Broncho-vaxom
Poland
Table of Contents
Attention! Keep the package leaflet; information on the immediate packaging is in a foreign language!
Broncho-Vaxom (Broncho-Vaxom for Adults)
7 mg, hard capsules
Lyophilized bacterial lysates
For use in adults
Broncho-Vaxom and БронхоВаксом За възрастни are different trade names of the same medicinal product written in Polish and Bulgarian, respectively.
Please read the following patient information 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 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 appear identical.
- If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.
Table of Contents
- 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 lysates 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 enhancing 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 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 should be stopped 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 study data confirming such an effect.
Use in elderly patients
In clinical studies, the elderly population was well represented. No overall safety concerns were identified.
Renal impairment
Data on the use of Broncho-Vaxom 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 of Broncho-Vaxom 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 the patient is currently taking, has recently taken, or might take any other medicines.
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 baby, 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, the use of Broncho-Vaxom during pregnancy is not recommended.
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 during breastfeeding is not recommended.
Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive and use machines.
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 physician or pharmacist. In case of doubt,
consult a physician 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.
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 is unable to swallow the capsule, it may be opened and its 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 consumption.
Taking more Broncho-Vaxom than recommended
Contact a physician.
Missing a 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.
In case of any doubts regarding 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, rash affecting the entire body, 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 the available data):
Swelling of the face, lips, tongue, throat, feet and hands (angioedema)
In case of skin reactions and respiratory, gastrointestinal disorders, 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 at 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 helps to provide more information on the safety of the medicine.
5. How to store Broncho-Vaxom
Keep this 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 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 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), magnesium stearate,
mannitol, pregelatinised starch.
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 an opaque capsule with a blue body and blue cap.
Packaging: 30 hard capsules (3 blisters of 10 capsules each, in a cardboard box).
For further 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
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Bulgaria, country of export: 20030171
Parallel import authorisation number: 321/20