EBERSCEPT

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EBERSEPT (EBERSEPT®)

Composition:

Active substance: ketoconazole;

1 ml of shampoo contains 20 mg of ketoconazole;

Excipients: sodium lauryl sulfate, diethanolamide of coconut fatty acids, imidourea, sodium lauryl sulfosuccinate, hydrolyzed animal collagen, hydrochloric acid diluted, sodium hydroxide, sodium erythrosine (E 127), floral flavor, purified water.

Pharmaceutical form. Shampoo.

Main physicochemical characteristics: pink-colored liquid with a specific odor.

Pharmacotherapeutic group.

Antifungal agents for topical use. Imidazole and triazole derivatives.

ATC code D01AC08.

Pharmacological properties.

Pharmacodynamics.

Ketoconazole is a synthetic imidazolodioxolane derivative that has fungicidal and fungistatic activity against dermatophytes such as Trichophyton sp., Epidermophyton sp., Microsporum sp., and yeasts such as Candida sp. and Malassezia furfur (Pityrosporum ovale). Ketoconazole shampoo rapidly reduces scaling and itching commonly associated with dandruff, seborrheic dermatitis, and pityriasis versicolor.

Pharmacokinetics.

After topical application of the shampoo, plasma concentrations of ketoconazole are not detectable. Plasma levels following topical application of the shampoo were measured after application to the entire body surface.

Clinical characteristics.

Indications.

Treatment and prevention of skin and hair disorders caused by yeast microorganisms Malassezia (previously known as Pityrosporum), such as dandruff, pityriasis versicolor (localized), and seborrheic dermatitis.

Contraindications.

The shampoo is contraindicated in patients with hypersensitivity to any component of the product.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use.

To avoid any rebound effect, it is recommended to gradually discontinue steroid therapy over a period of 2–3 weeks when using Ebersept shampoo in patients who have been undergoing prolonged local treatment with corticosteroids.

Avoid contact with eyes. If shampoo gets into the eyes, rinse thoroughly with water.

Use during pregnancy or breastfeeding.

There have been no adequate and well-controlled studies on the use of ketoconazole during pregnancy or breastfeeding. After topical application of Ebersept shampoo to the skin in non-pregnant women, plasma concentrations of ketoconazole were undetectable. Plasma levels following topical application of Ebersept shampoo were measured after application to the entire body surface. Due to the lack of known risk factors, use of the drug during pregnancy or breastfeeding is not contraindicated.

Effect on the ability to drive or operate machinery.

The shampoo does not affect the ability to drive a vehicle or operate machinery.

Method of Administration and Dosage.

Apply Eberscept shampoo to affected areas for 3−5 minutes, then rinse off with water.

Treatment:

• Dandruff and seborrheic dermatitis: twice a week for 2−4 weeks;
• Pityriasis versicolor: daily for 1−3 days.

Prevention:

• Dandruff and seborrheic dermatitis: once a week or once every 2 weeks.

Children.

Safety and efficacy in newborns and children under 12 years of age have not been established.

Overdose.

Since the shampoo is intended for external use only, overdose is not expected.

In case of accidental ingestion, treatment should consist of supportive and symptomatic measures. Inducing vomiting or gastric lavage is contraindicated due to the risk of aspiration.

Adverse Reactions

Eye disorders: eye irritation, increased lacrimation;

General disorders and administration site reactions: angioedema, erythema, sensation of discomfort, hypersensitivity, irritation, pruritus, pustular rash at the application site;

Infections and infestations: folliculitis;

Nervous system disorders: dysgeusia;

Immune system disorders: hypersensitivity;

Skin and subcutaneous tissue disorders: acne, alopecia, contact dermatitis, dry skin, change in hair texture, rash, skin burning sensation, skin changes, increased skin desquamation.

Post-marketing Surveillance

Adverse reactions reported for Eberscept shampoo for the first time during the post-marketing period:

Skin and subcutaneous tissue disorders: very rare – urticaria, angioedema, hair discoloration (mainly in patients with chemically damaged or grey hair).

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 ml, 60 ml, or 120 ml of shampoo in a plastic bottle, 1 bottle per cardboard box.

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

Manufacturer.

BROS LTD / BROS LTD.

Manufacturer's address and place of business.

Augis & Galinis 15, Nea Kifisia (Attiki) 14564, Greece / Augis & Galinis 15, Nea Kifisia (Attiki) 14564, Greece.