Lorolik

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LOROLIK (LOROLIK)

Composition:

Active substances: hexetidine, choline salicylate, chlorobutanol hemihydrate;

1 ml of spray contains: hexetidine 1.0 mg; choline salicylate 5.0 mg; chlorobutanol hemihydrate equivalent to chlorobutanol 2.5 mg;

Excipients: ethanol 96%, polysorbate 20, sodium saccharin, propionic acid, lemon flavor, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, slightly yellowish solution with a characteristic lemon-alcoholic odor.

Pharmacotherapeutic group.

Preparations used for throat disorders. Antiseptics.

ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

The action of the drug is due to its three active components.

Antibacterial and antifungal activity.

Hexetidine exerts an antibacterial effect on both Gram-positive and Gram-negative microbial strains, including both aerobes and anaerobes.

It should be noted that hexetidine generally has a bacteriostatic effect on aerobic strains, while its bactericidal activity is weak. In contrast, hexetidine exerts a pronounced bactericidal effect on anaerobic strains. 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 provides analgesic, antipyretic, and anti-inflammatory effects. It can be used for the treatment of oral cavity diseases.

Analgesic activity.

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

Pharmacokinetics.

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

Clinical characteristics.

Indications.

An antibacterial and analgesic agent for local treatment of diseases of the oral mucosa and oropharynx.

Contraindications.

• Hypersensitivity to any component of the drug.
• Atrophic pharyngitis.
• Bronchial asthma or any other respiratory tract diseases associated with existing airway hyperreactivity.

Interaction with other medicinal products and other forms of interaction.

Do not use simultaneously with products containing antiseptics.

Hexetidine may be inactivated by alkaline solutions.

Special precautions for use

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

The preparation should be used with caution in patients with epilepsy, as it may lower the epileptic threshold and provoke seizures in children.

Use with caution in patients with a predisposition to allergic reactions, including bronchial asthma, especially in patients with allergy to acetylsalicylic acid.

If signs of hypersensitivity to the drug occur, its use should be discontinued immediately.

Since the preparation contains ethanol, it should be used with caution in patients with liver disease.

Prolonged use is not recommended, as it may alter the natural microbial balance of the oral cavity and throat, increasing the 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 re-evaluated.

If inflammation worsens, treatment with the drug should be discontinued.

Use during pregnancy or breastfeeding

There are no human studies available on the ability of hexetidine to cross the placenta or be excreted in breast milk. Therefore, the drug should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery

The preparation contains ethanol. Drivers are advised not to operate a vehicle or machinery for at least 30 minutes after using the product.

Dosage and Administration.

For topical use as a spray for the oral cavity and oropharynx.

Adults and children aged 15 years and older: 1 spray 4–6 times daily.

Children aged 6 to 15 years: 1 spray 2–3 times daily.

Treatment duration – no longer than 5 days.

Children.

Do not use in children under 6 years of age.

Overdose.

There have been no reports of overdose with this medicinal product.

Alcohol intoxication due to the content of ethanol may occur if a sufficient amount of the solution is absorbed through the oral mucosa.

The concentration of hexetidine in the medicinal product is not toxic when used as directed.

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

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

Treatment of overdose is symptomatic but rarely required. In case a child has swallowed the contents of the bottle, seek immediate medical advice. Gastric lavage should be considered within 2 hours after ingestion, and measures should be taken to counteract symptoms of alcohol intoxication.

Adverse reactions.

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

Nervous system disorders: ageusia, dysgeusia, taste disturbances within 48 hours (the sensation of "sweet" may change twice to the sensation of "bitter").

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 sensation); irritation (painfulness, sensation of heat, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paraesthesia; inflammation; blisters; development of mucosal ulcers; throat irritation; swelling at the site of contact; dryness of nasal/throat mucosa.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

50 ml in a bottle with a spray pump; 1 bottle per cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer.

JSC "Tekhnolohiya".

Manufacturer's address and location of production activity.

8, Stara Prorizna Street, Uman, Cherkasy region, 20300, Ukraine.