Proposol-health

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROPOSOL-ZDOROV'YA (PROPOSOL-ZDOROVYE)

Composition:

Active ingredient: phenolic hydrophobic propolis preparation;

1 can (25 g) contains phenolic hydrophobic propolis preparation, recalculated to 100% content of total phenolic compounds – 0.75 g;

1 bottle (50 g) contains phenolic hydrophobic propolis preparation, recalculated to 100% content of total phenolic compounds – 1.5 g;

Excipients: ethanol 96%, glycerol.

Pharmaceutical form. Oral spray.

Main physicochemical properties: liquid ranging from dark yellow to brown in color, with a characteristic propolis odor.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents for local application in dentistry. ATC code A01AB11.

Pharmacological Properties.

Pharmacodynamics. A natural-origin preparation based on a bee product – propolis. The effect of the preparation is due to the properties of the complex of biologically active substances in propolis (flavones, flavonoids, derivatives of cinnamic acid).

It has anti-inflammatory, antimicrobial (against gram-positive bacteria), and analgesic properties (causes analgesia of mucous membranes and skin, reduces pain in affected tissues), promotes granulation growth, accelerates wound surface regeneration and epithelialization processes, and stimulates metabolic processes. It is effective both in early stages and in developed purulent-necrotic processes.

Clinical characteristics.

Indications. Local treatment of inflammatory diseases (catarrhal, aphthous, ulcerative stomatitis) and superficial injuries of the oral mucosa, catarrhal gingivitis, tonsillitis, glossitis.

Contraindications. Hypersensitivity to the components of the drug/bee products, eczema (acute forms), bleeding from affected areas of the mucosa.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with other antiseptics or bee products is not recommended.

Special precautions for use.

Before using the medication, it is recommended to rinse the oral cavity with warm boiled water. After spraying the medication into the oral cavity, refrain from eating for 15–30 minutes. Avoid contact of the medication with 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 speed when driving vehicles or operating machinery. The medication contains 65.6% of 96% ethanol. When a single dose is administered into the oral cavity, no more than 0.2 g of 96% ethanol enters the body, which does not affect reaction speed when driving vehicles or operating machinery.

Method of Administration and Dosage

For topical application to the oral mucosa by spraying in adults and children aged 12 years and older. Spray duration – 1–2 seconds.

Apply 2–3 times daily during the acute phase of the inflammatory process and 1–2 times daily as symptoms subside. Treatment duration – 3–7 days.

Instructions for Use

Remove the protective cap from the canister/bottle and, having ensured the nozzle is clean, attach it onto the valve stem.

Insert the free end of the nozzle into the oral cavity and press the nozzle head. Spray into the oral cavity during inhalation or directly onto the affected area. Spray duration – 1–2 seconds.

After completing the application, cover the canister/bottle with the protective cap to prevent contamination.

The nozzle should be kept clean; after use, it is advisable to rinse it under a stream of warm water and then dry it in a warm place.

Children. The product is intended for use in children aged 12 years and older.

Overdose

Cases of overdose have not been reported. Overdose may result in an intensification of the drug's adverse effects.

Treatment: rinse the oral cavity with warm boiled water; in case of allergic reactions, administer antihistamine agents.

Side effects.

In individual cases, allergic reactions (including allergic dermatitis, hyperemia, skin itching, rash, laryngospasm, shortness of breath, Quincke's edema), nausea, local effects (sensation of mild burning of the tongue, dry mouth) are possible.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 1 canister of 25 g with a spray nozzle and protective cap in a box; 1 bottle of 50 g with an oral spray device and protective cap in a box.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and place of business. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, 22.