Broncho-munal® p

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BRONCHO-MUNAL® P (BRONCHO-MUNAL® Р)

Composition:

Active substances: 1 capsule contains 3.5 mg of lyophilized bacterial lysate of Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Moraxella (Branhamella/Neisseria) catarrhalis;

Excipients: propyl gallate, sodium glutamate, mannitol (E 421), magnesium stearate, pregelatinized starch;

Capsule shell: indigo carmine (E 132), titanium dioxide (E 171), gelatin.

Pharmaceutical form. Hard capsules.

Main physicochemical properties: opaque white-blue capsule No. 3 containing a slightly beige-colored powder.

Pharmacotherapeutic group.

Other agents acting on the respiratory system. ATC code R07AX.

Pharmacological Properties

Pharmacodynamics

The medicinal product contains a lyophilized bacterial lysate from bacteria most commonly responsible for respiratory tract infections, including Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus viridans, Streptococcus pyogenes, Moraxella catarrhalis.

The preparation stimulates the body's natural defenses against respiratory tract infections, reducing the frequency, duration, and severity of respiratory infectious diseases, as well as decreasing the need for antibiotics.

The preparation activates both cellular and humoral immune responses in the respiratory mucosa and other immunocompetent structures of the body. It also enhances non-specific immune responses. The following effects on the body's defense mechanisms have been demonstrated in preclinical and clinical studies:

• Stimulates alveolar macrophages, which secrete cytokines protecting the body against infections;
• Increases the population of CD4 T-lymphocytes;
• Activates peripheral mononuclear cells responsible for protective functions;
• Increases the concentration of secretory IgA in the mucous membranes of the respiratory tract and gastrointestinal tract;
• Stimulates the formation of protective adhesive molecules;
• Reduces IgE levels in blood plasma, which may suppress the development of hypersensitivity reactions.

Pharmacokinetics

After oral administration, the bacterial lysate accumulates in the Peyer's patches of the gastrointestinal mucosa.

Antigen-presenting cells in the Peyer's patches take up the antigen and present it to subepithelial lymphoid cells, thereby inducing a humoral immune response that leads to increased IgA production in the mucosa and prevents microbial invasion.

The antigen also stimulates lymphoid cells via interaction with Peyer's patches. These cells then migrate through regional lymph nodes into the thoracic duct and subsequently enter the bloodstream.

Through the bloodstream, they migrate to the mucous membranes of the gastrointestinal tract, respiratory tract, and other organs, where they perform protective functions by enhancing immune defense against bacteria and viruses.

Clinical characteristics.

Indications.

Use for the prevention of recurrent respiratory tract infections.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients contained in the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Interaction of the medicinal product with other medicinal products is currently unknown.

Special precautions for use.

The drug is not prescribed for children under 6 months of age. Safety and efficacy of the drug in children under 6 months of age have not been established.

The drug may cause hypersensitivity reactions. If allergic reactions or signs of intolerance develop, treatment should be discontinued immediately.

Administration of the drug should not begin earlier than 4 weeks after vaccination with a live vaccine.

The excipient mannitol may exert a mild laxative effect.

The drug contains less than 1 mmol (23 mg)/dose of sodium in the form of sodium glutamate, i.e. it is practically sodium-free.

The use of the medicinal product for prevention of pneumonia is not recommended, as appropriate clinical trial data are lacking.

Use during pregnancy or breastfeeding.

The medicinal product is not used during the first three months of pregnancy.

Patients who are planning pregnancy or who become pregnant should inform their physician.

The safety of use during pregnancy has not been established; therefore, use of the medicinal product during pregnancy should be avoided.

No studies have been conducted in breastfeeding women. Therefore, caution should be exercised during breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Does not affect the ability to drive a vehicle or operate machinery.

Method of Administration and Dosage

Children aged 6 months to 12 years.

Course of prophylactic treatment for recurrent respiratory tract infections:

1 capsule per day on an empty stomach for 10 consecutive days each month, for 3 consecutive months.

The interval between courses should be 20 days.

Treatment may be initiated during the acute phase of respiratory tract infections, in combination with other therapeutic methods.

Capsules may be opened. If a child has difficulty swallowing the capsule, its contents can be mixed with a suitable beverage (water, fruit juice, milk).

The medication should be taken in the morning on an empty stomach.

If a dose was missed, administer it the next morning.

Children.

The use of the medicinal product is not recommended in children under 6 months of age due to the immaturity of their immune system. For children aged 12 years and older, use Broncho-Munal®, 7 mg capsules.

Overdose.

No clear clinical symptoms of overdose have been observed. Cases of overdose have not been reported. In the event of overdose, consult a physician.

Adverse Reactions

The reported adverse reactions are classified below according to MedDRA by system organ class and frequency: 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), including isolated cases, frequency not known (cannot be estimated from available data).

Immune system disorders:
Uncommon – hypersensitivity reactions (erythematous rashes, generalized skin rashes, erythema, swelling, eyelid edema, facial swelling, peripheral edema, swelling, facial swelling, pruritus, generalized pruritus, dyspnea).

Nervous system disorders:
Common – headache.

Respiratory, thoracic and mediastinal disorders:
Common – cough.

Gastrointestinal disorders:
Common – diarrhea, abdominal pain; uncommon – nausea, vomiting.

Skin and subcutaneous tissue disorders:
Common – rash; uncommon – urticaria; frequency not known – angioneurotic edema.

General disorders:
Uncommon – increased fatigue; rare – fever.

If prolonged gastrointestinal or respiratory disorders occur, treatment should be discontinued. Treatment should also be interrupted in case of skin reactions, as these manifestations may be of allergic nature.

Shelf life.

5 years.

Storage conditions.

Store at temperature not exceeding 25 °C in the original packaging to protect from moisture.

Keep out of reach of children.

Packaging.

10 capsules in a blister, 1 (10 × 1) or 3 (10 × 3) blisters in a cardboard box.

Classification.

Over-the-counter.

Manufacturer.

Lek Pharmaceuticals d.d., Slovenia.

Manufacturer's name and address of the place of business.

Verovškova 57, Ljubljana 1526, Slovenia.