Allergodil drops gl. 0.05% fl. 6ml

Release form, composition and packaging

Eye drops 0.05% in the form of a colorless, transparent or almost transparent solution, practically free from mechanical impurities.

1 ml

azelastine hydrochloride 500 mcg

hypromellose (hydroxypropyl methylcellulose), disodium edetate, benzalkonium chloride, sorbitol 70%, sodium hydroxide (up to pH 6.0), water d / i.

6 ml - polyethylene bottles (1) with a dropper - cardboard packs.

pharmachologic effect

Blocker of histamine H1 receptors, a phthalazinone derivative.

It has a strong and long-term prolonged anti-allergic effect.

With intraocular use, additional anti-inflammatory and membrane-stabilizing effects appear: azelastine inhibits the synthesis and release of mediators of the early and late phases of allergic reactions (including leukotriene, histamine, platelet activating factor and serotonin, reduces the number of molecular adhesion cells and eosinophils).

There was no clinically significant effect on the QT interval even with long-term use of azelastine in high doses.

Pharmacokinetics

With repeated use of Allergodil in the form of eye drops (1 drop in each eye 4 times / day) Cmax were very low and were detected at or below the limit of measurements.

Indications for use

- prevention and treatment of seasonal allergic conjunctivitis

- treatment of non-seasonal (year-round) allergic conjunctivitis.

Contraindications for use

- children under 4 years old

- hypersensitivity to azelastine or other components of the drug.

Dosage regimen

Seasonal allergic conjunctivitis: adults and children over 4 years of age are prescribed 1 drop in each eye 2 times / day (morning and evening).

If necessary, the frequency of use is increased up to 4 times / day.

In case of suspected exposure to an allergen, the drug is used for prophylactic purposes.

Non-seasonal (year-round) allergic conjunctivitis: adults and children 12 years of age and older are prescribed 1 drop in each eye 2 times / day (morning and evening).

If necessary, the frequency of use is increased up to 4 times / day.

Rules for the use of the drug Allergodil &

1. Dry the skin around the eyes with a clean cloth.

2. Unscrew the cap and make sure the dropper is clean.

3. Gently pull down the lower eyelid.

4. Carefully, without touching the eyeball and mucous membrane with the dropper, apply one drop of the drug to the middle of the lower eyelid.

5. Lower the lower eyelid and lightly press the inner corner of the eye with your finger.

While holding your finger, blink a few times.

Blot excess preparation with a napkin.

6. Repeat the same for the other eye.

Overdose

There are no data on an overdose of the drug Allergodil.

Side effect

From the side of the organ of vision: increased sensitivity of the eye, sensation of a foreign body, discoloration of the conjunctival membrane, irritation, soreness, itching, redness, edema, increased lacrimation

rarely - dry eyes, blepharitis.

Systemic reactions: dyspnea, dysgeusia, dry skin.

Drug interactions

Drug interaction of the drug Allergodil has not been identified.

Application during pregnancy and lactation

Allergodil in the form of eye drops is not recommended for use in the first trimester of pregnancy, as well as during lactation.

In experimental studies when used in doses many times exceeding the therapeutic range, data on the teratogenic effect of azelastine have not been obtained.

special instructions

Allergodil can be used to treat infectious eye diseases as part of complex therapy (as recommended by a doctor).

In the case of concomitant therapy with other eye drops, they should be instilled into the eyes with an interval of at least 15 minutes.

It is not recommended to wear contact lenses during the period of application of eye drops.

Name ENG

ALLERGODIL

Clinical and pharmacological group

Antiallergic drug for topical use in ophthalmology

ATX code

Azelastine

Dosage

0.05% x 6ml

Structure

The active substance is Azelastine hydrochloride.

Indications

Prevention and treatment of seasonal allergic conjunctivitis

treatment of non-seasonal (year-round) allergic conjunctivitis.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

Contraindications

Hypersensitivity to the active substance or other components of the drug

Age up to 4 years

I trimester of pregnancy.

INN / Active ingredient

azelastine hydrochloride

Specifications

Category

Allergy

Scope of the drug

General

Release form

Drops

Manufacturer country

Italy

Package quantity, pcs

one

Scope of application

Ophthalmology

Minimum age from

4 years old

Way of introduction

Into the conjunctival sac

Vacation conditions

Without recipe

Brand name

Tubilyuks Pharma S.p.A.

The amount of the dosage form in the primary package

6 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

S01GX07 Azelastine

Dosage form

Eye drops

The target audience

Children

Dosage (volume) of the substance in the preparation

azelastine hydrochloride 500 mcg

Expiration date in days

1095

Package weight, g

twenty

Mode of application

:

Seasonal allergic conjunctivitis: < br> in the absence of other doctor's recommendations for adults and children from 4 years old, instill 1 drop 2 times a day (morning and evening) in each eye.

If necessary, the dose is increased up to 4 times a day, one drop in each eye.

The drug is used until the symptoms disappear, but not more than 6 weeks.

In case of suspected exposure to an allergen, the drug is used for prophylactic purposes.

< br> Non-seasonal (year-round) allergic conjunctivitis: < br> in the absence of other doctor's recommendations, adults and children from 4 years of age should be instilled 2 times a day (morning and evening), 1 drop in each eye.

If necessary, the dose is increased up to 4 times a day, one drop in each eye.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture