Translation of the instruction Mose

STOMOLIK solution for an oral cavity of 0.1%

Instruction

On medical use of medicine

Stomolik

(stomolik)

Ingredients:

Active ingredient: Hexetidinum;

1 mg of Hexetidinum contains

1 ml of solution;

excipients: 96% ethanol; polysorbate 60; sodium saccharin; citric acid, monohydrate; menthol (left menthol); eucalyptus oil; calcium-sodium edetat; sodium hydroxide; karmoizin (E 122); the water purified.

Dosage form.

Solution for an oral cavity.

Main physical and chemical properties: transparent, red liquid with a mint smell.

Pharmacotherapeutic group.

Means for use in stomatology. antimicrobic and antiseptics for topical administration.

ATX A01A B12 Code.

Pharmacological properties.

Pharmacodynamics.

Hexetidinum is antimicrobial broad-spectrum agent. This remedy is effective both in vivo, and in vitro against gram-positive and gram-negative bacteria and also yeast (Candida albicans) and mushrooms.

Pharmacokinetics.

Specific pharmacokinetic researches of use of solution to the person were not conducted by

.

At use of medicament the dental plaque and residual amounts of Hexetidinum on mucous membranes can be defined by

. The research with use of marked Hexetidinum was shown that Hexetidinum can be defined on tissues of an oral cavity from 8 to 10 hours after single use, and be shown in certain cases on tissues of an oral cavity in 65 hours after treatment.

by

absorption Research after topical administration of Hexetidinum to the person was not conducted.

Specific researches of Hexetidinum with the assistance of patients with abnormal liver functions and/or kidneys and patients of advanced age were not conducted by

.

Clinical characteristics.

Indication.

Infection of an oral cavity, including candidiasis; as supportive application for prevention and treatment of an ulitis; at treatment of a sore throat and recurrent aphthous ulcers; for elimination of an unpleasant smell from a mouth; before carrying out surgeries in stomatology.

Contraindication.

Hypersensitivity to Hexetidinum, a karmoizin (e 122), to oil eucalyptus, to left menthol or to any other component of drug; children's age up to 6 years; atrophic pharyngitis.

Interaction with other medicines and other types of interactions.

Can interact with other antiseptic medicines. Hexetidinum can be inactivated by alkaline solutions.

Feature of use.

to Apply

with care to patients with epilepsy. medicament can reduce an epileptic threshold and cause spasms in children. to apply carefully to patients with allergic reactions, including asthma, especially to patients with an allergy to acetylsalicylic acid; to patients with a liver disease (in connection with existence in composition of medicament of ethanol).

children Have a risk of emergence of a laryngospasm because of presence of left menthol.

When strengthening inflammation of treatment should be stopped.

Use during pregnancy or feeding by a breast.

Data of researches of Hexetidinum on a possibility of penetration through a placenta and excretion in breast milk of the person are absent therefore stomolik it is not necessary to apply during pregnancy and during feeding by a breast.

Ability to influence speed of response at control of motor transport or other mechanisms.

Drug contains ethanol. drivers are not recommended to drive the car during

30 minutes after medicament use.

Route of administration and doses.

Stomolik is means for topical administration in an oral cavity.

to Wash out a mouth or to rinse a throat undiluted solution in number of 1 tablespoon (about 15 ml) within ½ minutes twice or three times a day after meal.

should not swallow of Drug.

Duration of treatment is defined by the doctor individually depending on severity and features of a course of the disease.

If symptoms of a disease do not disappear and/or are followed by the increased temperature, it is necessary to see a doctor.

not to apply

to treatment of long symptoms.

Children.

Stomolik is not applied to children under 6 years.

Overdose.

Signs and symptoms of overdose

Concentration of Hexetidinum which contains in solution for an oral cavity is not toxic if to use medicament for designated purpose.

Accidental hit of a large amount of solution in digestive system can theoretically cause intoxication because of alcohol content.

overdose Cases at topical administration of solution of Hexetidinum are not described by

.

overdose Treatment

symptomatic treatment. Gastric lavage for 2 hours after medicament ingestion is shown.

in case of ingestion by the child of contents of a bottle should see a doctor immediately.

Side reactions.

from the immune system: reactions of hypersensitivity, including urticaria, a Quincke's disease, a laryngospasm, a bronchospasm.

from nervous system: an ageusia, a dysgeusia, change of flavoring feelings within 48 hours (the feeling of "sweet" can change twice on feeling of "bitter").

from a respiratory system: cough, short wind.

from digestive system: dryness in a mouth, a dysphagy, increase in sialadens, pain when swallowing. At accidental ingestion of medicament there can be gastrointestinal disorders, first of all nausea and vomiting.

from skin and hypodermic cellulose: allergic contact dermatitis.

General disturbances and states in the place of use: local reactions — reversible discoloration of teeth and language; sensitivity of a mucous membrane, namely — burning, feeling of numbness; irritation (morbidity, feeling of heat, itching) language and/or mucous membrane of an oral cavity; decrease in sensitivity; paresthesia of a mucous membrane; inflammation; bubbles; developing of ulcers on a mucous membrane.

Drug contains

karmoizin (E 122) therefore can cause allergic reactions, including a bronchospasm, especially in patients with an allergy to acetylsalicylic acid.

Expiration date.

2 years.

Storage conditions.

to Store

in original packing at a temperature not above 25 °C. to store out of children's reach.

Packing.

On 125 ml in bank; after 1 bank in a pack from cardboard.

Category of release.

Without prescription.

Producer.

Chao's

is "technologist".

Location of the producer and its address of the place of implementation of activity.

Ukraine, 20300, Cherkassk Region, city of Uman, street old pro-carved, house 8.