ACTION AND MECHANISM

Analgesic, anti-inflammatory. Benzimidazole derivative. It acts by inhibiting prostaglandin synthesis.

PATIENT ADVICE

PATIENT ADVICE: - Do not use for more than 7 consecutive days. - In a limited number of patients, oropharyngeal ulcerations may be a sign of serious conditions. Therefore, patients whose symptoms do not disappear within 3 days should consult a doctor or dentist. - Prolonged use may lead to sensitization, as well as irritation and dryness of the oral mucosa due to the presence of ethanol as an excipient. - The use of benzydamine is not recommended in patients with hypersensitivity to salicylic acid and/or NSAIDs.

INDICATIONS

- [PHARYNGITIS], [STOMATITIS]: Symptomatic treatment for the relief of pain and irritation of the mouth and throat ([SORE THROAT]). Mouthwash: Local symptomatic relief of pain and irritation of the throat, mouth and gums without fever. Oral spray: Local symptomatic relief of throat and mouth irritations with pain and without fever.

GUIDELINES FOR PROPER ADMINISTRATION

- Mouthwash: Use after brushing your teeth, either undiluted or diluted with an equal amount of water. Apply for 30 seconds by rinsing in case of oral conditions or by gargling in case of throat conditions. - Oral Spray: Shake the spray vigorously for several seconds. Then lift the nozzle and press the button several times until a steady spray is obtained. Insert the nozzle into the affected area and press the button. Do not exceed the stated dose. Do not eat or drink for 1 hour after using the medication.

POSOLOGY

- Adults and children over 12 years, topical:* Oral lozenges, local: One lozenge to suck 3 times a day. Treatment should not exceed 7 days.* Mouthwash: Local rinse or gargle with 15 ml (1 tablespoon) every 6-12 hours.* Oral spray: 1-3 sprays daily for 4-6 days. Treatment should not exceed 6 days. - Children 6-11 years: * Lozenges: Administration of the product should be under adult supervision.* Mouthwash: Not recommended for children under 12 years, except on the advice of a doctor.* Oral spray: Not recommended for children under 12 years, except on the advice of a doctor.

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains aspartame as an excipient, which should be taken into account by people with phenylketonuria. 100 mg of aspartame corresponds to 56.13 mg of phenylalanine.

ADVERSE REACTIONS

- Occasionally, excessive local anesthesia, stinging sensation, dry mouth, skin irritation, and local irritation at the application site. - Rarely, laryngeal spasm and angioedema of allergic origin.

COMPOSITION

BENZIDAMINE (DENTAL): 3 MILLIGRAMS - HYDROCHLORIDE
ASPARTAME (E-951) (EXCIPIENT): 3.26 MILLIGRAMS