Bronho-vaxom

PATIENT LEAFLET: INFORMATION FOR THE USER

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Broncho-Vaxom (Бронхо-Ваксом За деца)

3.5 mg, hard capsules

To be used in children from 6 months to 12 years old
Active substance: lyophilized bacterial lysates
Broncho-Vaxom and Бронхо-Ваксом За деца are different trade names for the same medicine
recorded in Polish and Bulgarian.

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Broncho-Vaxom and what is it used for
• 2. Important information before using Broncho-Vaxom
• 3. How to use Broncho-Vaxom
• 4. Possible side effects
• 5. How to store Broncho-Vaxom
• 6. Contents of the pack and other information

1. What is Broncho-Vaxom and what is it used for

Broncho-Vaxom is an immunostimulating medicine. It contains bacterial lysates
most commonly causing respiratory tract infections.
In humans, the medicine stimulates cellular and humoral immunity mechanisms by activating macrophages,
increasing the number of circulating T lymphocytes and increasing the concentration of immunoglobulins secreted
by the mucous membrane of the respiratory system.
The indications for using Broncho-Vaxom are as follows:

• prevention of recurrent respiratory tract infections (RTI) in children from 6 months to 12 years old.

2. Important information before using Broncho-Vaxom

When not to use Broncho-Vaxom

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Broncho-Vaxom, you should discuss it with your doctor or pharmacist.
In case of an allergic reaction to Broncho-Vaxom, treatment should be stopped immediately
and the doctor should be informed.
It is not recommended to use Broncho-Vaxom to prevent pneumonia, as there are no clinical trial data confirming such an effect.
Children
Data on the use of Broncho-Vaxom in children under 6 months are limited.
As a precautionary measure, it is not recommended to give Broncho-Vaxom to children under 6 months.
Use in the elderly
The elderly population was widely represented in clinical trials of Broncho-Vaxom. No safety concerns were identified.
Kidney function impairment
Data on the use in patients with kidney function impairment are limited.
In preclinical toxicity studies, no signs of nephrotoxicity were found in rats or dogs. Therefore, the use in this patient group does not raise safety concerns.
Liver function impairment
There are no available data on the use in patients with liver function impairment.
In preclinical toxicity studies, no signs of hepatotoxicity were found in rats or dogs. Therefore, the use in this patient group does not raise safety concerns.

Broncho-Vaxom and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
So far, no interactions have been found between Broncho-Vaxom and other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Only limited data are available on the use of Broncho-Vaxom in pregnant women.
Animal studies have not shown any direct or indirect harmful effects on reproduction.
As a precautionary measure, it is recommended to avoid using Broncho-Vaxom in pregnant women.
Breastfeeding
No studies have been conducted to assess the use of the medicine in breastfeeding women.
As a precautionary measure, it is recommended to avoid using Broncho-Vaxom in breastfeeding women.

Driving and using machines

The medicine has no influence or insignificant influence on the ability to drive and use machines.

Broncho-Vaxom contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, which means the medicine is considered "sodium-free".

3. How to use Broncho-Vaxom

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Broncho-Vaxom is intended for oral use in children from 6 months to 12 years old.

Recommended dose:

Prophylactic treatment cycle in case of recurrent respiratory tract infections:
One hard capsule (3.5 mg for children) per day on an empty stomach, for 10 consecutive days per month for 3 consecutive months.
In case of an acute phase of respiratory tract infections, the medicinal product may be used simultaneously with appropriate treatment methods.
If necessary, the prophylactic treatment cycle can be repeated.
Method of administration
Oral administration.
If the patient or their child cannot swallow the capsule, it can be opened and its contents can be poured into an appropriate amount of water, fruit juice, or milk/modified milk.
The mixture dissolves under gentle stirring.
Then take the mixture in its entirety within a few minutes and always stir it just before drinking.

Overdose of Broncho-Vaxom

You should contact a doctor.

Missed dose of Broncho-Vaxom

You should not take a double dose to make up for a missed capsule. The next dose should be taken at the usual time.

Stopping the use of Broncho-Vaxom

You should not stop the treatment without consulting a doctor.
In case of doubts related to the use of the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed:

Common (may affect up to 1 in 10 people):

Headache, cough, diarrhea, abdominal pain, rash.

Uncommon (may affect up to 1 in 100 people):

Nausea, vomiting, hives, fever, fatigue
Allergic reactions, including: rash in the form of red spots on the skin, rash covering the whole body, redness (erythema), swelling, including swelling of the eyelids or face, fluid accumulation in the feet, ankles, or legs (peripheral edema), swelling, facial swelling, itching, including itching all over the body, shortness of breath.

Frequency not known (frequency cannot be estimated from the available data):

Facial swelling, lips, tongue, throat, feet, and hands (angioedema).
In case of skin reactions and respiratory system disorders, gastrointestinal disorders, you should stop using Broncho-Vaxom and consult a doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can also be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Broncho-Vaxom

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store in a temperature below 25°C.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Broncho-Vaxom contains

Active substance is OM-85 lyophilisate
20 mg
including lyophilized bacterial lysates:
Haemophilus influenzae
Streptococcus (Diplococcus) pneumoniae
Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae
Staphylococcus aureus
Streptococcus pyogenes and sanguinis (viridans)
Moraxella (Branhamella/Neisseria) catarrhalis
3.5 mg
Excipients: propyl gallate (E 310), sodium glutamate (E 621), mannitol, gelatin, magnesium stearate.
Capsule shell composition: gelatin, indigo carmine (E 132), titanium dioxide (E 171).

What Broncho-Vaxom looks like and contents of the pack

Broncho-Vaxom is in non-transparent capsules with a white body and blue cap.
Packaging of 10 hard capsules (1 blister of 10, in a cardboard box).
Packaging of 30 hard capsules (3 blisters of 10, in a cardboard box).
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

OMEDICAMED Unipessoal Lda, Avenida António Augusto de Aguiar nº 19 – 4º, 1050-012 Lisbon, Portugal

Manufacturer:

FLAVINE PHARMA FRANCE, 3 voie d’Allemagne, 13127 Vitrolles, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20030170

Parallel import authorization number: 199/20

Date of approval of the leaflet: 03.07.2025

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