Fenistil gel for external use 0.1% tube 30 g

Dosage form

Homogeneous colorless gel, transparent or slightly opalescent.

Structure

Active substance: dimethindene maleate.

100 g of gel for external use contains 0.1 g of dimethindene maleate.

Excipients: disodium edetate 0.05 g, carbomer about 0.9 g, sodium hydroxide solution 30% about 1.0 g, benzalkonium chloride 0.005 g, propylene glycol 15.0 g, purified water about 82.9 g.

pharmachologic effect

Antihistamine, anti-allergic and antipruritic agent.

H1-histamine receptor blocker, is a competitive histamine antagonist.

The drug reduces the increased capillary permeability associated with allergic reactions.

When applied to the skin, Fenistil gel reduces itching and irritation caused by skin-allergic reactions.

The drug also has a pronounced local anesthetic effect.

It also has an antikininic and weak anticholinergic effect.

When applied externally, thanks to the gel base, it has a quick onset of action (after a few minutes) and a slight cooling effect.

The maximum effect is after 1-4 hours.

Pharmacokinetics

When applied topically, it penetrates well into the skin

systemic bioavailability - 10%

Side effects

Classification of the frequency of occurrence of adverse reactions:

very often (greater than or equal to 1/10)

often (greater than or equal to 1/100, < 1/10)

infrequently (greater than or equal to 1/1000, < 1/100)

rarely (greater than or equal to 1/10000, < 1/1000)

very rare (< 1/10000), including isolated messages and reactions with an unknown frequency (cannot be calculated from the available data).

Skin and subcutaneous tissue disorders:

Uncommon: dryness, burning of the skin.

Very rare (post-registration data): allergic dermatitis, including skin rash, itching.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Selling features

Available without a prescription

Special conditions

In children from 1 month to 2 years, the drug is used after consulting a doctor.

In infants and young children, the drug should not be used on large areas of the skin, especially in the presence of inflammation or bleeding.

In case of severe itching or in case of damage to large areas of the skin, the drug can be used only after consulting a doctor.

When applying FSNISTEL® gel on large areas of the skin, prolonged exposure to sunlight should be avoided.

If during the period of application of the Fenistil® gel the severity of the symptoms of the disease does not decrease or, on the contrary, increases, it is necessary to consult a doctor.

Ineffective for pruritus associated with cholestasis.

The drug contains propylene glycol, benzalkonium chloride, which can cause local allergic reactions.

The effect of the drug on the ability to drive vehicles and other mechanisms:

Does not affect.

Indications

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

Sunburn, household and industrial burns (mild).

Contraindications

Hypersensitivity to dimetindene and other components that make up the drug, angle-closure glaucoma, prostatic hyperplasia, children under 1 month of age, especially premature babies.

Carefully:

Pregnancy I trimester, lactation period.

Pregnancy and lactation:

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

In the II and III trimesters of pregnancy, as well as during lactation, Fenistil® gel should not be used on large areas of the skin, especially in the presence of inflammation or bleeding.

Nursing mothers are not with

Name ENG

FENISTIL

Clinical and pharmacological group

Antiallergic drug for external use

ATX code

Dimetindene

Dosage

0.1% x 30g

Structure

100 g of gel for external use contains 0.1 g of dimethindene maleate.

Excipients: disodium edetate 0.05 g, carbomer about 0.9 g, sodium hydroxide solution 30% about 1.0 g, benzalkonium chloride 0.005 g, propylene glycol 15.0 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).

INN / Active ingredient

Dimetindene

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).

Specifications

Category

Allergy

Scope of the medicinal product

Dermatology

Release form

Gel

Manufacturer country

Switzerland

Package quantity, pcs

one

Scope of application

Dermatology

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

30 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

D04AA13 Dimetindene

Dosage form

Gel for external use

The target audience

Children

Dosage (volume) of the substance in the preparation

dimethindene maleate 100 mg

Expiration date in days

730

Package weight, g

45

Mode of application

:

The gel is applied to the affected skin area 2-4 times a 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