Proposol-km

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROPOSOL-KM

Composition:

Active ingredient: propolis;

1 bottle contains 1.5 g of propolis;

Excipients: ethanol (96%), glycerin.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear dark yellow liquid with a characteristic propolis odor.

Pharmacotherapeutic group. Agents used in dentistry. Antimicrobial and antiseptic agents for local application in dentistry.

ATC code A01AB11.

Pharmacological properties.

Pharmacodynamics.

An antiseptic, anti-inflammatory, analgesic and wound-healing agent, whose action is determined by the properties of the complex of biologically active substances of propolis (flavonoids, vitamins, amino acids).

Pharmacokinetics.

Data not available.

Clinical characteristics.

Indications.

Local treatment of inflammatory diseases of the oral mucosa: aphthous, catarrhal, and ulcerative stomatitis, catarrhal gingivitis, tonsillitis, glossitis.

Contraindications.

Hypersensitivity to the components of the medicinal product / beekeeping products, eczema (acute forms), bleeding from affected areas of the mucous membrane.

Interaction with other medicinal products and other types of interactions.

It is not recommended to use simultaneously with other antiseptic agents and beekeeping products.

Special precautions for use

Avoid contact of the medicinal product with the eyes, as it contains ethanol.

Before using the medicinal product, it is recommended to rinse the oral cavity with warm boiled water. Since the medicinal product contains ethanol, it should be administered with caution to patients with liver disease. After spraying the medicinal product into the oral cavity, food intake should be avoided for 15–30 minutes.

Use during pregnancy or breastfeeding

During pregnancy, the medicinal product should be used only if the benefit to the mother outweighs the potential risk to the fetus. If use of the medicinal product is necessary, breastfeeding should be discontinued.

Ability to influence reaction speed when driving or operating machinery

The medicinal product contains 80% of 96% ethanol. When the spray nozzle is pressed for 1–2 seconds, up to 0.8 g of 96% ethanol is delivered into the oral cavity together with the medicinal product. This amount is not expected to negatively affect reaction speed when driving or operating machinery.

Method of Administration and Dosage.

The medicinal product is intended for use in adults and children aged 12 years and older for spraying the affected area in the oral cavity. At the beginning of treatment, apply the medicinal product 2–3 times daily; after reduction in severity of the inflammatory process, reduce to 1–2 times daily until full recovery. Treatment duration is 3–7 days.

Instructions for using the aerosol canister.

1. Remove the protective cap from the canister and, ensuring the spray nozzle is clean, attach it onto the valve stem.
2. Holding the canister vertically, press the spray nozzle several times until the first drops of liquid appear.
3. Insert the free end of the spray nozzle into the oral cavity, direct it toward the affected area, press the nozzle 1–2 times, and evenly spray the medicinal product over the affected area of the oral cavity.
4. After spraying the medicinal product, avoid eating or drinking until the burning sensation in the oral cavity subsides.
5. After completing the spraying, always cover the canister with the protective cap.

Care of the spray nozzle. To prevent clogging of the spray nozzle, rinse it under a stream of warm water, shake off excess water, and dry it in a warm place, avoiding exposure to high temperatures.

Children.

The medicinal product is not recommended for children under 12 years of age.

Overdose.

Symptoms: allergic reactions, severe burning, and dryness in the oral cavity.

Treatment: in case of pronounced symptoms, rinse the oral cavity with warm boiled water; in the presence of allergic reactions, administer antihistamine medicinal products.

Side effects.

Immune system: allergic reactions, including allergic dermatitis, hyperemia, skin itching, rash, laryngospasm, dyspnea, angioedema (Quincke's edema).

Gastrointestinal tract: nausea.

Local effects: mild burning sensation of the tongue, dry mouth.

Shelf life.

3 years.

Storage conditions.

Keep out of reach of children.

Store in the original packaging at a temperature not exceeding 25 °C.

Packaging.

25 g in an aerosol can with a pump-type valve; 1 can with a spray nozzle and protective cap in a carton.

Category of release. Over-the-counter.

Manufacturer: JSC "STOMA".

Manufacturer's address and place of business:

3, Newton Street, Kharkiv, 61105, Ukraine.