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 from 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 questions, 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 similar.
- If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What is Broncho-Vaxom and what is it used for
- Important information before using Broncho-Vaxom
- How to use Broncho-Vaxom
- Possible side effects
- How to store Broncho-Vaxom
- Contents of the package 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 the most common bacteria 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. 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 well represented in clinical trials of Broncho-Vaxom. No general safety concerns were identified.
Renal impairment
Data on the use of Broncho-Vaxom in patients with renal impairment are limited.
Preclinical toxicity studies did not reveal any objective signs of nephrotoxicity 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 of Broncho-Vaxom in patients with hepatic impairment.
Preclinical toxicity studies did not reveal any objective signs of hepatotoxicity 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 about all medicines you are currently taking, have recently taken, or plan to take.
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 Broncho-Vaxom in breastfeeding women.
As a precautionary measure, the use of Broncho-Vaxom should be avoided during breastfeeding.
Driving and operating machinery
Broncho-Vaxom has no effect or 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 use Broncho-Vaxom
This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor 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 in the case of children) once daily on an empty stomach, for 10 consecutive days per month, for 3 consecutive months.
During the acute phase of respiratory tract infections, the medicine may be used concurrently 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 an appropriate amount of water, fruit juice, or milk/modified milk.
The mixture dissolves 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 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
Do not stop treatment without consulting a doctor.
If in doubt about the use of this medicine, consult a 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 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: red skin rash, generalized rash, redness (erythema), swelling, including swelling of the eyelids or face, fluid accumulation in the feet, ankles or legs (peripheral oedema), swelling, 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 and respiratory system disorders, gastrointestinal disturbances, discontinue use of Broncho-Vaxom and consult a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps 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 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), sodium glutamate, mannitol.
Other components of the medicine are: pregelatinized starch, magnesium stearate, mannitol.
Capsule shell: gelatin, indigo carmine (E 132), titanium dioxide (E 171).
What the Broncho-Vaxom capsules look like and contents of the pack
Broncho-Vaxom is supplied as opaque hard capsules with a white body and blue cap.
Pack size: 10 hard capsules (1 blister containing 10 capsules in a cardboard box)
Pack size: 30 hard capsules (3 blisters of 10 capsules each in a cardboard box)
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Belgium, country of export:
OMEDICAMED Unipessoal Lda
Avenida António Augusto de Aguiar nº 19 – 4º
1050-012 Lisbon
Portugal
Manufacturer:
OM PHARMA S.A.
Rua da Indústria, n°2 – Quinta grande
2610-088 Amadora
Portugal
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Belgium, country of export: BE137313
Parallel Import Licence Number: 263/24