ICHTHAMMOL OINTMENT

INSTRUCTIONS FOR MEDICAL USE OF ICHTHYOL OINTMENT

Composition:

Active substance: ichthammol;

1 g of ointment contains 0.1 g of ichthammol;

Excipient: soft white paraffin.

Pharmaceutical form. 10% ointment.

Main physicochemical properties: ointment of dark brown color with the odor of ichthammol. The ointment should be homogeneous in appearance.

Pharmacotherapeutic group.

Antiseptics and disinfectants. ATC code D08AX.

Pharmacological properties.

Pharmacodynamics.

Ichthammol ointment exerts local analgesic, anti-inflammatory, and antiseptic effects.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Burns, eczema, erysipelas, neuralgias, arthritis.

Contraindications.

Increased individual sensitivity to ichthammol.

Interaction with other medicinal products and other forms of interactions.

When applied simultaneously with other topical agents containing iodine salts, alkaloids, or heavy metal salts, new compounds may form, resulting in unpredictable effects. Therefore, the medicinal product should not be used simultaneously with other topical agents.

Special precautions for use.

Hands should be thoroughly washed after applying the ointment to prevent any residue from coming into contact with mucous membranes, eyes, nose, or oral cavity.

Use during pregnancy or breastfeeding.

Breastfeeding women must avoid contact of the ointment with nipples. Safety and efficacy of the medicinal product during pregnancy or breastfeeding have not been studied.

Ability to influence reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

For external use only. Apply a thin layer of the ointment to affected skin areas 2–3 times daily and cover with a dressing. The duration of treatment course is determined by the course of the disease and therapeutic response.

For the treatment of furunculosis, complicated forms of burns, arthritis, neuralgia, and eczema, "Ichthyolum Ointment" is used as part of complex therapy.

The patient should consult a physician if symptoms persist during treatment or if adverse reactions occur that are not listed in the instructions for medical use of the medicinal product.

Children.

Experience of use in children has not been described.

Overdose.

Overdose is not possible when following the recommended application guidelines.

No cases of overdose have been reported.

Side effects.

Allergic reactions and skin irritation (burning, itching, rash) are possible, especially at the beginning of treatment and with prolonged use. If severe skin irritation or other unusual reactions occur, discontinue use of the ointment.

Shelf life.

5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

25 g in a tube in a carton or without a carton.

Availability.

Over-the-counter (without prescription).

Manufacturer/Marketing Authorization Holder.

TOV "Ternopharm".

Manufacturer's address and address of its business activity / Marketing Authorization Holder's address.

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./Fax: (0352) 521-444, www.ternopharm.com.ua