Orasept®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ORASEPT®

Composition:

Active substance: phenol;

1 ml contains 14 mg of phenol;

Excipients: purified water, glycerol, sodium saccharin, cherry flavor, FD&C Red No. 40 (E 129) dye.

Pharmaceutical form. Oral spray.

Main physicochemical characteristics: clear red liquid with a cherry/phenol odor.

Pharmacotherapeutic group.

Preparations used for throat diseases. Antiseptics. Phenol.

ATC code R02A A19.

Pharmacological properties.

Pharmacodynamics. The active substance of this medicinal product is phenol; its aqueous glycerin solution at low concentrations (from 0.25% to 1.5%) is used as a local antiseptic (bactericidal and antifungal activity) and local anesthetic agent for treatment of the mucous membranes of the oral cavity and pharynx. Glycerin exerts a softening effect on the mucous membrane of the oral cavity.

Pharmacokinetics.

Phenol contained in the medicinal product is absorbed and secreted by mucus, with subsequent elimination through the gastrointestinal tract. In case of overdose, phenol is metabolized in the liver and excreted by the kidneys.

Clinical characteristics.

Indications.

As an analgesic and antiseptic agent:

• in infectious-inflammatory diseases of the oral cavity and pharynx (angina, pharyngitis, tonsillitis, stomatitis, gingivitis, periodontitis);
• after manipulations performed in the oral cavity and pharynx, dental surgeries;
• in patients using dental prostheses or orthodontic appliances.

Contraindications.

Hypersensitivity to any component of the drug. Severe impairment of liver or kidney function. Phenol in the form of a throat spray should not be used in patients with epiglottitis or inflammatory diseases involving extensive mucosal damage.

Interaction with other medicinal products and other types of interactions.

The drug may be prescribed as part of combination therapy for inflammatory diseases of the oral cavity and throat together with sulfonamides, antibiotics, and vitamins.

The drug should not be used concomitantly with the following without consulting a physician: drugs used to treat myasthenia; agents that depress the central nervous system; disinfectant solutions containing heavy metals; monoamine oxidase inhibitors; neuromuscular blocking agents; opioids; vasoconstrictors.

Special precautions for use

The spray is intended for short-term use. If symptoms do not resolve within 7 days, this may indicate the presence of an organic pathology (e.g., abscess, neoplasm) requiring different treatment approaches.

Medical advice should be sought within 1–2 days if severe sore throat occurs and/or symptoms such as fever, headache, rash, nausea, or vomiting develop. If the condition worsens, immediate medical consultation is required.

The concentration of phenol in the preparation is considered safe with regard to toxicity or oncogenic potential.

Orasept does not have a damaging effect on dental enamel.

Use during pregnancy or breastfeeding

Data on the use of phenol during pregnancy are lacking or limited (fewer than 300 cases of treatment in pregnant women).

Study results do not indicate the presence of direct or indirect reproductive toxicity when the drug is used according to recommended dosages.

If it is necessary to use the product during pregnancy, consult a physician.

Breastfeeding period

It is unknown whether phenol is excreted in breast milk. Therefore, a risk to newborns/infants cannot be excluded.

Ability to affect reaction speed when driving or operating machinery

No effects on the ability to drive or operate machinery have been observed.

Method of Administration and Dosage.

Spray into the oral cavity and/or pharynx. The liquid may be swallowed.

When used in the oral cavity – hold in the mouth for 15 seconds, then spit out.

For children aged 2 to 12 years: press the spray pump up to 3 times. For children aged 12 years and older, and adults: press the spray pump up to 5 times. Repeat spraying every 2–4 hours or as directed by a physician. Duration of treatment depends on clinical response and drug tolerance.

If a dose of phenol in the form of a spray is missed and the patient is using it regularly, the medication may be taken as soon as remembered. However, if it is almost time for the next dose, do not use a double dose without consulting a doctor. The duration of treatment for uncomplicated tonsillitis should not exceed 7 days.

Children.

This product should be used in children under 12 years of age under adult supervision. Do not use in children under 2 years of age.

Overdose.

When taken internally, phenol causes mucosal damage, nausea, vomiting, increased sweating, and diarrhea. Dizziness and weakness may occur. Initial excitation may be followed by loss of consciousness. Central nervous system depression with circulatory and respiratory depression may develop. In severe cases, pulmonary edema, liver or kidney damage may occur, leading to organ dysfunction. Fatal outcome may result from respiratory failure; the lethal dose of phenol taken internally is 1–15 g. In case of overdose, symptomatic treatment is recommended (gastric lavage, activated charcoal, and, if necessary, hospitalization in a toxicology unit).

Side effects.

Immune system disorders. Allergic reactions.

Skin and subcutaneous tissue disorders. Urticaria, pruritus, angioneurotic edema, rash. Possible reactions at the site of application, local throat swelling.

Renal and urinary disorders. Chromaturia (dark brown or green discoloration of urine).

Shelf life. 2 years.

Storage conditions.

Store in a place inaccessible to children, at a temperature not exceeding 25 ºС. Do not freeze.

Packaging.

177 ml of spray in a plastic bottle.

Supply category.

Over-the-counter.

Manufacturer.

Famar A.V.E. Avlon Plant

Manufacturer's address.

49th km National Road Athens-Lamia, Avlona Attiki, 19011, Greece