Properties
What is it?
Gervetin Medical Use Instructions Trade Name: Gervetin International Nonproprietary Name: Benzydamine Dosage Form: Lozenges Composition: Each lozenge contains: Active substance: Benzydamine hydrochloride 3 mg Excipients: Menthol, Mint oil 27198/14, Povidone, Sodium cyclamate, Mannitol, Sorbitol, Pregelatinized starch, Colloidal anhydrous silica, Magnesium stearate, Color Opadry Green Pharmacotherapeutic Group: Non-steroidal anti-inflammatory drug for topical use ATC Code: A01AD02 Pharmacological Action: Pharmacodynamics: Benzydamine belongs to the indazole group and is a non-steroidal anti-inflammatory drug. It has anti-inflammatory and local analgesic effects, and possesses antiseptic activity against a wide spectrum of microorganisms. The mechanism of action of the drug is related to the stabilization of cellular membranes and inhibition of prostaglandin synthesis. Benzydamine exerts antibacterial and specific antimicrobial effects by rapidly penetrating the membranes of microorganisms, leading to subsequent damage of cellular structures, disruption of metabolic processes, and cell lysis. The drug has antifungal activity against Candida Albicans. It causes structural modification of the fungal cell wall and metabolic chains of mycelia, thus preventing their reproduction, which is the basis for the use of benzydamine in inflammatory processes of the oral cavity, including those of infectious etiology. Pharmacokinetics: When used topically, it is well absorbed from mucous membranes and rapidly reaches inflamed tissues. Excretion occurs mainly through the kidneys and intestines in the form of metabolites or conjugation products. The dosage form intended for topical use has no systemic effect and is not transferred into breast milk. Indications for Use: Inflammatory diseases of the oral cavity and ENT organs (of various etiologies), for the relief of pain symptoms and irritation in the oral cavity and throat. Contraindications: • Hypersensitivity to the components of the drug • Children under 6 years of age Method of Administration and Dosage: The lozenge should be completely dissolved in the mouth (for better effect, it is desirable to keep it in the mouth for as long as possible). Adults and children over 6 years of age: one lozenge 3 times a day. Children aged 6-11 years: the drug is used under adult supervision. The course of treatment should not exceed 7 days. Do not swallow. Do not chew. Side Effects: Local reactions: dry mouth, numbness, burning sensation in the oral cavity. Allergic reactions: skin rash. Very rarely: laryngospasm. Overdose: There is no data on overdose. In cases of oral intake of doses more than 100 times the therapeutic doses in children, nervous excitation, convulsions, sweating, ataxia, tremor, and vomiting are observed; in such cases, seek medical attention immediately. In case of acute overdose, only symptomatic therapy is indicated; gastric emptying, induction of vomiting, or gastric lavage are necessary. Adequate hydration should be maintained. Interaction with Other Medicinal Products: No data available. Special Instructions: The use of the drug is not recommended in patients with hypersensitivity to salicylic acid or other non-steroidal anti-inflammatory drugs. Bronchospasm may develop in patients who have or have had bronchial asthma. Caution should be exercised in such patients. In some patients, small ulcers may appear on the mucous membrane of the cheeks or gums. If symptoms do not improve within 3 days, or if fever develops, consult your doctor. Effect on the Ability to Drive and Operate Machinery: The drug does not affect the ability to drive vehicles or perform other activities that require increased attention. Dosage Form: 10 lozenges in a blister. 2 blisters are placed in a cardboard box with instructions for use. Storage Conditions: Store in a dry, dark place, at a temperature not exceeding 25°C. Keep out of reach of children! Shelf Life: Indicated on the packaging. Do not use after the expiry date. Dispensing from Pharmacy: Over-the-counter. Trademark and Marketing Authorization Holder: SPEY MEDICAL Ltd., London, Great Britain. Manufacturer: REPLEK FARM LTD. Skopje Skopje, Republic of Macedonia.
