STOMOLIK

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT STOMOLIK (STOMOLIK)

Composition:

Active substance: hexetidine;

1 ml of solution contains 1 mg of hexetidine;

Excipients: ethanol 96%; polysorbate 60; sodium saccharin; citric acid monohydrate; menthol (levomenthol); eucalyptus oil; calcium disodium edetate; sodium hydroxide; carmoisine (E 122); purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: transparent red liquid with a minty odor.

Pharmacotherapeutic group. Agents for use in dentistry. Antimicrobial and antiseptic agents for local application.

ATC code A01AB12.

Pharmacological Properties.

Pharmacodynamics.

Hexetidine is a broad-spectrum antimicrobial agent. It is effective both in vivo and in vitro against Gram-positive and Gram-negative bacteria, as well as against yeasts (Candida albicans) and fungi.

Pharmacokinetics.

Specific pharmacokinetic studies of the solution administered to humans have not been conducted.

After application of the drug, hexetidine may be detected in dental plaque and as residual amounts on mucosal surfaces. Studies using radiolabeled hexetidine have shown that hexetidine can be detected in oral tissues from 8 to 10 hours after a single application, and in some cases, it may still be detected in oral tissues up to 65 hours after treatment.

Studies on absorption following topical application of hexetidine in humans have not been conducted.

Specific studies of hexetidine in patients with hepatic and/or renal impairment, as well as in elderly patients, have not been conducted.

Clinical characteristics.

Indications.

Minor oral infections, including candidiasis; as an adjunctive agent for the prevention and treatment of gingivitis; for the treatment of sore throat and recurrent aphthous ulcers; for the elimination of bad breath; before and after dental surgical procedures.

Contraindications.

Hypersensitivity to hexetidine, carmoisine (E 122), eucalyptus oil, levomenthol, or to any other component of the medicinal product; children under 12 years of age; atrophic pharyngitis.

Interaction with other medicinal products and other forms of interaction.

May interact with other antiseptic medicinal products. Hexetidine may be inactivated by alkaline solutions.

Special precautions for use

Stomolik is intended for oral use only and should not be swallowed.

Use with caution in patients with epilepsy. The drug may lower the epileptic threshold and cause seizures in children. Use with caution in patients with allergic reactions, including asthma, especially in patients allergic to acetylsalicylic acid; and in patients with liver disorders (due to the presence of ethanol in the formulation).

There is a risk of laryngospasm in children due to the presence of levomenthol.

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

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

Use during pregnancy or breastfeeding

There are no studies on hexetidine regarding its ability to cross the placenta or be excreted in human breast milk. Therefore, Stomolik should not be used during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery

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

Method of Administration and Dosage

Stomolik is a preparation intended for local application in the oral cavity.

Rinse the mouth or gargle with the undiluted solution in an amount of 1 tablespoon (approximately 15 mL) for ½ minute, 2–3 times daily after meals.

The preparation must not be swallowed.

The duration of treatment is determined individually by a physician, depending on the severity and specific course of the disease.

If symptoms of the disease do not resolve and/or are accompanied by elevated body temperature, medical advice should be sought.

Do not use for the treatment of prolonged symptoms.

The use of the medicinal product in children under 12 years of age must be supervised. Consult a physician before starting treatment.

Children

Stomolik is not recommended for use in children under 12 years of age.

Overdose

Signs and symptoms of overdose

The concentration of hexetidine contained in the oral solution is not toxic when the product is used as directed.

Accidental ingestion of a large amount of the solution may theoretically lead to intoxication due to the presence of ethyl alcohol.

Cases of overdose with topical application of hexetidine solution have not been reported.

Treatment of overdose

Treatment is symptomatic. Gastric lavage is indicated within 2 hours after ingestion of the product.

If a child accidentally swallows the contents of a bottle, seek immediate medical attention.

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 twice to bitter taste).

Respiratory system disorders: cough, dyspnea, laryngospasm.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. Accidental ingestion of the drug may lead to gastrointestinal disturbances, primarily nausea and vomiting.

Skin and subcutaneous tissue disorders: allergic contact dermatitis, angioedema.

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 paraesthesia; inflammation; vesicles; development of mucosal ulcers.

The product contains carmoisine (E 122), which may cause allergic reactions, including bronchospasm, particularly in patients with hypersensitivity to acetylsalicylic acid.

Reporting of suspected adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions in accordance with national regulatory requirements.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children.

Packaging.

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

Availability category. Over-the-counter.

Manufacturer.

JSC "Tekhnolog".

Manufacturer's address and location of operations.

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