Propolis

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROPOLIS (propolis)

Composition:

Active substance: phenolic hydrophobic propolis preparation;

1 suppository contains phenolic hydrophobic propolis preparation (calculated as 50% content of total phenolic compounds) 0.1 g (100 mg);

Excipients: dimethyl sulfoxide, propylene glycol, hard fat.

Pharmaceutical form. Suppositories.

Main physicochemical properties: suppositories ranging from light brown to dark brown in color, bullet-shaped, with a characteristic odor. The presence of a surface film, as well as color heterogeneity in the form of specks and marbling, is permissible.

Pharmacotherapeutic group. Preparations for the treatment of hemorrhoids and anal fissures for local use. ATC code C05A X.

Pharmacological properties.

Pharmacodynamics.

A phenolic hydrophobic propolis preparation provides anti-inflammatory, reparative, and antimicrobial effects. The presence of dimexide in the suppositories complements the drug's activity spectrum with analgesic properties and enhances the absorption of pharmacological substances through the mucous membrane.

Propylene glycol and the base create conditions for realization of the therapeutic effects of the active ingredients of the suppositories.

Pharmacokinetics.

No data available.

Clinical characteristics.

Indications.

Proctitis, anal fissures, postoperative wounds of the distal rectal segment.

Contraindications.

Hypersensitivity to the components of the drug, allergic reactions to beekeeping products.

Interaction with other medicinal products and other forms of interaction.

Can be used in combination with other medications prescribed for the treatment of concomitant diseases. Concurrent use with other beekeeping products is not recommended.

Special precautions for use.

Before using the suppository, it is necessary to:

• tear off one suppository in the primary packaging along the perforation line of the blister pack;
• then pull the edges of the film in opposite directions, tearing it apart and removing the suppository from the primary packaging.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the use of the drug is possible only upon a physician's recommendation, when the expected benefit to the woman outweighs the potential risk to the fetus/child.

Effect on the ability to drive or operate machinery.

There is no data available regarding the effect of the drug on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage.

For adults and children aged 7 years and older – 1 suppository three times daily after bowel movement. The duration of treatment is determined by the physician depending on the severity of the disease. The treatment course may last from 8–10 days to 14–21 days.

Children. The drug is not used for the treatment of children under 7 years of age.

Overdose.

Not established.

Side effects.

Allergic reactions are possible.

Shelf life.

2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

5 suppositories per blister; 1 or 2 blisters per carton.

Supply category.

Over-the-counter.

Manufacturer.

Private joint-stock company "Lekhim-Kharkiv".

Manufacturer's location and address of business activity.

36 Severina Pototskoho Street, Kharkiv, Kharkiv Oblast, 61115, Ukraine.