BRONCHO-VAXOM

Warning! Keep the package leaflet, information on the immediate packaging in a foreign language!
Broncho-Vaxom (Broncho-Vaxom for Children)
3.5 mg, hard capsules
Lyophilized bacterial lysates
For use in children aged from 6 months to 12 years
Broncho-Vaxom and БронхоВаксом За деца are different trade names of the same medicinal product written in Polish and Bulgarian languages.
Please read the leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What is Broncho-Vaxom and what is it used for
2. What you need to know 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 from bacteria most commonly causing 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 respiratory mucosa.
The indications for use of Broncho-Vaxom are as follows:

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

2. Information before using Broncho-Vaxom

When not to use Broncho-Vaxom

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Broncho-Vaxom, please consult your doctor or
pharmacist.
If an allergic reaction to Broncho-Vaxom occurs, treatment should be discontinued immediately and the doctor should be informed.
The use of Broncho-Vaxom for the prevention of pneumonia is not recommended, as there are no clinical data confirming such an effect.

Children
Clinical data on the use of Broncho-Vaxom in children under 6 months of age are limited.
As a precautionary measure, Broncho-Vaxom should not be administered to children under 6 months of age.

Use in elderly patients
The elderly population was well represented in clinical studies with Broncho-Vaxom. No safety concerns have been identified.

Renal impairment
Data on use in patients with renal impairment are limited.
In preclinical toxicity studies, no relevant 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 use in patients with hepatic impairment.
In preclinical toxicity studies, no relevant signs of hepatotoxicity were observed in rats or dogs. Therefore, use in this patient group does not raise safety concerns.

Other medicines and Broncho-Vaxom
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions between Broncho-Vaxom and other medicines have been reported to date.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using 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 precautionary measure, the use of Broncho-Vaxom in pregnant women should be avoided.

Breastfeeding
No studies have been conducted to evaluate the use of the medicine in breastfeeding women.
As a precautionary measure, the use of Broncho-Vaxom should be avoided during breastfeeding.

Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.

Broncho-Vaxom contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, i.e. it is considered "sodium-free".

3. How to take Broncho-Vaxom

This medicine should always be taken as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Broncho-Vaxom is intended for oral use in children aged 6 months to 12 years.
Recommended dose:
Prophylactic treatment cycle in cases of recurrent respiratory tract infections:
One hard capsule (3.5 mg for children) once daily on an empty stomach, for 10 consecutive days per month over 3 consecutive months.
During acute phases of respiratory tract infections, the medicinal product may be used concomitantly with appropriate treatment methods.
If necessary, the prophylactic treatment cycle may be repeated.
Method of administration
Oral administration.
If the patient or their child is unable to swallow the capsule, it may be opened and the contents mixed with a suitable amount of water, fruit juice, or milk/modified milk.
The mixture disperses with gentle stirring.
The mixture should then be taken entirely within a few minutes and should always be mixed immediately before consumption.
Taking more Broncho-Vaxom than recommended
Contact a physician.
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 discontinue treatment without consulting a physician.
If in doubt about the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been observed:
Common (may occur in up to 1 in 10 patients):
Headache, cough, diarrhoea, abdominal pain, rash.
Uncommon (may occur in up to 1 in 100 patients):
Nausea, vomiting, urticaria, fever, fatigue.
Allergic reactions, including: skin rash with red spots, generalized rash, redness (erythema), swelling, including swelling of the eyelids or face, fluid accumulation in the feet, ankles or legs (peripheral oedema), puffiness, facial swelling, itching, including generalized itching, dyspnoea.
Frequency not known (frequency cannot be estimated from the available data):
Swelling of the face, lips, tongue, throat, feet and hands (angioedema).
In case of skin reactions and disorders of the respiratory system, or gastrointestinal disturbances, treatment with Broncho-Vaxom should be discontinued and medical advice should be sought.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Broncho-Vaxom

Keep the medicine out of the 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 stated month.
Store below 25°C.
Keep in the original packaging.
Medicines must 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 packaging and other information

What Broncho-Vaxom contains
The active substance is OM-85 lyophilisate 20 mg
containing lyophilised 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
Excipients: propyl gallate (E 310), monosodium glutamate (E 621), mannitol, pregelatinised starch, magnesium stearate.
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 supplied as opaque capsules with a white body and blue cap.
Pack: 30 hard capsules (3 blisters of 10 units, in a cardboard box).

For further detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Bulgaria, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation number in Bulgaria, country of export: 20030170
Parallel import authorisation number: 320/20