Fenistil gel for external use 0.1% tube 50 g

Release form, composition and packaging

Gel for external use is homogeneous, colorless, transparent or slightly opalescent.

100 g

dimethindene maleate 100 mg

disodium edetate - 50 mg, carbomer - about 900 mg, sodium hydroxide (30% solution) - about 1 g, benzalkonium chloride - 5 mg, propylene glycol - 15 g, purified water - about 82.9 g.

30 g - aluminum tubes (1) - cardboard packs.

50 g - aluminum tubes (1) - cardboard packs.

pharmachologic effect

Blocker of histamine H1 receptors.

It has antiallergic and antipruritic effect.

Reduces increased capillary permeability associated with allergic reactions.

When applied to the skin, it reduces itching and irritation caused by allergic skin reactions.

The drug also has a pronounced local anesthetic effect.

Blocks the action of kinins, has a weak anticholinergic effect.

When applied externally, thanks to the gel base, the effect with a slight cooling effect begins after a few minutes and reaches a maximum after 1-4 hours.

Pharmacokinetics

When applied externally, it penetrates well into the skin.

The systemic bioavailability of the active substance is 10%.

Indications for use

Itching of various origins (except associated with cholestasis) with:

- itchy dermatoses

- eczema

- urticaria

- insect bites.

Sunburns, household and industrial burns (mild).

Contraindications for use

- angle-closure glaucoma

- prostatic hyperplasia

- children's age up to 1 month (especially premature ones)

- hypersensitivity to dimethindene and other components that make up the drug.

Fenistil should be prescribed with caution in the first trimester of pregnancy and during lactation (breastfeeding).

Dosage regimen

Apply externally.

The drug should be applied to the affected skin 2-4 times / day.

In cases of severe itching or widespread skin lesions, the simultaneous use of oral forms is recommended.

Overdose

Symptoms: if a large amount of the drug is accidentally swallowed, symptoms characteristic of histamine H1 receptor blockers may occur - CNS depression and drowsiness (mainly in adults), CNS stimulation and m-anticholinergic effects (especially in children), incl.

agitation, ataxia, tachycardia, hallucinations, tonic or clonic seizures, mydriasis, dry mouth, flushing of the face, urinary retention, fever.

This may be followed by a decrease in blood pressure.

Treatment: the specific antidote is unknown.

Activated charcoal, saline laxative should be prescribed

take measures to maintain the function of the cardiovascular and respiratory systems.

For the treatment of arterial hypotension, vasoconstrictors can be used.

In case of accidental overdose, the patient should consult a doctor.

Side effect

Determination of the frequency of side effects: very common (> = 1/10), often (> = 1/100 and < 1/10), infrequently (> = 1/1000 and < 1/100), rarely (> = 1/10 000 and < 1/1000), very rare (< 1/10 000), including isolated messages and reactions with an unknown frequency (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders: infrequently - dry skin, burning sensation of the skin.

Allergic reactions: very rarely (post-registration data) - allergic dermatitis, including skin rash, itching.

If any of the above side effects get worse, or any other side effects appear, the patient should inform the doctor about it.

Drug interactions

The drug interaction of the drug Fenistilne is described.

Application during pregnancy and lactation

The use of the drug Fenistil in the first trimester of pregnancy is possible only after consulting a doctor.

In the II and III trimesters of pregnancy

Name ENG

FENISTIL

Clinical and pharmacological group

Antiallergic drug for external use

ATX code

Dimetindene

Dosage

0.1% x 50g

Structure

Active ingredients: dimethindene maleate 100 mg.

Excipients: disodium edetate - 50 mg, carbomer - about 900 mg, sodium hydroxide (30% solution) - about 1 g, benzalkonium chloride - 5 mg, propylene glycol - 15 g, purified water - about 82.9 g.

Indications

Itching of various origins (except for those associated with cholestasis) with: itchy dermatoses, eczema, urticaria, insect bites.

Sunburns, household and industrial burns (mild).

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

Contraindications

Hypersensitivity to dimetindene and other components that make up the drug

angle-closure glaucoma

hyperplasia of the prostate

children up to 1 month old (especially premature ones).

With caution: Fenistil® should be prescribed in the first trimester of pregnancy and during lactation (breastfeeding).

INN / Active ingredient

Dimetindene

Specifications

Category

Allergy

Scope of the medicinal product

Dermatology

Release form

Gel

Manufacturer country

Switzerland

Package quantity, pcs

one

Minimum age from

1 month

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Fenistil

The amount of the dosage form in the primary package

50 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

D04AA13 Dimetindene

Dosage form

Gel for external use

Item weight, g

fifty

The target audience

Children

Expiration date in days

730

Dosage (volume) of the substance in the preparation

dimethindene maleate 100 mg

Package weight, g

65

Mode of application

:

Apply externally.

The gel should be applied to the affected skin 2-4 times / day.

In cases of severe itching or widespread skin lesions, the simultaneous use of oral forms is recommended.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture