Bronho-vaxom

PATIENT INFORMATION LEAFLET: USER INFORMATION

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

Please read carefully the contents of this leaflet before taking the medicine, as it contains

important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for this 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 possible side effects not listed in this leaflet, the doctor or pharmacist should be informed. 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 bacterial lysates 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 the 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 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 doctor or pharmacist should be consulted.
In case of an allergic reaction to Broncho-Vaxom, treatment should be stopped immediately and the doctor informed.
Broncho-Vaxom should not be used to prevent pneumonia, as there are no clinical 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, Broncho-Vaxom should not be given to children under 6 months of age.
Use in elderly patients
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, the use of Broncho-Vaxom in this patient group does not raise concerns in terms of safety.
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, the use of Broncho-Vaxom in this patient group does not raise concerns in terms of safety.

Broncho-Vaxom and other medicines

The doctor or pharmacist should be informed about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
No interactions have been identified 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
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, Broncho-Vaxom should be avoided in pregnant women.
Breastfeeding
No studies have been conducted to evaluate the use of Broncho-Vaxom in breastfeeding women.
As a precautionary measure, Broncho-Vaxom should be avoided 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 it is essentially 'sodium-free'.

3. How to take Broncho-Vaxom

This medicine should always be taken exactly as advised 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 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 medicinal product may be used concomitantly 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 its contents poured into a suitable amount of water, fruit juice, or milk/formula.
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 related to the use of the medicine, the doctor or pharmacist should be consulted.

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 (erythema), swelling, including swelling of the eyelids or face, fluid accumulation in the feet, ankles, or legs (peripheral edema), puffiness, facial puffiness, 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 possible 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 Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the 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 blister and carton, in the section marked 'Expiry date' EXP. The expiry date refers to the last day of the month.
Store below 25°C.
Store in the original package to protect from moisture.
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 pack and other information

What Broncho-Vaxom contains

The 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
propyl gallate (E 310)
42 micrograms
sodium glutamate (E 621)
1.515 mg
mannitol
up to 20 mg
The other ingredients of the medicine are: starch (gelatinized), magnesium stearate, mannitol
The capsule shell contains: gelatin, indigo carmine (E 132), titanium dioxide (E 171)

What Broncho-Vaxom looks like and contents of the pack

Broncho-Vaxom is available in non-transparent capsules with a white body and blue cap.
Pack of 10 hard capsules (1 blister of 10, in a carton)
Pack of 30 hard capsules (3 blisters of 10, in a carton)
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

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

Importer

FLAVINE PHARMA FRANCE
3 voie d’Allemagne,
13127 Vitrolles, France.
For more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
Phone: 22 209 70 00, e-mail: [email protected]
Date of last revision of the leaflet:January 2023