Instructions for Orasept oral spray 1.4% bottle 177 ml
Composition
active ingredient: phenol;
1 ml contains phenol 14 mg;
excipients: purified water, glycerin, sodium saccharin, cherry flavoring, FD&C red dye No. 40 (E 129).
Dosage form
Oral spray.
Main physicochemical properties: transparent red liquid with a cherry/phenol odor.
Pharmacotherapeutic group
Drugs used for throat diseases. Antiseptics. Phenol.
ATX code R02A A19.
Pharmacological properties
Pharmacodynamics. The active substance of this drug is phenol; in low concentrations (from 0.25% to 1.5%) its water-glycerol solution is used as a local antiseptic (bactericidal and antifungal action) and local anesthetic for the treatment of the mucous membrane of the oral cavity and pharynx. Glycerin has a softening effect on the mucous membrane of the oral cavity.
Pharmacokinetics.
Phenol, which is part of the drug, is absorbed and excreted by mucus, with subsequent excretion through the gastrointestinal tract. In case of overdose, phenol is metabolized in the liver and excreted by the kidneys.
Indication
As a painkiller and antiseptic:
− for infectious and inflammatory diseases of the oral cavity and pharynx (angina, pharyngitis, tonsillitis, stomatitis, gingivitis, periodontitis);
− after manipulations in the oral cavity and pharynx, dental surgeries;
− when using dentures or orthodontic appliances.
Contraindication
Increased individual sensitivity to any of the components of the drug. Severe liver or kidney dysfunction. Phenol in the form of a throat spray should not be used in patients with inflammation of the epiglottis, inflammatory diseases with widespread damage to the mucous membranes.
Interaction with other medicinal products and other types of interactions
The drug is prescribed in the complex therapy of inflammatory diseases of the oral cavity and throat together with sulfonamides, antibiotics, and vitamins.
Without consulting a doctor, the drug should not be used simultaneously with drugs for the treatment of myasthenia gravis; drugs that depress the central nervous system; disinfectant solutions containing heavy metals; monoamine oxidase inhibitors; neuromuscular transmission blockers; opioids; vasoconstrictors.
Application features
The spray is intended for short-term use. If the symptoms of the disease do not disappear within 7 days, this may indicate the presence of an organic pathology (abscess, neoplasm) that requires other methods of treatment.
A doctor should be consulted within 1-2 days if the sore throat is severe and/or symptoms such as fever, headache, rash, nausea or vomiting occur. If the condition worsens, a doctor should be consulted immediately.
The concentration of phenol in the preparation is recognized as safe in terms of toxicity or oncogenicity.
Orasept does not have a damaging effect on tooth enamel.
Use during pregnancy or breastfeeding
Data on the use of phenol during pregnancy are lacking or limited (less than 300 cases of treatment of pregnant women).
The results of the studies do not indicate the presence of direct or indirect reproductive toxicity when the drug is dosed according to recommendations.
If necessary, use the drug during pregnancy, you should consult a doctor.
Breastfeeding period
It is not known whether phenol is excreted in breast milk. Therefore, a risk to newborns/infants cannot be excluded.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect on the ability to drive or use machines was observed.
Method of administration and doses
Spray into the mouth and/or throat. The liquid can be swallowed.
When used in the mouth – hold in the mouth for 15 seconds, then remove.
For children aged 2 to 12 years, spray by pressing the spray bottle up to 3 times. For children aged 12 years and older and adults, spray up to 5 times. Repeat spray every 2-4 hours or as recommended by your doctor. Duration of use is determined by the clinical effect and tolerability of the drug.
If a dose of phenol spray is missed and the patient uses it regularly, the drug can be used when the patient remembers. If it is almost time for the next dose, it is not recommended to take a double dose without consulting a doctor. The duration of treatment for uncomplicated angina should not exceed 7 days.
Children.
Children under 12 years of age should use this product under adult supervision. Do not use in children under 2 years of age.
Overdose
When administered orally, phenol causes damage to the mucous membranes, nausea, vomiting, increased sweating, diarrhea. Dizziness and weakness are possible. At first, excitement may occur, followed by loss of consciousness. Depression of the central nervous system with circulatory and respiratory depression is noted. In severe cases, pulmonary edema, liver or kidney damage may develop, leading to impaired function of these organs. Death occurs due to respiratory failure, the lethal dose is 1-15 g of phenol administered orally. In case of overdose, symptomatic treatment is recommended (gastric lavage, administration of activated charcoal, if necessary, hospitalization in a toxicology department).
Adverse reactions
On the part of the immune system: Allergic reactions.
Skin and subcutaneous tissue disorders: Urticaria, pruritus, angioedema, rash. Possible reactions at the site of application, local swelling of the throat.
On the part of the kidneys and urinary tract: Chromaturia (dark brown or green urine color).
Expiration date
2 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 ° C. Do not freeze.
Packaging
177 ml of spray in a plastic bottle.
Vacation category
Without a prescription.
Producer
Famar A.V.E. Avlon Plant / Famar AVE Avlon Plant
Location of the manufacturer and its business address.
49th km National Road Athens-Lamia, Avlona Attiki, 19011, Greece
