Debara 0.25/0.03mg 20 lozenges

Trade name DEBARA, DEBARA International Nonproprietary Name or Group Name Dequalinium chloride + Dibucaine hydrochloride Drug form Lozenges. Description: Round flat tablets with a bevel, white or almost white in color. See blog: DEBARA: Effective management of oral and throat inflammation Composition Composition of a lozenge Active substance: Dequalinium chloride 0.25 mg, Dibucaine hydrochloride 0.03 mg. Excipients: Sorbitol, Magnesium stearate, Talc, Colloidal anhydrous silica, "Garden mint" flavoring, Garden mint oil. ATC code of the preparation R02AA02 Pharmacotherapeutic group Medicines for the treatment of throat diseases. Antiseptic agents. Pharmacological properties Pharmacodynamics Dequalinium chloride has a bactericidal and fungistatic effect on microorganisms that cause mixed infections of the oral cavity and throat. It has a broad spectrum of action, including most Gram-positive and Gram-negative bacteria, as well as fungi, spirochetes, and other microorganisms causing laryngopharyngeal infections. Dibucaine hydrochloride eliminates pain associated with inflammatory processes of the oral cavity and throat. Microorganisms resistant to the action of dequalinium chloride are unknown. The preparation does not cause the development of caries. Pharmacokinetics The main active component (dequalinium chloride) is absorbed in very insignificant amounts. Indications for use Local treatment of inflammatory diseases of the oral cavity and throat (including stomatitis, gingivitis) accompanied by pain syndrome and/or aphthae. Method of administration and dosage Tablets should be dissolved in the mouth. Tablets should be dissolved slowly, without chewing. The duration of the treatment course is determined by the doctor individually. For adults and children over 12 years of age, 1 tablet is prescribed every 2 hours, after reduction of inflammation symptoms – 1 tablet every 4 hours. For children over 4 years of age – 1 tablet every 3 hours, after reduction of inflammation symptoms – 1 tablet every 4 hours. The patient should consult a doctor if symptoms do not disappear or the condition worsens after 7 days of treatment with the preparation. Contraindications _ Hypersensitivity to any component of the preparation; _ Known allergy to quaternary ammonium compounds (e.g., benzalkonium chloride). Adverse reactions Frequencies of adverse reactions are defined as follows: very common (≥1/10); common (≥1/100, but <1/10); uncommon (≥1/1000, but <1/100); rare (≥1/10000, but <1/1000), very rare (<1/10000), unknown frequency (frequency cannot be determined from available data). Immune system disorders: Rare – hypersensitivity reactions; Very rare – rash and allergic reactions accompanied by itching. Respiratory, thoracic and mediastinal disorders: Unknown frequency – dyspnea. Special instructions The preparation does not contain sugar, therefore it can be used by individuals with diabetes mellitus. The preparation contains sorbitol, therefore it should not be used in patients with rare hereditary diseases such as fructose intolerance syndrome. Effect on ability to drive and use machines No studies have been conducted on the effect of the medication on the ability to drive vehicles and operate machinery requiring increased speed of psychomotor reactions. However, the probability that the preparation has a negative impact on these functions is unlikely. Use during pregnancy and lactation Controlled studies on the use of the preparation during pregnancy have not been conducted. Due to this situation, the preparation DEBARA is used during pregnancy only after consulting a doctor, if the therapeutic effect outweighs the possible risk to the fetus. Clinical studies on the penetration of active substances into breast milk have not been conducted. Use of the preparation during lactation is not recommended. Use in pediatrics The preparation in this dosage form is not prescribed for children under 4 years of age. Interaction with other medicinal products The effectiveness of the preparation is reduced when used with anionic surfactants contained in ordinary toothpaste. Therefore, after brushing teeth, the preparation DEBARA can be used no earlier than half an hour later. Overdose This combination is usually well tolerated. However, the following symptoms may develop: dizziness, vomiting, esophageal irritation. Treatment: symptomatic. Avoid gastric lavage and induction of vomiting. Dosage form Lozenges. 10 tablets in a blister. 2 blisters with instructions for use in a cardboard box. Storage conditions Store at a temperature not exceeding 25ºС. Keep out of reach of children! Shelf life 3 years from the date of manufacture. Do not use after the expiry date. Dispensing from pharmacies Pharmaceutical product group III, available without a prescription.