Pharmaseptic

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARMASEPTIC (PHARMASEPTIC)

Composition:

Active substance: liquid phenol;

1 ml of solution contains 14 mg of liquid phenol;

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

Pharmaceutical form. Solution

Main physico-chemical properties: transparent red liquid with a cherry and phenol odor.

Pharmacotherapeutic group. Agents used in throat diseases. Antiseptics. Phenol. ATC code R02A A19.

Pharmacological properties.

Pharmacodynamics.

Phenols belong to aromatic alcohols; their solutions at concentrations of 0.5–1.5% exert antiseptic and short-term weak analgesic effects (due to blocking the generation and conduction of nerve impulses by reducing membrane permeability to sodium ions). They act bacteriostatically against vegetative forms of Gram-positive and Gram-negative microorganisms and some viruses, while acting very slowly on spores and acid-resistant bacteria.

Pharmacokinetics.

The drug is minimally absorbed through mucous membranes. Half-life – 1–4 hours. Duration of action – 30–60 minutes. Rapidly excreted from the body without accumulation, primarily via the kidneys in the form of metabolites.

Clinical characteristics.

Indications.

In otolaryngological and dental practice, as an adjunctive treatment agent in the complex therapy of inflammatory diseases of the pharyngeal and oral mucosa (tonsillitis, after tonsillectomy, tooth extraction, aphthous and ulcerative lesions of the oral mucosa, minor surgical procedures, prosthetics).

Contraindications.

Individual hypersensitivity to the components of the drug.

Inflammatory diseases with extensive mucosal involvement due to increased absorption of the drug and higher risk of systemic toxic effects.

Significant impairment of liver or kidney function.

Phenol in the form of a throat spray should not be used in patients with inflammation of the epiglottis.

Interaction with other medicinal products and other forms of interaction.

The drug is 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 medications for myasthenia treatment; central nervous system depressants; disinfectant solutions containing heavy metals; monoamine oxidase inhibitors; neuromuscular blocking agents; opioids; vasoconstrictors—without prior medical consultation.

Special precautions for use.

The medicinal product is intended for short-term local application.

Recommended doses of the medicinal product should not be exceeded.

The solution containing phenol should not be applied to large areas of skin or extensive wounds, as absorption may lead to development of toxic effects.

If severe sore throat persists for more than 2 days and is accompanied by fever, headache, rash, nausea or vomiting, medical advice must be sought.

If symptoms of illness do not resolve within 7 days of using the medicinal product, or are accompanied by fever lasting more than 3 days, or by rash or persistent headache, medical consultation is also required.

Use during pregnancy or breastfeeding.

There are no data on the use of the medicinal product during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

No special warnings apply.

Administration and Dosage

Before use, remove the protective cap from the bottle, then spray the throat or oral cavity, after which the contents may be swallowed.

For adults and children aged 12 years and older, the single dose is 5 aerosol sprays.

For children aged 2 to 12 years, the single dose is 3 aerosol sprays, administered under adult supervision.

Spraying should be repeated every 2–4 hours or as directed by a physician. The duration of treatment is determined individually by a physician, taking into account the clinical response and tolerability of the drug.

One aerosol spray contains 0.17 mL of Pharmaseptic.

1 spray contains 2.38 mg of phenol, 3 sprays contain 7.14 mg of phenol, 5 sprays contain 11.9 mg of phenol.

Children

Use with caution in pediatric practice.

Do not use in children under 2 years of age.

In children under 12 years of age, the drug should be used under adult supervision.

Overdose

In case of overdose (oral intake of more than 1 g of phenol), symptoms may include nausea, vomiting, dizziness, weakness, excitement, and respiratory disturbances.

When taken orally, phenol causes damage to mucous membranes, nausea, vomiting, increased sweating, and diarrhea. Initial excitement may occur, followed by loss of consciousness. Central nervous system depression with circulatory and respiratory depression may develop. Pulmonary edema, liver or kidney damage may occur, leading to impaired function of these organs. Fatal outcome may result from respiratory failure. The lethal dose of phenol administered orally is 1–15 g.

Treatment: gastric lavage and symptomatic therapy. Hospitalization in a toxicology unit may be necessary.

Adverse reactions.

In individual cases, allergic reactions such as skin rashes, redness and swelling of the skin, and local swelling of the throat are possible.

Shelf life. 4 years.

Storage conditions.

Store at a temperature not exceeding 30 °C in a place inaccessible to children.

Packaging.

120 ml in bottles with a spray dispenser.

Availability category. Over-the-counter.

Manufacturer. Pharmascience Inc./

Pharmascience Inc.

Manufacturer's address and place of business.

6111 Royalmount Avenue, 100, Montreal, Quebec H4R 2T4, Canada/

6111 Royalmount Avenue 100, Montreal, Quebec H4P 2T4, Canada.