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
Lyophilized bacterial lysates
For use in adults
Broncho-Vaxom and Бронхо-Ваксом за възрастни are different trade names of the same medicinal product written in Polish and Bulgarian, respectively.
Please read the entire 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 pass it on to others. The medicine may harm others, even if their symptoms are identical.
- 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 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 bacterial lysates from the most common bacteria causing respiratory tract infections.
In humans, the medicine stimulates both 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 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 study data confirming such an effect.
Use in elderly patients
The elderly population was widely represented in clinical studies with Broncho-Vaxom. No overall safety concerns were identified.
Renal impairment
Data on the use in patients with impaired renal function are limited.
In preclinical toxicity studies, no relevant signs of nephrotoxicity were observed in rats or dogs. Therefore, use in this patient group raises no safety concerns.
Hepatic impairment
There are no available data on the use in patients with impaired liver function.
In preclinical toxicity studies, no relevant signs of hepatotoxicity were observed in rats or dogs. Therefore, use in this patient group raises no safety concerns.
Broncho-Vaxom with other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken or might take in the future.
No interactions between Broncho-Vaxom and other medicines have been observed to date.
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, the use of Broncho-Vaxom during pregnancy is not recommended.
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 in breastfeeding women is not recommended.
Driving and using machines
Broncho-Vaxom 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. the medicine is considered "sodium-free".
3. How to use Broncho-Vaxom
This medicine should always be taken according to the recommendations of your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Broncho-Vaxom is intended for oral use in adults.
Recommended dose:
Prophylactic treatment cycle in cases 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 acute phases of respiratory tract infections, the medicinal product may be used concomitantly with appropriate therapeutic methods. If necessary, the prophylactic treatment cycle may be repeated.
Administration method
For oral use.
If the patient is unable to swallow the capsule, it may be opened and its contents mixed into 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 must 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 the 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 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: skin rash with red spots, generalized skin 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 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store the medicine Broncho-Vaxom
Keep the medicine 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.
Store below 25°C.
Keep in the original packaging.
Medicines must not be disposed of via sewage systems 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), sodium 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 supplied as opaque capsules with a blue body and blue cap.
Pack size: 10 hard capsules (1 blister strip of 10 capsules in a cardboard box).
Pack size: 30 hard capsules (3 blister strips of 10 capsules each in a cardboard box).
For further detailed 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:
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 Bulgaria, country of export: 20030171
Parallel Import Licence Number: 324/20