Broncho-vaxom
Poland
Table of Contents
Warning! Keep the package leaflet. Information on the immediate packaging in a foreign language.
Broncho-Vaxom (Broncho-Vaxom for Adults)
7 mg, hard capsules
For use in adults
Active substance: lyophilized bacterial lysates
Broncho-Vaxom and Broncho-Vaxom for Adults are different trade names of the same medicine 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 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. The 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 a doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What is Broncho-Vaxom and what it is used for
- Important information before using Broncho-Vaxom
- How to use Broncho-Vaxom
- Possible side effects
- How to store Broncho-Vaxom
- Contents of the pack and other information
1. What is Broncho-Vaxom 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 adults.
2. Information before using Broncho-Vaxom
When not to take 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 must be informed.
The use of Broncho-Vaxom for the prevention of pneumonia is not recommended, as there are no clinical study data confirming such an effect.
Use in elderly patients
In clinical studies, elderly patients were widely represented. No general safety concerns have been identified.
Renal impairment
Data on the use of Broncho-Vaxom in patients with renal impairment are limited.
Preclinical toxicity studies did not reveal any significant 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 significant signs of hepatotoxicity in rats or dogs. Therefore, use in this patient group does not raise safety concerns.
Broncho-Vaxom with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Available data on the use of Broncho-Vaxom in pregnant women are limited.
Animal studies have not shown any direct or indirect harmful effects on reproduction.
As a precautionary measure, it is recommended to avoid using Broncho-Vaxom during pregnancy.
Breastfeeding
No studies have been conducted to evaluate the use of this medicine in breastfeeding women.
As a precautionary measure, it is recommended to avoid using Broncho-Vaxom during breastfeeding.
Driving and using machines
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, meaning the medicine is considered "sodium-free".
3. How to take Broncho-Vaxom
This medicine should always be taken exactly as directed by the physician or pharmacist. In case of doubt,
consult your physician or pharmacist.
Broncho-Vaxom is intended for oral use in adults.
Recommended dose:
Prophylactic treatment cycle in the case of 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.
During 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 is unable to swallow the capsule, it may be opened and the contents mixed with an
appropriate amount of water, fruit juice, or milk.
The mixture disperses with gentle stirring.
The mixture should then be taken entirely within a few minutes and should always be stirred
immediately before consumption.
Taking more Broncho-Vaxom than recommended
Contact your 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 treatment
Do not discontinue treatment without consulting your doctor.
If you have any doubts regarding the use of this medicine, consult your physician or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects 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 unknown (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 should be sought.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects 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
Reporting adverse effects helps to provide more information on the safety of this medicine.
5. How to store the medicine Broncho-Vaxom
Keep the medicine 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.
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 in use. This will help protect the environment.
6. Contents of the pack and other information
What Broncho-Vaxom contains
The active substance is OM-85 lyophilisate 40 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 7 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 capsules look like and contents of the pack
Broncho-Vaxom is supplied as opaque capsules with a blue body and blue cap.
Pack containing 10 hard capsules (1 blister of 10 capsules, in a cardboard box).
Pack containing 30 hard capsules (3 blisters of 10 capsules each, in a cardboard box).
For further detailed information, please contact the marketing authorisation holder or 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Bulgaria, country of export: 20030171
Parallel import authorisation number: 200/20