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Description

The instruction for medical use

of Fenistil Torgovoye medicine a name

Fenistil

the International non-proprietary name Dimetinden Lekarstvennaya a form

Gel for external use, 30 g

Structure

of 1 g of gel contains

active agent – a dimetinden a maleate of 1 mg,

excipients: propylene glycol, sodium of hydroxide of 30% solution, carbomers (Karbopol 974 P), dinatrium edetat, a benzalkoniya chloride or solution the chloride benzalkoniya, water purified.

The description

Homogeneous transparent or poorly opalescent gel, from colourless till slightly yellowish color, almost flavourless.

Pharmacotherapeutic group

Drugs for treatment of an itching of skin (including antihistaminic drugs and anesthetics). Antihistaminic drugs for topical administration. Dimetinden.

The ATX D04AA13 code

the Pharmacological

Pharmacokinetics At properties topical administration well gets into skin, system bioavailability of 10%. The antihistaminic effect is observed already in a few minutes after drawing on skin. The maximum effect is reached in 1-4 hours.

Pharmacodynamics

Antihistaminic, antiallergic and antipruritic means.

H1 blocker – histamine receptors, has high affinity to this type of receptors that leads to considerable decrease in hyperpermeability of capillaries, connected with reactions of immediate hypersensitivity. When drawing Fenistil gel reduces the itching and irritation caused by skin allergic reactions by skin. Drug has also significant mestnoanesteziruyushchy effect.

Has also anti-kinin and weak anticholinergic effect.

Indications

– a skin itching at a pruritic dermatosis, a small tortoiseshell, stings of insects, sunblisters, household and production burns of easy degree (except for the itching connected with a cholestasia)

the Route of administration and doses

Outwardly. It is applied at adults and children.

Gel is applied on an affected area of skin by 2-4 times a day. In cases of the profound itching or extensive damages of skin simultaneous use of oral forms is recommended.

Side effects

Infrequently (& ge, 1/1000 – & lt, 1/100):

– xeroderma

– the burning sensation on the site of application

is Very rare (& lt, 1/10000):

– allergic dermatitis

of the Contraindication

– hypersensitivity to a dimetinden to the maleate or other excipients which are a part of drug

With care: pregnancy, the lactation period, children’s age up to 2 years.

Medicinal interactions

of the Research were not carried out, however owing to low absorption of a dimetinden of a maleate at topical administration of drug, interaction with other medicinal substances is improbable.

Special instructions

In the profound itching or at defeat of extensive sites of skin it is possible to use drug only after consultation with the doctor.

At drug Fenistil use gel on extensive sites of skin it is necessary to avoid influence of sunshine.

If during use Fenistil of gel expressiveness of symptoms of a disease does not decrease or, on the contrary, amplifies, it is necessary to see a doctor.

It is inefficient in the itching connected with a cholestasia.

Propylene glycol and a benzalkoniya chloride which can cause local irritation of skin are a part of drug.

It is not necessary to use drug on extensive sites of skin (15% and more body surface) at premature newborns and children is younger than 2 years, especially in the presence of the phenomena of inflammation or bleeding.

Pregnancy and the period of a lactation

of the Research on animals did not reveal any teratogenic potential of a dimetinden and did not indicate direct or indirect harmful effects of a dimetinden on a pregnancy course, embryonic/pre-natal development, childbirth or post-natal development.

It is not necessary to apply Fenistil gel during pregnancy and the period of a lactation on extensive sites of skin, especially in the presence of the inflammation phenomena. Nursing mothers should not apply Fenistil gel on nipples of mammary glands.

Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms.

Does not affect ability to run motor transport and potentially dangerous mechanisms.

The overdose

Overdose is not revealed at topical administration of drug.

At accidental ingestion of a significant amount of drug the following symptoms characteristic of overdose of blockers of N1-of histamine receptors can be shown: oppression of the central nervous system (drowsiness) or stimulation of the central nervous system (excitement, an ataxy, hallucinations, tonic and clonic spasms, expansion of pupils, dryness in a mouth, hyperaemia of the person, a delay of urination, fever, hypotonia).

Treatment: intake of activated carbon, salt depletive, if necessary. In hypotonia it is recommended to use angiotonic drugs.

The form of release and packing

On 30 g of drug place in aluminum tubas with internal coating from epoxyphenolic pitch, with an aluminum membrane or without it, closed by the screw-on polyethylene cover.

On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions at a temperature not higher than 25 wasps.

To store out of children’s reach!

2 years

not to use a period of storage after expiry date.

Prescription status

Without prescription

of Proizvoditel Novartis Konsyyumer Hels SA, Switzerland

the Owner of the registration certificate

of Novartis Konsyyumer Hels SA, Switzerland

Upakovshchik Novartis Konsyyumer Hels SA, Switzerland

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine

of GSC KH KAZAKHSTAN LLP Almaty, Manas St., 32A. ph. +7 (727), 2446999, fax +7 (727) 2446997

kz.safety@gsk.com

the Latest version of the instruction for medical use is available on the website www.dari.kz (State reestrpoisk drugs).

Additional information

Ingredient

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