Dimetindene

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIMETINDENE (DIMETINDENE)

Composition:

active substance: dimetindene maleate;

1 g of gel contains 1 mg of dimetindene maleate;

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

Pharmaceutical form. Gel.

Main physical and chemical properties: homogeneous, colorless or slightly yellowish, transparent or slightly opalescent gel.

Pharmacotherapeutic group. Antihistamines for topical use.

ATC code D04AA13.

Pharmacological Properties

Pharmacodynamics. Dimethindene maleate is a phenindane derivative and an antagonist at H1-histamine receptors. It exerts antiallergic and antipruritic effects. Due to the active ingredient of the medicinal product — dimethindene maleate — itching and irritation accompanying cutaneous allergic reactions are reduced after application of the gel to the skin. The preparation also has local anesthetic properties and produces a cooling sensation upon application.

When the gel is applied topically, its 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 from 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 following application of Dimethindene gel is extremely low, interaction with other medicinal products is unlikely.

Special precautions for use

The medicinal 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 treatment products should be used.

Avoid using the medicinal product Dimetinden on large areas of skin, especially in children or adolescents.

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

Use during pregnancy or breastfeeding. There are no clinical data on the use of the medicinal product in pregnant women. In animal studies, dimetindene maleate did not cause harmful effects (either direct or indirect) on the course of pregnancy, fetal development, or subsequent offspring development. However, during pregnancy, Dimetinden should not be used except when the benefit of use outweighs the potential risk to the fetus. In such cases, the use of the product is possible only under a physician's prescription.

It is not recommended to apply Dimetinden to large areas of skin, 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 rate while driving or operating machinery. Dimetindene maleate, when applied topically, does not affect reaction speed during driving or operating machinery.

Dosage and Administration.

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

For adults and children aged 2 years and older, apply the gel to affected skin areas 2–4 times daily. If the skin condition does not improve after 7 days of treatment, consult a physician.

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

Overdose. There have been no reports of overdose with this medicinal product to date. In case of accidental ingestion of a large amount of Dimethinden gel, seek immediate medical attention.

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 (particularly 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 the healthcare facility should be taken according to the symptoms that occur.

Side effects

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

Possible side effects

Skin and connective tissue disorders: frequency unknown (cannot be estimated from available data) — skin dryness, skin burning sensation, allergic reactions including skin rash, itching and swelling, allergic dermatitis, urticaria.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicinal product authorization is highly important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Shelf life after first opening: 3 months.

Storage conditions. Store at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 30 g in a tube, 1 tube in a cardboard box.

Marketing authorization holder. JSC "Lubnipharm".

Manufacturer's name and address. 16, Barvinkova Street, Lubny, Poltava region, 37500, Ukraine.