Broncho-munal P, 3.5mg capsules 30 pcs

ATX code: L03AX.

Pharmacotherapeutic group:immunostimulant.
Nosological classification: ICD-10

Pharmacological properties

Pharmacodynamics
The drug Broncho-Munal® P has an immune stimulating effect, increasing immunity against respiratory tract infections.
In patients receiving the drug Broncho-Munal ® P, the protective properties of the body against bacteria and viruses are enhanced.
After taking the capsule bacterial lysate accumulates in the peyre plaques of the mucous membrane of the gastrointestinal tract, particularly located in the small intestine. The antigen-presenting cells in the peyer plaques are activated by the bacterial lysate and subsequently stimulate other cell types (B-lymphocytes) responsible for specific immunity. This leads to an increase in the number of circulating B-lymphocytes leading to increased production of polyclonal antibodies, especially serum IgG and IgA, secreted by the respiratory mucosa and salivary glands.

The drug also affects non-specific immunity by stimulating leukocytes, characterized by increase of myeloid and lymphoid cells number and selective increase of receptors expression on their surface.

Clinically Broncho-Munal® P reduces the frequency of acute respiratory tract infections, reduces the duration of their course, reduces the likelihood of exacerbations of chronic bronchitis, as well as increases the body’s resistance to infections of the respiratory system. It also reduces the need to use other medicines, especially antibiotics.

Indications

Broncho-Munal® P is used in children aged 6 months to 12 years:
• as part of complex therapy of acute respiratory tract infections;
• for the prevention of recurrent respiratory tract infections and exacerbations of chronic bronchitis.

Pharmacological effect

ATX code: L03AX.

Pharmacotherapeutic group: immunostimulating agent.
Nosological classification: ICD-10

Pharmacological properties

Pharmacodynamics
The drug Broncho-Munal® P has an immunostimulating effect, strengthening the immune system against respiratory tract infections.
In patients receiving the drug Broncho-Munal® P, the body’s protective properties against bacteria and viruses are enhanced.
After taking the capsule, the bacterial lysate accumulates in Peyer’s patches of the mucous membrane of the gastrointestinal tract, in particular located in the small intestine. Antigen-presenting cells in Peyer’s patches are activated by the bacterial lysate and subsequently stimulate other types of cells (B lymphocytes) responsible for specific immunity. This leads to an increase in the number of circulating B lymphocytes, which leads to an increase in the production of polyclonal antibodies, especially serum IgG and IgA, secreted by the mucous membrane of the respiratory tract and salivary glands.

The drug also has an effect on nonspecific immunity, stimulating leukocytes, which is characterized by an increase in the number of myeloid and lymphoid cells, as well as a selective increase in the expression of receptors on their surface.

Clinically, Broncho-Munal® P reduces the frequency of acute respiratory tract infections, shortens the duration of their course, reduces the likelihood of exacerbations of chronic bronchitis, and also increases the body’s resistance to respiratory system infections. This reduces the need to use other medications, especially antibiotics.

Special instructions

To avoid overdose, children from 6 months to 12 years should not use the drug Broncho-Munal® capsules 7 mg, intended for adults. Manifestations of hypersensitivity reactions to the drug are possible. If gastrointestinal disorders, skin reactions, respiratory problems or other symptoms of intolerance to the drug persist, discontinue the drug and consult a doctor.

Active ingredient

Bacterial lysates

Active components

Bacterial lysates

Composition

1 capsule contains:

Active ingredient:
bacterial lysates in the form of a standardized bacterial lyophilisate (OM-85) (OM-Pharma, Switzerland) – 3,500 mg:
Haemophilus influenzae
Streptococcus pneumoniae
Streptococcus viridans
Streptococcus pyogenes
Klebsiella pneumoniae
Klebsiella ozaenae
Staphylococcus aureus
Moraxella catarrhalis

Excipients:
propyl gallate (anhydrous)
sodium glutamate (anhydrous)
mannitol
magnesium stearate
pregelatinized starch
mannitol
Capsule shell:
indigotine E132
titanium dioxide E171
gelatin

Contraindications

• hypersensitivity to the components of the drug;
• pregnancy;
• breastfeeding period;
• children under 6 months of age.

Side Effects

Broncho-Munal® P is usually well tolerated. Most adverse reactions are classified into the general category with moderate or moderate-severe severity. The most common side effects are gastrointestinal upset, skin reactions and respiratory problems.

According to the World Health Organization (WHO), adverse effects are classified according to their frequency as follows:
• very often (≥ 1/10);
• often (≥ 1/100, < 1/10);
• uncommon (≥ 1/1000, < 1/100);
• rare (≥ 1/10000, < 1/1000);
• very rare (< 1/10000);
• frequency unknown (the frequency of occurrence of events cannot be determined based on available data).

Gastrointestinal disorders:
• often: diarrhea, abdominal pain;
• frequency unknown: nausea, vomiting.

Respiratory system disorders:
• often: cough;
• uncommon: shortness of breath.

Skin and subcutaneous tissue disorders:
• often: rash;
• frequency unknown: urticaria, angioedema.

Immune system disorders:
• uncommon: hypersensitivity reactions (erythematous rash, generalized rash, erythema, edema, eyelid edema, facial edema, peripheral edema, swelling, facial swelling, itching, generalized itching).

Nervous system disorders:
• frequency unknown: headache.

General disorders:
• frequency unknown: fever, fatigue.

Interaction

The drug can be used simultaneously with other drugs, including antibiotics.

Overdose

There are no reports of intoxication due to drug overdose. The nature of the drug Broncho-Munal® P and the results of studies of its toxicity in animals indicate that an overdose is unlikely.

Short product description

Broncho-Munal – a comprehensive system for fighting colds!

The immunostimulant Broncho-Munal® P (3.5 mg) is used in children aged 6 months to 12 years.

Proven benefits:
• helps strengthen the immune system in a natural (physiological) way;
• fights not only viruses – the cause of colds, but also bacteria – the cause of complications;
• helps reduce the duration of the disease;
• reduces the need for antibiotics;
• reduces the incidence of ARVI (“acute respiratory viral infection”) by 36% during the year;
• helps reduce the risk of complications;
• use from 6 months;
• the most studied drug in the group of immunostimulants.

The drug can be used at any stage in the complex treatment of acute respiratory viral infections and colds.

To boost immunity, take 1 capsule 30 minutes before meals, 1 time per day.

For children under 3 years of age or if the child has difficulty swallowing the capsule, it should be opened and the contents mixed with a small amount of liquid (tea, milk or juice).

Indications for use and dosage:
• in the complex treatment of respiratory infections – until symptoms disappear (runny nose, cough, etc.), but not less than 10 days.
• for the prevention of recurrent acute respiratory viral infections – three courses of 10 days each with an interval of 20 days between courses.

A serious danger of ARVI and colds is the rapid reproduction of viruses, their ability to be instantly transmitted from person to person and possible bacterial complications – bronchitis, sinusitis, otitis. It is important to block the proliferation of viruses in the body and not prolong a cold.
The immunomodulator Broncho-Munal® is used in the complex treatment of acute and prevention of recurrent respiratory tract infections and exacerbation of chronic bronchitis.

Prescribing

Children from 6 months to 12 years

Storage conditions

At temperatures from 15 ◦C to 25 ◦C.
Keep out of the reach of children.

Shelf life

5 years.
Do not use the drug after the expiration date.

Manufacturer

Lek d.d., Slovenia