Stomatidin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STOMATIDIN® (STOMATIDIN®)

Composition:

Active substance: hexetidine;

1 ml of solution contains hexetidine 1 mg;

Excipients: propylene glycol, polysorbate 20, citric acid monohydrate, sodium saccharin, menthol, methyl salicylate, azorubine (E 122), ethanol 96%, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear red-colored solution.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents for local use in dentistry. ATC code A01A B12.

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 yeasts (Candida albicans) and fungi. The antibacterial efficacy of hexetidine is due to its antimetabolic action on the amino acid thiamine, which is essential for the growth of bacteria and fungi.

Pharmacokinetics.

After a single mouthwash, hexetidine is retained in the mucous membranes of the oral cavity and pharynx, as well as in dental plaque, for 8–10 hours, and in some cases – for an even longer period (up to 65 hours).

There are no studies in humans regarding the absorption of hexetidine following topical application of Stomatidin® 0.1% solution.

There are no specific studies available for Stomatidin® 0.1% solution or hexetidine in patients with renal/hepatic impairment or in elderly patients.

Clinical characteristics.

Indications.

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

Contraindications.

• Hypersensitivity to hexetidine or to any of the excipients;
• atrophic pharyngitis;
• patients with bronchial asthma or any other respiratory tract diseases associated with existing airway hyperreactivity. Inhalation may cause bronchoconstriction.

Interaction with other medicinal products and other forms of interaction.

Possible interaction with other antiseptic medicinal products. Hexetidine may be inactivated by alkaline solutions.

Special precautions for use.

Stomatidin® should be used with caution in patients with epilepsy. The medicinal product may lower the epileptic threshold and cause seizures in children.

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

If inflammation worsens, discontinue use of the medicinal product and consult a physician.

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

Inhalation should be avoided during application of the medicinal product, as the solution may enter the respiratory tract and cause laryngospasm.

Excipients:

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

Ethyl alcohol (ethanol). The medicinal product contains 10% ethanol; therefore, it should be prescribed with caution to patients with liver disease.

Azorubine (E122). May cause allergic reactions (this is important in case of accidental swallowing of the medicinal product).

Prolonged use is not recommended (do not use for longer than 10 days without medical advice).

Use during pregnancy or breastfeeding.

Adequate and well-controlled clinical studies on the use of hexetidine in pregnant or breastfeeding women have not been conducted. It is unknown whether hexetidine or its metabolites are excreted in breast milk. Systemic absorption of hexetidine is minimal. It is unlikely that the use of hexetidine during pregnancy or breastfeeding poses a risk to the fetus or infant.

However, hexetidine should not be used during pregnancy or breastfeeding except when the potential benefit of treatment to the mother outweighs the possible risks to fetal or child development.

Ability to affect reaction speed when driving or operating machinery.

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

Method of Administration and Dosage.

Stomatidin®, 0.1% solution, is intended for local application in the oral cavity.

Rinse the mouth or gargle with 15 mL of undiluted solution for ½ minute, 2–3 times daily.

The product should not be swallowed.

Use the undiluted solution for rinsing.

The duration of treatment should be determined by a physician depending on the severity and specific course of the disease.

Do not use for the treatment of prolonged symptoms.

Children.

The medicinal product is not recommended for use in children under 6 years of age.

Overdose.

Hexetidine is not toxic at the recommended dose. There are no reported cases of excessive use of hexetidine leading to hypersensitivity reactions.

Symptoms. Since the medicinal product contains ethanol, some amount may be absorbed when the solution is used in the oral cavity. Acute alcohol poisoning is highly unlikely, but theoretically possible if a large dose is swallowed by a young child.

Treatment. In any case of overdose, immediate medical advice must be sought. Symptomatic therapy as for alcohol intoxication may be administered, although such treatment is rarely necessary. Gastric lavage is advisable within 2 hours after ingestion of an excessive dose.

Keep out of reach of children. In case of overdose, seek immediate medical assistance.

Adverse Reactions

Stomatidin**®** is generally well tolerated, even with prolonged use.

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

Nervous system disorders: Ageusia, dysgeusia, altered taste sensation for up to 48 hours (the sensation of "sweet" may change twice to the sensation of "bitter").

Respiratory system disorders: Cough, dyspnea, laryngospasm.

Gastrointestinal disorders: Dry mouth, dysphagia, enlargement of salivary glands, pain on swallowing. Accidental ingestion of the medication 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, including 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 ulcers on the mucosa.

The product contains azorubine and may therefore cause allergic reactions, including bronchial asthma, particularly in patients allergic to acetylsalicylic acid.

Healthcare professionals, patients, and pharmacists are kindly requested to report any suspicion of adverse reactions or lack of therapeutic effect to the Bosnalijek d.d. representative at the following email address: [email protected]

Shelf life. 2 years.

Storage conditions.

Store in a place inaccessible to children, at a temperature not exceeding 25 °C. Do not freeze.

Packaging.

200 ml in a bottle, 1 bottle per cardboard box.

Supply classification.

Over-the-counter (without prescription).

Manufacturer/Applicant.

Bosnalijek d.d.

Manufacturer's address and location of business operations.

71000 Sarajevo, Yukicheva 53, Bosnia and Herzegovina.