Fenistil® (Fenistil®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDimethindenDimethinden
Dosage form: & nbspemulsion for external use.
Composition:

Active substance: in 1 g of emulsion contains 1.00 mg of dimethindene maleate.

Excipients: benzalkonium chloride 0.1 mg, benzyl alcohol 5.0 mg, butyl hydroxytoluene 0.2 mg, disodium edetate 0.5 mg, cocoyl caprylcaprate 25.0 mg, paraffin liquid 25.0 mg, cetostearmacrogol 20.0 mg, carbomer about 4 mg , 0 mg, sodium hydroxide, a solution of 30% m / m about 4.0 mg, propylene glycol 150.0 mg, water about 765.2 mg.

Description:Homogeneous semi-liquid whitish emulsion with a slight smell of benzyl alcohol.
Pharmacotherapeutic group:Anti-allergic agent-H1-histamine receptor blocker.
ATX: & nbsp

R.06.A.B.03   Dimethinden

D.04.A.A.13   Dimethinden

D.04.A.A   Antihistamines for external use

R.06.A.B   Alkylamines substituted

Pharmacodynamics:

Antihistamine, anti-allergic and antipruritic. Blocker H1-histamine receptors, is a competitive histamine antagonist.

The drug reduces the increased permeability of capillaries, associated with allergic reactions.When applied to the skin emulsion Fenistil ® reduces itching and irritation caused by skin-allergic reactions, which is due to the antikininic and anticholinergic effect of the drug.

Fenistil® emulsion also has a pronounced local anesthetic effect. With topical application, the drug quickly penetrates into the skin and provides a quick onset of action - in a few minutes. The emulsion base of the drug provides cooling, softening and moisturizing properties of the drug.

Pharmacokinetics:

With topical application, it penetrates well into the skin, systemic bioavailability is about 10%.

Indications:Itching of various origin (except for those associated with cholestasis): itching dermatoses, eczema, urticaria, insect bites, also sunburn, household and industrial burns (mild).
Contraindications:

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

Carefully:

Pregnancy I trimester, lactation.

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® emulsion should not be used on large areas of the skin, especially if inflammation or bleeding occurs. Nursing mothers should not apply the drug to the nipples of the mammary glands.

Dosing and Administration:

Apply externally.

The emulsion is applied 2 to 4 times a day on the affected skin.
Side effects:

Classification of incidence of adverse reactions:

Often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1/10000, < 1/1000); rarely (< 1/10000), including individual messages and reactions with unknown frequency (can not be calculated based on available data).

Disturbances from the skin and subcutaneous tissues:

Infrequent: dryness, burning of the skin.

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

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.
Overdose:

In case of accidental ingestion of a large amount of the drug, symptoms characteristic of overdose of drugs of H1-histamine receptor blockers,including depression of central nervous system functions, drowsiness (mainly in adults), stimulation of central nervous system functions, antimuscarinic effects (especially in children), including increased excitability, ataxia, hallucinations, tonic-clonic convulsions, mydriasis, dry mouth, "tides" of blood to the face, urine retention and fever. This may be followed by a drop in blood pressure.

Treatment:

The specific antidote is not known. It is necessary to take the usual measures of emergency care: when ingestion - reception of activated charcoal, salt laxatives; if necessary, carry out activities to maintain the function of the cardiovascular and respiratory systems. To treat arterial hypotension, vasoconstrictors can be used.

Do not exceed the recommended dose of Fenistil® emulsion.

In case of accidental overdose, immediately inform a doctor.

Interaction:Not described.
Special instructions:

In children from 1 month to 2 years, the drug is used after consultation with a doctor. In infants and young children, the drug should not be used on large areas of the skin, especially if inflammation or bleeding occurs.With severe itching or with extensive lesions, the drug can be used only after consulting a doctor.

When using Fsnistil® emulsion on large areas of the skin, prolonged exposure to sunlight should be avoided.

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

Ineffective in itching associated with cholestasis.

The preparation contains propylene glycol, benzalkonium chloride, butylhydroxytoluene which can cause local allergic reactions (contact dermatitis).

Butylhydroxytoluene can also irritate the eyes and mucous membranes.


Effect on the ability to drive transp. cf. and fur:Does not affect.
Form release / dosage:Emulsion for external use 0,1%.
Packaging:

For 8 ml in a bottle of milky glass with a polypropylene ball applicator and a lid. The bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:At a temperature of no higher than 30 ° C. Keep out of the reach of children.
Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe
Registration number:LP-000794
Date of registration:03.10.2011
The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland
Manufacturer: & nbsp
Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland
Information update date: & nbsp05.01.16
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