Bronho-vaxom

Patient Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Broncho-Vaxom, 3.5 mg, Hard Capsules

To be Used in Children from 6 Months to 12 Years of Age

Active Substance: Lyophilized Bacterial Lysates

You Should Carefully Read the Contents of the Leaflet Before Taking the Medicinal Product, as it Contains Important Information for the Patient.

• You Should Keep this Leaflet, so that You can Read it Again if Necessary.
• In Case of Any Doubts, You Should Consult a Doctor or Pharmacist.
• This Medicinal Product has been Prescribed to You Personally. You Should not Pass it on to Others. The Medicinal Product may Harm Another Person, even if their Symptoms are the Same as Yours.
• If You Experience any Undesirable Effects, including any Possible Undesirable Effects not Listed in this Leaflet, You Should Inform 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 Undesirable Effects
• 5. How to Store Broncho-Vaxom
• 6. Contents of the Packaging and Other Information

1. What is Broncho-Vaxom and What is it Used for

Broncho-Vaxom is an Immunostimulant Medicinal Product. It Contains Lysates of Bacteria that Most Frequently Cause Respiratory Tract Infections.
In Humans, the Medicinal Product Stimulates the Cellular and Humoral Immune 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 the Use of Broncho-Vaxom are as Follows:

• Prevention of Recurring Respiratory Tract Infections (RTIs) in Children from 6 Months to 12 Years of Age.

2. Important Information Before Taking Broncho-Vaxom

When not to Use Broncho-Vaxom

• If You are Allergic to the Active Substance or any of the Other Ingredients of this Medicinal Product (Listed in Section 6).

Warnings and Precautions

Before Starting to Take Broncho-Vaxom, You Should Discuss it with Your Doctor or Pharmacist.
In Case of an Allergic Reaction to Broncho-Vaxom, Treatment Should be Stopped Immediately and the Doctor Informed.
It is not Recommended to Use Broncho-Vaxom for the Prevention of Pneumonia, as there are no Clinical Trial Data Confirming such an Effect.
Children
There are Limited Data on the Use of Broncho-Vaxom in Children Under 6 Months of Age.
As a Precautionary Measure, it is not Recommended to Administer Broncho-Vaxom to Children Under 6 Months of Age.
Use in the Elderly
The Elderly Population was Widely Represented in Clinical Trials of Broncho-Vaxom. No Risks to Overall Safety were Found.
Kidney Impairment
There are Limited Data on the Use of Broncho-Vaxom in Patients with Renal Impairment.
In Preclinical Toxicity Studies, no Objective 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.
Liver Impairment
There are no Available Data on the Use of Broncho-Vaxom in Patients with Liver Impairment.
In Preclinical Toxicity Studies, no Objective 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 Medicinal Products

You Should Inform Your Doctor or Pharmacist about all Medicinal Products You are Currently Taking or have Recently Taken, as well as any Medicinal Products You Plan to Take.
So far, no Interactions have been Found between Broncho-Vaxom and Other Medicinal Products.

Pregnancy, Breast-feeding, and Fertility

If You are Pregnant or Breast-feeding, Think You may be Pregnant or are Planning to have a Child, You Should Consult Your Doctor or Pharmacist Before Taking this Medicinal Product.
Pregnancy
There are only Limited Data 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, it is Recommended to Avoid the Use of Broncho-Vaxom in Pregnant Women.
Breast-feeding
No Studies have been Conducted to Evaluate the Use of Broncho-Vaxom in Breast-feeding Women.
As a Precautionary Measure, it is Recommended to Avoid the Use of Broncho-Vaxom in Breast-feeding Women.

Driving and Using Machines

The Medicinal Product has no Influence or has a Negligible Influence on the Ability to Drive and Use Machines.

Broncho-Vaxom Contains Sodium

This Medicinal Product Contains less than 1 mmol of Sodium (23 mg) per Hard Capsule, which means that the Medicinal Product is Considered to be "Sodium-Free".

3. How to Take Broncho-Vaxom

This Medicinal Product Should Always be Taken in Accordance with the Recommendations of Your Doctor or Pharmacist. In Case of Doubts, You Should Consult Your Doctor or Pharmacist.
Broncho-Vaxom is Intended for Oral Use in Children from 6 Months to 12 Years of Age.
The Recommended Dose is:
Prophylactic Treatment Cycle in Case of Recurring Respiratory Tract Infections:
One Hard Capsule (3.5 mg for Children) 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 in Conjunction with Appropriate Treatment Methods.
If Necessary, the Prophylactic Treatment Cycle can be Repeated.
Method of Administration
Oral Administration.
If the Patient or their Child Cannot Swallow the Capsule, it can be Opened and its Contents can be Poured into an Appropriate Amount of Water, Fruit Juice, or Milk/Modified Milk.
The Mixture Dissolves under Gentle Stirring.
The Mixture Should be Taken in its Entirety within a Few Minutes and Should Always be Stirred Immediately 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 the Use of Broncho-Vaxom

You Should not Stop the Treatment without Consulting Your Doctor.
In Case of Doubts Related to the Use of the Medicinal Product, You Should Consult Your Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medicinal Products, this Medicinal Product can Cause Undesirable Effects, although they may not Occur in Everyone.
The Following Undesirable Effects have been Observed:

Frequent (may Occur in up to 1 in 10 Patients):

Headache, Cough, Diarrhea, Abdominal Pain, Rash

Infrequent (may Occur in up to 1 in 100 Patients):

Nausea, Vomiting, Urticaria, Fever, Fatigue
Allergic Reactions, including: Rash in the Form of Red Spots on the Skin, Rash Covering the Entire Body, Redness (Erythema), Swelling, including Swelling of the Eyelids or Face, Fluid Accumulation in the Feet, Ankles, or Legs (Peripheral Edema), Swelling, Swelling of the Face, Itching, including Itching of the Entire Body, Shortness of Breath

Frequency not Known (Frequency cannot be Estimated from the Available Data):

Facial Edema, Lips, Tongue, Throat, Hands, and Feet (Angioedema)
In Case of Skin Reactions and Respiratory System Disorders, Gastrointestinal Disorders, You Should Stop Taking Broncho-Vaxom and Consult Your Doctor.

Reporting of Undesirable Effects

If You Experience any Undesirable Effects, including any Possible Undesirable Effects not Listed in this Leaflet, You Should Inform Your Doctor or Pharmacist. Undesirable Effects can also be Reported Directly to the Department of Monitoring of Undesirable Effects 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.
By Reporting Undesirable Effects, You can Help Gather more Information on the Safety of the Medicinal Product.

5. How to Store Broncho-Vaxom

Store in a Place Inaccessible to Children.
Do not Use this Medicinal Product after the Expiry Date Stated on the Packaging. The Expiry Date refers to the Last Day of the Specified Month.
Do not Store above 25°C.
Medicinal Products should not be Disposed of via Wastewater or Household Waste. You Should Ask Your Pharmacist how to Dispose of Medicinal Products that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Packaging and Other Information

What Broncho-Vaxom Contains

The Active Substances are Lyophilized OM-85 20 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) catarrhalis3.5 mg
propyl gallate (E 310), sodium glutamine, mannitol.
The Other Ingredients of the Medicinal Product are: pregelatinized starch, magnesium stearate, mannitol.
Capsule Shell: gelatin, indigo carmine (E 132), titanium dioxide (E 171).

What Broncho-Vaxom Looks like and What the Packaging Contains

Broncho-Vaxom is Available in Non-Transparent Capsules with a White 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, You Should Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in Belgium, the Country of Export:

OMEDICAMED Unipessoal Lda
Avenida António Augusto de Aguiar nº 19 – 4º
1050-012 Lisbon
Portugal

Manufacturer:

OM PHARMA S.A.
Rua da Indústria, n°2 – Quinta grande
2610-088 Amadora
Portugal

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Belgium, the Country of Export:BE137313

Parallel Import Authorization Number: 263/24

Date of Approval of the Leaflet: 01.07.2024

[Information about the Trademark]