Alletek® derma

INSTRUCTION FOR MEDICAL USE OF MEDICINAL PRODUCT ALLETERC® Derma (ALLERTEC® Derma)

Composition:

Active substance: dimetindene maleate (dimetindeni maleate);

1 g of gel contains 1 mg of dimetindene maleate;

Excipients: carbomer (type 974 P), disodium edetate, sodium hydroxide, propylene glycol, benzalkonium chloride, purified water.

Pharmaceutical form. Gel.

Main physicochemical characteristics: transparent, colorless, homogeneous gel.

Pharmacotherapeutic group.

Antihistamines for topical use. ATC code D04A A13.

Pharmacological properties.

Pharmacodynamics.

Dimetindene maleate is a phenindane derivative and an antagonist at H1 receptors. It exerts antiallergic and antipruritic effects. Due to the active ingredient—dimetindene maleate—present in the medicinal product, itching and irritation associated with allergic skin reactions are reduced when the preparation is applied to the skin. The preparation also has local anesthetic properties and produces a cooling sensation upon application.

When applied topically, the gel base of the preparation facilitates rapid penetration of the active ingredient into the skin, with onset of action occurring 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 skin areas.

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 when using this medicinal product is extremely low, interaction with other medicinal products is unlikely.

Special precautions for use

The medicinal product must not be used if there is a known allergy to insect bites. In such cases, systemic-acting agents should be used.

Use of the medicinal product Allertek® Derm should be avoided when large areas of skin are affected, especially in children under 18 years of age, and in the presence of skin injuries or inflammation.

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

In cases of severe itching or extensive skin involvement, in addition to topical application of the medicinal product, oral dosage forms containing the active substance dimetindene maleate should also be used.

Excipients

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

Use during pregnancy or breastfeeding

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

Application of the medicinal product Allertek® Derm to large skin areas, particularly injured or inflamed skin, is not recommended. This also applies to breastfeeding women. In addition, breastfeeding women should not apply the gel to the nipples.

Ability to affect reaction speed while driving or operating machinery

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

Method of Administration and Dosage.

The drug may be used in children under 2 years of age only as prescribed by a physician. Infants and young children should not apply the drug to large areas of skin, especially 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 there is no improvement in the condition after 7 days of treatment, consult a physician.

In cases of severe itching or extensive skin lesions, in addition to topical application of the drug, oral formulations containing the active substance dimethindene maleate should also be used.

Children.

The drug may be used in children under 2 years of age only as prescribed by a physician. Infants and young children should not apply the drug to large areas of skin, especially 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 Allertek**®** Derma, seek immediate medical attention.

Symptoms typical of overdose with systemic H1-antihistamines 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 flushing, urinary retention, fever, and possible arterial hypotension.

In case of overdose, measures recommended by a healthcare facility should be implemented according to the symptoms presented.

Adverse Reactions

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

Possible adverse effects

Skin and subcutaneous tissue disorders

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

*Data obtained from post-marketing surveillance.

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to 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.

Storage conditions.

Keep in the original packaging to protect from light.

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Packaging.

Tubes of 5 g, 20 g, 30 g or 50 g, made of aluminum with a membrane, fitted with a PEHD cap equipped with a puncturing device. One tube per cardboard box.

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

Manufacturer.

Pharmaceutical Works "POLPHARMA" S.A.

Manufacturer's location and address of business operations.

Medan Plant in Sieradz, ul. Władysława Łokietka 10, Sieradz 98-200, Poland