Sea buckthorn oil

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SEA BUCKTHORN OIL

Composition:

Active substance: sea buckthorn oil concentrate;

1 suppository contains sea buckthorn oil concentrate (Oleum Hippophaes) with carotenoid content not less than 300 mg% – 0.35 g;

Excipient: hard fat.

Pharmaceutical form. Suppositories.

Main physicochemical properties: suppositories of orange-red to orange color, bullet-shaped, with a specific odor. Presence of a white coating on the surface of the suppository is permissible.

Pharmacotherapeutic group. Agents acting on the digestive system and metabolic processes. ATC code A16A X.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of the suppositories is sea buckthorn oil concentrate. Sea buckthorn oil, due to the presence of fat-soluble bioantioxidants, reduces the intensity of free radical processes and protects cell membranes from damage, stimulates reparative processes and accelerates wound healing, and has certain antibacterial activity. It stimulates reparative processes in skin and mucous membrane injuries.

Pharmacokinetics.

Not described.

Clinical characteristics.

Indications.

In gynecology – colpitis, endocervicitis, cervical erosion.

In proctology – anal fissures.

Contraindications.

Hypersensitivity to the components of the medicinal product, pancreatitis, cholelithiasis, diarrhea.

Interaction with other medicinal products and other forms of interactions.

There are no data on drug interactions with sea buckthorn oil.

Special precautions for use.

Consult a physician before starting treatment. Do not use the medication for longer than the recommended duration without medical advice. If symptoms do not begin to improve, or if the condition worsens, or if adverse effects occur, consult a physician for advice regarding further use of the medication.

The excipient substance, hard fat, may reduce the effectiveness of latex products such as condoms.

Use during pregnancy or breastfeeding.

The necessity of using the medicinal product is determined by a physician after evaluating the benefit-risk ratio.

Ability to influence reaction rate when driving or operating machinery.

Has no effect.

Method of administration and dosage.

Before using the suppository:

• Detach one suppository in the primary packaging along the perforation line of the blister pack;
• Pull the edges of the film in opposite directions, tearing it open, and remove the suppository from the primary packaging.

Vaginally.

For adults: 1 suppository twice daily for 8–12 days.

Rectally.

For adults and children aged 12 years and older: 1 suppository twice daily for 7–10 days.

For children aged 6 to 12 years: 1 suppository once daily for 7–10 days.

The duration of treatment is determined by the physician depending on the nature and course of the disease.

Children.

The drug should not be used rectally for the treatment of children under 6 years of age.

The drug should not be used vaginally for the treatment of children.

Overdose.

Cases of overdose have not been reported.

Side effects.

Allergic reactions at the site of administration are possible, including a burning sensation in the anal area with rectal use.

Shelf life.

2 years.

Storage conditions.

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

Packaging. 5 suppositories in a blister; 2 blisters in a carton.

Availability.

Over-the-counter.

Manufacturer.

Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's address and location of business activity.

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