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

Composition:

Active substances: 100 g of solution contain liquid extract (0.65:1) from a mixture of raw materials: chamomile flowers (Matricaria chamomilla L.) – 13 g, oak bark (Quercus robur L.) – 13 g, sage leaves (Salvia officinalis L.) – 13 g, arnica herb (Arnica montana L.) – 6.5 g, sweet flag rhizomes (Acorus calamus L.) – 6.5 g, peppermint herb (Mentha piperita L.) – 6.5 g, common thyme herb (Thymus vulgaris L.) – 6.5 g; extraction solvent: 70% ethanol (m/m);

Excipients: 96% ethanol, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical characteristics: opaque dark brown liquid with a specific odor.

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

Pharmacological Properties.

Pharmacodynamics.

The medicinal product exerts an astringent, soothing, and anti-inflammatory effect on the oral mucosa due to extracts of oak bark, chamomile flowers, and sage leaves. In addition, tannins and essential oils contained in the preparation exert antiseptic, antibacterial, and antifungal effects on the oral mucosa and gums. In vitro tests have shown that essential oils of sage and chamomile exert bactericidal activity against gram-positive and gram-negative bacteria, as well as fungicidal activity against Candida albicans.

Clinical characteristics.

Indications.

The medicinal product is intended for use in individuals aged 6 years and older as an anti-inflammatory, antibacterial, disinfectant, and astringent agent in:

inflammations of the oral and pharyngeal mucosa;
gingivitis and stomatitis (including glossitis);
superficial periodontitis;
tendency to bleeding gums;
as part of complex therapy in periodontosis.

Contraindications.

Hypersensitivity to the components of the drug or to other plants of the Lamiaceae family, as well as to celery and birch pollen (cross-reactivity possible), hypersensitivity to arnica, chamomile, or other plants of the Asteraceae family; bronchial asthma.

Interaction with other medicinal products and other types of interactions.

Not known.

Special precautions for use.

If symptoms persist for more than one week or worsen during treatment with the medicinal product, consult a physician.

10 ml of the medicinal product contain up to 5.67 g of ethanol, which should be taken into account when administering the product to pregnant women, women during lactation, and children.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction rate when driving or operating machinery.

Alcohol may be detected by measuring devices in exhaled air immediately after administration of the medicinal product. When used according to the instructions, the medicinal product should not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

For mouth rinsing 3–4 times daily: adults – rinse the oral cavity with a 15 % aqueous-alcoholic solution of the drug (dissolve 7.5 ml of the drug in ¼ cup of water); children from 6 years of age – after consultation with a physician, use 10 ml of the drug dissolved in 1 cup of water. Treatment duration is 7 days. If symptoms worsen or persist, consult a physician.

Children.

The drug contains ethyl alcohol; therefore, it should not be used in children under 6 years of age.

Overdose.

Cases of overdose have not been reported.

In case of overdose, adverse effects may be intensified.

Side effects.

Allergic reactions are possible, including hyperemia and itching.

Local – transient burning sensation of the oral mucosa immediately after rinsing, as well as reversible tooth discoloration, which disappears with regular brushing.

Shelf life.

3 years.

Storage conditions.

Store in a dry, dark place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

45 ml, 50 ml, 100 ml, and 120 ml in a bottle; 1 bottle per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer/Applicant. Fitopharm Klęka S.A., Poland.

Manufacturer's address/Address of the applicant.

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