Broncho Vaxom

Patient Information Leaflet

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

Lyophilised bacterial lysate
Please read all of this leaflet carefully before you take this medicine because 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BRONCHO VAXOM is and what it is used for
2. What you need to know 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 BRONCHO VAXOM is and what it is used for

BRONCHO VAXOM is a preparation that works by stimulating the body to produce antibodies (proteins that protect it against germs causing infectious diseases).
BRONCHO VAXOM is used in adults to prevent recurrent respiratory tract infections.
BRONCHO VAXOM is used in children and adolescents (aged between 1 and 17 years) to prevent recurrent infections (number of episodes higher than normally expected in this age group) of the upper airways.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking BRONCHO VAXOM

Do not take BRONCHO VAXOM

• If you are 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 you suffer from autoimmune diseases (conditions in which the immune system reacts against the body's own organs and tissues).
• If you have acute intestinal infections.

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

• If you/your child develops fever, especially at the beginning of treatment, stop taking BRONCHO VAXOM and consult your doctor. If you develop high fever exceeding 39°C (see section 4 “Possible side effects”), discontinue 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 is taking other medicines with non-specific immunomodulatory activity, such as those containing bacterial extracts, do not take/give BRONCHO VAXOM as well.
• In some cases, asthma attacks have been observed in predisposed patients after taking medicines containing bacterial extracts. In such cases, BRONCHO VAXOM for adults/children should no longer be taken.
• If you/your child has an allergic reaction, stop taking BRONCHO VAXOM immediately and consult your doctor (see section 4 “Possible side effects”). Treatment with BRONCHO VAXOM should not be resumed.
• The use of BRONCHO VAXOM for the prevention of pneumonia is not recommended, as there are no clinical study data demonstrating such an effect.
• BRONCHO VAXOM is not indicated for the treatment of acute respiratory infections but exclusively for the prevention of recurrences; however, it is not necessary to interrupt prophylaxis against recurrent respiratory infections during treatment of an ongoing respiratory tract infection.

Children
Do not give BRONCHO VAXOM to children under 1 year of age.
Other medicines and BRONCHO VAXOM
Tell your doctor or pharmacist if you/your child are taking, have recently taken, or might take any other medicines.
No interaction studies with other drugs or vaccines have been conducted.
Immune response may be suppressed in individuals with congenital or acquired immunodeficiency, or those undergoing immunosuppressive therapy or taking corticosteroids.
BRONCHO VAXOM with food and drinks
See section 3 “How to take BRONCHO VAXOM”.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Data on the use of BRONCHO VAXOM 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 VAXOM 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 VAXOM has shown no effects on fertility.
Driving and using machines
BRONCHO VAXOM does not affect, or has negligible influence on, the ability to drive vehicles or operate machinery.
Broncho Vaxom 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 VAXOM

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) once 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) once 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
Oral use.
The contents of the sachet should be poured into a drink (water, fruit juice, milk/formula) before administration.
If you or the child cannot swallow the capsule, it may be opened and its contents mixed with a suitable amount of water, fruit juice, milk/formula, as with the sachet formulation.
The mixture dissolves by gently stirring. Take the entire mixture within a few minutes, and always stir gently just before drinking.
If you take more BRONCHO VAXOM than you should
If you have taken too much BRONCHO VAXOM, contact your doctor or go to hospital
immediately.
If you forget to take BRONCHO VAXOM
Do not take a double dose to make up for the forgotten dose.
If you stop taking BRONCHO VAXOM
If you have any doubts about using 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.
If you/your child experience

• stomach and intestinal disturbances
• long-term breathing problems
• allergic reactions, stop the treatment. If you/your child experience skin reactions, stop the treatment, as they may be a sign of an allergic reaction.

Other side effects reported with BRONCHO VAXOM 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 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 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 VAXOM

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 VAXOM contains

BRONCHO VAXOM Adults 7 mg hard capsules

• The active substances contained in one hard capsule are 7 mg of OM-85 lyophilized 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 corn starch, mannitol, anhydrous propyl gallate (E310), anhydrous monosodium glutamate, magnesium stearate.
  Capsule cap composition: gelatin; titanium dioxide (E171), indigo carmine (E132).

BRONCHO VAXOM Children 3.5 mg hard capsules

• The active substances contained in one hard capsule are 3.5 mg of OM-85 lyophilized 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 corn starch, mannitol, anhydrous propyl gallate (E310), anhydrous monosodium glutamate, magnesium stearate.
  Capsule cap composition: gelatin; titanium dioxide (E171), indigo carmine (E132).

BRONCHO VAXOM Children 3.5 mg granules in sachets

• The active substances contained in one sachet are 3.5 mg of OM-85 lyophilized 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 corn starch, mannitol, magnesium silicate, anhydrous propyl gallate (E310), anhydrous monosodium glutamate, magnesium stearate.

Description of the appearance of BRONCHO VAXOM and contents of the pack

BRONCHO VAXOM 7 mg hard capsules are presented as opaque blue-bodied and blue-capped capsules containing a white to light beige powder.
Available in cartons containing 10 or 30 hard capsules.

BRONCHO VAXOM 3.5 mg hard capsules are presented as opaque white-bodied and blue-capped capsules containing a white to light beige powder.
Available in cartons containing 10 or 30 hard capsules.

BRONCHO VAXOM 3.5 mg granules in sachets are presented as light beige granules.
Available in cartons containing 10 or 30 sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
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

Exclusive distributor for sale in Italy:
Aziende Chimiche Riunite Angelini Francesco
A.C.R.A.F. - S.p.A. - Viale Amelia, 70
00181 Rome, Italy