OXOLIN LAVENDER

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT OXOLIN LAVANDER (OXOLIN LAVANDER)

Composition:

Active substance: oxolin;

1 g of ointment contains 2.5 mg of oxolin;

Excipients: polyethylene glycol 4000; stearyl alcohol; glycerol; citric acid monohydrate; dimethicone; lavender essential oil; propylene glycol.

Pharmaceutical form. Ointment.

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

Pharmacotherapeutic group. Medicinal products used for cough and colds. Other anti-cold medicinal products. ATC code R05X.

Pharmacological properties.

Pharmacodynamics.

Oxolin is an antiviral agent for topical use, possessing virucidal activity by blocking binding sites of the influenza virus (mainly type A2) on the surface of the cell membrane, thus protecting cells from viral penetration. Oxolin is also effective against Herpes simplex virus, varicella-zoster virus, adenoviruses, viruses causing infectious warts, and molluscum contagiosum virus.

Pharmacokinetics.

The drug is non-toxic; no systemic effects have been observed with local application, and it does not accumulate in the body. When applied to mucous membranes, 20% is absorbed and excreted mainly by the kidneys within 24 hours.

Clinical characteristics.

Indications.

Prevention of influenza; treatment of viral rhinitis.

Contraindications.

Individual hypersensitivity to the active substance or to other components of the drug.

Interaction with other medicinal products and other forms of interaction.

Concomitant intranasal use with adrenomimetic agents may lead to drying of the nasal mucosa.

Special precautions for use

The ointment is not intended for application to the mucous membrane of the eyes. The product must not be applied to damaged skin.

OXOLIN LAVENDER contains propylene glycol, which may cause skin irritation.

Cetyl alcohol may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding

There is a lack of safety data; therefore, use of the product during these periods is not recommended.

Ability to influence reaction rate when driving or operating machinery

The product does not affect the ability to drive or operate other potentially hazardous machinery.

Method of administration and dosage.

For influenza prophylaxis: apply to the nasal mucosa 2–3 times daily for 25 days or upon contact with infected individuals.

Treatment of viral rhinitis: apply to the nasal mucosa 2–3 times daily for 3–4 days.

Children.

Data on the safety and efficacy of the drug in children are lacking.

Overdose.

Cases of overdose are unknown. In the event of overdose, sensations of burning, skin and mucous membrane irritation at the site of application, rhinorrhea, and hypersensitivity reactions may occur.

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

Side effects.

At the site of ointment application, a transient burning sensation may occur, rhinorrhea, and discoloration of the mucous membrane to blue. Hypersensitivity reactions are possible.

Reporting suspected adverse reactions.

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life.

2 years. Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature between 2 °C and 15 °C. After opening the tube, store at a temperature between 2 °C and 8 °C. Keep out of reach of children.

Packaging.

3 g in a tube, 1 tube in a box, 1 box in a cardboard package; or 10 g in a tube, 1 tube in a cardboard package.

Availability classification.

Over-the-counter (without prescription).

Manufacturer.

Ukrainian-Spanish joint venture "Sperko Ukraine".

Manufacturer's address and place of business.

21027, Ukraine, Vinnytsia, vul. 600-Richchia, 25.