Oxolinic ointment

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT OXOLINIC OINTMENT

Composition:

Active substance: oxolin;

1 g of ointment contains 2.5 mg of oxolin;

Excipients: mineral oil, white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of white to yellow color. A pinkish tint may appear upon storage.

Pharmacotherapeutic group.

Preparations used for cough and colds. Other cold remedies. ATC code R05 X.

Pharmacological properties.

Pharmacodynamics.

The medicinal product exhibits virucidal activity against influenza viruses and adenoviruses when applied locally.

Pharmacokinetics.

Blocks the binding sites of the influenza virus (mainly type A2) to the cell membrane surface, thereby protecting cells from viral entry.

Clinical characteristics.

Indications.

Individual prevention of influenza during the epidemic period; treatment of viral rhinitis.

Contraindications.

Individual hypersensitivity to oxolinic acid and other components of the drug.

Interaction with other medicinal products and other forms of interaction.

The drug should be used with caution simultaneously with intranasal adrenomimetic agents due to the possible overdrying of the nasal mucosa.

Special precautions for use.

The ointment is not intended for application to the mucous membrane of the eyes.

The medicinal product must not be applied to damaged skin.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the drug should be used with caution when the benefit of use outweighs the potential risk to the fetus.

Ability to affect reaction speed when driving or operating machinery.

There is no data available on the effect of Oxolinic ointment on the ability to drive or operate machinery.

Method of administration and dosage.

For the treatment of viral rhinitis and influenza prophylaxis, the medicinal product is administered intranasally. To treat viral rhinitis, apply the ointment to the nasal mucosa 2–3 times daily for 3–4 days. For individual influenza prophylaxis during an epidemic period, it is recommended to apply the ointment to the nasal mucosa twice daily (morning and evening), as well as throughout the day immediately before potential contact with influenza-infected individuals.

Children.

Safety and efficacy studies of oxolinic acid in children have not been conducted.

Overdose.

Cases of overdose are unknown.

Symptoms: possible sensation of burning on the nasal mucosa and rhinorrhea.

Treatment: discontinue use of the ointment; wash off any residual product with warm water.

Side effects.

A burning sensation at the site of ointment application, which quickly resolves; increased nasal discharge; blue discoloration of the mucous membrane. Hypersensitivity reactions are possible.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature between 2 °C and 8 °C.

Keep out of reach of children.

Packaging.

10 g in a tube, 1 tube per pack.

Availability.

Over-the-counter (without prescription).

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address / Applicant's address.

46010, Ternopil, Fabrychna Street, 4, Ukraine.

Phone/fax: (0352) 521-444, www.ternopharm.com.ua