Patient Information Leaflet

IMMUBRON 50 mg sublingual tablets

Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What IMMUBRON is and what it is used for
What you need to know before taking IMMUBRON
How to take IMMUBRON
Possible side effects
How to store IMMUBRON
Contents of the pack and other information

1. What IMMUBRON is and what it is used for

IMMUBRON contains as its active ingredient a lyophilized mixture of bacterial lysates (bacterial antigens),
belonging to the group of bacterial vaccines, which locally stimulate the activity of the body's defense
system (immune system).
IMMUBRON is indicated for the prophylaxis of recurrent respiratory tract infections in adults.

2. What you need to know before taking IMMUBRON

Do not take IMMUBRON

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from immune system disorders (autoimmune diseases);
if you have developed an intestinal infection (acute intestinal infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking IMMUBRON.
Take this medicine with caution and inform your doctor if you suffer from any type of allergy.
Stop treatment and consult your doctor, who will assess whether to definitively discontinue therapy with
IMMUBRON, if you experience any of the following conditions:

allergic reactions (hypersensitivity reactions);
asthma attacks in predisposed patients;
fever, particularly if it occurs at the beginning of treatment; The type of high fever exceeding 39°C that may occur as a rare, isolated adverse event with no known cause must be differentiated from fever arising due to the underlying disease, based on laryngeal, nasal or otological conditions.

The use of IMMUBRON for the prevention of pneumonia is not recommended, as there are no clinical study data demonstrating such an effect.
Other medicines and IMMUBRON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking IMMUBRON together with other medicines that stimulate the activity of the immune system (immunostimulants).
IMMUBRON may be less effective if you suffer from immune system disorders (with congenital or acquired immunodeficiency), if you are undergoing treatment with medicines that reduce immune system activity (immunosuppressive therapy), or if you are taking medicines used to treat allergies and inflammation (corticosteroids).
No interaction studies with other drugs or vaccines have been conducted.
IMMUBRON with food and drink
This medicine should be taken on an empty stomach.
Pregnancy and breastfeeding
Do not take IMMUBRON if you are pregnant.
Do not take IMMUBRON if you are breastfeeding.
Driving and using machines
No effects on the ability to drive vehicles or use machinery have been reported, and no specific studies have been conducted.

3. How to take IMMUBRON

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet per day, to be dissolved under the tongue.
The treatment consists of taking 1 tablet daily for 10 consecutive days per month, for a duration of
3 months.
If you take more IMMUBRON than you should
Cases of overdose are not known.
In the event of accidental ingestion of an excessive dose of IMMUBRON, contact your doctor immediately or go to the nearest hospital.
If you forget to take IMMUBRON
Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

pain in the mouth and throat (oropharyngeal pain);
allergic skin reactions (urticaria, rash, itching, swelling);
fever and headache;
stomach ache and vomiting;
inflammation of the nasal mucosa (rhinitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IMMUBRON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month and to the product in its original, unopened packaging stored correctly.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What IMMUBRON contains

The active substance is a lyophilized bacterial lysate: 50 mg, of which 7 mg corresponds to: Staphylococcus aureus 6 billion - Streptococcus pyogenes 6 billion - Streptococcus oralis 6 billion - Klebsiella pneumoniae 6 billion - Klebsiella ozaenae 6 billion - Haemophilus influenzae type B 6 billion - Neisseria catarrhalis 6 billion - Streptococcus pneumoniae 6 billion (of which type TY1/EQ11 1 billion - TY2/EQ22 1 billion - TY3/EQ14 1 billion - TY5/EQ15 1 billion - TY8/EQ23 1 billion - TY47/EQ24 1 billion), and 43 mg of lyophilization support consisting of gelatin.
The other components are: silicon dioxide, microcrystalline cellulose, dibasic calcium phosphate, magnesium stearate, ammonium glycyrrhizinate, powdered mint flavor.

Description of the appearance of IMMUBRON and the contents of the pack
Carton containing 30 sublingual tablets of 50 mg.
Marketing Authorization Holder and Manufacturer
Bruschettini s.r.l. – Via Isonzo, 6 – 16147 Genoa – Italy