Ilon® classic

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT Ilon® Classic (Ilon® Classic)

Composition:

Active substances: 1 g of ointment contains juniper tar oil — 54 mg, turpentine oil — 72 mg, eucalyptus oil — 12 mg;

Excipients: white soft paraffin, yellow wax, stearic acid, oleic acid, polysorbate 20, rosemary oil, thyme oil, copper chlorophyllin complex (E 141), thymol.

Pharmaceutical form. Ointment.

Main physicochemical properties: light green, transparent, homogeneous ointment with a characteristic odour of essential oils and turpentine oil.

Pharmacotherapeutic group.

Other antiseptics and disinfectants. ATC code D08AX.

Pharmacological properties.

Pharmacodynamics.

Ilon® Classic is a herbal medicinal product that promotes blood supply to the affected area of the skin, reduces inflammation, and exerts a disinfectant effect. The ointment promotes ripening and rupture of abscesses, ensuring complete drainage of pus, thus preventing encapsulation of incompletely emptied purulent inflammatory foci.

Pharmacokinetics.

Pharmacokinetic studies have not been conducted.

Clinical characteristics.

Indications.

Treatment of moderate, localized purulent skin infections such as abscesses, furuncles, purulent nodules, inflammation of hair follicles and sweat glands.

Contraindications.

Hypersensitivity to essential oils or to any of the other components of the medicinal product.

Contraindicated in children with a history of seizures (whether associated with fever or not).

Interaction with other medicinal products and other forms of interaction.

To date, there have been no reports of any interactions.

Special precautions for use.

The medicinal product contains butylhydroxytoluene (E 321). Therefore, it should be noted that the drug may cause local skin reactions (e.g. contact dermatitis) or irritation of eyes and mucous membranes.

When using Ilong® Classic ointment, care should be taken to ensure that the ointment does not enter the eyes or areas near the eyes. Hands should be thoroughly washed after application of the ointment.

The use of the ointment should be limited to approved indications. Do not use Ilong® Classic ointment for the treatment of fresh wounds or skin rashes.

If skin inflammation worsens (increased redness, swelling, pain) or if general condition deteriorates (fever), or if no improvement occurs, the patient should consult a physician.

Use during pregnancy or breastfeeding.

Ilong® Classic is not recommended during pregnancy or breastfeeding, as studies on the effects of the medicinal product on the reproductive system, course of pregnancy, and condition of the fetus/infant have not been conducted.

Ability to affect reaction rate while driving or operating machinery.

Not observed.

Administration and Dosage.

For topical use only.

Thoroughly clean the affected area with alcohol or another disinfectant before application. Avoid applying any pressure on the affected skin area. Depending on the size of the inflamed skin area, apply a strip of ointment 2–3 cm in length and cover the wound with a dressing. The dressing should be changed daily.

Use of Ilong® Classic ointment is not recommended for children under 6 years of age.

Duration of use.

Successful treatment outcome may require using Ilong® Classic ointment for at least 3 days. If symptoms persist beyond 3 days of using the medication, consult a physician.

Children.

For children aged 6 years and older.

Overdose.

No cases of overdose have been reported.

Side effects.

Allergic reactions (itching, swelling, redness of the skin, rash, burning sensation) are possible in rare cases; these usually resolve after discontinuation of the medicinal product Ilong® Classic, ointment.

If any adverse effects occur, the patient should consult a physician.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after the medicinal product has been registered is of great importance. It allows ongoing monitoring of the benefit-risk balance of the use of this medicinal product. Healthcare professionals and patients, as well as 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. 3 years.

Shelf life after first opening: 6 months.

Storage conditions.

No special storage conditions required. Keep out of reach of children.

Packaging.

25 g, 50 g, or 100 g of ointment in a tube. 1 tube per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer. Cesar Arzneimittel GmbH & Co. KG.

Manufacturer's address and place of business.

Flugstraße 11, 76532 Baden-Baden, Germany.