BELADONNI EKSTRAKT

INSTRUCTIONS for medical use of the medicinal product DIMETINDENE (DIMETINDENE)

Composition

active substance: dimetindene maleate; 1 g of gel contains dimetindene maleate 1 mg; excipients: benzalkonium chloride, disodium edetate, carbomer, sodium hydroxide solution 30%, propylene glycol, purified water.

Pharmaceutical form

Gel.

Main physical and chemical properties

Homogeneous, colorless or slightly yellowish, transparent or slightly opalescent gel.

Pharmacotherapeutic group

Antihistamine drugs for topical use.

ATC code D04A A13.

Pharmacological properties

Pharmacodynamics

Dimetindene maleate is a derivative of phenindamine, an antagonist of histamine at the level of H1-receptors. It has anti-allergic and anti-itching effects. Due to the active substance of the medicinal product - dimetindene maleate - after applying the gel to the skin, itching and irritation that accompany skin allergic reactions are reduced. The preparation also has local anesthetic properties and cools the skin when applied.

When applied topically, the gel, due to its specially designed base, quickly penetrates the skin and starts acting within a few minutes. The maximum effect is achieved within 1-4 hours.

Pharmacokinetics

The systemic bioavailability of the active substance is 10%.

Clinical characteristics

Indications

Skin itching, for example, with insect bites, non-extensive sun erythema, uncomplicated small skin burns, and allergic irritation of small skin areas.

Contraindications

Increased sensitivity to any component of the medicinal product.

Interaction with other medicinal products and other types of interactions

No studies on the interaction of the medicinal product have been conducted; however, since the systemic absorption of dimetindene maleate when using the Dimetindene gel is extremely low, interaction with other medicinal products is unlikely.

Special warnings and precautions for use

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

The preparation cannot be used in case of known allergy to insect bites. In such cases, systemically acting preparations should be used.

It is recommended to avoid using the Dimetindene medicinal product when large areas of skin are affected, especially in children or adolescents.

During treatment with the preparation, it is recommended to avoid prolonged exposure to the sun on the affected skin areas.

Use during pregnancy or breastfeeding

Clinical data on the use of the medicinal product in pregnant women are not available. In animal studies, dimetindene maleate did not cause harmful effects (either direct or indirect) on the course of pregnancy, fetal development, and subsequent development of offspring. However, during pregnancy, it is not recommended to use Dimetindene, except in cases where the benefit of use outweighs the potential risk to the fetus. In such cases, the use of the preparation is possible only under the supervision of a doctor.

It is not recommended to apply Dimetindene to large areas of skin, especially damaged or inflamed skin. This also applies to women who are breastfeeding. In addition, women who are breastfeeding should not apply the gel to the nipples of the mammary glands.

Ability to influence the reaction rate when driving vehicles or operating other mechanisms

Dimetindene maleate, when used externally, does not affect the reaction rate while driving vehicles or working with other mechanisms.

Method of administration and dosage

Children under 2 years of age can use the medicinal product only under the supervision of a doctor. Infants and young children should not apply the gel to large areas of skin, especially damaged or inflamed.

Adults and children over 2 years of age should apply the gel to the affected skin areas 2-4 times a day. If the skin condition does not improve after 7 days of using the preparation, it is necessary to consult a doctor.

Children

Children under 2 years of age can use the medicinal product only under the supervision of a doctor. Infants and young children should not apply the gel to large areas of skin, especially damaged or inflamed.

Overdose

To date, there have been no reports of cases of overdose of the medicinal product. In case of accidental ingestion of a large amount of Dimetindene gel, it is necessary to immediately consult a doctor.

Some symptoms characteristic of overdose with H1-antihistamine drugs for systemic use may be observed: depression of the central nervous system, accompanied by drowsiness (mainly in adults), stimulation of the central nervous system and anticholinergic effect (especially in children and the elderly), including excitement, ataxia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, hyperemia of the face, urinary retention, fever, as well as possible arterial hypotension.

In case of overdose, it is necessary to take measures recommended by the medical institution according to the symptoms that occur.

Side effects

The most common side effects are minor and short-term reactions on the skin at the site of application. The medicinal product contains benzalkonium chloride and propylene glycol, which can cause skin irritation.

Possible side effects

• From the skin and subcutaneous tissue: frequency unknown (cannot be determined based on available data) - dry skin, burning sensation of the skin, allergic reactions, including skin rash, itching, and swelling, allergic dermatitis, urticaria.

Reporting of suspected side effects

Reporting of side effects after registration of the medicinal product is of great importance. This allows monitoring the benefit/risk ratio of the use of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their authorized representatives, should report all cases of suspected side effects and lack of efficacy of the medicinal product through the Automated Information System for Pharmacovigilance at: 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.

Store in a place inaccessible to children.

Packaging

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

Release category

Without a prescription.

Manufacturer

Lubnypharm PJSC.

Location of the manufacturer and address of the place of its activity

Ukraine, 37500, Poltava region, Lubny, Barvinkova street, 16.