Instructions Hepilor oral spray bottle 50 ml
Composition
active ingredients: hexetidine, choline salicylate, chlorobutanol hemihydrate;
1 ml of spray contains: hexetidine in terms of 100% substance – 1 mg, choline salicylate 80% in terms of 100% substance – 5 mg, chlorobutanol hemihydrate in terms of 100% anhydrous substance – 2.5 mg;
excipients: ethanol 96%, sodium saccharin, polysorbate 20, propionic acid, lemon oil, star anise oil, menthol (levomenthol), eucalyptol, purified water.
Dosage form
Oral spray.
Main physicochemical properties: transparent or slightly opalescent liquid with a specific aromatic odor and anise-alcohol taste, contained in a bottle with a pump valve equipped with a sprayer. The drug is removed from the bottle through the sprayer in the form of an aerosol jet.
Pharmacotherapeutic group
Remedies used for throat diseases.
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.
On aerobic strains it has a generally bacteriostatic effect, the bactericidal effect is weak. On anaerobic strains hexetidine has a pronounced bactericidal effect. 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 diseases of the oral cavity.
Analgesic activity.
Chlorobutanol has an analgesic effect. It can be used, in particular, in otolaryngology (nose drops, rinses) and in dental practice (applications and irrigations). It can be classically used as an anesthetic.
Pharmacokinetics
The active substances are fixed on the mucous membrane of the oral cavity, from where they are gradually released.
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 preparations containing antiseptics.
Hexetidine can be inactivated by alkaline solutions.
Application features
When using the drug, do not swallow and avoid contact with eyes, as the drug 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 administered 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 increases, treatment with the drug should be discontinued.
This medicine contains a small amount of ethanol (alcohol), less than 100 mg/dose.
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 drug contains ethanol. Drivers are not recommended to drive a car for 30 minutes after using the drug.
Method of administration and doses
Apply topically for oral irrigation.
Adults and children over 15 years of age: 1 spray 4–6 times a day.
Children aged 6 to 15 years: 1 spray 2–3 times a day.
The course of treatment is no longer than 5 days.
Children
Use the medicine in children over 6 years of age.
Overdose
There have been no reports of overdose.
In connection with the absorption of a sufficient amount of solution in the oral cavity, alcohol intoxication may occur due to the ethyl alcohol content.
Acute alcohol intoxication is unlikely. If a child swallows a significant dose of the drug, alcohol intoxication may occur due to the ethyl alcohol content.
There have been no cases of excessive use of hexetidine leading to hypersensitivity reactions.
Treatment of overdose is symptomatic, but is 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.
Side effects
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, thoracic and mediastinal disorders: 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.
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; sensitivity of the mucous membrane, namely burning, numbness; irritation (pain, feeling of heat, itching) of the tongue and/or mucous membrane of the oral cavity; decreased sensitivity; paraesthesia of the mucous membrane; inflammation; blisters; ulceration of the mucous membrane, sensation of tickling in the throat, swelling at the site of contact, dryness of the mucous membrane of the nose/throat.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Packaging
20 ml or 50 ml in a bottle. 1 bottle in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
