Broncho-vaxom
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language
Broncho-Vaxom (Broncho-Vaxom Adults)
7 mg, hard capsules
For use in adults
Active substance: bacterial lysate, lyophilized
Broncho-Vaxom and Broncho-Vaxom Adults are different trade names for the same medicinal product.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any doubts, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same as yours.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What Broncho-Vaxom is and what it is used for
- Important information before taking Broncho-Vaxom
- How to take Broncho-Vaxom
- Possible side effects
- How to store Broncho-Vaxom
- Contents of the pack and other information
1. What Broncho-Vaxom is and what it is used for
Broncho-Vaxom is an immunostimulant medicine. It contains a lysate of bacteria most commonly responsible for 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 adults.
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, consult 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.
Use in elderly patients
The elderly population was widely represented in clinical studies with Broncho-Vaxom. No general safety concerns were 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.
Broncho-Vaxom and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
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 have not shown any direct or indirect harmful effects on reproduction.
As a precautionary measure, use of Broncho-Vaxom during pregnancy should be avoided.
Breastfeeding
No studies have been conducted to evaluate the use of this medicine in breastfeeding women. As a precautionary measure, 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 use Broncho-Vaxom
This medicine should always be taken as directed by a doctor or pharmacist. In case of
doubt, consult a doctor or pharmacist.
Broncho-Vaxom is intended for oral use in adults.
Recommended dose:
Prophylactic treatment cycle in recurrent respiratory tract infections:
One hard capsule (7 mg for adults) once daily on an empty stomach, for 10 consecutive days
per month over 3 consecutive months.
In the acute phase 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 cannot swallow the capsule, it may be opened and the contents mixed with
an appropriate amount of water, fruit juice, or milk.
The mixture dissolves with gentle stirring.
The mixture should then be taken entirely within a few minutes and should always be stirred
immediately before ingestion.
Taking more Broncho-Vaxom than recommended
Contact a doctor.
If you forget to take Broncho-Vaxom
Do not take a double dose to make up for the missed capsule. Take the next dose at the usual time.
Stopping Broncho-Vaxom treatment
Do not stop treatment without consulting your doctor.
In case of any doubts regarding 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 experiences 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), swelling, facial swelling, itching, including generalized itching, shortness of breath
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, respiratory disorders, 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 of 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
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 packaging. The expiry date refers to the last day of the stated month.
Store below 25°C 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. Such measures will help protect the environment.
6. Package contents and other information
What Broncho-Vaxom contains
Active substance: OM-85 lyophilisate 40 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) 7 mg
catarrhalis
propyl gallate (E 310) 84 micrograms
monosodium glutamate (E 621) 3.03 mg
mannitol up to 40 mg
Other ingredients in Broncho-Vaxom are: pregelatinized starch, magnesium stearate, mannitol
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 hard capsules with a blue body and blue cap.
Pack size: 10 hard capsules (1 blister of 10 units in a cardboard box)
Pack size: 30 hard capsules (3 blisters of 10 units each in a cardboard box)
For further information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in Romania, country of export:
OMEDICAMED UNIPESSOAL LDA
Avenida António Augusto de Aguiar n 19-4
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
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorization Number in Romania, country of export: 5733/2013/01
5733/2013/02
Parallel Import Authorization Number: 344/24