ACTION AND MECHANISM

Association of ester-type local anesthetic, anti-inflammatory, and antiseptic. Benzocaine acts by locally blocking sensory receptors in mucous membranes. Chlorhexidine is a broad-spectrum antiseptic with particular activity against gram-positive bacteria and also has a fungistatic effect against Candida. Enoxolone is a compound, structurally related to corticosteroids, with anti-inflammatory and mineralocorticoid properties.

SENIORS

The elderly are particularly sensitive during prolonged treatment to the mineralocorticoid effects of enoxolone and to the systemic toxicity of benzocaine.

PATIENT ADVICE

- If symptoms worsen or persist after 2-3 days, a visit to the doctor may be advisable.

- Maintain proper oral hygiene, using special anti-tartar toothpaste to reduce tooth discoloration caused by chlorhexidine.

CONTRAINDICATIONS

- Allergy to any of the components, [ALLERGY TO LOCAL ANESTHETICS OF THE ESTER TYPE] such as PABA, parabens or paraphenylenediamine (a hair dye).

- Children under 6 years of age, due to their special sensitivity to the systemic toxicity of benzocaine, which may cause methemoglobinemia.

PREGNANCY

Not recommended due to the mineralocorticoid effects manifested by enoxolone, with high doses during prolonged treatments.

INDICATIONS

- Local and temporary symptomatic relief of mild [ORAL INFECTION], [STOMATITIS] and [PHARYNGITIS]: [ORAL CANKER SORES], [IRRITATION] of the throat due to external aggressive agents such as tobacco, sudden changes in temperature, dust, which cause pain and no fever.

INTERACTIONS

- Topical hydrocortisone: Possible increase in the effect of topical hydrocortisone (animal studies). Whether it also increases systemic absorption and toxicity has not been determined.

Analytical interferences:

- Benzocaine: Possible interference with the diagnostic test for pancreatic function using bentiromide. It is advisable to discontinue treatment at least 3 days before the test.

LACTATION

Not recommended for use.

CHILDREN

Children are more susceptible to the systemic toxic effects of benzocaine.

RULES FOR CORRECT ADMINISTRATION

- Oropharyngeal use.
- Dissolve slowly in the mouth, without chewing or swallowing.
- Do not use this medicine before meals or drinks.

POSOLOGY

Oropharyngeal use:

- Adults and children over 12 years: 1 tablet every 2-3 hours, allowing it to dissolve slowly in the mouth. Maximum dose: 8 tablets/day.

- Children over 6 years: Take 1 tablet every 4-5 hours, allowing it to dissolve slowly in the mouth. Maximum dose: 6 tablets/day.

PRECAUTIONS

- Chronic or abusive use: due to the mineralocorticoid effect of enoxolone there is a risk of edema formation, potassium loss and hypertension.

Evaluate the risk-benefit ratio in the following cases:

- Severe trauma to the oral mucosa (increases the absorption of anesthetics).

- Incisor fillings: if the surface is rough, there is a risk of permanent staining due to chlorhexidine.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains sorbitol. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medicine.

ADVERSE REACTIONS

Adverse effects are generally mild and transient. The most common adverse reactions are:

- Occasionally: Discoloration of oral surfaces (teeth, gums, tongue, fillings, etc.) that is visible within a week of treatment. Tongue discoloration disappears spontaneously. Tooth discoloration can be removed by oral cleaning. Filling discoloration may be permanent. Increased tartar buildup on teeth, altered taste perception.

Enoxolone at high doses (60 mg/day) and during prolonged treatment can cause edema, hypertension and hypokalemia.

-Rarely (<1%): anaphylactoid reaction, burning sensation in the mouth.

-Exceptionally (<<1%): methemoglobinemia characterized by cyanosis.

COMPOSITION

ENOXOLONE: 3 MILLIGRAMS
BENZOCAINE (STOMATOLOGICAL): 4 MILLIGRAMS
CHLORHEXIDINE (STOMATOLOGICAL): 5 MILLIGRAMS - HYDROCHLORIDE
SORBITOL (E-420) (EXCIPIENT): 1238 MILLIGRAMS