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

7 mg, hard capsules

To be used in adults

Active substance: lyophilized bacterial lysate

You should 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 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, 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 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 a lysate of bacteria that most commonly cause 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 tract.
The indications for the use of Broncho-Vaxom are as follows:

• prevention of recurrent respiratory tract infections (RTI) in adults.

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, 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.
Use in the elderly
Clinical trials of Broncho-Vaxom included a wide range of elderly patients. No risks to overall safety were found.
Renal impairment
Data on the use of Broncho-Vaxom in patients with renal impairment are limited.
In preclinical toxicity studies, no signs of nephrotoxicity were found in rats or dogs. Therefore, the use of Broncho-Vaxom 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 found in rats or dogs. Therefore, the use of Broncho-Vaxom in this patient group does not raise safety concerns.

Broncho-Vaxom and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
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 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 precaution, 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 precaution, it is recommended to avoid the use of Broncho-Vaxom in breastfeeding women.

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 means that the medicine is considered "sodium-free".

Broncho-Vaxom contains mannitol

The medicine may have a mild laxative effect.

3. How to take 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 adults.
The recommended dose is:
Prophylactic treatment cycle in case of recurrent respiratory tract infections:
One hard capsule (7 mg for adults) 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
For oral use.
If the patient cannot swallow the capsule, it can be opened and its contents can be poured into an appropriate amount of water, fruit juice, or 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

You should contact a doctor.

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 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, 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 should be sought.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
Side effects can also be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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 provide 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.
Do not store above 25°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. 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

The active substance is 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
7 mg
Other ingredients of the medicine arepropyl gallate (E 310), simethicone emulsion (dimethicone, silicon dioxide), sodium chloride, sodium glutamate, gelatinized starch, magnesium stearate, mannitol.
Shell:gelatin, indigo carmine, titanium dioxide (E 171).

What Broncho-Vaxom looks like and contents of the pack

Broncho-Vaxom is a hard capsule with a blue body and blue cap.
Pack of 10 hard capsules (1 blister pack of 10, in a cardboard box).
Pack of 30 hard capsules (3 blister packs of 10, in a cardboard box).
For more detailed information, you should 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:

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
Austrian export authorization number: 2-00001

Parallel import authorization number: 176/24

Date of approval of the leaflet: 26.04.2024

[Information about the trademark]