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

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Dosage form: & nbsplozenges

Composition:

One tablet contains:

active ingredients: chlorhexidine dihydrochloride 5 mg, benzocaine 1.5 mg;

Excipients: isomalt - 2243.681 mg, peppermint oil - 0.9 mg, menthol-0.645 mg, thymol - 0.045 mg, aspartame -2.29 mg, purified water - 45.789 mg.

Description:Round biconvex opaque tablets with a rough surface from white or yellowish-white to light gray or yellowish-gray in color. Uneven staining, the presence of air bubbles and a slight unevenness of the edges are allowed. Possible appearance of white coating (dusting).

Pharmacotherapeutic group:Antiseptic

ATX: & nbsp

Other drugs

Pharmacodynamics:

The dual effect of the drug is due to the presence of two active substances. Antibacterial activity of the drug is due to the presence of chlorhexidine. The action of a local anesthetic - benzocaine - provides a reduction in pain symptoms.

Chlorhexidine

Chlorhexidine has a broad antibacterial spectrum of action against gram-positive and gram-negative bacteria; acts by destroying the cytoplasmic membrane of a bacterial cell. Low efficiency in yeasts, dermatophytes, mycobacteria, some Pseudomonas and Proteus species.

Chlorhexidine is most effective in a neutral or slightly alkaline environment.In an acidic environment, its activity decreases. Efficiency decreases in the presence of soaps, blood and purulent discharge.

The use of tablets for resorption with chlorhexidine leads to a significant decrease in the content of bacteria in the saliva. The use of chlorhexidine for several months is accompanied by a decrease in its effectiveness due to a decrease in the sensitivity of bacteria.

Benzocaine

Benzocaine - a well-known local anesthetic, quickly and for a long time facilitates pain in the oral cavity and pharynx. Benzocaine penetrates through the lipophilic regions of the cell membrane and acts on the peripheral pain receptors of the mucous membrane and skin. Anesthetic action of benzocaine occurs in 15-30 seconds; As the substance is diluted with saliva, the anesthetic action gradually decreases (within 5-10 minutes).

Pharmacokinetics:

Chlorhexidine

There is no clinical data on the absorption of chlorhexidine through the slime Chlorhexidine can persist in saliva up to 8 hours.

Benzocaine

Benzocaine is slightly soluble in water, which causes its slow absorption. Like all ether derivatives of para-aminobenzoic acid, it is cleaved by esterase in blood plasma and liver.As a result, para-aminobenzoic acid and ethyl alcohol metabolized to acetylcoenzyme A are formed. Para-aminobenzoic acid is conjugated with glycine or excreted unchanged by the kidneys.

Indications:

Infectious-inflammatory diseases of the throat or oral cavity:

- pharyngitis, tonsillitis and other inflammatory diseases of the pharynx;

- stomatitis;

- Gingivitis.

Contraindications:

- Hypersensitivity to any of the components of the drug;

- wound and ulcerative lesions of the oral cavity or throat;

- low concentration of cholinesterase in the blood plasma;

- phenylketonuria;

- Children's age up to 4 years.

Carefully:With erosive, desquamative changes in the oral mucosa, the drug "Geksoral Tabs" can be used with caution and only under the supervision of a doctor.

Pregnancy and lactation:

There is insufficient experience in the use of the drug in pregnant and lactating women.

The use of the drug "Hexoral Tabs" during pregnancy and lactation is possible only in those cases when the expected benefit for the mother exceeds the potential risk of harmful effects on the fetus and the baby.

Dosing and Administration:

Locally.The tablet slowly dissolve in the mouth until it dissolves completely.

The drug should be started immediately after the appearance of the first symptoms of the disease and continue to take within a few days after the disappearance of symptoms.

General recommendations for dosing

Adults and children over 12 years of age

- 1 tablet every 1-2 hours as needed, but not more than 8 tablets per day, unless otherwise specified.

Children aged 4-12 years

- Up to 4 tablets per day.

In occasion of application at children consult the doctor. Do not use for children under 4 years.

Information for patients with diabetes: the carbohydrate content in one tablet corresponds to 0.1 bread unit (BU).

Side effects:

The undesirable reactions revealed during the post-marketing use of the preparation were classified as follows: very frequent (≥ 10%), frequent (≥ 1%, but <10%), not frequent (≥ 0.1%, but <1%), rare (≥ 0.01%, but <0.1%), very rare (<0.01%), the frequency is unknown (the incidence rate can not be estimated from the available data). The undesirable reactions listed below were classified according to 1) clinical or epidemiological studies, or 2) when the number of cases is unknown or information on an undesired reaction is found in the analysis of literature data,"Frequency is unknown". According to spontaneous reports of adverse reactions *

Disorders from the gastrointestinal tract. Frequency is not known: the reduction of the oral mucosa sensitivity temporary numbness tongue, taste disturbance (dysgeusia) discoloration of teeth, changing the language of color (nondestructive), discoloration silicate and composite restoratives, plaque formation (tartar), stomatitis , detachment of the oral mucosa, glossodynia, an increase in parotid salivary glands.

Impaired immune system. Frequency unknown: hypersensitivity reactions (including urticaria, angioneurotic edema, anaphylactic reactions, anaphylactic shock).

Violations of the blood and lymphatic system. The frequency is unknown: methemoglobinemia.

* According to the literature. 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:

With proper application, an overdose of the drug is not possible, since chlorhexidine almost not absorbed into the blood, and the amount of absorbed benzocaine is extremely low. Chlorhexidine

Chlorhexidine hydrochloride is poorly soluble in water, all cases of overdose are described only with the intake of a readily water-soluble chlorhexidine gluconate. In these cases, mucosal lesions were observed with direct contact with chlorhexidine gluconate, as well as a systematic reversible increase in the concentration of the hepatic enzyme. Specific treatment is absent.

Benzocaine

Overdose is possible only if used improperly. Symptoms: possibly a toxic effect on the central nervous system, manifested initially tremor, vomiting, convulsions, and later - CNS depression. Due to respiratory depression, a coma is possible. High toxic concentrations cause bradycardia, blockade of atrioventricular conduction and cardiac arrest. Benzocaine can cause methemoglobinemia (especially in children), accompanied by suffocation and cyanosis.

Treatment: induce vomiting and rinse the stomach. It is possible to use activated carbon. With hypoxia and anoxia, artificial respiration with oxygen support is recommended, with cardiac arrest - cardiac massage.When convulsions are prescribed diazepam or high-speed barbiturates (contraindicated in anoxic seizures); in especially severe cases after intubation and artificial respiration suxamethonium chloride. Blood circulation should be supported by the introduction of blood plasma or solutions of electrolytes. With methemoglobinemia, up to 50 ml of 1% solution of methylene blue intravenously can be used.

Interaction:

Benzocaine due to the formation of its metabolite 4-aminobenzoic acid reduces the antibacterial activity of sulfonamides and aminosalicidates.

Sucrose, polysorbate 80, insoluble salts of magnesium, zinc and calcium reduce the effect of chlorhexidine.

Special instructions:

Benzocaine can cause methemoglobinemia. This condition is manifested by such symptoms as a change in the color of the skin, lips and nails in gray or blue or their blanching; headache, pre-stupor, dyspnea, fatigue and tachycardia.

The appearance of these symptoms indicates the presence of moderate to high amounts of methaemoglobin and a significant decrease in the oxygen transport function of the blood.

Children, elderly patients may be at a higher risk of developing methaemoglobinaemia.

In children, the drug should be administered under adult supervision.

The preparation contains in its composition aspartame, which is a derivative of phenylalanine, which is dangerous for patients with phenylketonuria. The use of the drug is contraindicated in the presence of wound and ulcerative lesions of the oral cavity or throat.

Care should be taken when using the drug in young children and in people with aspiration or with swallowing disorders due to the danger of suffocation. If the medicine has become unusable or the expiration date has expired, do not throw it into the waste water and into the street! 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:"Hexoral® tabs" does not affect the ability to drive vehicles and engage in other potentially hazardous activities.

Form release / dosage:Lozenges.

Packaging:For 10 tablets in a blister of PVC / PVDC / A1 foil. 2 blisters per cardboard pack together with instructions for use.

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.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-002626/07

Date of registration:14.03.2008 / 17.05.2013

Expiration Date:Unlimited

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

Manufacturer: & nbsp

SOLDAN HOLDING + BONBONSPEZIALITATEN, GmbH Germany

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

Information update date: & nbsp20.03.2017

Illustrated instructions

Instructions

Hexoral® tabs (Hexoral® tabs)