Bronho-vaxom

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Broncho-Vaxom (Broncho Vaxom), 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 Broncho Vaxom are different trade names for the same drug.

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 in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• 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 illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Broncho-Vaxom is an immunostimulant drug. It contains lysates of bacteria that most commonly cause respiratory tract infections.
In humans, the drug stimulates cellular and humoral immune 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 the use of Broncho-Vaxom are as follows:

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

2. Important information before taking Broncho-Vaxom

When not to take 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, the patient should discuss it with their doctor or pharmacist.
In case of an allergic reaction to Broncho-Vaxom, treatment should be stopped immediately and the doctor 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 administer Broncho-Vaxom to children under 6 months.
Use in elderly patients
The elderly population was widely represented in clinical trials of Broncho-Vaxom. No safety concerns were identified.
Kidney function impairment
Data on the use of Broncho-Vaxom in patients with kidney function impairment are limited.
In preclinical toxicity studies, no signs of nephrotoxicity were observed in rats or dogs. Therefore, the use of Broncho-Vaxom in this patient group does not raise safety concerns.
Liver function impairment
There are no available data on the use of Broncho-Vaxom in patients with liver function impairment.
In preclinical toxicity studies, no signs of hepatotoxicity were observed in rats or dogs. Therefore, the use of Broncho-Vaxom in this patient group does not raise safety concerns.

Broncho-Vaxom and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions have been observed between Broncho-Vaxom and other medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking 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 the use of Broncho-Vaxom in pregnant women.
Breastfeeding
No studies have been conducted to evaluate the use of Broncho-Vaxom in breastfeeding women.
As a precautionary measure, it is recommended to avoid the use of Broncho-Vaxom in breastfeeding women.

Driving and using machines

The medicine has no influence or negligible 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 it is considered "sodium-free".

3. How to take Broncho-Vaxom

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
Broncho-Vaxom is intended for oral use in children from 6 months to 12 years old.
The recommended dose is:
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 medicine can 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 poured into a suitable amount of water, fruit juice, or milk/modified milk.
The mixture dissolves under gentle stirring.
The mixture should be taken in its entirety within a few minutes and always stirred just before drinking.

Overdose of Broncho-Vaxom

The doctor should be contacted.

Missed dose of Broncho-Vaxom

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

Stopping treatment with Broncho-Vaxom

Treatment should not be stopped without consulting the doctor.
In case of doubts about the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Broncho-Vaxom 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 entire 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, treatment with Broncho-Vaxom should be stopped and medical advice sought.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can also be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Broncho-Vaxom

Store in a place 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 month stated.
There are no special storage temperature requirements. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Broncho-Vaxom contains

The active substance is OM-85 lyophilisate, containing 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
The other ingredients of the medicine are: propyl gallate (E 310), sodium glutamate, mannitol, gelatinized starch, magnesium stearate.
Capsule shell: gelatin, indigo carmine (E 132), titanium dioxide (E 171).

What Broncho-Vaxom looks like and contents of the packaging

Broncho-Vaxom is a white capsule body and blue cap, non-transparent hard capsules.
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)
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Italy, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Italy, the country of export:026029037
026029088

Parallel import authorization number: 8/25

Date of approval of the leaflet: 13.01.2025

[Information about the trademark]