Buccalin

Patient Information Leaflet

Buccalin

Adult Enteric-Coated Tablets
Children Enteric-Coated Tablets
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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Buccalin is and what it is used for

Buccalin contains "inactivated" bacteria (that have lost their ability to cause infections).
The medicine is indicated for:
Adults:
Prophylaxis of recurrent respiratory tract infections in adults.
Children:
Prophylaxis of recurrent upper airway infections in children from 2 years of age.

2. What you need to know before taking Buccalin

Do not take Buccalin

• 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 or your child have an autoimmune disease (immune system disorder);
• if you or your child have an intestinal infection;
• if your child is under 2 years of age;
• if you are being treated with immunostimulant medicines.

Warnings and precautions
The use of Buccalin for the prevention of pneumonia is not recommended, as there are no clinical study data demonstrating such an effect.
Consult your doctor before taking Buccalin if you have a congenital or acquired immunodeficiency (weakened immune system).
If, after the first dose of Buccalin, you or your child develop fever, especially at the beginning of treatment, you must stop treatment and contact your doctor (see also section 4. Possible side effects).
If, after the first dose of Buccalin, you or your child experience any of the following reactions, you must stop treatment and not restart it (see also section 4. Possible side effects):

• fever above 39°C, isolated and without known cause; this type of fever must be differentiated from fever arising due to the underlying condition, based on laryngeal, nasal, or otological conditions, and thus not attributable to respiratory tract infections;
• asthma attacks;
• allergic-type reactions.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist.
Children
This medicine must not be given to children under 2 years of age.
Other medicines and Buccalin
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Consult your doctor if you or your child are taking immunosuppressive medicines (which reduce your immune defenses) or corticosteroid medicines (used to treat inflammation).
This medicine must NOT be used if you or your child are taking another medicine that stimulates the immune system (immunostimulants).
If you or your child are scheduled to receive any vaccine, it is important that at least 4 weeks pass between the end of treatment with Buccalin and administration of the vaccine.
The immune response may be suppressed in subjects with congenital or acquired immunodeficiency, undergoing immunosuppressive therapy, or receiving corticosteroids.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no data on the use of Buccalin in pregnant women; therefore, as a precautionary measure, the use of Buccalin during pregnancy should be avoided.
Breastfeeding
The use of Buccalin should be avoided during breastfeeding, as specific studies have not been conducted and no data are available.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

• Buccalin contains:
• Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Buccalin

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
Use in adults
The recommended dose follows this treatment cycle:

The packaging for Buccalin Adults is available, containing the exact number of gastro-resistant tablets necessary for a full course of treatment.
Use in children over 2 years of age
The recommended dose involves the following treatment regimen:

A pack of Buccalin Children is available, containing the exact number of gastro-resistant tablets required for one course of treatment.
Administration method
Take each dose in the morning, on an empty stomach.
Duration of treatment
It is recommended to repeat the treatment cycle every 30–40 days.
Do not perform more than 3 treatment cycles.
If you take more Buccalin than you should
In case of accidental overdose of Buccalin, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Buccalin, consult your doctor or pharmacist.
If you forget to take Buccalin
Do not take a double dose to make up for the missed tablet.
If you stop treatment with Buccalin
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 everyone experiences them.
Stop treatment and contact your doctor immediately if you experience any of the
following side effects:

• allergic reactions such as swelling, redness and itching of the throat, mouth, eyes or nose, difficulty breathing, or skin rashes;
• asthma attacks;
• fever above 39°C.

The following side effects have been reported with the use of this medicine (although frequency is unknown):

• reduction in the number of platelets in the blood (thrombocytopenia);
• headache;
• cough, difficulty breathing, cold symptoms;
• stomach and abdominal pain, diarrhea, nausea, flatulence (intestinal gas), constipation, inflammation of the mouth (stomatitis), upper abdominal pain;
• skin rashes, allergy, itching, swollen hands;
• joint pain;
• influenza-like symptoms, weakness, feeling of fatigue, fever.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via 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 Buccalin

This medicine does not require any special storage conditions.
Keep the blister in the outer packaging to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
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 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 Buccalin contains

• The active substances are inactivated bacteria of the strains Streptococcus pneumoniae I, II, III, Streptococcus agalactiae, Staphylococcus aureus, Haemophilus influenzae. Each gastro-resistant tablet contains:
  • Streptococcus pneumoniae I, II, III: 1 billion inactivated bacteria
  • Streptococcus agalactiae: 1 billion inactivated bacteria
  • Staphylococcus aureus: 1 billion inactivated bacteria
  • Haemophilus influenzae: 1.5 billion inactivated bacteria
• The other components are lactose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, Eudragit L 100-55, sodium hydroxide, talc, triethyl citrate, titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide, Opaglos.

Description of the appearance of Buccalin and contents of the pack
Buccalin is available in two pack sizes:

• Adults: pack containing one blister of 7 gastro-resistant tablets in PVC/aluminum.
• Children: pack containing one blister of 4 gastro-resistant tablets in PVC/aluminum. Each pack contains the exact number of gastro-resistant tablets required for one treatment cycle.

Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)