Bronchobos®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BROMCHOBOS® (BRONCHOBOS®)

Composition:

Active substance: carbocysteine;

1 hard capsule contains carbocysteine 375 mg;

Excipients: corn starch, gelatin, colloidal anhydrous silicon dioxide, magnesium stearate; size 0 hard gelatin capsule contains: titanium dioxide (E 171), quinoline yellow (E 104), indigo carmine (E 110), gelatin.

Pharmaceutical form. Hard capsules.

Main physicochemical properties: Size 0 hard gelatin capsules.

Color of the body and cap: yellow. Capsule contents: white powder.

Pharmacotherapeutic group.

Medicinal products used for cough and colds. Mucolytics. Carbocysteine. ATC code R05C B03.

Pharmacological properties.

Pharmacodynamics.

Carbocysteine (S-carboxymethyl L-cysteine), as demonstrated in studies in animals, both healthy and with bronchitis, affects the quality and quantity of mucus glycoproteins secreted in the respiratory tract. An increased ratio of acidic to neutral glycoproteins in mucus composition and transformation of serous cells into mucus cells are initial responses to irritation, followed by hypersecretion. In animals exposed to irritants, administration of carbocysteine was shown to maintain normal glycoprotein secretion; administration after exposure accelerated normalization of the animals' condition. In clinical studies, it has been demonstrated that carbocysteine reduces goblet cell hyperplasia. Therefore, the use of carbocysteine is appropriate in the treatment of diseases characterized by abnormal mucus formation.

Pharmacokinetics.

Carbocysteine is rapidly absorbed from the gastrointestinal tract. In a steady-state study (7 days) in which carbocysteine 375 mg capsules, 2 capsules three times daily, were administered to healthy volunteers, the following pharmacokinetic parameters were observed:

Clinical characteristics.

Indications.

Adjunctive therapy of respiratory diseases characterized by excessive production of viscous mucus, including chronic obstructive pulmonary disease.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.

Peptic ulcer of the stomach and duodenum during exacerbation.

Interaction with other medicinal products and other forms of interaction.

Not established.

Usage particulars.

Caution is recommended when administering to elderly patients, patients with a history of gastric or duodenal ulcer, or patients receiving medicinal products capable of causing gastrointestinal bleeding. If gastrointestinal bleeding occurs, the drug should be discontinued.

BROCHOBOS®, hard capsules, contains the colouring agent Sunset Yellow FCF (E 110), which may cause an allergic reaction (delayed hypersensitivity reactions are possible).

Use during pregnancy or breastfeeding.

There are no data on the use of carbocisteine in pregnant women. It is not possible to draw conclusions regarding the safety of carbocisteine use during pregnancy. The use of carbocisteine for the treatment of pregnant women is not recommended, particularly during the first trimester of pregnancy.

There are no data on the penetration of carbocisteine into breast milk, its effect on milk production, or its effect on the breastfed infant. It is not possible to draw conclusions regarding the safety of carbocisteine use during breastfeeding. The use of carbocisteine for the treatment of women during breastfeeding is not recommended.

Ability to influence reaction rate while driving or operating machinery.

BROCHOBOS®, hard capsules, has no or negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage

For oral use.

Adults, including elderly patients: the initial daily dose is 2250 mg of carbocysteine, divided into several doses – 2 capsules three times a day. After achieving a satisfactory response, gradually reduce the dose to 1500 mg daily, divided into several doses – 1 capsule four times a day.

The duration of treatment should not exceed 8–10 days.

Children.

This medicinal form is not recommended for use in children. To achieve the recommended daily dose of 20 mg/kg body weight, divided into several doses, it is recommended to use BROMHEXINE SYRUP 125 mg/5 ml.

Overdose.

The most likely symptoms of overdose are gastrointestinal disturbances. Treatment: gastric lavage followed by medical supervision.

Side effects

Immune system disorders: There have been reports of anaphylactic reactions, allergic skin rash, and fixed drug eruption.

Gastrointestinal disorders: There have been reports of diarrhea, nausea, epigastric discomfort, and gastrointestinal bleeding during the use of carbocysteine. Frequency not known: vomiting, gastrointestinal bleeding.

Skin and subcutaneous tissue disorders: There have been reports of skin rash and allergic skin eruptions. Isolated cases of bullous dermatitis, including Stevens-Johnson syndrome and erythema multiforme, have also been reported.

Information on suspected adverse reactions.

Reporting of suspected adverse reactions after marketing authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and/or lack of therapeutic effect of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua and to the email address of Bosnalijek d.d.: [email protected].

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C. Keep out of reach and sight of children.

Packaging.

10 capsules in a blister, 3 blisters in a cardboard box.

Supply classification. Over-the-counter.

Manufacturer: Bosnalijek d.d.

Manufacturer's address and place of business.

71000, Jukićevo 53, Sarajevo, Bosnia and Herzegovina.

Marketing authorization holder: Bosnalijek d.d.

Address of the marketing authorization holder:

71000, Jukićevo 53, Sarajevo, Bosnia and Herzegovina.