Proposol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROPOSOL

Composition:

Active ingredient: 1 can contains 2.1 g of propolis;

Excipients: ethanol 96%, glycerol, propellant gas 134a.

Pharmaceutical form. Aerosol.

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

Pharmacotherapeutic group.
Agents for use in dentistry. Antimicrobial and antiseptic agents for local use 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).

When applied locally, less than 5% of the active substance is absorbed.

Pharmacokinetics.

Data not available.

Clinical characteristics.

Indications.

Aphthous, catarrhal, and ulcerative stomatitis; catarrhal gingivitis; chronic tonsillitis.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Concomitant use with other antiseptics and beekeeping products is not recommended.

Special precautions for use

Before using the medication, it is recommended to rinse the mouth with warm boiled water.

Avoid getting the medication into the eyes.

Use during pregnancy or breastfeeding

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

Ability to affect reaction rate when driving or operating machinery

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

Method of Administration and Dosage.

For use in adults and children aged 12 years and older, to irrigate affected areas in the oral cavity or throat. Before use, hold the canister in an upright vertical position only, remove the protective cap, ensure the spray nozzle provided in the kit is clean, and attach it onto the valve stem. Insert the free end of the spray nozzle into the oral cavity and, by gently pressing the actuator, evenly spray the medication onto the affected area. After completing the irrigation, always replace the protective cap on the canister.

After spraying the medication, avoid eating or drinking until the burning sensation in the mouth subsides.

Use the medication 2–3 times daily. After reduction of inflammatory symptoms, reduce frequency to 1–2 times daily until full recovery.

Treatment duration: 3–7 days.

Children.

Do not use in children under 12 years of age.

Overdose.

Allergic reactions, severe burning, and dryness in the oral cavity. If these symptoms are pronounced, rinse the mouth with warm boiled water. In case of allergic reactions, administer antihistamine medications.

Side effects.

Immune system side effects: allergic reactions, including allergic dermatitis, skin itching, rash, angioneurotic edema (Quincke's edema).

Respiratory system side effects: laryngospasm, dyspnea.

Gastrointestinal tract side effects: nausea.

Skin and skin appendages side effects: skin hyperemia.

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

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Protect from falls, impacts, and direct sunlight.

Packaging.

50 g in an aluminum aerosol can; 1 can with a spray dispenser in a carton.

Availability. Over-the-counter.

Manufacturer. JSC "STOMA".

Manufacturer's name and address of place of business.

3, Newton Street, Kharkiv, 61105, Ukraine.