Septefril

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SEPTIFRIL (SEPTEFRIL)

Composition:

Active ingredient: decamethoxine;

1 tablet contains decamethoxine (calculated as 100% dry substance) – 0.2 mg;

Excipients: sucrose, povidone, potato starch, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: round, flat-surfaced tablets with beveled edges and a score line, white or almost white in color.

Pharmacotherapeutic group. Preparations used in throat disorders. Various antiseptics.
ATC Code
C
R02A A20.

Pharmacological properties.

Pharmacodynamics.

Decamethoxin is a quaternary ammonium compound and belongs to the group of cationic surfactants. Decamethoxin binds to the phosphate groups of lipids in the microbial cell cytoplasmic membrane, leading to disruption of its permeability and subsequent destruction.

Decamethoxin has a broad spectrum of antimicrobial activity. It is active against
Staphylococcus spp.
(including penicillin-resistant strains of
S. aureus),
Streptococcus spp., Stomatococcus spp., Corynebacterium spp.
(including
C. diphtheriae). It demonstrates activity against protozoa, yeast-like fungi, especially
Candida albicans, and dermatophytes.

Decamethoxin exerts bactericidal, fungicidal, and sporicidal effects and also inactivates diphtheria exotoxin.

Decamethoxin does not suppress specific or non-specific immune reactivity in humans.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

• Local treatment as part of complex therapy for diseases of the oral cavity, pharynx, and larynx (gingivitis, periodontitis, stomatitis, oral mucosal candidiasis, pharyngitis, laryngitis, tonsillitis, initial stage of angina);
• sanitation of the oral cavity, pharynx, and nasopharynx in carriers of pathogenic staphylococci, diphtheria bacillus, or Candida;
• antimicrobial prophylaxis following surgical interventions in the oral cavity, pharynx, or larynx.

Contraindications.

Hypersensitivity to decamethoxine or to any other component of the drug.

Interaction with other medicinal products and other types of interactions.

When used concomitantly with antibiotics and systemic antimicrobial agents, the antibacterial effect of the drug is enhanced.

Special precautions for use.

The formulation contains sucrose; therefore, patients with diabetes should use the drug with caution. The drug is contraindicated in patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

Prolonged use for more than 7 days may lead to disturbances in the microbial balance of the pharynx.

To increase the concentration of the drug in saliva, avoid frequent swallowing of saliva during the dissolving of the tablet.

Concomitant use of the drug with various types of oral and pharyngeal rinses is not recommended.

Use during pregnancy or breastfeeding.

Clinical data on the use of Septefril during pregnancy or breastfeeding are lacking. The drug should not be used during pregnancy. If use of the drug is necessary, breastfeeding should be discontinued.

Effect on the ability to drive or operate machinery.

No effect.

Method of Administration and Dosage.

After preliminary rinsing of the mouth, place the tablet in the oral cavity and allow it to dissolve completely. For adults, Septefril should be administered at a dose of 1 tablet 4–6 times daily. The duration of treatment should not exceed 7 days. The drug should be taken after meals; for 1 hour afterwards, eating and drinking should be avoided.

Children.

There is no clinical experience regarding the safety and efficacy of Septefril in children.

Overdose.

No cases of overdose with Septefril have been reported.

Side effects.

Allergic reactions, including skin rashes, itching.

Increased salivation may occur, which disappears after dissolving the tablets.

Shelf life.
3 years.

Storage conditions.
In the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.

Packaging.
10 tablets in a blister pack;
10 tablets in a blister pack, 1, 2, 3, 4 or 5 blisters per carton.

Pharmaceutical category.
Over-the-counter (without prescription).

Manufacturer.

Public Joint-Stock Company "Scientific and Production Center "Borshchahivskyy Chemical and Pharmaceutical Plant".

Limited Liability Company "Agrofarm".

Manufacturer's address and place of business activity:

Ukraine, 03134, Kyiv, Mir Street, 17.

Ukraine, 08200, Kyiv region, Irpin, Central Street, 113-A.