LORANGINE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LORANGIN

Composition:

Active substances: hexetidine, choline salicylate, chlorobutanol hemihydrate;

1 ml of solution contains hexetidine (calculated as 100 % substance) 1.0 mg, choline salicylate (calculated as 100 % substance) 5.0 mg, chlorobutanol hemihydrate (calculated as 100 % anhydrous substance) 2.5 mg;

Excipients: propionic acid, sodium saccharin, polysorbate 20, lemon oil, anise oil, peppermint oil, eucalyptol (cineole), ethanol 96 %, menthol (levomenthol), methyl salicylate, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical characteristics: clear or slightly opalescent liquid, colorless to slightly yellowish, with a characteristic aromatic odor and a sweet-sour lemon-alcoholic taste.

Pharmacotherapeutic group. Antiseptics. ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

The effect of the medicinal product is due to three active components.

Antibacterial and antifungal activity. Hexetidine exerts antibacterial effects against both Gram-positive and Gram-negative microbial strains, as well as against both aerobes and anaerobes.

It should be noted that hexetidine generally exerts a bacteriostatic effect on aerobic strains, with weak bactericidal activity. Against anaerobic strains, hexetidine has a pronounced bactericidal effect. The mechanism of action involves competitive interaction with thiamine: the structure of hexetidine resembles that of thiamine, which is essential for microbial growth.

Anti-inflammatory activity. Choline salicylate exerts analgesic, antipyretic, and anti-inflammatory effects. It is used for the treatment of diseases of the oral cavity.

Analgesic activity. Chlorobutanol exerts an analgesic effect. It can be used, in particular, in otorhinolaryngology (nasal drops, mouthwashes) and in dental practice (applications and irrigations). It can classically be used as an anesthetic.

Pharmacokinetics.

The active substances bind to the mucous membrane of the oral cavity, from where they are gradually released.

Clinical characteristics.

Indications.

Local treatment of oral cavity infections. Postoperative dental care.

Contraindications.

• Hypersensitivity to any component of the medicinal product;
• Atrophic pharyngitis;
• Bronchial asthma or any other respiratory tract diseases associated with existing respiratory hypersensitivity.

Interaction with other medicinal products and other forms of interactions.

Do not use together with products containing antiseptics.

Hexetidine may be inactivated by alkaline solutions.

Special precautions for use

The medicinal product contains 58% ethanol (alcohol), meaning one dose (10 ml) contains 5.8 ml of ethanol.

The preparation must not be swallowed, and contact with the eyes should be avoided, as it contains ethanol.

The preparation should be used with caution in patients with epilepsy. The preparation may lower the epileptic threshold and may cause seizures in children.

Use with caution in patients predisposed to allergic reactions, including bronchial asthma, especially in patients with allergy to acetylsalicylic acid. If signs of hypersensitivity to the preparation occur, its use should be discontinued immediately.

Since the medicinal product contains ethanol, it should be prescribed with caution to patients with liver diseases.

Prolonged use is not recommended, as it may alter the natural microbial balance of the oral cavity and pharynx, with a risk of bacterial and fungal overgrowth.

If general clinical signs of bacterial infection appear, systemic antibacterial therapy should be initiated.

If symptoms persist for more than 5 days and/or body temperature remains elevated, the treatment strategy should be reevaluated.

If inflammation worsens, the use of the medicinal product should be discontinued.

Use during pregnancy or breastfeeding

There are no human study data available on the potential of hexetidine to cross the placenta or its excretion in breast milk. Therefore, the medicinal product should not be used during pregnancy and during breastfeeding.

Ability to affect reaction speed when driving vehicles or operating machinery

The medicinal product contains ethanol. Drivers are advised not to operate a vehicle for 30 minutes after using Lorange.

Method of Administration and Dosage

Use as a topical agent for rinsing the oral cavity.

For one mouth rinse in adults and children aged 6 years and older: pour the solution into the measuring cup up to the 10 mL mark and dilute with warm water to the 50 mL mark, or dissolve 2 teaspoons of the medicinal product in ¼ cup of warm water.

Perform 2 to 4 rinses per day.

Do not swallow.

Treatment duration — no longer than 5 days.

Children

Do not use in children under 6 years of age.

Overdose

No reports of overdose with this medicinal product have been reported.

The concentration of hexetidine in the preparation is non-toxic when used as directed.

No cases of excessive use of hexetidine leading to hypersensitivity reactions have been observed.

If a sufficient amount of the solution is absorbed in the oral cavity, alcohol intoxication may occur due to the presence of ethanol.

Acute alcohol intoxication is unlikely. However, if a child has swallowed a large dose of the product, alcohol intoxication may occur due to the presence of ethanol.

Treatment of overdose is symptomatic and rarely required. If a child has ingested the contents of the bottle, seek immediate medical attention. Gastric lavage should be considered within 2 hours after ingestion, along with measures to counteract signs of alcohol intoxication.

Adverse reactions.

Immune system disorders: hypersensitivity reactions, including urticaria, angioneurotic edema, laryngospasm, bronchospasm.

Nervous system disorders: ageusia, dysgeusia, altered taste sensations within 48 hours (sweet taste may change to bitter taste).

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. In case of accidental ingestion, gastrointestinal disturbances may occur, primarily nausea and vomiting.

Skin and subcutaneous tissue disorders: allergic contact dermatitis, skin reactions (rash).

General disorders and administration site conditions: local reactions — reversible discoloration of teeth and tongue; mucosal sensitivity: burning, numbness; irritation (pain, sensation of warmth, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paresthesia; inflammation; blisters; ulceration of the mucosa, irritation sensation in the throat, swelling at the site of contact, dryness of nasal/throat mucosa.

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

100 ml or 120 ml in a bottle, 1 bottle in a cardboard box.

Availability category. Over-the-counter.

Manufacturer/Marketing Authorization Holder.

LLC "Ternopharm".

Manufacturer's address / Marketing Authorization Holder's address.

4 Fabrychna Street, Ternopil, 46010, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua