Broncho-vaxom
Poland
Table of Contents
Warning! Keep the package leaflet. Information on the immediate packaging in a foreign language.
Broncho-Vaxom
3.5 mg, hard capsules
For use in children aged 6 months to 12 years
Active substance: lyophilized bacterial lysates
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.
- Keep this leaflet for future reference.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are identical.
- If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What Broncho-Vaxom is and what it is used for
- What you need to know before taking Broncho-Vaxom
- How to take Broncho-Vaxom
- Possible side effects
- How to store Broncho-Vaxom
- Contents of the package and other information
1. What Broncho-Vaxom is and what it is 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 6 months to 12 years.
2. Important 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, discuss it with your doctor or pharmacist.
If an allergic reaction to Broncho-Vaxom occurs, treatment must 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 widely represented in clinical studies with Broncho-Vaxom. No safety concerns were identified.
Renal impairment
Data on the 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 the 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.
Interaction of Broncho-Vaxom with other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or might take in the future.
To date, no interactions between Broncho-Vaxom and other medicines have been reported.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Only limited data are available on the use of Broncho-Vaxom in pregnant women.
Animal studies did not reveal 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 this 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. the medicine is considered "sodium-free".
3. How to use Broncho-Vaxom
This medicine should always be taken according to the instructions provided by the doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
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Broncho-Vaxom is intended for oral use in children aged 6 months to 12 years.
Recommended dosage:
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 concurrently with appropriate treatment methods.
If necessary, the prophylactic treatment cycle may be repeated.
Method of administration
For oral use.
If the patient or their child cannot 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 dissolves with gentle stirring.
The entire mixture should then be taken within a few minutes and must always be stirred immediately before consumption.
Taking more Broncho-Vaxom than recommended
Contact your doctor.
Missing a dose of Broncho-Vaxom
Do not take a double dose to make up for the missed capsule. Take the next dose at the usual time.
Stopping treatment with Broncho-Vaxom
Do not discontinue treatment without consulting your doctor.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed:
Common (may affect up to 1 in 10 patients):
Headache, cough, diarrhoea, abdominal pain, rash.
Uncommon (may affect 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, shortness of breath.
Frequency not known (frequency cannot be estimated from available data):
Swelling of the face, lips, tongue, throat, feet and hands (angioedema).
In case of skin reactions, respiratory disorders, or gastrointestinal disturbances, treatment with Broncho-Vaxom should be discontinued and medical advice sought.
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.
5. How to store Broncho-Vaxom
Keep 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.
Do not store above 25°C. Store 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. These measures help protect the environment.
6. Contents of the pack and other information
What Broncho-Vaxom contains
The active substances are 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
Other ingredients in the medicine are: propyl gallate (E 310), simethicone emulsion (dimethicone, silicon dioxide), sodium chloride, monosodium glutamate, gelatinised starch, magnesium stearate, mannitol.
Coating: gelatin, indigo carmine, titanium dioxide (E 171).
What Broncho-Vaxom capsules look like and contents of the pack
Broncho-Vaxom is an opaque capsule with a white body and a blue cap.
Pack: 10 hard capsules (1 blister of PVC/PVDC-Aluminium/PVDC, 10 pieces, in a cardboard box).
Pack: 30 hard capsules (3 blisters of PVC/PVDC-Aluminium/PVDC, 10 pieces each, in a cardboard box).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Austria, country of export:
OMEDICAMED Unipessoal Lda, Avenida António Augusto de Aguiar nº 19 – 4º, 1050-012 Lisbon, Portugal
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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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Austrian Marketing Authorisation Number, country of export: 2-00002
Parallel Import Authorisation Number: 175/24
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