Fenistil drops 1mg / ml 20ml bottle

Release form, composition and packaging

Drops for oral administration in the form of a clear, colorless liquid, practically odorless

1 ml (20 drops)

dimethindene maleate 1 mg

sodium hydrogen phosphate dodecahydrate - 16 mg, citric acid monohydrate - 5 mg, benzoic acid - 1 mg, disodium edetate - 1 mg, sodium saccharinate - 0.5 mg, propylene glycol - 100 mg, purified water - 888.5 mg

20 ml - dark glass bottles (1) with a dropper-dispenser - cardboard packs.

pharmachologic effect

A blocker of histamine H1 receptors, is a competitive histamine antagonist.

It has antiallergic and antipruritic effect.

Reduces increased capillary permeability associated with allergic reactions.

It also has an anti-bradykinin and weak m-anticholinergic effect.

When taking the drug during the day, there may be a slight sedation

The antihistamine effect begins to manifest itself 30 minutes after ingestion, reaching maximum severity within 5 hours.

Pharmacokinetics

Absorption After oral administration, it is absorbed quickly and completely.

Cmax in blood plasma is achieved within 2 hours.Bioavailability is about 70%

Distribution Plasma protein binding is 90%.

Penetrates well into tissues

Metabolism Metabolized in the liver by hydroxylation and methoxylation

Excretion T1 / 2 is 6 hours. It is excreted in the bile and urine (90% - in the form of a metabolite, 10% - unchanged).

Indications for use

allergic diseases (urticaria, hay fever, perennial allergic rhinitis, food and drug allergies, angioedema)

itching of various origins (eczema, other itchy dermatoses / including atopic dermatitis /, itching with measles, rubella, chicken pox, insect bites)

prevention of allergic reactions during hyposensitizing therapy.

Contraindications for use

hypersensitivity to drug components

angle-closure glaucoma

bronchial asthma

hyperplasia of the prostate

children's age up to 1 month

I trimester of pregnancy

lactation (breastfeeding) period

Care should be taken to prescribe Fenistil to patients with chronic obstructive pulmonary disease, epilepsy, children aged 1 month to 1 year (since their sedation may be accompanied by episodes of sleep apnea).

Dosage regimen

The drug is taken orally

For children aged 1 month to 12 years, a daily dose of 100 μg / kg of body weight is recommended, which is equivalent to 2 drops per kg of body weight.

The daily dose must be divided into 3 doses.

In children aged 1 month to 1 year, the drug should be used only as directed by a doctor and if there are indications for the use of histamine H1 receptor blockers.

For children over 12 years old and for adults, the recommended daily dose is 3-6 mg (60-120 drops), divided into 3 doses, i.e.

20-40 drops 3 times / day

Patients prone to sleepiness are advised to prescribe 40 drops before bedtime and 20 drops in the morning

20 drops = 1 ml = 1 mg dimetindene

For elderly patients (over 65 years), dose adjustment is not required.

Overdose

Symptoms: depression of the central nervous system and drowsiness (mainly in adults), stimulation of the central nervous system and m-anticholinergic effects (especially in children), incl.

agitation, ataxia, tachycardia, hallucinations, tonic or clonic seizures, mydriasis, dry mouth, flushing, urinary retention, fever, decreased blood pressure, collapse.

Treatment: activated charcoal, saline laxative should be prescribed

take measures to maintain the function of the cardiovascular and respiratory systems (do not use analeptics).

Side effect

Determination of the frequency of side effects: very often (? 1/10), often (? 1/100 and < 1/10), infrequently (? 1/1000 and < 1/100), rarely (? 1/10 000 and < 1 / 1000), very rarely (< 1/10 000), including individual messages and re

Name ENG

FENISTIL

Clinical and pharmacological group

Blocker of histamine H1 receptors.

Antiallergic drug

ATX code

Dimetindene

Dosage

1mg / ml x 20ml

Structure

1 ml (20 drops for oral administration) of the solution contains: active substance: dimethindene maleate 1 mg

excipients: methyl parahydroxybenzoate (preservative E 218), ethanol, dehydrogenated sodium phosphate dihydrate, sorbitol, purified water

Indications

allergic diseases (urticaria, hay fever, perennial allergic rhinitis, food and drug allergies, angioedema)

itching of various origins (eczema, other itchy dermatoses / including atopic dermatitis /, itching with measles, rubella, chicken pox, insect bites)

prevention of allergic reactions during hyposensitizing therapy.

Contraindications

hypersensitivity to drug components

angle-closure glaucoma

bronchial asthma

hyperplasia of the prostate

children's age up to 1 month

I trimester of pregnancy

lactation period (breastfeeding).

Care should be taken to prescribe Fenistil® to patients with chronic obstructive pulmonary disease, epilepsy, children aged 1 month to 1 year (since their sedation may be accompanied by episodes of sleep apnea).

INN / Active ingredient

Dimetindene

Storage conditions and periods

At a temperature not exceeding 25 degrees, in the original packaging.

Expiration date: 2 years

Specifications

Category

Allergy

Scope of the medicinal product

The immune system

Release form

Drops

Manufacturer country

Switzerland

Package quantity, pcs

one

Minimum age from

1 month

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Volume, ml.

20 ml

Brand name

Fenistil

The amount of the dosage form in the primary package

20 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

R06AB03 Dimethindene

Dosage form

Drops for oral administration

Expiration date in days

730

Dosage (volume) of the substance in the preparation

0.1%

Package weight, g

fifty

Mode of application

:

For adults and children over 12 years old, the daily dose is usually 3-6 mg, divided into 3 doses (ie, 20-40 drops 3 times / day) < br> Patients prone to drowsiness are recommended to prescribe 40 drops before bedtime and 20 drops in the morning, during breakfast. For children aged 1 month to 12 years, the daily doses are shown in the table.

The daily dose should be divided into 3 doses.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture