Package leaflet: Information for the patient

PASPAT tablets

bactolisate
Please read this leaflet carefully before taking or giving this medicine to your child
because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours or your child's, because it could be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PASPAT is and what it is used for
What you need to know before taking/giving PASPAT to your child
How to take/give PASPAT to your child
Possible side effects
How to store PASPAT
Contents of the pack and other information

1. What PASPAT is and what it is used for

What is PASPAT?
PASPAT contains inactivated bacteria that stimulate the body to produce antibodies (proteins that protect it
against germs causing infectious diseases).
PASPAT is used for the prophylaxis of recurrent respiratory tract infections in adults.
PASPAT is used for the prophylaxis of recurrent upper airway infections in children from 4 years of age.
Please consult your doctor if you/your child do not feel better or feel worse.

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

Do not take/give PASPAT to the child

if you or your child are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if you or your child have a fever. In such cases, treatment should be postponed;
if you are pregnant;
if you or your child suffer from autoimmune diseases (diseases of the immune system that cause it to react against the body's own organs and tissues);
if you or your child currently have intestinal infections.

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

If you or your child have a fever, especially at the beginning of treatment: stop PASPAT treatment. You may develop a high fever exceeding 39°C, occurring in isolation and without known causes; this type of fever must be differentiated from the fever associated with the underlying disease, based on laryngeal, nasal, or otological conditions. In such cases, treatment must be suspended and not resumed (see section 4 "Possible side effects"). Your doctor will explain the difference between this fever and the fever caused by the infections you/the child frequently suffer from.
If you/the child suffer from or are predisposed to asthma. If an asthma attack occurs, discontinue PASPAT treatment.
If you/the child are taking another immunostimulant. Do not take/give PASPAT as well.
If you/the child experience an allergic reaction. Immediately stop taking PASPAT (adult/child formulation) and consult your doctor (see section 4 "Possible side effects").

PASPAT cannot replace antibiotic treatment or vaccination.
The use of PASPAT for the prevention of pneumonia is not recommended, as there are no clinical study data available demonstrating such an effect.
Other medicines and PASPAT
Inform your doctor or pharmacist if you/the child are taking, have recently taken, or might take any other medicines.
Inform your doctor if you/the child are taking:

immunosuppressants (medicines that prevent your immune system, the body's defense system against diseases, from fighting infections). PASPAT must not be administered if you are taking such medicines;
if you or your child are scheduled to receive any vaccine, it is important that at least 4 weeks elapse between the end of PASPAT treatment and administration of the new vaccine;
corticosteroids, medicines used to treat inflammation. PASPAT must not be administered if you are taking such medicines.

PASPAT with food and drinks
The medicine should be taken on an empty stomach.
Pregnancy and breastfeeding
Pregnancy
Do not take PASPAT during pregnancy
Breastfeeding
Do not take PASPAT during breastfeeding
Driving and using machines
PASPAT does not affect the ability to drive vehicles (e.g. bicycle) or operate machinery.

3. How to take/give PASPAT to the child

Take/give this medicine to the child exactly as directed by the doctor or pharmacist.
If in doubt, consult the doctor or pharmacist.
The recommended dose is 1 tablet of PASPAT daily, taken on an empty stomach in the morning with some water.
Take/give PASPAT to the child for 14–28 days.
Then stop treatment for 14–28 days.
Afterwards, take/give PASPAT to the child for a further 14–28 days.
If necessary, the doctor may recommend additional treatment periods separated by treatment-free intervals.

If you take/give the child more PASPAT than prescribed
If you have taken/given too much PASPAT to the child, contact your doctor or go to hospital immediately.

If you forget to take/give the child PASPAT
Do not take/give a double dose to make up for the forgotten dose.

If you stop treatment/administration of PASPAT to the child
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 will get them.
If you/your child experience allergic reactions, stop treatment immediately.
Other side effects reported for PASPAT are listed below, classified by frequency:
Uncommon (may affect up to 1 in 100 people)

abdominal pain, nausea, flatulence, diarrhoea
skin rash, urticaria, pruritus
Very rare (may affect up to 1 in 10,000 people)
joint pain
decrease in platelet count (thrombocytopenia)

Reporting of side effects
If you/your child experience any side effects, including those not listed in this leaflet, contact your doctor. 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 PASPAT

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
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 PASPAT contains

The active substances in one tablet are at least 1x10 of bacterial lysate from Staphylococcus aureus, Streptococcus mitis, Streptococcus pyogenes, Streptococcus pneumoniae, Klebsiella pneumoniae, Branhamella catarrhalis, Haemophilus influenzae, equivalent to 3 mg.
The other components are mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of PASPAT and package contents
PASPAT is presented as white tablets.
It is available in a carton containing 28 tablets.
Marketing Authorization Holder and Manufacturer
V.I.M. G. Ottaviani SpA
Piazza Giovanni XXIII, 5
06012 Città di Castello (PG)
Manufacturer
Daiichi Sankyo Europe GmbH
Pfaffenhofen (Germany)