Broncho-vaxom
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Broncho-Vaxom (Broncho-Vaxom Adults)
7 mg, hard capsules
For use in adults
Active substance: lyophilized bacterial lysate
Broncho-Vaxom and Broncho-Vaxom Adults are different brand names for the same medicine.
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 further questions, please 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 similar.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 a lysate of bacteria most commonly responsible for respiratory tract infections.
In humans, Broncho-Vaxom 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 components 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 study data confirming such an effect.
Use in elderly patients
In clinical studies of Broncho-Vaxom, 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. 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.
Other medicines and Broncho-Vaxom
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 might 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 Broncho-Vaxom in breastfeeding women. As a precautionary measure, it is recommended to avoid using Broncho-Vaxom 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, meaning it is considered "sodium-free".
3. How to use Broncho-Vaxom
This medicine should always be taken according to the doctor's or pharmacist's instructions.
If in doubt, consult a doctor or pharmacist.
Broncho-Vaxom is intended for oral use in adults.
Recommended dosage:
Prophylactic treatment cycle in 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 simultaneously 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 poured into a suitable 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 drinking.
Taking more Broncho-Vaxom than recommended
Contact a doctor.
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 stop treatment without consulting your doctor.
If in doubt about the use of this medicine, consult a doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
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: 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), oedema, facial swelling, itching, including generalized pruritus, 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 system disorders, or gastrointestinal disturbances, treatment with Broncho-Vaxom should be discontinued and medical advice should be sought immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions 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 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
By reporting adverse reactions, additional information on the safety of this 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. This will help protect the environment.
6. Contents of the pack and other information
What the medicine Broncho-Vaxom contains
The active substance is 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) catarrhalis 7 mg
propyl gallate (E 310) 84 micrograms
monosodium glutamate (E 621) 3.03 mg
mannitol up to 40 mg
Other components of the medicine are: pregelatinized starch, magnesium stearate, mannitol.
Capsule shell composition:
gelatin, indigo carmine (E 132), titanium dioxide (E 171).
What the Broncho-Vaxom capsules look like and contents of the pack
Broncho-Vaxom capsules are opaque, with a blue body and blue cap.
Pack size: 10 hard capsules (1 blister of 10 capsules, in a cardboard box).
Pack size: 30 hard capsules (3 blisters of 10 capsules each, in a cardboard box).
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation 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:
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 authorisation number in Romania, country of export: 5733/2013/01
5733/2013/02
Parallel import authorisation number: 92/23