Bronho-vaxom dla dzieci

PATIENT INFORMATION LEAFLET: USER INFORMATION

Broncho-Vaxom for children

3.5 mg, granules in sachets

Active substance: lyophilized bacterial lysate

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

important information for the patient.

• This leaflet should be kept, as it may be necessary to read it again.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Broncho-Vaxom for children 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 the use of Broncho-Vaxom for children 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 for children

When not to take Broncho-Vaxom for children

• 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 for children, the patient should discuss it with their doctor or pharmacist.
In case of an allergic reaction to Broncho-Vaxom for children, treatment should be stopped immediately and the doctor informed.
It is not recommended to use Broncho-Vaxom for children to prevent pneumonia, as there are no clinical data to support such use.
Children
Data on the use of Broncho-Vaxom for children in children under 6 months of age are limited.
As a precaution, it is not recommended to administer Broncho-Vaxom for children to children under 6 months of age.
Use in elderly patients
In clinical trials of Broncho-Vaxom for children, the elderly population was widely represented. No safety concerns were identified.
Kidney function impairment
Data on the use of Broncho-Vaxom for children 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 for children in this patient group does not raise safety concerns.
Liver function impairment
There are no available data on the use of Broncho-Vaxom for children 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 for children in this patient group does not raise safety concerns.

Broncho-Vaxom for children 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 identified between Broncho-Vaxom for children 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 available on the use of Broncho-Vaxom for children 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 for children in pregnant women.
Breastfeeding
No studies have been conducted to evaluate the use of Broncho-Vaxom for children in breastfeeding women.
As a precaution, it is recommended to avoid the use of Broncho-Vaxom for children in breastfeeding women.

Driving and using machines

This 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 for children

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Broncho-Vaxom for children is intended for use in children from 6 months to 12 years of age.
The recommended dose is:
Prophylactic treatment cycle for recurrent respiratory tract infections: One sachet (3.5 mg) 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 infection, the medicinal product may be used in conjunction with appropriate treatment methods.
If necessary, the prophylactic treatment cycle can be repeated.
Method of administration
Oral administration.
The contents of the sachet should be poured into an appropriate 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 for children

The patient should contact their doctor.

Missed dose of Broncho-Vaxom for children

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

4. Possible side effects

Like all medicines, Broncho-Vaxom for children can cause side effects, although not everybody gets them.
Adverse events observed during treatment were as follows:

Common (may affect up to 1 in 10 people):

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 whole body, redness (erythema), swelling, including swelling of the eyelids or face, fluid accumulation in the feet, ankles, or legs (peripheral edema), swelling, swelling of the face, itching, including itching all over the body, shortness of breath

Frequency not known (frequency cannot be estimated from the available data):

Headache, facial swelling, lips, tongue, throat, feet, and hands (angioedema)
In case of skin reactions and respiratory system disorders, gastrointestinal disorders, the use of Broncho-Vaxom for children should be stopped and the doctor consulted.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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:
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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Broncho-Vaxom for children

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the blister and carton, after the expiry date stated on the label.
Store in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 for children contains

1 dose (sachet) contains:
lyophilized OM-85
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 are: starch (gelatinized), magnesium silicate, magnesium stearate, mannitol.

What Broncho-Vaxom for children looks like and contents of the pack

1 sachet contains 240 mg of granules, including 3.5 mg of lyophilized bacterial lysate.
The granules are light beige.
10 or 30 sachets 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.
To obtain more detailed information, the patient should consult their doctor or:
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: