Dimetindene gel 0.1% tube 30 g

Itching of the skin, for example from insect bites, non-extensive solar erythema, uncomplicated small skin burns and allergic irritations of small areas of the skin.

• active ingredient: dimethindene maleate;
• 1 g of gel contains 1 mg of dimethindene maleate;
• Excipients: benzalkonium chloride, disodium edetate, carbomer, sodium hydroxide solution 30%, propylene glycol, purified water.

Hypersensitivity to any component of the drug.

The most common side effects are minor and short-term skin reactions at the application site. The medicine 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 the available data) – dry skin, burning sensation of the skin, allergic reactions including skin rashes, itching and swelling, allergic dermatitis, urticaria.

Children under 2 years of age should only use the medicine as directed by a doctor. Infants and young children should not apply the gel to large areas of skin, especially damaged or inflamed skin.

Adults and children over 2 years of age should apply the gel to the affected areas of the skin 2–4 times a day. If the skin condition does not improve after 7 days of use, you should consult a doctor.

Use during pregnancy or breastfeeding

There are no clinical data on the use of the drug in pregnant women. In animal studies, dimetinden maleate did not cause any harmful effects (either direct or indirect) on the course of pregnancy, fetal development, or the subsequent development of the offspring. However, Dimetindene is not recommended for use during pregnancy, except in cases where the benefit of use outweighs the potential risk to the fetus. In this case, the drug should be used only as prescribed by a doctor.

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

Children

Children under 2 years of age should only use the medicine as directed by a doctor. Infants and young children should not apply the gel to large areas of skin, especially damaged or inflamed skin.

Ability to influence reaction speed when driving vehicles or other mechanisms

Dimethindene maleate when applied externally does not affect the reaction rate when driving or working with other mechanisms.

There have been no reports of overdose of the drug at this time. If a large amount of Dimetindene gel is accidentally swallowed, consult a doctor immediately.

Some symptoms characteristic 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 the elderly), including agitation, ataxia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, facial flushing, urinary disorders, fever, and hypotension is also possible.

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

Drug interaction studies have not been conducted; however, since systemic absorption of dimethindene maleate when using Dimetindene gel is extremely low, interactions with other drugs are unlikely.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.