Bronho-vaxom

Package Leaflet: Information for the Patient

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

Broncho-Vaxom (Broncho-Vaxom Adults)

7 mg, hard capsules

To be used in adults

Active substance: lyophilized bacterial lysate

Broncho-Vaxom and Broncho-Vaxom Adults are different trade names for the same medicine.

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not give it to others. The medicine may harm another person, even if their symptoms 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 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 using Broncho-Vaxom are as follows:

• preventing recurrent respiratory tract infections (RTIs) 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, 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 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.
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 found in rats or dogs. Therefore, the use of Broncho-Vaxom in this patient group does not raise concerns in terms of safety.
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 found in rats or dogs. Therefore, the use of Broncho-Vaxom in this patient group does not raise concerns in terms of safety.

Broncho-Vaxom and other medicines

Tell your doctor or pharmacist about all 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, 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 using Broncho-Vaxom during pregnancy.
Breastfeeding
No studies have been conducted to evaluate the use of Broncho-Vaxom in breastfeeding women. As a precaution, it is recommended to avoid using 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 the medicine is considered "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 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
concomitantly 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
a suitable amount of water, fruit juice, or 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

Contact your 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 Broncho-Vaxom treatment

Do not stop treatment without consulting your doctor.
If you have any doubts about taking the medicine, consult your 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 with 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, stop taking Broncho-Vaxom and consult your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, 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:
Jerozolimskie Avenue 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 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.
Store in a temperature below 25°C 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
40 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
7 mg
propyl gallate (E 310)
84 micrograms
sodium glutamate (E 621)
3.03 mg
mannitol
up to 40 mg
Other ingredients of the medicine aregelatin, magnesium stearate, mannitol.
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 blue body and blue cap.
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, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

OMEDICAMED UNIPESSOAL LDA
Avenida António Augusto de Aguiar n 19-4
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
Authorization number in Romania, the country of export:
5733/2013/01
5733/2013/02

Parallel import authorization number: 92/23

Date of leaflet approval: 24.05.2023

[Information about the trademark]