitrosation of bromhexine may occur.

Clinical characteristics.

Indications. Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with impaired mucus formation and transport.

Contraindications. Hypersensitivity to the active substance or to any of the excipients. The medicinal product must not be used in patients with gastric or duodenal ulcers or with a history of peptic ulcer disease, since bromhexine may affect the gastrointestinal mucosa.

The drug must not be used during breastfeeding.

The medicinal product is contraindicated in children under 6 years of age due to the high content of the active substance. For this age group, medicinal products with reduced dosage should be prescribed.

Interaction with other medicinal products and other forms of interaction. Bromhexine may be administered in combination with bronchodilators, antibacterial agents, and drugs used in cardiology.

Medicinal products that irritate the gastrointestinal tract (e.g., nonsteroidal anti-inflammatory drugs) — when used concomitantly with bromhexine, mutual enhancement of mucosal irritation effects is possible.

Antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) and sulfonamide drugs — when used concomitantly with bromhexine, concentrations of antibiotics and sulfonamides in bronchopulmonary secretions and sputum are increased.

Antitussives — concomitant use with bromhexine leads to accumulation of mucus in the airways and impaired sputum clearance due to reduced coughing. This combination is not recommended.

Special precautions for use.

Skin reactions

Severe skin reactions associated with bromhexine use have been reported, including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If symptoms or signs of progressive skin rash (sometimes with blisters or mucosal lesions) occur, medical advice should be sought immediately and treatment with bromhexine should be discontinued.

Gastric or duodenal ulcer

This medicinal product should not be administered to patients with gastric or duodenal ulcer or a history of peptic ulcer disease, as bromhexine may affect the gastrointestinal mucosa.

Lungs and respiratory tract

The product should be used with particular caution in patients with impaired bronchial motility associated with excessive bronchial secretion (e.g. in rare conditions such as primary ciliary dyskinesia), due to the risk of secretion accumulation.

Liver and kidney disorders

The product should be administered with particular caution (i.e. with longer intervals or in lower doses) to patients with renal impairment or severe liver disease.

In cases of severe renal insufficiency, accumulation of bromhexine metabolites formed in the liver may occur.

Periodic monitoring of liver function is recommended, especially during prolonged treatment.

Lactose

If a patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Use during pregnancy or breastfeeding

Pregnancy. Data on the use of bromhexine in pregnant women are limited. Therefore, the drug should be prescribed only by a physician after careful assessment of the benefit-risk ratio and is not recommended during the first trimester of pregnancy.

Breastfeeding. Since the active substance passes into breast milk, the medicinal product should not be used during breastfeeding.

Ability to influence reaction speed when driving or operating machinery.
Bromhexine has no effect or has a negligible effect on the ability to drive or operate machinery.

Method of administration and dosage.
The product should be taken orally after meals, with plenty of fluid.

Adults and adolescents aged 14 years and older: 8–16 mg (1–2 tablets) three times daily, corresponding to 24–48 mg/day of bromhexine hydrochloride.

Children aged 6 to 14 years and patients with body weight below 50 kg: 8 mg (1 tablet) three times daily, corresponding to 24 mg/day of bromhexine hydrochloride.

The duration of treatment should be determined individually according to the indication and disease progression, but should not exceed 4–5 days without appropriate medical advice.

In patients with renal impairment or severe liver disease, the dose should be appropriately reduced.

Children. This medicinal product in this pharmaceutical form should not be administered to children under 6 years of age.

Overdose.
Symptoms: Dyspeptic disorders, nausea, vomiting, diarrhea. Dizziness, headache, ataxia, diplopia, metabolic acidosis, rapid breathing.

No symptoms have been observed in young children after ingestion of up to 40 mg of bromhexine, even without decontamination procedures. No chronic toxic effects in humans have been identified.

Treatment: Induce vomiting and perform gastric lavage (within the first 1–2 hours after ingestion). In cases of significant overdose, cardiovascular monitoring should be performed and symptomatic treatment administered as needed. Due to the high degree of plasma protein binding, large volume of distribution, and slow redistribution of bromhexine from tissues into blood, enhanced elimination by hemodialysis or forced diuresis is not expected to be effective.

Side effects.

The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency not known (cannot be estimated from available data).

Immune system disorders.

Rare: hypersensitivity reactions (e.g., respiratory distress).

Frequency not known: anaphylactic reactions, including anaphylactic shock, angioedema, pruritus.

Gastrointestinal disorders.

Uncommon: nausea, stomach pain, vomiting, diarrhea.

Exacerbation of gastric or duodenal ulcer.

Skin and subcutaneous tissue disorders.

Rare: rash, urticaria.

Frequency not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens*–*Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

General disorders.

Uncommon: fever.

Respiratory disorders, dizziness, respiratory distress, headache, increased sweating, transient increase in serum aspartate aminotransferase levels, chills.

In case of hypersensitivity reactions, anaphylactic reactions, or any skin or mucosal disorders, bromhexine should be discontinued immediately and medical advice should be sought.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. Tablets|tablets| No. 20 (10×2), No. 20 (20×1), No. 50 (10×5) in blisters in a box; No. 20 in blisters.

Dispensing category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY «CORPORATION «ZDOROV’YA».

Manufacturer's address and place of business. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.