DIMETHYL®

INSTRUCTION for medical use of the medicinal product Dimestil® (DiMESTIL®)

Composition:

Active substance: dimethindene maleate;

1 g of gel contains dimethindene maleate 1 mg;

Excipients: propylene glycol, carbomers type 947P, sodium hydroxide, disodium edetate, benzalkonium chloride, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: transparent to slightly opalescent, colorless gel, practically odorless.

Pharmacotherapeutic group. Antihistamines for topical use.

ATC code D04AA13.

Pharmacological properties.

Pharmacodynamics.

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

With topical application of the gel, owing to its specially designed base, the active ingredient rapidly penetrates the skin and begins to act 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 sun 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.

No studies on drug interactions have been conducted; however, since systemic absorption of dimetindene maleate when using this medicinal product is extremely 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 treatment products should be used.

Avoid using Dimestil® gel on large areas of skin, especially in children or adolescents.

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

In cases of severe itching or extensive skin involvement, in addition to topical application of the gel, oral formulations of the drug should also be used.

Use during pregnancy or breastfeeding

There are no clinical data on the use of the product in pregnant women. Animal studies have shown no harmful effects (either direct or indirect) on pregnancy, fetal development, or subsequent offspring development. However, Dimestil® gel should not be used during pregnancy unless the expected benefit outweighs the potential risk to the fetus. In such cases, the use of the product is possible only under medical supervision.

Applying Dimestil® gel to large skin areas, particularly damaged or inflamed skin, is not recommended. This also applies to breastfeeding women. Moreover, breastfeeding women should not apply the gel to the nipples.

Ability to influence reaction rate when driving or operating machinery

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

Dosage and Administration.

The drug may be used in children under 2 years of age only as prescribed by a physician. Dimeticon® 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 there is no improvement in the condition after 7 days of treatment, consult a physician.

In cases of severe itching or extensive skin involvement, in addition to topical application of the gel, oral formulations of the drug should also be used.

Children.

The drug may be used in children under 2 years of age only as prescribed by a physician. Dimeticon® 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 drug to date.

In case of accidental ingestion of a large amount of Dimeticon® gel, seek immediate medical attention.

Symptoms typical of overdose with systemic H1-antihistamines may occur: central nervous system depression, manifested 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; arterial hypotension may also occur.

In case of overdose, appropriate measures recommended by a healthcare facility should be taken, depending on the symptoms presented.

Side effects

The most common side 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 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, itching and swelling, allergic dermatitis, urticaria*.

*Data obtained from post-marketing surveillance.

Reporting suspected adverse reactions

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

Shelf life. 2 years.

Shelf life after first opening: 3 months.

Do not use after the expiry date.

Storage conditions.

Store at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging. 30 g or 50 g in aluminum tubes. 1 tube per cardboard box.

Availability. Over-the-counter.

Manufacturer.

JSC "Grindeks".

Manufacturer's address and location of its business operations.

Krustpils Street 53, Riga, LV-1057, Latvia.

Marketing authorization holder.

JSC "Grindeks".

Address of the marketing authorization holder.

Krustpils Street 53, Riga, LV-1057, Latvia.

Phone/fax: +371 67083205 / +371 67083505

Email: [email protected]