Broncho-vaxom
Poland
Table of Contents
Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Broncho-Vaxom
7 mg, hard capsules
For use in adults
Active substance: bacterial lysate, lyophilized
Please read the entire leaflet carefully before taking this 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. It may harm someone else, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
Leaflet 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 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 circulating T-lymphocyte counts, and enhancing immunoglobulin concentrations 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, discuss it with your doctor or pharmacist.
If an allergic reaction to Broncho-Vaxom occurs, treatment should 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 trials with Broncho-Vaxom. No 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 with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
To date, no interactions between Broncho-Vaxom and other medicines have been reported.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, 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
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 during breastfeeding is not recommended.
Driving and operating machinery
Broncho-Vaxom 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. the medicine is considered "sodium-free".
Broncho-Vaxom contains mannitol
This medicine may have a mild laxative effect.
3. How to use 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 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 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 its contents mixed with a suitable 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 mixed immediately before ingestion.
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 concerning the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicinal products, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been observed:
Common (may affect up to 1 in 10 people):
Headache, cough, diarrhoea, abdominal pain, rash
Uncommon (may affect up to 1 in 100 people):
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), 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 disorders, or gastrointestinal disturbances, discontinue use of Broncho-Vaxom and consult a physician.
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
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 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 reactions helps to provide more information on the safety of the medicine.
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. Store 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 pack and other information
What Broncho-Vaxom contains
The active substances are 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 7 mg
Other components of Broncho-Vaxom are: propyl gallate (E 310), simethicone emulsion (dimethicone, silicon dioxide), sodium chloride, sodium glutamate, pregelatinized starch, magnesium stearate, mannitol.
Capsule shell: gelatin, indigo carmine, titanium dioxide (E 171).
What Broncho-Vaxom capsules look like and contents of the pack
Broncho-Vaxom is an opaque capsule with a blue body and blue cap.
Pack size: 10 hard capsules (1 blister made of PVC/PVDC-Aluminum/PVDC, 10 pieces, in a cardboard box).
Pack size: 30 hard capsules (3 blisters made of PVC/PVDC-Aluminum/PVDC, 10 pieces each, in a cardboard box).
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Austria, 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, Poland
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorization number in Austria, country of export: 2-00001
Parallel import license number: 176/24