Bronho-vaxom

Patient Information Leaflet: User Information

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

Broncho-Vaxom, 3.5 mg, hard capsules

To be used in children from 6 months to 12 years of age

Active substance: lyophilized bacterial lysates

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible 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 pack and other information

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

Broncho-Vaxom is an immunostimulant medicine. It contains lysates of bacteria that most commonly cause respiratory tract infections.
In humans, the medicine 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 tract.
The indications for use of Broncho-Vaxom are as follows:

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

2. Important information before taking Broncho-Vaxom

When not to use Broncho-Vaxom

Warnings and precautions

Before starting treatment with Broncho-Vaxom, discuss it with your 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 to support such use.
Children
There are limited data on the use of Broncho-Vaxom in children under 6 months of age.
As a precautionary measure, it is not recommended to administer Broncho-Vaxom to children under 6 months of age.
Use in the elderly
The elderly population was widely represented in clinical trials of Broncho-Vaxom. No safety concerns were identified.
Renal impairment
There are limited data on the use of Broncho-Vaxom in patients with renal impairment.
In preclinical toxicity studies, no signs of nephrotoxicity were observed in rats or dogs. Therefore, use in this patient group does not raise safety concerns.
Hepatic impairment
There are no available data on the use of Broncho-Vaxom in patients with hepatic impairment.
In preclinical toxicity studies, no signs of hepatotoxicity were observed in rats or dogs. Therefore, use in this patient group does not raise safety concerns.

Broncho-Vaxom and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.
No interactions have been identified between Broncho-Vaxom and other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are only limited data 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 during pregnancy.
Breastfeeding
No studies have been conducted to assess the use of Broncho-Vaxom in breastfeeding women.
As a precautionary measure, it is recommended to avoid the use of Broncho-Vaxom during breastfeeding.

Driving and using machines

The medicine has no 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 is considered to be essentially sodium-free.

3. How to take Broncho-Vaxom

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Broncho-Vaxom is intended for oral use in children from 6 months to 12 years of age.
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 acute phase of respiratory tract infections, the medicine can be used in conjunction with appropriate treatment methods.
If necessary, the prophylactic treatment cycle can be repeated.
Method of administration
Oral use.
If the patient or their child cannot swallow the capsule, it can be opened and the contents poured into a suitable amount of water, fruit juice, or milk/formula.
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

Contact a doctor.

Missed dose of Broncho-Vaxom

Do not take a double dose to make up for a missed capsule. Take the next dose at the usual time.

Stopping treatment with Broncho-Vaxom

Do not stop treatment without consulting a doctor.
In case of any doubts about the use of the medicine, 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 with red spots on the skin, rash covering the whole body, redness, 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 you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Broncho-Vaxom

Keep 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.
Do not store above 25°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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) catarrhalis3.5 mg.
The other ingredients of the medicine are: simethicone emulsion (dimethicone, anhydrous colloidal silica), sodium chloride, propyl gallate (E 310), sodium glutamate, gelatinized starch, magnesium stearate, mannitol.
Capsule shell: gelatin, indigo carmine (E 132), titanium dioxide (E 171).

What Broncho-Vaxom looks like and contents of the pack

Broncho-Vaxom is a white capsule body and blue cap, opaque hard capsules.
Pack of 10 hard capsules (1 blister of 10, in a cardboard box).
Pack of 30 hard capsules (3 blisters of 10, in a cardboard box).
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, 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
Austrian marketing authorization number: 2-00002

Parallel import authorization number: 70/25

Date of approval of the leaflet: 20.02.2025

[Information about the trademark]