Stomatophit^® Expert (Spray) Instructions for Use

Marketing Authorization Holder

Phytopharm Kleka, S.A. (Poland)

ATC Code

A01AD11 (Other drugs)

Dosage Form

Stomatophit® Expert

Spray for topical use: 50 ml bottle with spray nozzle

Dosage Form, Packaging, and Composition

Spray for topical use in the form of a dark brown liquid with a characteristic odor.

Excipients : ethanol 96% – 24.64 g, propylene glycol – 42.19 g, sodium saccharin – 0.11 g, purified water – 15.42 g.

50 ml – orange glass bottles (1) with a spray nozzle – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with anti-inflammatory action for topical use in dentistry

Pharmacotherapeutic Group

Herbal anti-inflammatory agent

Pharmacological Action

A combined herbal medicine. It has anti-inflammatory, astringent, and antiseptic effects, and reduces gum bleeding.

Indications

• Inflammatory diseases of the oral cavity, including stomatitis.
• Use for gingivitis to reduce inflammation and gum bleeding.
• Use for periodontitis as part of a comprehensive treatment regimen.

Apply topically to affected areas in the mouth for symptomatic relief and treatment of inflammatory conditions.

ICD codes

Dosage Regimen

Administer 3-4 times daily for local treatment of oral cavity inflammation.

Continue treatment for 10-15 days as a standard therapeutic course. Do not exceed the recommended frequency of application.

Apply directly to affected areas in the mouth using the spray nozzle. Avoid eating or drinking for at least 30 minutes after application.

Adverse Reactions

Monitor for allergic reactions including skin rash, itching, or swelling at the application site.

Observe for transient slight staining of teeth, which typically resolves with regular oral hygiene practices.

Discontinue use immediately if severe irritation or hypersensitivity reactions occur and consult a healthcare professional.

Drug Interactions

No specific drug interactions have been reported to date with this herbal preparation.

Exercise caution when using concurrently with other topical oral medications due to potential unknown interactions.

Consult a healthcare professional before combining with other anti-inflammatory or antiseptic oral treatments.

Contraindications

• Do not use in patients with hypersensitivity to any component of the formulation, including plant extracts or excipients.
• Contraindicated in children under 12 years of age due to alcohol content and lack of safety data.
• Avoid use in patients with known allergy to plants from the Asteraceae/Compositae family (arnica, chamomile).

Overdose

No cases of overdose have been reported with topical use of this preparation.

In case of accidental ingestion of large quantities, seek immediate medical attention and provide symptomatic treatment.

If excessive topical application occurs, rinse thoroughly with water and discontinue use until symptoms resolve.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is not recommended due to the lack of clinical data.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age

Special Precautions

When used in the form of an alcohol extract, use with caution in patients with liver diseases, traumatic brain injury, brain diseases, and alcoholism.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.