Geksoral - instructions for use, dose, side effects, contraindications

Excipients: polysorbate 80 - 1.400 g, citric acid monohydrate - 0.070 g, sodium saccharinate - 0.040 g, levomentol - 0.070 g, eucalyptus of the leaf-shaped leaf oil - 0.0011 g, sodium calcium edetate - 0.100 g, ethanol 96% - 4.333 g, sodium hydroxide - qs to pH 5.5 ± 0.2, purified water - q.s. up to 100 ml, nitrogen - q.s. up to 5 bar.

Description:Transparent colorless liquid with a smell of menthol.

Pharmacotherapeutic group:Antiseptic

ATX: & nbsp

A.01.A.B.12 Hexetidine

Pharmacodynamics:

The antimicrobial effect of the drug "Hexorol®" is associated with the suppression of oxidative reactions of the metabolism of bacteria (thiamine antagonist). The drug has a broad spectrum of antibacterial and antifungal effects, in particular against gram-positive bacteria and fungi of the genus Candida, however, the drug "Hexoral®" can also have an effect in the treatment of infections caused, for example, by Pseudomonas aeruginosa or Proteus spp.At a concentration of 100 mg / ml, the drug suppresses most strains of bacteria. The development of stability was not observed. Hexetidine has a weak anesthetic effect on the mucosa.

The drug has an antiviral effect against influenza A viruses, respiratory syncytial virus (PC virus), herpes simplex virus type 1, affecting the respiratory tract.

Pharmacokinetics:

Hexetidine adheres very well on the mucous membrane and is not practically absorbed.

After a single application of the active substance, its traces are found on the gingival mucosa for 65 hours. In dental plaque, active concentrations persist for 10-14 hours after application.

Indications:

As a symptomatic agent.

- Symptomatic treatment for inflammatory-infectious diseases of the oral cavity and larynx:

- tonsillitis, tonsillitis (including Plaut-Vincent's angina, angina of lateral ridges), pharyngitis, gingivitis, stomatitis, glossitis, periodontitis;

- fungal diseases;

- prevention of infectious complications before and after surgical interventions in the oral cavity and larynx and in trauma, including prevention of infection of the alveoli after extraction of the tooth;

- hygiene of the oral cavity, including and to eliminate bad breath from the mouth.

Contraindications:

- Hypersensitivity to any of the components of the drug;

- erosive-desquamous lesions of the mucous membrane of the oral cavity;

- Children under 3 years old.

Pregnancy and lactation:Information about any undesirable effects of the drug "Hexoral ®" during pregnancy and during breastfeeding there. However, before prescribing Hexorol® to pregnant or lactating women, the physician should carefully weigh the benefits and risks of treatment, given the lack of sufficient data on the penetration of the drug through the placenta and into breast milk.

Dosing and Administration:

Locally. Children from 3 to 6 years: use of the drug is possible after consultation with a medical professional.

Adults and children over 6 years of age: treated affected areas with a delay in breathing, 1 injection for 1-2 seconds 2 times a day.

Hexetidine adheres to the mucosa and thus gives a lasting effect. In this regard, the drug should be used after meals.

General recommendations for the introduction of

The drug is sprayed into the mouth or throat.Using aerosol, it is possible to easily and quickly treat affected areas. It is necessary to perform the following actions:

- put the spray nozzle on the aerosol can;

- direct the end of the nozzle-sprayer to the affected area of the mouth or pharynx;

- During the introduction of the drug, the vial should be kept constantly in an upright position, as shown in the figure;

- Enter the required amount of the drug, pressing on the head of the nozzle-sprayer for 1-2 seconds, do not breathe when injecting the aerosol.

The duration of treatment is determined by the doctor.

Side effects:

Undesirable reactions identified by post-marketing use of the drug were classified as follows: very frequent (≥ 1/10), frequent (≥ 1/100, <1/10), not frequent (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000), very rare (<1/10000), the frequency is unknown (the incidence rate can not be estimated from the available data).

Impaired immune system. Very rarely: hypersensitivity reactions (including urticaria), angioedema.

Violations from the nervous system. Very rarely: agesia, dysgeusia.

Disturbances from the respiratory system, chest and mediastinum.

Very rarely: cough, shortness of breath due to the appearance of a hypersensitivity reaction.

Disorders from the gastrointestinal tract. Very rarely: dry mouth, dysphagia, nausea, enlarged salivary glands, vomiting.

General disorders and disorders at the site of administration. Very rarely: reactions at the site of application (including irritation of the mucous membrane of the mouth and throat, burning sensation, oral paresthesia, discoloration of the tongue, discoloration of the teeth, inflammation, blistering and ulceration).

If any of the side effects indicated in the instructions are aggravated or you notice other side effects, it is recommended that you consult a doctor.

Overdose:

It is unlikely that hexedidium can have toxic effects when administered according to the instructions for use of the drug. Ingestion of large quantities of the preparation containing ethanol, can lead to the appearance of signs / symptoms of alcohol intoxication.

In all cases of overdose, consult a doctor immediately. Treatment is symptomatic, as with alcohol intoxication.Gastric lavage is necessary within 2 hours after ingestion of an excessive dose.

Interaction:No data available.

Special instructions:

There are no special regulations.

Children can use the drug at an age when there is no danger of uncontrolled swallowing or when they do not resist the foreign object (nozzle) in the mouth when using an aerosol and are able to hold their breath when injecting the drug. The content of ethanol in the preparation is 5.15%. One dose of the drug contains 20.3 mg of ethanol (in terms of absolute alcohol). The contents of the aerosol can is under pressure. Do not open, pierce or burn, even if the can is empty.

If the medicine has become unusable or the expiration date has expired, do not throw it into the waste water and throw it out! Place the drug in a bag and put it in the trash. These measures will help protect the environment!

Effect on the ability to drive transp. cf. and fur:The medicinal preparation "Hexorol®", aerosol for topical application does not affect the ability to drive vehicles and engage in other potentially dangerous speciesactivities.

Form release / dosage:Aerosol for topical application 0,2%.

Packaging:For 40 ml of the preparation in an aluminum aerosol can with an internal lacquer coating. 1 aerosol can, complete with one nozzle-sprayer or four nozzles-sprayers of different colors together with instructions for use in a cardboard bundle.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the product after the expiry date printed on the package.

The contents of the aerosol canister should be used within 6 months after the first application.

Terms of leave from pharmacies:Without recipe

Registration number:П N014010 / 01

Date of registration:10.08.2010 / 31.08.2015

Expiration Date:Unlimited

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

FAMAR ORLEANS France

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp20.03.2017

Illustrated instructions

Instructions

Hexoral® (Hexoral®)