About BioModulus

XILONIBSA SPRAY 10%
Lidocaine
COMPOSITION
Every ml contains:
Lidocaine (INN)………………………………………………………100 mg
96° Ethanol………………………………………………………………30.0% v/v
Menthol, saccharine, macrogol 400, banana aroma and purified water s.q.
PHARMACOTHERAPEUTIC CATEGORY
Xilonibsa spray 10% contains lidocaine, an amide-like local anaesthetic that stabilises
the neuronal membrane and prevents the onset and conduction of nervous pulses. The
topical anaesthesia is fast and strong, the latency period generally lasting 2 to 5 minutes.
THERAPEUTIC INDICATIONS
Superficial anaesthetic of the mucosa in surgery, obstetrics, dentistry and
otorhinolaryngology.
CONTRA-INDICATIONS
In patients hypersensitive to amide-like local anaesthetics.
The use of this drug product is contra-indicated in children aged under 6, due to the risk
of a very fast absorption of the anaesthetic and the risk of a reflex laryngeal spasm in
babies, when it is given per spraying in the oral-pharyngeal cavity.
SUITABLE PRECAUTIONS FOR USE
After all oral-pharyngeal anaesthesia, the patient must avoid the consumption of any
solid or liquid foods for at least two hours, to avoid a false route for lumps of food and
lesions to the tongue resulting from bites.
Avoid applying Xilonibsa spray 10% to the eyes; however, if this does occur by
accident, instil drops of liquid paraffin and wash the eyes with a solution of 2-3% boric
acid.
No more than 20 applications must be given per adult patient.
Do not expose the product to the sun or to high temperatures.
INTERACTIONS
None known
SPECIAL WARNINGS
Use in pregnancy
As in the case of all drug products, only apply this one to pregnant women if it is strictly
necessary.
Use during lactation
Special precautions must be taken when it is given to breastfeeding women.
Sports competitors
Sports competitors are informed that this drug product contains an ingredient that can
cause a positive result in doping tests.
WARNING ON EXCIPIENTS
Frequent applications can cause irritation and dry skin.
DOSAGE
The dose varies according to the area that has to be anaesthetised, the vascularisation of
the tissues and the anaesthetic technique being used.
It must be given at the lowest dose required to provide the suitable anaesthesia. Do not
administer to children aged under 6.
In dentistry: 1 to 5 applications on the mucosa are sufficient. Apply three atomisations
when the maxillary sinus is punctured.
In otorhinolaryngology: the dose depends on the area being anaesthetised. Make 4-6
applications to avoid reflex nausea. 1-2 applications are sufficient in parecentesis.
In gynecology-obstetrics: 20 atomisations (200 mg) are sufficient.
The absorption of anaesthetics in the trachea and the bronchial tree is very fast, so avoid
the administration of excessive doses, which will cause toxic reactions.
In children, the maximum dose will be calculated according to body weight. The
maximum dose over 24 hours for an adult weighing around 70 kg is 200 mg (20
applications with the dosing valve). If the drug product is dosed according to the
patient’s weight, do not exceed the dose of 3 mg/kg of body weight per day.
In debilitated or elderly patients and children aged over 6, this drug product must only
be applied when it is necessary, and the dose must be reduced according to the age and
general condition.
INTOXICATION AND ITS TREATMENT
As in other local anaesthetics, systemic reactions that can affect the CNS and the
cardiovascular system may occur, due to an excessive dose or a quick absorption,
especially via the trachea and bronchial tree, which can simulate an intravenous
injection. In these cases, the treatment to follow comprises the maintenance of the vital
signs, and if convulsions appear, the administration intravenously of short-acting
barbiturates (e.g. thiopental) or benzodiazepines (diazepam).
In cases of overdose or accidental ingestion, consult the Toxicological Information
Service. Phone 91 562 04 20.
ADVERSE REACTIONS
The anaesthetic is well tolerated, and no adverse reactions are observed at the normal
recommended doses.
Inform your doctor or pharmacist of any adverse reaction not described in this package
insert.
HOW SUPPLIED
Spray pack with 50 ml.
It is fitted with a dosing valve that provides a dose of 10 mg of lidocaine with each
press