Fenistil gel for external use 0.1% tube 30g
Dosage:
0.1% x 30g
0.1% x 50g
Category
Allergy
Scope of the medicinal product
Dermatology
Release form
Gel
Manufacturer country
Switzerland
Package quantity, pcs
one
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).
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
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
Dosage (volume) of the substance in the preparation
dimethindene maleate 100 mg
Expiration date in days
730
The target audience
Children
Package weight, g
thirty
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