Lorolik

INSTRUCTION FOR MEDICINAL USE OF THE MEDICINAL PRODUCT LOROLIK (LOROLIK)

Composition:

Active substances: hexetidine, choline salicylate, chlorobutanol hemihydrate;

1 ml of solution 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 (containing propylene glycol), purified water.

Medicinal form. Oral solution.

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

Pharmacotherapeutic group.

Agents acting on the respiratory system. Preparations used in throat disorders. Antiseptics.

ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

The effect of the drug is due to three active components.

Antibacterial and antifungal activity.

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

Against aerobic strains, hexetidine generally produces a bacteriostatic effect, with weak bactericidal activity. Against anaerobic strains, hexetidine exhibits pronounced bactericidal activity. The mechanism of action involves competitive interaction with thiamine: the structure of hexetidine is similar to that of thiamine, which is essential for microbial growth.

Anti-inflammatory activity.

Choline salicylate has analgesic, antipyretic, and anti-inflammatory effects. It can be used for the treatment of oral cavity diseases.

Analgesic activity.

Chlorobutanol has analgesic properties. 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 oral mucosa, from where they are gradually released.

Clinical characteristics.

Indications.

Local treatment of oral cavity infections. Postoperative care in dentistry.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Do not use together 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 product should be used with caution in patients with epilepsy. The product may lower the epileptic threshold and may provoke seizures in children.

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

Since the product 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 pharynx, with a risk of bacterial and fungal overgrowth.

In case of appearance of general clinical signs of bacterial infection, systemic antibacterial therapy should be initiated.

If symptoms persist for more than 5 days and/or body temperature is elevated, the treatment strategy should be re-evaluated.

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

Use during pregnancy or breastfeeding.

There are no human data available on the ability of hexetidine to cross the placenta or to be excreted in breast milk; therefore, the product should not be used during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

The product contains ethanol. It is not recommended for drivers to operate a vehicle within 30 minutes after using the product.

Method of Administration and Dosage

Use as a topical agent for mouth rinsing.

For one mouth rinse in adults and children aged 6 years and older: dissolve 2 teaspoons of the preparation in ¼ cup of warm water.

Perform 2 to 4 rinses per day.

Do not swallow.

Treatment duration – 5 days.

Children

Do not use in children under 6 years of age.

Overdose

No cases of overdose have been reported.

Alcohol intoxication due to the content of ethyl alcohol 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 preparation, alcohol intoxication may occur due to its ethyl alcohol content.

No cases of excessive use of hexetidine or occurrence of hypersensitivity reactions have been reported.

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

Side effects.

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

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

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. Accidental ingestion may cause gastrointestinal disturbances, 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, namely burning sensation, numbness; irritation (pain, sensation of warmth, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paraesthesia; inflammation; blisters; development of ulcers on the mucosa; irritation sensation in the throat; local 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 of children.

Packaging.

125 ml in a bottle; 1 bottle in a cardboard box.

Release category.

Over-the-counter.

Manufacturer.

JSC "Tekhnolog".

Manufacturer's address and location of business activity.

8 Staroprizhna Street, Uman, Cherkasy region, 20300, Ukraine.