EDERMIC

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT EDERMIK (EDERMIK)

Composition:

Active substance: dimetindene maleate;

1 g of gel contains 1 mg of dimetindene maleate;

Excipients: disodium edetate, carbomer, benzalkonium chloride, propylene glycol, sodium hydroxide 30% solution, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: homogeneous, transparent or with slight opalescence, colorless gel.

Pharmacotherapeutic group.

Antihistamines for topical use.

ATC code D04A A13.

Pharmacological Properties

Pharmacodynamics

Dimetindene maleate is a phenindene derivative and acts as an antagonist at H1-histamine receptors. It exerts antiallergic and antipruritic effects. Due to the active ingredient dimetindene maleate contained in the medicinal product Edermic, application of the gel to the skin reduces itching and irritation associated with allergic skin reactions. The preparation also has local anesthetic properties and produces a cooling sensation upon application.

When applied topically, the gel's specially designed base enables the active ingredient to rapidly penetrate the skin and begin acting within a few minutes. Maximum effect is achieved within 1–4 hours.

Pharmacokinetics

Systemic bioavailability of the active ingredient is 10%.

Clinical characteristics.

Indications.

Skin itching, for example due to insect bites, limited sunburn erythema, uncomplicated minor skin burns, and allergic irritations of small areas of skin.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Studies on drug interactions have not been conducted. However, since systemic absorption of dimethindene maleate after topical application is very low, interaction with other medicinal products is unlikely.

Special precautions for use

The product contains benzalkonium chloride and propylene glycol, which may cause skin irritation.

The product must not be used in cases of known allergy to insect bites. In such cases, systemic-acting products should be used.

Avoid using Edermic medication on large areas of skin, especially in children or adolescents.

During treatment with the product, prolonged exposure of affected skin areas to sunlight should be avoided.

In cases of very severe itching or extensive skin lesions, in addition to topical application of the product, oral forms of the medication (Edermic, oral drops) should also be used.

Use during pregnancy or breastfeeding

Clinical data on the use of the medication in pregnant women are lacking. Animal studies have shown no harmful effects (either direct or indirect) of the medication on the course of pregnancy, fetal development, or subsequent child development. However, during pregnancy, the use of Edermic medication is not recommended except when the expected benefit outweighs the potential risk to the fetus. In such cases, the medication may be used only under medical supervision.

It is not recommended to apply Edermic gel to large skin areas, particularly damaged or inflamed skin. This also applies to breastfeeding women. In addition, breastfeeding women should not apply the gel to the nipples.

Ability to influence reaction speed when driving or operating machinery

Dimetindene maleate, when applied topically, does not affect reaction speed when driving or operating machinery.

Method of Administration and Dosage

The medication may be used in children under 2 years of age only as prescribed by a physician. The medication should not be applied to large skin areas in infants and young children, especially to damaged or inflamed skin.

For adults and children aged 2 years and older, apply the gel to affected skin areas 2–4 times daily. If the patient's condition does not improve after 7 days of treatment, medical advice should be sought.

In cases of severe itching or extensive skin lesions, in addition to topical application, oral forms of the medication should also be used (Edermic, oral drops).

Children.

The medication may be used in children under 2 years of age only as prescribed by a physician. The medication should not be applied to large skin areas in infants and young children, especially to damaged or inflamed skin.

Overdose.

There have been no reports of overdose with this medication to date.

In case of accidental ingestion of a large amount of gel, immediate medical attention is required.

Some symptoms characteristic of systemic H1-antihistamine overdose may occur: central nervous system depression accompanied by drowsiness (mainly in adults), central nervous system stimulation and antimuscarinic effects (especially in children and elderly individuals), including agitation, ataxia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, facial hyperemia, urinary retention, fever, and possible arterial hypotension.

In case of overdose, measures recommended by a medical facility should be taken according to the symptoms that occur.

Side effects

The most common side effects are mild and transient skin reactions at the site of gel application. The product contains benzalkonium chloride and propylene glycol, which may cause skin irritation.

Possible side effects

Skin and subcutaneous tissue disorders:

Frequency unknown (cannot be estimated from available data): skin dryness, skin burning sensation, allergic reactions including skin rash, pruritus and swelling, allergic dermatitis, urticaria*.

*Data obtained from post-marketing surveillance.

Reporting suspected side effects

Reporting suspected side effects after medicine registration is important. It allows continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals and pharmacists, as well as patients or their legal representatives, should report all suspected side effects 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 the medicine after the expiry date stated on the packaging.

Storage conditions:

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

Keep out of reach and sight of children.

Packaging: 30 g in a tube. 1 tube per carton.

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

Manufacturer: JSC "Farmak".

Manufacturer's address:

74, Kyrylivska Street, Kyiv, 04080, Ukraine.