Description
Briefly about
Fenistil Gel reduces the itching and irritation caused by skin-allergic reactions.
* It is used for skin reactions caused by insect bites, mild superficial burns, sunburn, dermatoses, and urticaria.
* Effective after a few minutes and has a slight cooling effect.
* Suitable for use from 1 month of age.
* Medical Instructions, RU No Ñ N011663 / 02 of 04/01/2011
Description
Gel for external use is homogeneous, colorless, transparent or slightly opalescent, practically odorless.
Latin name
FENISTIL
Release form
Gel for external use.
Pharmacological action
Histamine H1 receptor blocker.
Has anti-allergic and antipruritic effect.
Reduces the increased capillary permeability associated with allergic reactions.
When applied to the skin, reduces itching and irritation caused by skin-allergic reactions.
The drug also has a pronounced local anesthetic effect.
Blocks the action of kinins, has a weak anticholinergic effect.
For external use, due to the gel base, the action with a slight cooling effect begins after a few minutes and reaches a maximum after 1-4 hours.
Indications
Itchy skin of various origins (except associated with cholestasis) with: itching dermatoses, eczema urticaria, insect bites.
Sunburn, domestic and industrial burns (mild).
Contraindications
Angle-closure glaucoma prostatic hyperplasia children under 1 month of age (especially premature), 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).
Use 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 second and third trimesters of pregnancy and during lactation, the drug should not be used on large areas of the skin, especially in the presence of inflammation and bleeding.
Nursing mothers should not apply the drug to the nipples of the mammary glands.
Special instructions
For severe itching or for lesions of large areas of the skin, the drug can only be used after consulting a doctor.
When using Fenistil ® on large areas of the skin, exposure to sunlight should be avoided.
If during the period of use of the drug Fenistil ® the severity of the symptoms of the disease does not decrease or intensifies, a doctor’s consultation is necessary.
The drug is ineffective for itching associated with cholestasis.
The drug contains propylene glycol and benzalkonium chloride. The emulsion also contains butylhydroxytoluene. The listed excipients can cause local allergic reactions (contact dermatitis). Butylhydroxytoluene can also cause irritation to the eyes and mucous membranes.
Use in pediatrics
In children aged 1 month to 2 years, the drug should be used only 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.
Impact on the ability to drive vehicles
Not affected.
Composition
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,
82 purified water – 9 g
Dosage and administration
Applied externally.
The drug should be applied to affected areas of the skin 2-4 times / day.
In cases of severe itching or widespread skin lesions, the simultaneous use of oral forms is recommended.
Side effects
Determination of frequency of side effects:
is very common ( 1/10), often ( 1/100 and <1/10), infrequent ( 1/1000 and <1/100), rare ( 1 / 10,000 and <1/1000), very rare (<1 / 10,000), including individual reports and reactions with unknown frequency (cannot be estimated based on available data). From the skin and subcutaneous tissues: infrequently – dry skin, burning sensation. Allergic reactions: very rare (post-registration data) – Allergic dermatitis, including skin rash, itching. If any of the above side effects are exacerbated, or any other side effects occur, the patient should tell the doctor. Drug Interaction The drug interaction of Fenistil ® has not been described. Overdose No cases of drug overdose reported. Storage conditions Keep out of the reach and sight of children at temperatures not exceeding 25 ° C. Expiration 3 years. active substance dimethindene Dispensing conditions at pharmacies Dispensing conditions at pharmacies Without prescription Novartis Farma Stein AG, Switzerland
