Bromhexine (Tablets, Solution, Drops, Syrup) Instructions for Use

Instructions
Dosage forms

ATC Code

R05CB02 (Bromhexine)

Active Substance

Bromhexine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Mucolytic and expectorant drug

Pharmacotherapeutic Group

Drugs used for cough and colds; expectorants, excluding combinations with antitussives; mucolytic agents

Pharmacological Action

A mucolytic agent with an expectorant effect.

It reduces the viscosity of bronchial secretions by depolymerizing the acidic polysaccharides contained within it and by stimulating the secretory cells of the bronchial mucosa that produce a secretion containing neutral polysaccharides.

It is believed that Bromhexine promotes the formation of surfactant.

Pharmacokinetics

Bromhexine is rapidly absorbed from the gastrointestinal tract and undergoes intensive metabolism during the first pass through the liver.

Its bioavailability is about 20%.

In healthy patients, the C_max in plasma is determined after 1 hour.

It is widely distributed in the body tissues. About 85-90% is excreted in the urine, mainly in the form of metabolites.

The metabolite of bromhexine is ambroxol.

The binding of bromhexine to plasma proteins is high. The T_1/2 in the terminal phase is about 12 hours.

Bromhexine penetrates the blood-brain barrier. It penetrates the placental barrier in small amounts.

Only small amounts are excreted in the urine with a T_1/2 of 6.5 hours.

The clearance of bromhexine or its metabolites may decrease in patients with severe hepatic and renal impairment.

Indications

Diseases of the respiratory tract accompanied by the formation of difficult-to-separate viscous secretions: tracheobronchitis, chronic bronchitis with a broncho-obstructive component, bronchial asthma, cystic fibrosis, chronic pneumonia.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E84	Cystic fibrosis
J04	Acute laryngitis and tracheitis
J15	Bacterial pneumonia, not elsewhere classified
J20	Acute bronchitis
J37	Chronic laryngitis and laryngotracheitis
J42	Unspecified chronic bronchitis
J44	Other chronic obstructive pulmonary disease
J45	Asthma
R05	Cough

ICD-11 code	Indication
CA05	Acute laryngitis or tracheitis
CA0G	Chronic laryngitis or laryngotracheitis
CA20.1Z	Chronic bronchitis, unspecified
CA22.Z	Chronic obstructive pulmonary disease, unspecified
CA23	Asthma
CA25.Z	Cystic fibrosis, unspecified
CA40.0Z	Bacterial pneumonia, unspecified
CA42.Z	Acute bronchitis, unspecified
MD12	Cough

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets, Solution, Drops, Syrup

Orally, for adults and children over 10 years old – 8 mg 3-4 times/day.

For children under 2 years old – 2 mg 3 times/day; for children aged 2 to 6 years – 4 mg 3 times/day; for children aged 6 to 10 years – 6-8 mg 3 times/day.

If necessary, the dose can be increased for adults to 16 mg 4 times/day, for children – to 16 mg 2 times/day.

As inhalations, for adults – 8 mg, for children over 10 years old – 4 mg, for children aged 6-10 years – 2 mg. For children under 6 years old – used in doses up to 2 mg. Inhalations are performed 2 times/day.

The therapeutic effect may appear on the 4th-6th day of treatment.

Parenteral administration is recommended for treatment in severe cases, as well as in the postoperative period to prevent the accumulation of thick sputum in the bronchi. Administer 2 mg subcutaneously, intramuscularly, or intravenously 2-3 times/day slowly over 2-3 minutes.

Adverse Reactions

From the digestive system: dyspeptic phenomena, transient increase in the activity of liver transaminases in the blood serum.

From the CNS: headache, dizziness.

Dermatological reactions: increased sweating, skin rash.

From the respiratory system: cough, bronchospasm.

Contraindications

Hypersensitivity to bromhexine.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy and during breastfeeding is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Use in Hepatic Impairment

Should be used with caution in patients with impaired liver function.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function.

Pediatric Use

Use with caution in children – according to indications, in age-appropriate recommended doses and dosage forms.

Special Precautions

In case of gastric ulcer, as well as with a history of gastric bleeding, Bromhexine should be used under medical supervision.

Use with caution in patients suffering from bronchial asthma.

Bromhexine should not be used simultaneously with medicines containing codeine, as this makes it difficult to cough up liquefied sputum.

It is used as part of combined herbal preparations with essential oils (including eucalyptus oil, anise oil, peppermint oil, menthol).

Drug Interactions

Bromhexine is incompatible with alkaline solutions.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Bromhexine [Jivdhara Pharma, Private Limited (India)]
Syrup 8 mg/5 ml: bottle 50 or 100 ml

Marketing Authorization Holder

Jivdhara Pharma, Private Limited (India)

Dosage Form

Bromhexine

Syrup 8 mg/5 ml: bottle 50 or 100 ml

Dosage Form, Packaging, and Composition

Syrup	5 ml
Bromhexine hydrochloride	8 mg

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Bromhexine [Jivdhara Pharma, Private Limited (India)]
Syrup 4 mg/5 ml: 50 or 100 ml bottle

Marketing Authorization Holder

Jivdhara Pharma, Private Limited (India)

Dosage Form

Bromhexine

Syrup 4 mg/5 ml: 50 or 100 ml bottle

Dosage Form, Packaging, and Composition

Syrup	5 ml
Bromhexine hydrochloride	4 mg

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Bromhexine [Simpex Pharma, Pvt. Ltd. (India)]
Oral solution 4 mg/5 ml: fl. 100 ml

Marketing Authorization Holder

Simpex Pharma, Pvt. Ltd. (India)

Dosage Form

Bromhexine

Oral solution 4 mg/5 ml: fl. 100 ml

Dosage Form, Packaging, and Composition

Oral solution	5 ml
Bromhexine hydrochloride	4 mg

100 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.

Bromhexine [Atoll LLC (Russia)]
Oral solution 4 mg/5 ml: fl. 60 ml or 100 ml with a measuring cup or a measuring spoon

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bromhexine

Oral solution 4 mg/5 ml: fl. 60 ml or 100 ml with a measuring cup or a measuring spoon

Dosage Form, Packaging, and Composition

Oral solution colorless, transparent or slightly opalescent, with a characteristic odor.

	5 ml
Bromhexine hydrochloride	4 mg

Excipients: ethanol 95% – 150 mg, levomenthol – 0.34 mg, sorbitol 70% (non-crystallizing) -2142.855 mg, methylparahydroxybenzoate – 8.2 mg, hydrochloric acid – 1.42 mg, water – up to 5 ml.

60 ml – dark glass bottles (1) with a measuring cup or a measuring spoon – cardboard packs.
60 ml – polymer bottles (1) with a measuring cup or a measuring spoon – cardboard packs.
100 ml – dark glass bottles (1) with a measuring cup or a measuring spoon – cardboard packs.
100 ml – polymer bottles (1) with a measuring cup or a measuring spoon – cardboard packs.

Bromhexine [Atoll LLC (Russia)]
Tablets 8 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 90, 100, 120, 125, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 280, 300, 320, 350, 360, 400, 450 or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Ozon Pharm, LLC (Russia)

Dosage Form

Bromhexine

Tablets 8 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 90, 100, 120, 125, 140, 150, 160, 175, 180, 200, 210, 225, 240, 250, 270, 280, 300, 320, 350, 360, 400, 450 or 500 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Bromhexine hydrochloride	8 mg

Excipients: lactose monohydrate (milk sugar) – 101.5 mg, corn starch – 15 mg, povidone K25 – 4.5 mg, magnesium stearate – 1 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (7) – cardboard packs.
20 pcs. – contour cell packs (8) – cardboard packs.
20 pcs. – contour cell packs (9) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
25 pcs. – contour cell packs (3) – cardboard packs.
25 pcs. – contour cell packs (4) – cardboard packs.
25 pcs. – contour cell packs (5) – cardboard packs.
25 pcs. – contour cell packs (6) – cardboard packs.
25 pcs. – contour cell packs (7) – cardboard packs.
25 pcs. – contour cell packs (8) – cardboard packs.
25 pcs. – contour cell packs (9) – cardboard packs.
25 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (7) – cardboard packs.
30 pcs. – contour cell packs (8) – cardboard packs.
30 pcs. – contour cell packs (9) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.
40 pcs. – contour cell packs (1) – cardboard packs.
40 pcs. – contour cell packs (2) – cardboard packs.
40 pcs. – contour cell packs (3) – cardboard packs.
40 pcs. – contour cell packs (4) – cardboard packs.
40 pcs. – contour cell packs (5) – cardboard packs.
40 pcs. – contour cell packs (6) – cardboard packs.
40 pcs. – contour cell packs (7) – cardboard packs.
40 pcs. – contour cell packs (8) – cardboard packs.
40 pcs. – contour cell packs (9) – cardboard packs.
40 pcs. – contour cell packs (10) – cardboard packs.
50 pcs. – contour cell packs (1) – cardboard packs.
50 pcs. – contour cell packs (2) – cardboard packs.
50 pcs. – contour cell packs (3) – cardboard packs.
50 pcs. – contour cell packs (4) – cardboard packs.
50 pcs. – contour cell packs (5) – cardboard packs.
50 pcs. – contour cell packs (6) – cardboard packs.
50 pcs. – contour cell packs (7) – cardboard packs.
50 pcs. – contour cell packs (8) – cardboard packs.
50 pcs. – contour cell packs (9) – cardboard packs.
50 pcs. – contour cell packs (10) – cardboard packs.

Bromhexine [Biosintez, PJSC (Russia)]
Tablets 8 mg: 50 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bromhexine

Tablets 8 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, flat-cylindrical, with a bevel.

	1 tab.
Bromhexine hydrochloride	8 mg

Excipients: sucrose (white sugar), lactose monohydrate (milk sugar), potato starch, calcium stearate, gelatin.

10 pcs. – contour cell packs (5) – cardboard packs.
50 pcs. – polymer bottles (1) – cardboard packs.

Bromhexine [Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)]
Tablets 8 mg: 50 pcs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Bromhexine

Tablets 8 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, flat-cylindrical, with a bevel.

	1 tab.
Bromhexine hydrochloride	8 mg

Excipients: sucrose, lactose monohydrate, microcrystalline cellulose, stearic acid, potato starch.

10 pcs. – contour cell packs (5) – cardboard packs.

Bromhexine [Dalkhimpharm, JSC (Russia)]
Tablets 8 mg: 10, 20, 30, or 50 pcs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bromhexine

Tablets 8 mg: 10, 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Bromhexine hydrochloride	8 mg

10 pcs. – contour cell packs.
20 pcs. – jars.
30 pcs. – dark glass jars (1) – cardboard packs.
50 pcs. – jars.

Bromhexine [Ivanovo Pharmaceutical Factory PJSC (Russia)]
Oral solution 4 mg/5 ml: fl. or jars 60 ml, 100 ml, 150 ml or 200 ml

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Bromhexine

Oral solution 4 mg/5 ml: fl. or jars 60 ml, 100 ml, 150 ml or 200 ml

Dosage Form, Packaging, and Composition

Oral solution is a transparent, colorless, slightly viscous liquid with a characteristic apricot odor.

	5 ml
Bromhexine hydrochloride	4 mg

Excipients: propylene glycol, sorbitol solution 70% (non-crystallizing), apricot flavor, hydrochloric acid 0.1M solution, purified water.

60 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
150 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
60 ml – jars (1) – cardboard packs.
100 ml – jars (1) – cardboard packs.
150 ml – jars (1) – cardboard packs.
200 ml – jars (1) – cardboard packs.
60 ml – bottles (1) – cardboard packs (with a measuring syringe or a measuring cup, or a measuring spoon).
100 ml – bottles (1) – cardboard packs (with a measuring syringe or a measuring cup, or a measuring spoon).
150 ml – bottles (1) – cardboard packs (with a measuring syringe or a measuring cup, or a measuring spoon).
200 ml – bottles (1) – cardboard packs (with a measuring syringe or a measuring cup, or a measuring spoon).
60 ml – jars (1) – cardboard packs (with a measuring syringe or a measuring cup, or a measuring spoon).
100 ml – jars (1) – cardboard packs (with a measuring syringe or a measuring cup, or a measuring spoon).
150 ml – jars (1) – cardboard packs (with a measuring syringe or a measuring cup, or a measuring spoon).
200 ml – jars (1) – cardboard packs (with a measuring syringe or a measuring cup, or a measuring spoon).
60 ml – bottles (9-300) – cardboard boxes (for hospitals).
100 ml – bottles (9-300) – cardboard boxes (for hospitals).
150 ml – bottles (9-300) – cardboard boxes (for hospitals).
200 ml – bottles (9-300) – cardboard boxes (for hospitals).
60 ml – jars (9-300) – cardboard boxes (for hospitals).
100 ml – jars (9-300) – cardboard boxes (for hospitals).
150 ml – jars (9-300) – cardboard boxes (for hospitals).
200 ml – jars (9-300) – cardboard boxes (for hospitals).

Bromhexine [Kirov Pharmaceutical Company, LLC (Russia)]
Tablets 8 mg: 20, 30, 40 or 50 pcs.

Marketing Authorization Holder

Kirov Pharmaceutical Company, LLC (Russia)

Dosage Form

Bromhexine

Tablets 8 mg: 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Bromhexine hydrochloride	8 mg

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Bromhexine [Obnovlenie Pfc, JSC (Russia)]
Tablets 8 mg: 10, 14, 20, 28, 50, or 200 pcs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bromhexine

Tablets 8 mg: 10, 14, 20, 28, 50, or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, flat-cylindrical, with a bevel, with the marking “R” on one side or without it.

	1 tab.
Bromhexine hydrochloride	8 mg

Excipients: sucrose (sugar) – 0.081 g, potato starch – 0.01 g, calcium stearate – 0.001 g.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (20) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
50 pcs. – contour cell packs (1) – cardboard packs.

Bromhexine [Rif LLC (Russia)]
Tablets for children 4 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 90, 100, 120, 125, 150, 160, 200, or 250 pcs.

Marketing Authorization Holder

Rif LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bromhexine

Tablets for children 4 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 90, 100, 120, 125, 150, 160, 200, or 250 pcs.

Dosage Form, Packaging, and Composition

Tablets for children are white or almost white, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Bromhexine hydrochloride	4 mg

Excipients: lactose monohydrate (milk sugar) – 80.23 mg, corn starch – 11.54 mg, povidone K25 – 3.46 mg, magnesium stearate – 0.77 mg.

Bromhexine [Tula Pharmaceutical Factory, LLC (Russia)]
Oral solution 4 mg/5 ml: fl. 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 90 ml, 100 ml, 110 ml, 120 ml, 130 ml, 140 ml, 150 ml, 200 ml or 250 ml

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bromhexine

Oral solution 4 mg/5 ml: fl. 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 90 ml, 100 ml, 110 ml, 120 ml, 130 ml, 140 ml, 150 ml, 200 ml or 250 ml

Dosage Form, Packaging, and Composition

Oral solution is a transparent, colorless, slightly viscous liquid with a characteristic apricot odor.

	5 ml
Bromhexine hydrochloride	4 mg

Excipients: propylene glycol – 1250 mg, sorbitol – 2000 mg, apricot flavor concentrate – 2.5 mg, hydrochloric acid 0.1M solution – 7.8 mg, purified water – up to 5 ml.

10 ml – bottles (1) – cardboard packs^x.
20 ml – bottles (1) – cardboard packs^x.
30 ml – bottles (1) – cardboard packs^x.
40 ml – bottles (1) – cardboard packs^x.
50 ml – bottles (1) – cardboard packs^x.
60 ml – bottles (1) – cardboard packs^x.
70 ml – bottles (1) – cardboard packs^x.
80 ml – bottles (1) – cardboard packs^x.
90 ml – bottles (1) – cardboard packs^x.
100 ml – bottles (1) – cardboard packs^x.
110 ml – bottles (1) – cardboard packs^x.
120 ml – bottles (1) – cardboard packs^x.
130 ml – bottles (1) – cardboard packs^x.
140 ml – bottles (1) – cardboard packs^x.
150 ml – bottles (1) – cardboard packs^x.
200 ml – bottles (1) – cardboard packs^x.
250 ml – bottles (1) – cardboard packs^x.

^x a measuring cup or a measuring spoon may be placed in the cardboard pack.

Bromhexine [Tula Pharmaceutical Factory, LLC (Russia)]
Oral drops 8 mg/1 ml: 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 90 ml or 100 ml bottle

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bromhexine

Oral drops 8 mg/1 ml: 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 90 ml or 100 ml bottle

Dosage Form, Packaging, and Composition

Oral drops are a colorless or slightly yellowish, transparent, viscous liquid with a characteristic odor.

	1 ml
Bromhexine hydrochloride	8 mg

Excipients: star anise fruit oil – 0.25 mg, bitter fennel fruit oil – 0.75 mg, levomenthol – 1.5 mg, thyme herb oil – 0.25 mg, peppermint leaf oil – 0.25 mg, eucalyptus oil – 0.25 mg, sucrose – 100 mg, polysorbate 80 – 4 mg, ethanol 95% – 360 mg, hydrochloric acid – 0.39 mg, potassium dihydrogen phosphate anhydrous – 6 mg, sodium phosphate dodecahydrate – 0.31 mg, purified water – up to 1 ml.

10 ml – dropper bottles (1) – cardboard packs.
20 ml – dropper bottles (1) – cardboard packs.
30 ml – dropper bottles (1) – cardboard packs.
40 ml – dropper bottles (1) – cardboard packs.
50 ml – dropper bottles (1) – cardboard packs.
60 ml – dropper bottles (1) – cardboard packs.
70 ml – dropper bottles (1) – cardboard packs.
80 ml – dropper bottles (1) – cardboard packs.
90 ml – dropper bottles (1) – cardboard packs.
100 ml – dropper bottles (1) – cardboard packs.

Bromhexine [Pharmstandard-Lexredstva OJSC (Russia)]
Syrup 4 mg/5 ml: bottle 100 ml

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bromhexine

Syrup 4 mg/5 ml: bottle 100 ml

Dosage Form, Packaging, and Composition

Syrup	5 ml
Bromhexine hydrochloride	4 mg

100 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.
100 ml – dark glass bottles (1) with a measuring spoon – packs.

Bromhexine [Pharmstandard-Lexredstva OJSC (Russia)]
Tablets 8 mg: 10, 20, 30, 40, 50, 60, 80 or 100 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bromhexine

Tablets 8 mg: 10, 20, 30, 40, 50, 60, 80 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, round, flat-cylindrical, with a bevel.

	1 tab.
Bromhexine hydrochloride	8 mg

Excipients: potato starch, lactose (milk sugar), sucrose (white sugar), calcium stearate.

Bromhexine 4 Berlin-chemie [Berlin-Chemie, AG (Germany)]
Oral solution 4 mg/5 ml: fl. 60 ml with a measuring spoon

Marketing Authorization Holder

Berlin-Chemie, AG (Germany)

Dosage Form

Bromhexine 4 Berlin-chemie

Oral solution 4 mg/5 ml: fl. 60 ml with a measuring spoon

Dosage Form, Packaging, and Composition

Oral solution is transparent, colorless, slightly viscous, odorless or with a faint characteristic apricot odor.

	5 ml	100 ml
Bromhexine hydrochloride	4 mg	80 mg

Excipients: benzoic acid, maltitol, apricot flavor, anhydrous citric acid, purified water.

60 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.

Bromhexine 8 [Krewel Meuselbach, GmbH (Germany)]
Oral drops 8 mg/1 ml: 20 ml, 50 ml or 100 ml bottle

Marketing Authorization Holder

Krewel Meuselbach, GmbH (Germany)

Dosage Form

Bromhexine 8

Oral drops 8 mg/1 ml: 20 ml, 50 ml or 100 ml bottle

Dosage Form, Packaging, and Composition

Oral drops	1 ml
Bromhexine hydrochloride	8 mg

20 ml – dark glass dropper bottles (1) – cardboard packs.
50 ml – dark glass dropper bottles (1) – cardboard packs.
100 ml – dark glass dropper bottles (1) – cardboard packs.

Bromhexine 8 Berlin-chemie [Berlin-Chemie, AG (Germany)]
Film-coated tablets 8 mg: 25 pcs.

Marketing Authorization Holder

Berlin-Chemie, AG (Germany)

Manufactured By

Berlin-Chemie, AG (Germany)

Berlin-Pharma CJS (Russia)

Dosage Form

Bromhexine 8 Berlin-chemie

Film-coated tablets 8 mg: 25 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets are yellow to greenish-yellow, slightly biconvex, with an almost white core.

	1 tab.
Bromhexine (as bromhexine hydrochloride)	8 mg

Excipients: lactose monohydrate, corn starch, gelatin, colloidal anhydrous silica, magnesium stearate.

Tablets white, round, flat-cylindrical, with a bevel.

	1 tab.
Bromhexine hydrochloride	8 mg

Excipients: lactose monohydrate, potato starch, sucrose, calcium stearate.

7 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.) – cardboard packs.
10 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.) – cardboard packs.
14 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Bromhexine Nycomed [Takeda Pharma A/S (Denmark)]
Oral solution 4 mg/5 ml: bottle 60 ml, 100 ml or 150 ml

Marketing Authorization Holder

Takeda Pharma A/S (Denmark)

Dosage Form

Bromhexine Nycomed

Oral solution 4 mg/5 ml: bottle 60 ml, 100 ml or 150 ml

Dosage Form, Packaging, and Composition

Oral solution for children	5 ml
Bromhexine hydrochloride	4 mg

60 ml – dark glass bottles.
100 ml – dark glass bottles.
150 ml – dark glass bottles.

Bromhexine Stada [Nizhpharm JSC (Russia)]
Oral solution 0.8 mg/1 ml: bottle 150 ml in a kit with a measuring cup

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Takeda Pharma Sp. z o.o. (Poland)

Dosage Form

Bromhexine Stada

Oral solution 0.8 mg/1 ml: bottle 150 ml in a kit with a measuring cup

Dosage Form, Packaging, and Composition

Oral solution as a colorless, clear or slightly opalescent liquid.

	1 ml
Bromhexine hydrochloride	0.8 mg

Bromhexine-Akrikhin

Syrup 4 mg/5 ml: 100 ml bottle with a measuring spoon or measuring cup

Dosage Form, Packaging, and Composition

Syrup	5 ml
Bromhexine hydrochloride	4 mg

100 ml – dark glass bottles (1) with a measuring spoon or measuring cup – cardboard packs.

Bromhexine-Akrikhin [Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)]
Tablets 4 mg: 10, 20, 30, 40, 50, or 100 pcs.
Tablets 8 mg: 10, 20, 30, 40, 50, or 100 pcs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Forms

	Bromhexine-Akrikhin	Tablets 4 mg: 10, 20, 30, 40, 50, or 100 pcs.
		Tablets 8 mg: 10, 20, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Bromhexine hydrochloride	4 mg

Tablets	1 tab.
Bromhexine hydrochloride	8 mg

Bromhexine-Alium [Aliym, JSC (Russia)]
Film-coated tablets 4 mg: 10, 20, 30, 40, 50, 60, 80, 100, or 200 pcs.
Film-coated tablets 8 mg: 10, 20, 30, 40, 50, 60, 80, 100, or 200 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Forms

	Bromhexine-Alium	Film-coated tablets 4 mg: 10, 20, 30, 40, 50, 60, 80, 100, or 200 pcs.
		Film-coated tablets 8 mg: 10, 20, 30, 40, 50, 60, 80, 100, or 200 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets red in color, round, biconvex; a cross-section shows two layers: a white or almost white core and a red coating.

	1 tab.
Bromhexine hydrochloride	4 mg

Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.

Coating composition: sucrose, povidone K17, magnesium carbonate hydroxide, colloidal silicon dioxide (aerosil), titanium dioxide, talc, carnauba wax, azorubine dye.

Film-coated tablets yellow in color, round, biconvex; a cross-section shows two layers: a white or almost white core and a yellow coating.

	1 tab.
Bromhexine hydrochloride	8 mg

Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.

Coating composition: sucrose, povidone K17, magnesium carbonate hydroxide, colloidal silicon dioxide (aerosil), titanium dioxide, talc, carnauba wax, quinoline yellow dye.