Stomatophit^® A (Extract) Instructions for Use

Marketing Authorization Holder

Phytopharm Kleka, S.A. (Poland)

ATC Code

A01AD11 (Other drugs)

Dosage Form

Stomatophit® A

Extract for topical administration (liquid): 25 g bottle

Dosage Form, Packaging, and Composition

Excipients: purified water 6.487 g, hydroxyethylcellulose 0.5 g, glycerol 4 g, ethanol 96% 1.013 g.

25 g – orange glass bottles (1) – 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 medicinal product. It has anti-inflammatory, astringent, and antiseptic effects, and also reduces gum bleeding due to the components of the herbal raw materials.

Benzocaine has a local anesthetic effect.

Indications

• Inflammatory diseases of the oral cavity, including stomatitis.
• Gingivitis.
• Aphthae.
• Ulcerative lesions of the oral cavity caused by dentures.
• Use as an auxiliary agent for periodontosis.

ICD codes

Dosage Regimen

Apply the extract to the affected areas in the oral cavity at least 3 times per day.

Use a cotton swab or a clean finger to gently dab the liquid onto the inflamed gums, aphthae, or ulcerations.

Adhere to a treatment course of 5 days. Do not exceed the recommended duration of use without consulting a healthcare professional.

Adverse Reactions

Possible adverse reactions include allergic reactions such as skin rash, itching, or localized swelling at the application site.

Be aware that the product may cause slight, temporary staining of teeth, which typically resolves with regular oral hygiene practices like brushing.

Discontinue use immediately and seek medical advice if you experience signs of a severe allergic reaction.

Drug Interactions

No specific drug interactions have been reported to date. The systemic absorption of the topical formulation is expected to be low.

Concurrent use with other topical oral preparations should be avoided to prevent potential incompatibility or dilution of effects.

Inform your doctor about all other medicines you are using before starting this treatment.

Contraindications

• Hypersensitivity to any component of the medicinal product, including the active herbal extracts or benzocaine.
• Known allergy to plants of the Asteraceae/Compositae family (e.g., arnica, chamomile).
• Use in children and adolescents under 18 years of age.

Overdose

Accidental ingestion of large quantities may lead to symptoms associated with ethanol content, such as dizziness or intoxication.

Topical overdose is unlikely; however, excessive application may increase the risk of local adverse effects like mucosal irritation.

In case of accidental ingestion, seek medical attention or contact a Poison Control Center immediately.

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, in cases of traumatic brain injury, brain diseases, and alcoholism.

Effect on the ability to drive vehicles and machinery

During the use of the drug, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles, operating moving machinery).

Storage Conditions

Store at 15°C (59°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.