Bronho-vaxom

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Broncho-Vaxom(Бронxо-Ваксом For adults)

7 mg, hard capsules

To be used in adults

Active substance: lyophilized bacterial lysates

Broncho-Vaxom and Бронxо-Ваксом За възрастни are different trade names for the same drug, 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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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 respiratory tract mucosa. The indications for using Broncho-Vaxom are as follows:

• preventing recurrent respiratory tract infections (RTIs) in adults.

2. Important information before taking Broncho-Vaxom

When not to take Broncho-Vaxom

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, you should stop the treatment immediately and inform your doctor. 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 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 signs of nephrotoxicity were observed in rats or dogs. Therefore, the use of Broncho-Vaxom 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 signs of hepatotoxicity were observed in rats or dogs. Therefore, the use of Broncho-Vaxom in this patient group does not raise safety concerns.

Broncho-Vaxom and other medicines

You should 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 observed 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, you should consult your doctor or pharmacist 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 using Broncho-Vaxom during pregnancy. Breastfeeding No studies have been conducted to evaluate the use of Broncho-Vaxom in breastfeeding women. As a precaution, it is recommended to avoid using 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 considered "sodium-free".

3. How to take Broncho-Vaxom

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. Broncho-Vaxom is intended for oral use in adults. The recommended dose is: 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 simultaneously 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 can be poured into a suitable amount of water, fruit juice, or milk. The mixture dissolves under gentle stirring. Then, the mixture should be taken in its entirety within a few minutes and always stirred just before drinking.

Overdose of Broncho-Vaxom

You should contact your doctor.

Missed dose of Broncho-Vaxom

You should not take a double dose to make up for a missed capsule. The next dose should be taken at the usual time.

Stopping treatment with Broncho-Vaxom

You should not stop the treatment without consulting your doctor. If you have any doubts about taking the medicine, you should consult 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, swelling, swelling of the face, 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) In case of 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, you should tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 By reporting side effects, you can help provide more information on the safety of the medicine.

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 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. You should 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) catarrhalis 7 mg propyl gallate (E 310) 84 micrograms sodium glutamate (E 621) 3.03 mg mannitol up to 40 mg Other ingredients of the medicine are corn starch, magnesium stearate, mannitol. The capsule shell contains: 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. The pack contains 30 hard capsules (3 blisters of 10 each, in a cardboard box). For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

OM PHARMA S.A.

• R. da Indústria, 2 – Quinta Grande 2610-088 Amadora 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 by:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź CEFEA Sp. z o.o. Sp. komandytowa ul. Działkowa 56 02-234 Warszawa Pharma Innovations Sp. z o.o. ul. Jagiellońska 76 03-301 Warszawa Synoptis Industrial Sp. z o.o. ul. Szosa Bydgoska 58 87-100 Toruń IVA Pharm Sp. z o.o. ul. Drawska 14/1 02-202 Warszawa CANPOLAND SPÓŁKA AKCYJNA ul. Beskidzka 190 91-610 Łódź Marketing authorization number in Bulgaria, the country of export: 20030171 Parallel import authorization number: 321/20

Date of approval of the leaflet: 23.10.2023

[Information about the trademark]