Broncho Munal

Patient Information Leaflet

BRONCHO MUNAL Adults 7 mg Hard Capsules, Children 3.5 mg Hard Capsules, Children 3.5 mg Granules in Sachets

Lyophilized bacterial lysate
Please read 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 adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BRONCHO MUNAL is and what it is used for
2. What you need to know before taking BRONCHO MUNAL
3. How to take BRONCHO MUNAL
4. Possible side effects
5. How to store BRONCHO MUNAL
6. Contents of the pack and other information

1. What BRONCHO MUNAL is and what it is used for

BRONCHO MUNAL is a preparation that works by stimulating the body to produce antibodies (proteins
that protect it against germs causing infectious diseases).
BRONCHO MUNAL is used in adults to prevent recurrent respiratory tract infections.
BRONCHO MUNAL is used in children and adolescents aged 1 to 17 years to prevent recurrent upper airway infections.
Consult your doctor if you/your child do not feel better or feel worse.

2. What you should know before taking/giving BRONCHO MUNAL to the child

Do not take/give BRONCHO MUNAL to the child

• If he/she is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• If the child is under 1 year of age.
• If he/she suffers from autoimmune diseases (diseases of the immune system that react against the body's own organs and tissues).
• If he/she has acute intestinal infections.

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving BRONCHO MUNAL to the child:

• If you/the child develop fever, particularly at the beginning of treatment, stop taking BRONCHO MUNAL and consult your doctor.
• If you/the child develop high fever above 39°C (see section 4 “Possible side effects”), stop treatment and do not restart it. Your doctor will assess whether this fever is related to taking the medicine or to your/your child’s underlying condition. If you/your child are taking other medicines with non-specific immunomodulatory activity, such as those containing bacterial extracts, do not take/give BRONCHO MUNAL as well.
• In some cases, asthma attacks have been observed in predisposed patients after taking medicines containing bacterial extracts. In such cases, BRONCHO MUNAL for adults/children should no longer be taken.
• If you/the child have an allergic reaction. Immediately stop taking BRONCHO MUNAL and consult your doctor (see section 4 “Possible side effects”). Treatment with BRONCHO MUNAL must not be resumed.
• The use of BRONCHO MUNAL for the prevention of pneumonia is not recommended, as there are no clinical study data available demonstrating such an effect.
• BRONCHO MUNAL is not indicated for the treatment of acute respiratory infections but exclusively for the prevention of recurrences; however, it is not necessary to interrupt the prophylaxis of respiratory infection recurrences during treatment of an ongoing respiratory tract infection.

Children
Do not give BRONCHO MUNAL to children under 1 year of age.
Other medicines and BRONCHO MUNAL
Tell your doctor or pharmacist if you/the child are taking, have recently taken, or might take any other medicines.
No interaction studies have been conducted with other drugs or vaccines.
The immune response may be suppressed in subjects with congenital or acquired immunodeficiency, or those undergoing immunosuppressive therapy or taking corticosteroids.

• BRONCHO MUNAL with food and drink See section 3 “How to take BRONCHO MUNAL”.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Data on the use of BRONCHO MUNAL in pregnant women are limited. Animal studies do not indicate any direct or indirect harmful effects related to reproductive toxicity. As a precautionary measure, it is preferable to avoid using BRONCHO MUNAL during pregnancy.
Breastfeeding
Specific studies on breastfeeding have not been conducted and data are lacking. Therefore, as a precautionary measure, it is preferable to avoid using this product during breastfeeding.
Fertility
BRONCHO MUNAL has not shown effects on fertility.
Driving and using machines
BRONCHO MUNAL does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.
BRONCHO MUNAL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take BRONCHO MUNAL

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age:
One hard capsule (7 mg) daily on an empty stomach, for 10 consecutive days per month, over 3 consecutive months.
The prophylactic treatment cycle may be repeated if necessary.
Use in children aged between 1 and 12 years:
One hard capsule or one sachet (3.5 mg) daily on an empty stomach, for 10 consecutive days per month, over 3 consecutive months.
The prophylactic treatment cycle may be repeated if necessary.
Method of administration
For oral use.
The contents of the sachet should be poured into a drink (water, fruit juice, milk) before administration.
If you or your child have difficulty swallowing the capsule, it may be opened and the contents mixed with a drink (water, fruit juice, milk/formula) before administration, as with the sachet formulation.
Gently shake the mixture until dissolved. Then consume the entire mixture within a few minutes, and always shake it gently immediately before drinking.
If you take more BRONCHO MUNAL than you should
If you have taken too much BRONCHO MUNAL, contact your doctor or go to hospital immediately.
If you forget to take BRONCHO MUNAL
Do not take a double dose to make up for the missed dose.
If you stop taking BRONCHO MUNAL
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you/your child experience

• stomach and intestinal disturbances
• long-lasting respiratory disorders
• allergic reactions, stop treatment. If you/your child experience skin reactions, stop treatment, as these may be symptoms of an allergic reaction.

The other side effects reported for BRONCHO MUNAL are listed below by frequency:
Common (may affect up to 1 in 10 people)

• headache
• cough
• diarrhoea
• stomach pain
• skin rash

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (erythematous rash, generalized rash, erythema, oedema, eyelid oedema, facial oedema, peripheral oedema, swelling, facial swelling, pruritus, generalized pruritus, dyspnoea)
• urticaria
• fatigue

Rare (may affect up to 1 in 1,000 people)

• fever

Not known (frequency cannot be estimated from the available data)

• rapid swelling of the skin and mucous membranes (angioedema)
• vomiting
• nausea

Reporting of side effects
If you/your child experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website 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 BRONCHO MUNAL

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 BRONCHO MUNAL contains
BRONCHO MUNAL Adults 7 mg hard capsules

• The active substances in one hard capsule are 7 mg of OM-85, a freeze-dried bacterial lysate from Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis.
• The other components are pregelatinized maize starch, mannitol, propyl gallate anhydrous (E310), anhydrous sodium glutamate, magnesium stearate. Capsule cap composition: gelatin; titanium dioxide (E 171), indigotine (E 132).

BRONCHO MUNAL Children 3.5 mg hard capsules

• The active substances in one hard capsule are 3.5 mg of OM-85, a freeze-dried bacterial lysate from Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis.
• The other components are pregelatinized maize starch, mannitol, propyl gallate anhydrous (E310), anhydrous sodium glutamate, magnesium stearate. Capsule cap composition: gelatin; titanium dioxide (E 171), indigotine (E 132).

BRONCHO MUNAL Children 3.5 mg granules in sachet

• The active substances in one sachet are 3.5 mg of OM-85, a freeze-dried bacterial lysate from Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis.
• The other components are pregelatinized maize starch, mannitol, magnesium silicate, propyl gallate anhydrous (E310), anhydrous sodium glutamate, magnesium stearate.

Description of the appearance of BRONCHO MUNAL and contents of the pack
BRONCHO MUNAL 7 mg hard capsules are presented as opaque capsules with a blue body and blue cap, containing a white to light beige powder.
Available in cartons of 10 and 30 hard capsules.
BRONCHO MUNAL 3.5 mg hard capsules are presented as opaque capsules with a white body and blue cap, containing a white to light beige powder.
Available in cartons of 10 and 30 hard capsules.
BRONCHO MUNAL 3.5 mg granules in sachet are presented as light beige granules.
Available in cartons of 10 and 30 sachets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ABIOGEN PHARMA S.p.A.
Via Meucci, 36 – Ospedaletto - Pisa
Manufacturer
OM PHARMA S.A.
R. da Industria, 2 _Quinta Grande
2610-088 Amadora - Lisbon
Portugal
ABIOGEN PHARMA S.p.A.
Via Meucci, 36 – Ospedaletto - Pisa