Lantigen B
Italy
Package leaflet: information for the patient
LANTIGEN B oral drops, suspension
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 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:
- What LANTIGEN B is and what it is used for
- What you need to know before taking LANTIGEN B
- How to take LANTIGEN B
- Possible side effects
- How to store LANTIGEN B
- Contents of the pack and other information
1. What LANTIGEN B is and what it is used for
LANTIGEN B contains, as active substances, bacterial antigens belonging to the group of bacterial vaccines,
which locally stimulate the activity of the body's defence system (immune system).
LANTIGEN B is indicated:
- for the prophylaxis of recurrent respiratory tract infections in adults;
- for the prophylaxis of recurrent upper respiratory tract infections in children from 3 months of age.
2. What you need to know before taking LANTIGEN B
Do not take LANTIGEN B
- if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
- if you suffer from diseases of the immune system (autoimmune diseases);
- if you have developed an intestinal infection (acute intestinal infections).
Warnings and precautions
Talk to your doctor or pharmacist before taking LANTIGEN B.
Take this medicine with caution and inform your doctor if you or your child suffer from any type of allergy.
Stop treatment and consult your doctor if you or your child experience any of the following conditions:
- allergic reactions (hypersensitivity reactions);
- asthma attacks in predisposed patients;
- fever, particularly if it occurs at the beginning of treatment. The type of high fever exceeding 39°C that may occur as a rare, isolated adverse event with no known cause must be differentiated from fever arising due to the underlying condition, based on laryngeal, nasal, or otological symptoms. The use of Lantigen B for the prevention of pneumonia is not recommended, as there are no clinical study data available demonstrating such an effect. If you/your child are taking other medicines with non-specific immunostimulant activity, such as those containing bacterial extracts, do not take/give Lantigen B as well.
Other medicines and LANTIGEN B
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interaction studies with other drugs or vaccines have been conducted.
This medicine may be less effective if you have disorders of the immune system (with congenital or acquired immunodeficiency), if you are undergoing treatment with medicines that reduce immune system activity (immunosuppressive therapy), or if you are taking medicines used to treat allergies and inflammation (corticosteroids).
Pregnancy and breastfeeding
Do not take LANTIGEN B if you are pregnant.
Avoid taking LANTIGEN B if you are breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
LANTIGEN B contains sodium methyl parahydroxybenzoate
This medicine contains sodium methyl parahydroxybenzoate which may cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm.
3. How to take LANTIGEN B
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in adults and children over 10 years of age
The recommended dose is 15 drops, taken twice daily (morning and evening). One dose of Lantigen B
for adults is obtained by inverting the bottle and pressing the dispenser until 15 drops are delivered under the tongue.
Use in children aged between 3 months and 10 years
The recommended dose is 7–8 drops (half dose), taken twice daily (morning and evening). The half dose for children is obtained by pressing the dispenser until 7–8 drops are delivered under the tongue.
Alternatively, the recommended dose is 15 drops administered once in the morning, preferably on an empty stomach.
In very young children, LANTIGEN B may be administered during sleep by placing the drops between the lower lip and gum.
METHOD OF USE: for correct use of the medicine, carefully follow the instructions below:
- shake the bottle well;
- do not be concerned if, after shaking, you notice suspended particles, as this does not affect the safety of the product;
- break the security seal by grasping the plastic tab located at the middle of the cap and pulling outward;
- completely remove the seal by rotating it around the bottle;
- remove the cap and invert the bottle;
- press the dispenser between thumb and index finger, applying gradual pressure, until the desired number of drops is dispensed;
- hold the drops in the mouth, under the tongue, for about 2 minutes, without swallowing.
DURATION OF TREATMENT: treatment consists, based on the recommended daily dose, of 2 bottles (36 ml) for adults and 1 bottle (18 ml) for children under 10 years of age.
Afterwards, discontinue treatment for 2–3 weeks.
For booster treatment, administration of 1 bottle is recommended for adults and half a bottle for children under 10 years of age (including infants), at the recommended doses.
To achieve and maintain adequate protection throughout the winter season, treatment should begin in September and repeated starting from January.
If you take more LANTIGEN B than you should
Cases of overdose are not known.
In case of accidental ingestion of an excessive dose of LANTIGEN B, contact your doctor immediately or go to the nearest hospital.
If you forget to take LANTIGEN B
Do not take a double dose to make up for the missed dose.
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 everybody will experience them.
Possible side effects may occur as an increase in symptoms (feeling of nasal congestion and rhinorrhea) at the beginning of treatment.
The following side effects, generally mild in intensity, may occur.
Rare (may affect up to 1 in 1,000 people)
- sensation of suffocation (feeling of nasal congestion);
- runny nose (rhinorrhea).
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 the address 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 LANTIGEN B
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month and to the product in its original, unopened packaging stored correctly.
Do not store above 25°C and protect from light, keeping it in the original bottle closed with the cap.
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 LANTIGEN B contains
- The active substances are antigenic extracts of: Streptococcus pneumoniae type 3, Streptococcus pyogenes group A, Branhamella catarrhalis, Staphylococcus aureus, Haemophilus influenzae type b, Klebsiella pneumoniae. 1 ml of product contains 63.2 Antigenic Units of Streptococcus pneumoniae type 3, 126.2 Antigenic Units of Streptococcus pyogenes group A, 39.9 Antigenic Units of Branhamella catarrhalis, 79.6 Antigenic Units of Staphylococcus aureus, 50.2 Antigenic Units of Haemophilus influenzae type b, 39.8 Antigenic Units of Klebsiella pneumoniae.
- The other components are: polysorbate 80, chlorhexidine diacetate, sodium methyl para-hydroxybenzoate, purified water.
Description of the appearance of LANTIGEN B and contents of the pack
Vial containing 18 ml of bacterial antigen suspension, complete with dispenser and safety closure.
Marketing Authorization Holder and Manufacturer
Bruschettini s.r.l. – Via Isonzo, 6 – 16147 Genoa – Italy