STOMATOPHYT A

I N S T R U C T I O N for medical use of the medicinal product STOMATOPHYT A

Composition:

Active substances: 100 g of solution contains 50 g of liquid extract (0.65:1) from a mixture of raw materials: chamomile flowers (Matricaria chamomilla L.) – 6.5 g, oak bark (Quercus robur L.) – 6.5 g, sage leaves (Salvia officinalis L.) – 6.5 g, arnica herb (Arnica montana L.) – 3.25 g, sweet flag rhizomes (Acorus calamus L.) – 3.25 g, peppermint herb (Mentha piperita L.) – 3.25 g, common thyme herb (Thymus vulgaris L.) – 3.25 g, anestezin 2 g; extraction solvent: ethanol 70% (m/m);

Excipients: glycerin, hydroxyethylcellulose, ethanol 96%, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical characteristics: viscous, opaque, dark brown liquid.

Pharmacotherapeutic group.

Other agents for local application in dentistry. ATC code A01AD11.

Pharmacological Properties.

Pharmacodynamics.

The medicinal product exerts antibacterial, anti-inflammatory, and astringent effects due to substances derived from plant raw materials contained in the formulation (oak bark, chamomile flowers, sage leaves, thyme herb, arnica herb, peppermint herb, and calamus rhizome). Due to the presence of anesthezine in Stomatophyt A, the preparation also produces an anesthetic effect. Prolonged action of the preparation and its retention at the affected site are ensured by thickeners (hydroxyethylcellulose, glycerin). Active against Candida albicans.

Clinical characteristics.

Indications.

Complex local treatment of inflammatory diseases of the oral mucosa: gingivitis, periodontitis, stomatitis, glossitis.

Contraindications.

Hypersensitivity to the components of the drug or to other plants of the mint family (Lamiaceae), as well as to celery and birch pollen (cross-reaction possible), hypersensitivity to arnica, chamomile, or other plants of the aster family (Asteraceae), bronchial asthma. Hypersensitivity to other amide-type anesthetics.

Do not use on open wounds.

Interaction with other medicinal products and other types of interactions.

Not known.

Special precautions.

If symptoms persist for more than one week or worsen during treatment with the medicinal product, a doctor should be consulted.

The medicinal product contains 35–45 % (v/v) ethanol, which should be taken into account when administering the product to pregnant women, women during lactation, and children under 12 years of age.

Use during pregnancy or breastfeeding.

Due to insufficient data, the use of the medicinal product is not recommended during these periods.

Ability to affect reaction rate when driving or operating machinery.

Alcohol may be detected by breathalyzer devices immediately after taking the product. For this reason, driving or operating machinery should not be undertaken earlier than 30 minutes after administration of the product.

Method of Administration and Dosage.

Packaging without an applicator:

For adults and children aged 12 years and older: treat affected areas using a cotton swab soaked in the medication, at least 3 times daily.

Packaging with spray and applicator: For adults and children aged 12 years and older: apply one dose (one spray) to the affected area of the oral cavity. Maximum single application – 5 doses (sprays) of the medication applied to different affected areas of the oral cavity, up to 3 times daily. Maximum daily dose – 15 doses. The distance from the applicator to the application site should be from 1 cm to approximately 5 cm.

Do not rinse the mouth immediately after applying the medication.

Treatment duration is 7 days.

If symptoms worsen or persist, consult a physician.

Children.

Since the formulation contains ethyl alcohol, the medication should not be used in children under 12 years of age.

Overdose.

Cases of overdose have not been reported. In the event of overdose, adverse effects may be intensified.

Side effects.

Hypersensitivity, burning sensation, fever. Methemoglobinemia. Oak bark may cause dark discoloration of teeth and oral mucosa. The color of teeth and oral mucosa returns to normal with daily cleaning. Transient burning sensation on the mucous membrane immediately after application is also temporary. Glycerin contained in the product may cause irritation of the skin and mucous membranes.

Shelf life.

3 years.

The package with the applicator should be used within 9 months after first opening.

Storage conditions.

Store in a dry, dark place at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

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

25 ml in a bottle with a spray pump and applicator; 1 bottle in a cardboard box.

Classification.

Over-the-counter (without prescription).

Manufacturer/Marketing Authorization Holder.

Fitofarm Klęka S.A., Poland.

Address of manufacturer and its place of business activity / Address of the marketing authorization holder.

Klęka 1, 63-040 Nowe Miasto nad Wartą, Poland.