Bronho-vaxom

PATIENT LEAFLET: INFORMATION FOR THE USER

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Broncho-Vaxom (Бронхо-Ваксом За вьзрастни)

7 mg, hard capsules

To be used in adults

Active substance: lyophilized bacterial lysates

Broncho-Vaxom and Бронхо-Ваксом За вьзрастни are different trade names for the same medicine written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Broncho-Vaxom and what is it used for
• 2. Important information before taking Broncho-Vaxom
• 3. How to take Broncho-Vaxom
• 4. Possible side effects
• 5. How to store Broncho-Vaxom
• 6. Contents of the pack and other information

1. What is Broncho-Vaxom and what is it used for

Broncho-Vaxom is an immunostimulant medicine. It contains bacterial lysates that most commonly cause respiratory tract infections. In humans, the medicine stimulates cellular and humoral immunity mechanisms by activating macrophages, increasing the number of circulating T lymphocytes, and increasing the concentration of immunoglobulins secreted by the mucous membrane of the respiratory tract. The indications for use of Broncho-Vaxom are as follows:

• prevention of recurrent respiratory tract infections (RTIs) in adults.

2. Important information before taking Broncho-Vaxom

When not to take Broncho-Vaxom

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Broncho-Vaxom, you should discuss it with your doctor or pharmacist. If you experience an allergic reaction to Broncho-Vaxom, treatment should be stopped immediately and your doctor informed. It is not recommended to use Broncho-Vaxom to prevent pneumonia, as there are no clinical trial data confirming such an effect. Use in the elderly In clinical trials of Broncho-Vaxom, the elderly population was widely represented. No risks to overall safety were found. Renal impairment Data on the use of Broncho-Vaxom in patients with renal impairment are limited. In preclinical toxicity studies, no signs of nephrotoxicity were found in rats or dogs. Therefore, the use of Broncho-Vaxom in this patient group does not raise concerns in terms of safety. Hepatic impairment There are no available data on the use of Broncho-Vaxom in patients with hepatic impairment. In preclinical toxicity studies, no signs of hepatotoxicity were found in rats or dogs. Therefore, the use of Broncho-Vaxom in this patient group does not raise concerns in terms of safety.

Broncho-Vaxom and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. So far, no interactions have been found between Broncho-Vaxom and other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy There are only limited data 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 precaution, it is recommended to avoid the use of Broncho-Vaxom during pregnancy. Breastfeeding No studies have been conducted to assess the use of Broncho-Vaxom in breastfeeding women. As a precaution, it is recommended to avoid the use of Broncho-Vaxom in breastfeeding women.

Driving and using machines

The medicine has no or negligible influence 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, which means that the medicine is essentially 'sodium-free'.

3. How to take Broncho-Vaxom

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. Broncho-Vaxom is intended for oral use in adults.

Recommended dose:

Prophylactic treatment cycle in case of recurrent respiratory tract infections: One hard capsule (7 mg for adults) per day on an empty stomach, for 10 consecutive days per month for 3 consecutive months. In case of acute phase of respiratory tract infections, the medicinal product may be used concomitantly with appropriate treatment methods. If necessary, the prophylactic treatment cycle can be repeated. Method of administration For oral use. If the patient cannot swallow the capsule, it can be opened and its contents poured into a sufficient amount of water, fruit juice, or milk. The mixture dissolves under gentle stirring. Then, take the mixture in its entirety within a few minutes and always stir it just before drinking.

Overdose of Broncho-Vaxom

Contact your doctor.

Missed dose of Broncho-Vaxom

Do not take a double dose to make up for a forgotten capsule. Take the next dose at the usual time.

Stopping treatment with Broncho-Vaxom

Do not stop treatment without consulting your doctor. If you have any doubts about the use of the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Broncho-Vaxom can cause side effects, although not everybody gets them.

The following side effects have been observed:

Common (may affect up to 1 in 10 people):

Headache, cough, diarrhea, abdominal pain, rash

Uncommon (may affect up to 1 in 100 people):

Nausea, vomiting, hives, fever, fatigue Allergic reactions, including: rash in the form of red spots on the skin, rash covering the whole body, redness, swelling, including swelling of the eyelids or face, fluid accumulation in the feet, ankles, or legs (peripheral edema), swelling, facial swelling, itching, including itching all over the body, shortness of breath

Frequency not known (frequency cannot be estimated from the available data):

Facial swelling, lips, tongue, throat, feet, and hands (angioedema) If you experience skin reactions and respiratory system disorders, gastrointestinal disorders, you should stop taking Broncho-Vaxom and consult your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Adverse Reaction Monitoring 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 By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Broncho-Vaxom

Keep this 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 month stated. Store in a temperature below 25°C. Store in the original packaging. Medicines should 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 substance is OM-85 lyophilisate 40 mg, including 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) catarrhalis7 mg Excipients: propyl gallate (E 310), sodium glutamate (E 621), mannitol, gelatin, magnesium stearate. 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 in non-transparent capsules with a blue body and blue cap. Packaging of 10 hard capsules (1 blister of 10, in a cardboard box). Packaging of 30 hard capsules (3 blisters of 10, in a cardboard box). For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Bulgaria export permit number: 20030171

Parallel import permit number: 200/20

Date of leaflet approval: 23.06.2025

[Information about the trademark]