BUCCALIN Enteric-coated tablet
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Treść ulotki
Buccalin
Adults gastro-resistant tablets
Children gastro-resistant tablets
Read this leaflet carefully before taking 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is Buccalin and what is it used for
Buccalin contains “inactivated” bacteria (which have lost the ability to cause infections).
The medicine is indicated for
Adults:
Prevention of recurrent respiratory tract infections in adults.
Children:
Prevention of recurrent upper respiratory tract infections in children from 2 years of age.
2. What you need to know before you take Buccalin
Do not take Buccalin
- if you or your child is allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
- if you or your child has a fever. In these cases, treatment should be postponed;
- if you or your child has an autoimmune disease (disease of the immune defenses);
- if you or your child has an intestinal infection;
- if your child is under 2 years of age;
- if you are being treated with immunostimulating medicines.
Warnings and precautions
The use of Buccalin for the prevention of pneumonia is not recommended because there is no data
from clinical studies demonstrating such an effect.
Consult your doctor before taking Buccalin if you have a congenital or acquired immune deficiency
(weakened immune system).
If, after the first dose of Buccalin, you or your child should develop a fever in
particular at the beginning of treatment, you should stop treatment and contact your doctor (see
also section 4.Possible side effects).
If, after the first dose of Buccalin, you or your child should experience any of the
following reactions, you should stop treatment and do not resume it (see also section
- 4.Possible side effects):
- fever above 39°C, isolated and without known causes and the type of fever must be differentiated from the fever that occurs following the original pathology, based on the conditions of the larynx, nose or ears, therefore not attributable to respiratory tract infections;
- asthma attacks;
- allergic-type reactions.
If you are not sure if any of these conditions apply to you, consult your doctor or pharmacist.
Children
This medicine should not be given to children under 2 years of age.
Other medicines and Buccalin
Tell your doctor or pharmacist if you or your child is taking, has recently taken or
may take any other medicine.
Consult your doctor if you or your child is taking immunosuppressants (which reduce
your immune defenses) or corticosteroid medicines (used against inflammation).
The medicine MUST NOT be used if you or your child is taking another medicine that can
stimulate the immune system (immunostimulants).
If you or your child are to undergo the administration of any vaccine, it is
important that at least 4 weeks pass between the end of treatment with Buccalin and the
administration of the new vaccine.
The immune response may be inhibited in subjects with congenital or acquired immunodeficiency, in
immunosuppressive therapy or with corticosteroids.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is no data relating to the use of Buccalin in pregnant women, therefore as a precautionary
measure, the use of Buccalin in pregnancy should be avoided.
Breastfeeding
The use of Buccalin should be avoided during breastfeeding, as no specific studies have been conducted and
no data are available.
Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.
- Buccalin contains:
- Lactose:if your doctor has diagnosed you with intolerance to certain sugars, contact them 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 following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
Use in adults
The recommended dose provides for the following therapy cycle:
The Buccalin Adulti pack is available containing the exact number of gastro-resistant tablets
needed for a therapy cycle.
Use in children over 2 years of age
The recommended dose provides for the following therapy cycle:
The Buccalin Bambini pack is available containing the exact number of gastro-resistant tablets
needed for a therapy cycle.
Method of administration
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 undergo more than 3 treatment cycles.
If you use more Buccalin than you should
In case of accidental intake of an excessive dose of Buccalin, immediately notify your
doctor 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 a missed tablet.
If you stop taking 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 everybody gets them.
Stop treatment and tell your doctor immediatelyif you experience any of the following side effects:
| Treatment day | Recommended daily dose |
| Day 1 | 1 gastro-resistant tablet |
| Day 2 | 2 gastro-resistant tablets |
| Day 3 | 4 gastro-resistant tablets |
| Treatment day | Recommended daily dose |
| Day 1 | d 1 gastro-resistant tablet |
| Day 2 | 1 gastro-resistant tablet |
| Day 3 | 2 gastro-resistant tablets |
- allergic reactions such as swelling, redness and itching of the throat, mouth or eyes or nose, difficulty breathing or skin rashes;
- asthma attacks;
- fever over 39°C.
The following side effects have been reported with the use of this medicine (frequency not known):
- reduction in the number of platelets in the blood (thrombocytopenia);
- headache;
- cough, difficulty breathing, cold;
- abdominal and stomach pain, diarrhoea, nausea, flatulence (intestinal gas), constipation, inflammation of the mouth (stomatitis), upper abdominal pain;
- skin rashes, allergy, itching, swollen hands;
- joint pain;
- flu-like symptoms, weakness, feeling tired, fever.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 particular 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 that is reported on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Buccalin contains
- The active ingredients are inactivated bacteria of the strains of Streptococcus pneumoniae I, II, III,Streptococcus agalactiae, Staphylococcus aureus, Haemophilus influenzae.Each gastro-resistant tablet contains:
- Streptococcus pneumoniae I, II, III1 billion inactivated bacteria
- Streptococcus agalactiae1 billion inactivated bacteria
- Staphylococcus aureus1 billion inactivated bacteria
- Haemophilus influenzae1.5 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 packs:
- Adults: pack containing a blister of 7 tablets in PVC/Aluminum.
- Children: pack containing a blister of 4 tablets in PVC/Aluminum. Each pack contains the exact number of gastro-resistant tablets needed for a course of therapy.
Marketing Authorisation Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
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- Kraj rejestracji
- Postać farmaceutycznaEnteric-coated tablet
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki BUKKALINPostać farmaceutyczna: Powder and solvent for injectable solution, 0,5 MLSubstancja czynna: haemophilus influenzae B, combinations with toxoidsProducent: SANOFI WINTHROP INDUSTRIEWymaga receptyPostać farmaceutyczna: Injectable suspension in pre-filled syringe, 0.5MLSubstancja czynna: meningococcus B, multicomponent vaccineProducent: GLAXOSMITHKLINE VACCINES S.R.L.Bez receptyPostać farmaceutyczna: Injectable suspension, 0.5 MLSubstancja czynna: pertussis, purified antigen, combinations with toxoidsProducent: GLAXOSMITHKLINE S.P.A.Bez recepty
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BUKKALIN jest produkowany przez LABORATORIO FARMACEUTICO SIT SPECIALITA IGIENICO TERAPEUTICHE S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie BUKKALIN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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