Instructions Sangiva oral spray bottle 50 ml
Composition
active ingredients: chlorobutanol hemihydrate, choline salicylate, hexetidine;
1 ml of solution contains: hexetidine 1.0 mg; choline salicylate 5.0 mg; chlorobutanol hemihydrate in terms of chlorobutanol 2.5 mg;
excipients: sodium saccharin, ethanol 96%, polysorbate 20, levomenthol, anise oil, lemon oil, lime oil, eucalyptus oil, methyl salicylate, citric acid monohydrate, purified water.
Dosage form
Oral spray.
Main physicochemical properties: clear colorless or slightly yellowish liquid with a specific aromatic odor.
Pharmacotherapeutic group
Means used for diseases of the throat. Antiseptics. ATX code R02A A20.
Pharmacological properties
Pharmacodynamics.
The effect of the drug is due to three active components.
Antibacterial and antifungal activity. Hexetidine has an antibacterial effect on both gram-positive and gram-negative strains of microorganisms, both aerobes and anaerobes.
Hexetidine has a generally bacteriostatic effect on aerobic strains, a weak bactericidal effect. Hexetidine has a pronounced bactericidal effect on anaerobic strains. The mechanism of action is a competitive action with thiamine: the structure of hexetidine is similar to the structure of thiamine, which is necessary for the growth of microorganisms.
Anti-inflammatory activity. Choline salicylate has analgesic, antipyretic, and anti-inflammatory effects. It is used to treat oral diseases.
Analgesic activity. Chlorobutanol has an analgesic effect. It can be used, in particular, in otolaryngology (nasal drops, rinses) and in dental practice (applications and irrigations). Classically, it can be used as an anesthetic.
Pharmacokinetics.
The active substances are fixed on the mucous membrane of the oral cavity, from where they are gradually released.
Clinical characteristics.
Indication
Antibacterial and analgesic for the local treatment of diseases of the oral cavity and oropharynx mucosa.
Contraindication
– Hypersensitivity to any component of the drug;
– atrophic pharyngitis;
– bronchial asthma or any other respiratory diseases associated with existing respiratory hypersensitivity.
Interaction with other medicinal products and other types of interactions
Do not use together with medicines containing antiseptics.
Hexetidine can be inactivated by alkaline solutions.
Application features
When using the medicine, do not swallow it and avoid contact with the eyes, as the medicine contains ethanol.
The drug should be used with caution in patients with epilepsy. The drug may lower the epileptic threshold and cause seizures in children.
Use with caution in patients with a tendency to allergic reactions, including bronchial asthma, especially in patients with an allergy to acetylsalicylic acid.
If signs of hypersensitivity to the drug appear, its use should be discontinued immediately.
Since the drug contains ethanol, it should be prescribed with caution to patients with liver disease.
Long-term use is not recommended, as it may alter the natural microbial balance of the mouth and throat, where there is a risk of bacterial and fungal spread. If general clinical signs of bacterial infection appear, general antibacterial therapy should be prescribed.
If symptoms persist for longer than 5 days and/or body temperature is elevated, treatment tactics should be reviewed.
If inflammation worsens, treatment with the drug should be discontinued.
Use during pregnancy or breastfeeding
There are no human studies on the possibility of hexetidine crossing the placenta and being excreted in breast milk, so the drug should not be used during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The medicine contains ethanol. Drivers are not recommended to drive a car for 30 minutes after using the medicine.
Method of administration and doses
Use as a topical agent for irrigation of the oral cavity and oropharynx.
Adults and children over 15 years of age: 1 spray 4–6 times a day.
Children from 6 to 15 years old: 1 spray 2–3 times a day.
The course of treatment is no longer than 5 days.
Children
Do not use in children under 6 years of age.
Overdose
There have been no reports of overdose of the drug.
Alcohol intoxication may occur due to the ethyl alcohol content due to the absorption of a sufficient amount of the solution in the oral cavity.
The concentration of hexetidine in the drug is not toxic if the drug is used as directed.
There have been no cases of excessive use of hexetidine leading to hypersensitivity reactions.
Treatment of overdose is symptomatic, but rarely necessary. If a child swallows the contents of the bottle, seek medical attention immediately. Gastric lavage should be considered within 2 hours of ingestion and measures should be taken to eliminate signs of alcohol intoxication.
Adverse reactions
Respiratory, thoracic and mediastinal disorders: cough, shortness of breath.
Gastrointestinal: dry mouth, dysphagia, salivary gland enlargement, pain when swallowing. Accidental ingestion of the drug may cause gastrointestinal disorders, primarily nausea and vomiting.
From the nervous system: ageusia, dysgeusia, change in taste sensations within 48 hours (the sensation of "sweet" may change to the sensation of "bitter").
Immune system disorders: hypersensitivity reactions, including urticaria, angioedema, laryngospasm, bronchospasm.
Skin and subcutaneous tissue disorders: allergic contact dermatitis, skin reactions (rash).
General disorders and administration site conditions: local reactions: reversible discoloration of teeth and tongue; mucosal sensitivity, namely: burning, numbness; irritation (pain, heat, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paraesthesia; inflammation; blisters; mucosal ulceration, throat irritation, contact site swelling, dryness of the nasal/throat mucosa.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and/or lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children.
Packaging
50 ml in a bottle; 1 bottle with a spray nozzle in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and address of its place of business.
Ukraine, 02093, Kyiv, Boryspilska St., 13.
