Translation of the instructions can be
STOMOLIC oral solution 0.1%
Instruction
For medical use of the medicinal product
Stomachache
(Stomolik)
Composition:
Active ingredient: hexetidine;
1 ml of solution contains 1 mg of hexetidine;
Excipients: ethanol 96%; polysorbate 60; sodium saccharin; citric acid, monohydrate; menthol (levomenthol); eucalyptus oil; calcium sodium edetate; sodium hydroxide; carmoisine (E 122); purified water.
Dosage form.
Oral solution.
Main physicochemical properties: clear, red liquid with a minty odor.
Pharmacotherapeutic group.
Means for use in dentistry. Antimicrobial and antiseptic agents for topical use.
PBX code A01A B12.
Pharmacological properties.
Pharmacodynamics.
Hexetidine is a broad-spectrum antimicrobial agent. This agent is effective both in vivo and in vitro against gram-positive and gram-negative bacteria, as well as yeasts (Candida albicans) and fungi.
Pharmacokinetics.
Specific pharmacokinetic studies of the solution in humans have not been conducted.
When using the drug, plaque and residual amounts of hexetidine on the mucous membranes can be detected. Studies using labeled hexetidine have shown that hexetidine can be detected on oral tissues 8 to 10 hours after a single application, and in some cases, it can be detected on oral tissues 65 hours after treatment.
Absorption studies after topical application of hexetidine in humans have not been conducted.
Specific studies of hexetidine in patients with impaired liver and/or kidney function and elderly patients have not been conducted.
Clinical characteristics.
Indication.
Oral infections, including candidiasis; as an adjunct to the prevention and treatment of gingivitis; in the treatment of sore throat and recurrent aphthous ulcers; to eliminate bad breath; before and after surgical operations in dentistry.
Contraindication.
Hypersensitivity to hexetidine, carmoisine (E 122), eucalyptus oil, levomenthol or any component of the drug; children under 6 years of age; atrophic pharyngitis.
Interaction with other drugs and other types of interactions.
May interact with other antiseptic drugs. Hexetidine can be inactivated by alkaline solutions.
Application features.
Use with caution in patients with epilepsy. The drug may reduce the epileptic threshold and cause seizures in children. Use with caution in patients with allergic reactions, including asthma, especially in patients with allergy to acetylsalicylic acid; in patients with liver disease (due to the presence of ethanol in the drug).
There is a risk of laryngospasm in children due to the presence of levomenthol.
If inflammation increases, treatment should be discontinued.
Use during pregnancy or breastfeeding.
There are no data on the possibility of hexetidine penetration through the placenta and excretion into human breast milk, therefore, stomolik should not be used during pregnancy and breastfeeding.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
The drug contains ethanol. Drivers are not recommended to drive a car for
30 minutes after using the drug.
Method of administration and doses.
Stomolik is a product for topical use in the oral cavity.
Rinse your mouth or gargle with 1 tablespoon (approximately 15 ml) of undiluted solution for ½ minute twice or three times a day after meals.
The drug should not be swallowed.
The duration of treatment is determined by the doctor individually depending on the severity and characteristics of the disease.
If the symptoms of the disease do not disappear and/or are accompanied by a high fever, you should consult a doctor.
Do not use to treat long-term symptoms.
Children.
Stomolik is not used in children under 6 years of age.
Overdose.
Signs and symptoms of overdose
The concentration of hexetidine contained in the oral solution is not toxic if the drug is used as directed.
Accidental ingestion of a large amount of the solution into the digestive system could theoretically cause intoxication due to the ethyl alcohol content.
Cases of overdose with topical application of hexetidine solution have not been described.
overdose treatment
Treatment is symptomatic. Gastric lavage is indicated for 2 hours after ingestion of the drug.
If a child swallows the contents of the bottle, consult a doctor immediately.
Adverse reactions.
Immune system disorders: hypersensitivity reactions, including urticaria, angioedema, laryngospasm, bronchospasm.
From the nervous system: ageusia, dysgeusia, change in taste sensations within 48 hours (the sensation of "sweet" can change to the sensation of "bitter" twice).
Respiratory system: cough, shortness of breath.
On the part of the digestive system: dry mouth, dysphagia, enlargement of the salivary glands, pain when swallowing. In case of accidental ingestion of the drug, gastrointestinal disorders may occur, primarily nausea and vomiting.
General disorders and conditions at the site of application: local reactions - reversible discoloration of the teeth and tongue; sensitivity of the mucous membrane, namely - burning, numbness; irritation (soreness, feeling of heat, itching) of the tongue and / or mucous membrane of the oral cavity; decreased sensitivity; paresthesia of the mucous membrane; inflammation; blisters; the appearance of ulcers on the mucous membrane.
The drug contains carmoisine (E 122), therefore it may cause allergic reactions, including bronchospasm, especially in patients with an allergy to acetylsalicylic acid.
Expiration date.
2 years.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging.
125 ml in a jar; 1 jar in a cardboard pack.
Vacation category.
Without a prescription.
Producer.
Ciao "technologist".
Location of production and its address of place of business.
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
